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## Effect of a Probiotic on Microbiota Associated With the Immune System and Inflammation. - NCT ID: NCT06313346 - Study ID: 2023.200 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2024-06-15 - Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra ### Study Description The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention.The main questions to answer are:1. To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake.2. To evaluate changes in salivary cortisol after ingestion of the probiotic.3. To compile the number and intensity of catarrhal episodes suffered by the participants along the study.For this purpose, a randomized, double blind parallel study has been designed.Target sample size is 60 subjects.Participants will be allocated in two groups for 6 weeks:* Experimental group (n=30): daily consumption of one probiotic capsule.* Placebo group (n=30): daily consumption of one placebo capsule. ### Conditions - Probiotic - Microbiota ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Probiotic - Placebo ### Outcomes Primary Outcomes - Fecal microbiota Secondary Outcomes - Salivary cortisol - Body weight - Height - Body mass index - Body fat percentage - Body muscle mass - Body lean mass - Body water mass - Body bone mass - The incidence of catarrhal episodes - The gravity of catarrhal episodes - Gastrointestinal symptoms - Dietary intake - Physical activity - Adherence to capsule consumption ### Location - Facility: Centre for Nutrition Research, Pamplona, Navarre, 31008, Spain @@
## National Register of Moderate and Severe Adult Atopic Dermatitis - NCT ID: NCT06313333 - Study ID: SID01 - Status: RECRUITING - Start Date: 2020-06-15 - Completion Date: 2030-06-15 - Lead Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse ### Study Description Collect clinical history and treatment data of AD in adulthood; ### Conditions - Atopic Dermatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Epidemiological data - Identification of factors for specific treatment - clinical and therapeutic data - characterization of diagnostic criteria - Assessment of possible conditioning factors Secondary Outcomes ### Location - Facility: ASST Spedali Civili di Brescia, Brescia, N/A, 25123, Italy @@
## Intraoperative Electroencephalographic Biomarkers of Postoperative Pain - NCT ID: NCT06313320 - Study ID: OAIC1344-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: University of Chile ### Study Description The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain. ### Conditions - Pain Postoperative - Nociceptive Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Maximum Pain in PACU Secondary Outcomes - Opioid Consumption in PACU - Maximum Pain at 24h - Presence of surgical related pain at day 7 - Presence of surgical related pain at day 30 ### Location - Facility: Hospital Clinico de la Universidad de Chile, Santiago, RM, 7563215, Chile @@
## The Efficacy in Treatment of Facial Melasma Combined With Thulium 1927-nm Fractional Laser and Topical H2R Antagonist - NCT ID: NCT06313307 - Study ID: famotidine and melasma - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-11-25 - Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University ### Study Description Melasma is a hyperpigmentary disorder of the skin especially of the face. Compared with normal skin, histologic features of melasma include the enhanced activity of melanocytes, higher solar elastosis in upper dermis, basement membrane disruption which promotes melanocytes and melanin into the dermis, increased vascularization, and an increased number of mast cells.1927nm fractional laser was approved to treat melasma with no major side effects, however,hyperpigmentation and recurrence occasionally happened after laser therapy. Mast cells may paly a key role in the refractory melasma and hyperpigmentation. We hypothesized that laser treatment may stimulate the activation of pre-existing mast cell in melasma skin and promote mast cell proliferation and degranulation to release mediators such as histamine (HA). HA has been demonstrated to increase the melanin content and tyrosinase activity of melanocytes and induce melanogenesis and morphological changes by activating cAMP-PKA pathway through H2 receptors on melanocytes5. H2R antagonist(H2RA) can suppress pigmentation by reducing the increase of activated melanocytes by UVB irradiation.In the present study, the investigators speculated that H2RA can enhance the efficacy of laser treatment of melasma and block the histamine-mediated melanogenesis and dendricity to prevent postoperative hyperpigmentation. The investigators combined 1927nm fractional laser with topical famotidine for melasma as a new therapeutic strategy to treat melasma.The investigators performed a split-face, single-blinded study to evaluate the efficacy and safety of 1927nm fractional laser with topical famotidine for the treatment of facial melasma. ### Conditions - Melasma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - topical H2R antagonist - Thulium 1927-nm Fractional Laser ### Outcomes Primary Outcomes - Modified Melasma Area Severity Score（mMASI） Secondary Outcomes - melanin index（MI） - erythema index(EI) ### Location - Facility: The second affiliated hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710000, China @@
## Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia - NCT ID: NCT06313294 - Study ID: 230929002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-12-31 - Lead Sponsor: Pontificia Universidad Catolica de Chile ### Study Description Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. However, this direct communication strategy requires time and resources, especially if many patients are involved.A modern and convenient approach involves the use of immediate communication technology for follow-up after a procedure. They may contain specific questions that patients can easily answer from their mobile devices.Automated text messages could be associated with greater convenience and ease for patients with response rates at least like the traditional method. Phone calls, on the other hand, may be less scalable and require more human resources.The objective of the project is to evaluate the feasibility of monitoring through automated electronic messaging by evaluating its usability using a validated scale in Spanish. response rate on the first day and adherence rate compared to that of the traditional method. Secondarily, adherence and differences in satisfaction will be compared. ### Conditions - Anesthesia - Regional Anesthesia - Nerve Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Tracking application app - Telephone interview ### Outcomes Primary Outcomes - Usability level of the tracking application Secondary Outcomes - Patient satisfaction with Perception of Quality in Anesthesia - Patient adherence ### Location - Facility: Pontificia Universidad Catolica de Chile, Santiago, Metropolitana, 450881, Chile @@
## Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery - NCT ID: NCT06313281 - Study ID: E-18-3331 - Status: COMPLETED - Start Date: 2019-02-01 - Completion Date: 2021-09-30 - Lead Sponsor: King Saud University ### Study Description Objective: Transnasal skull-base surgery is a complex and invasive procedure that involves the use of preoperative antiseptic preparations. However, evidence supporting their use in preventing postoperative infectious complications is limited. The aim of this study is to assess the efficacy of preoperative antiseptic techniques in reducing postoperative infectious complications within 30 days of surgery.Methods: A multicenter, prospective, randomized, single-blind, three-arm trial was conducted from February 2019 to October 2021. Participants were randomized to either of three antiseptic preparation techniques: external 0.9%NaCl nasal preparation, external 0.05% chlorhexidine gluconate, or intranasal irrigation with 80 mg of gentamicin added to 1000 ml of 0.9%NaCl plus external nasal preparation with chlorhexidine gluconate 0.05%. A total of 130 adults with skull-base pathologies were randomized, 12 were excluded before randomization for failure to meet inclusion criteria (n=9) or refusal to participate (n=3). The investigators excluded patients with evidence of infection adjacent to the surgical site, allergies to preparation methods, those who underwent craniotomy during the same admission, and pediatric patients. ### Conditions - Meningitis and Sinusitis in Transnasal Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Preoperative Antiseptic preparation prior to transnasal skull base surgery ### Outcomes Primary Outcomes - the difference in the incidence of postoperative infections within 30 days of surgery between the three interventional groups Secondary Outcomes ### Location - Facility: King Saud University, Riyadh, N/A, 12394, Saudi Arabia @@
## Safety of Effivia®, a Bevacizumab Biosimilar - NCT ID: NCT06313268 - Study ID: LT-02-20 - Status: RECRUITING - Start Date: 2022-04-21 - Completion Date: 2024-06-30 - Lead Sponsor: Laboratorios Liomont ### Study Description This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer. ### Conditions - Metastatic Colorectal Cancer - Metastatic Cervical Cancer - Non Squamous Non Small Cell Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bevacizumab Biosimilar MB02 ### Outcomes Primary Outcomes - Adverse events Secondary Outcomes ### Location - Facility: UMAE Hospital de Especialidades No. 1, León, Guanajuato, 37320, Mexico @@
## A Retrospective Observational Study on the Effects of Prebiotics on HBsAg Clearance - NCT ID: NCT06313255 - Study ID: KYLL-202301-008-1 - Status: RECRUITING - Start Date: 2023-05-09 - Completion Date: 2025-12-31 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The goal of this retrospective observational study is to find out the effects of prebiotics on HBV clearance. The main question it aims to answer is:Are the prebiotics have an effect in promoting HBV clearance? The participants will observe the HBV clearance rate in chronic hepatitis B patients receive prebiotics in addition to the routine antiviral therapy.Researchers will compare the HBV clearance rate in chronic hepatitis B patients receive prebiotics and antiviral therapy with those receiving solely antiviral therapy. ### Conditions - Chronic Hepatitis B ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PegIFNα2b - PegIFNα2b+prebiotics - Nucleoside analog - Nucleoside analog+prebiotics ### Outcomes Primary Outcomes - HBsAg clearance Secondary Outcomes ### Location - Facility: Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China @@
## Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy - NCT ID: NCT06313242 - Study ID: 202403 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-06 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens. ### Conditions - Magnetically Controlled Capsule Endoscopy - Bowel Preparation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Polyethylene Glycol Electrolytes Powder (II) - Low residue diet - Normal diet ### Outcomes Primary Outcomes - Image quality of small intestine Secondary Outcomes - Rate of completion of inspections - Small intestine transit time - Lesion detection rate - Patient tolerance - Rate of adverse events ### Location - Facility: Qilu Hospital of Shandong University, Jinan, N/A, N/A, China @@
## Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation - NCT ID: NCT06313229 - Study ID: KFSIRB200-195 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2025-03-31 - Lead Sponsor: Kafrelsheikh University ### Study Description The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement. ### Conditions - Alveolar Bone Loss - Dental Implant Failed ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - implant placement 6 months after ridge augmentation - implant placement Simultaneously with ridge augmentation ### Outcomes Primary Outcomes - Stability Quotient of Implants (SQI) - Horizontal bone dimensions (HBDs) - Peri-implant Bone Density (PBD) Secondary Outcomes ### Location - Facility: faculty of dentistry, kafrelsheikh University, Kafr Ash Shaykh, Kafrelsheikh, 214312, Egypt @@
## Treatment of Peri-implant Bone Dehiscence Using Autogenous Tooth Plate - NCT ID: NCT06313216 - Study ID: KFSIRB200-187 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-04-15 - Lead Sponsor: Kafrelsheikh University ### Study Description The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate. ### Conditions - Implant Complication - Peri-Implantitis - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - duoteck membrane - autogenous demineralized tooth graft - autogenous demineralized tooth graft and plate ### Outcomes Primary Outcomes - Stability Quotient of dental implant (SQDI) - pink esthetic score (PES) - facial marginal bone level (FMBL) Secondary Outcomes ### Location - Facility: faculty of dentistry, kafrelsheikh University, Kafr Ash Shaykh, Kafrelsheikh, 214312, Egypt @@
## HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT) - NCT ID: NCT06313203 - Study ID: 'TOMCAT' SMR-4066 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2034-01 - Lead Sponsor: Oslo University Hospital ### Study Description Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design ### Conditions - Intrahepatic Cholangiocarcinoma - Chemotherapy Effect ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Floxuridine - Selective Internal Radiation Therapy (SIRT) ### Outcomes Primary Outcomes - Overall Survival (OS) at 3 years Secondary Outcomes - Tumor response - Quality of Life by using EORTC QLQ-C30 - Quality of Life by using EQ-5D-5L - Assess the resection rate following downstaging - Assess complications, toxicity and side effects in treatment groups - Assess circulating cell-free (ctDNA) before and after treatment and correlate with treatment outcomes ### Location - Facility: Oslo University Hospital, Oslo, N/A, 0424, Norway @@
## Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402) - NCT ID: NCT06313190 - Study ID: SL-B2024-061 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2030-04-30 - Lead Sponsor: Sun Yat-sen University ### Study Description For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stereotactic body radiotherapy - Sintilimab ### Outcomes Primary Outcomes - Progression-free survival (PFS) rate Secondary Outcomes - Overall survival - Local control rate (DCR) - Treatment-related adverse events ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study. - NCT ID: NCT06313177 - Study ID: Soh-Med-24-03-03MS - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-03-10 - Lead Sponsor: Sohag University ### Study Description Ankle fracture is one of the most common orthopedic injuries. Approximately, 20% of surgically treated ankle fractures are associated with syndesmotic instability.According to the mechanism of the injury the syndesmotic disruption should be considered in Danis-Weber C-type fractures. However, such injuries were also frequently seen in Danis-Weber B-type fractures. Failure to detect and repair syndesmotic injuries early may result in poor clinical outcomes and complications affecting ankle function, such as long-term residual pain, post traumatic arthritis, and ankle impingement syndromes. Therefore, aggressive treatment is important when facing syndesmotic instability .The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking. Syndesmotic injuries are most commonly associated with fibular fractures, but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination. The need for syndesmotic fixation of the distal tibiofibular joint has been controversia. fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures, and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture. An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability, evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally. If more than 3 or 4 mm of lateral displacement occurs, syndesmotic fixation is necessary.Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complications.The main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint. The syndesmosis is traditionally fixed with a metallic screw, which is a method that has been used for decades and demonstrates good to excellent outcomes.Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of ankle.in this study we are going to compare between these two ### Conditions - Syndesmotic Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - syndesmosis fixation with screws ### Outcomes Primary Outcomes - pain with AOFAS score Secondary Outcomes ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients - NCT ID: NCT06313164 - Study ID: SW009 - Status: COMPLETED - Start Date: 2023-06-20 - Completion Date: 2024-02-29 - Lead Sponsor: S.LAB (SOLOWAYS) ### Study Description This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients. The primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (GSH), oxidized glutathione (GSSG), 8-hydroxydeoxyguanosine (8-OHdG), and glycated hemoglobin (HbA1c), along with other metabolic parameters.Hypothesis: The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients. This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - enhanced glutathione - placebo comparator ### Outcomes Primary Outcomes - Reduced glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus Secondary Outcomes - Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus - 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus - Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus - Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus - Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus - Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus - Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus ### Location - Facility: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation @@
## The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients - NCT ID: NCT06313151 - Study ID: Soh-Med-24-02-02MD - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2026-03-15 - Lead Sponsor: Sohag University ### Study Description The goal of this observational study is to investigate if the 2019 EULAR/ACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus (SLE) and as predictor for prognosis . ### Conditions - SLE, and Organ Damage Index ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria. Secondary Outcomes ### Location - Facility: Sohag University, Sohag, N/A, 82511, Egypt @@
## Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity - NCT ID: NCT06313138 - Study ID: NantongJS - Status: COMPLETED - Start Date: 2023-07-15 - Completion Date: 2024-01-30 - Lead Sponsor: Nantong University ### Study Description The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.Specific objectives are:1. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.2. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total. ### Conditions - Multiple Chronic Conditions；Diabetes；Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - The Individual and Family Enhancement Program ### Outcomes Primary Outcomes - Self-management - Treatment burden - Symptom burden Secondary Outcomes - Health literacy ### Location - Facility: Nantong University, Nantong, Jiang Su, 226001, China @@
## Comparison of Exercise Effects in Individuals With Flatfoot - NCT ID: NCT06313125 - Study ID: E-77082166-302.08.01-796166 - Status: RECRUITING - Start Date: 2024-04-21 - Completion Date: 2024-08-31 - Lead Sponsor: Mustafa Kemal University ### Study Description Flexible flatfoot deformity, also known as flexible pes planus, is a common pathological condition characterized by decreased medial longitudinal arch height, eversion of the calcaneus and abduction of the forefoot, especially during loading. Conservative treatments are generally considered as the first step in treatment. In conservative treatments, exercise methods are one of the most frequently used interventions. It has been reported that exercise can improve functional outcomes such as navicular drop, plantar pressure distribution, foot posture, balance, and muscle strength in adults with flexible flatfoot. Although it is known that intrinsic muscle strengthening exercises are a frequently used intervention method in foot pathologies, there is a deficiency in the literature regarding studies investigating the effect of the combination of the most basic foot intrinsic muscle strengthening exercises with different exercise interventions on targeted clinical gains. However, the effect of three-dimensional foot-ankle exercise on flat feet is unknown. Additionally, there are a limited number of studies in the literature investigating the effects of hip abductor and external rotator muscle strength training on foot posture in individuals with flat feet. The aim of this thesis study, planned in the light of this information, is to determine the effects of three-dimensional foot-ankle extension exercises and hip abductor-external rotator muscle strengthening exercise primarily on navicular drop and MLA height in individuals with flexible flat feet; Secondly, it is to examine and compare the effects of static foot posture, hip abductor/external rotator, ankle circumference and intrinsic muscle strength on the functional performance of the lower extremity (endurance, dynamic balance and single leg forward jumping performance). To our knowledge, this study will be the first randomized controlled study to examine and compare the effects of two different exercise interventions that exercise the proximal and distal regions in flatfoot rehabilitation, and the results obtained will contribute to the development of better exercise and treatment programs in this population. In individuals with flat feet, when hip abductor/external rotator strengthening exercises or 3D foot-ankle extension exercises in the PNF pattern are added to short-foot exercise, MLA structure, muscle strength and lower extremity function will be improved more, and when these exercises are combined with short-foot exercise, they are comparable to intrinsic muscle strengthening exercises alone. The investigators hypothesized that it would produce superior clinical results. ### Conditions - Flat Foot [Pes Planus] (Acquired), Unspecified Foot ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3-dimensional foot-ankle extension exercises - Clam exercise - Short-foot exercise ### Outcomes Primary Outcomes - Medial longitudinal arch height-Navicular Drop Test Secondary Outcomes - Static foot posture-Foot Posture Index-6 - Foot structure-Photopodometric analysis - Recording demographic and clinical information on the evaluation form ### Location - Facility: Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Çankaya, 06540, Turkey @@
## Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India - NCT ID: NCT06313112 - Study ID: JCDC/BHR/23/036 - Status: RECRUITING - Start Date: 2023-09-25 - Completion Date: 2025-02 - Lead Sponsor: Hirabai Cowasji Jehangir Medical Research Institute ### Study Description The goal of this observational study is to assess household food insecurity among slum-dwelling women in India and to explore if household food insecurity is associated with utilization of maternal healthcare services, birth outcomes and infant growth.The main questions it aims to answer are:* Is the utilization of maternal healthcare services antenatally, during delivery, and postnatally associated with household food insecurity among slum-dwelling women in Pine, India?* Is household food insecurity associated with birth outcomes and infant growth in these women?Participants will be asked:* For information related to socio-demographic characteristics, healthcare services utilization, food insecurity experience, dietary intake, and infant feeding indicators using a questionnaire.* Anthropometric measurements of the participant, her husband and her infant/s will be collected.* Two focused group discussions (FGDs) will also be conducted to gain insight into the perceptions of these women with respect to the utilization of maternal healthcare services. One FGD will be conducted for women who availed all the healthcare services and the other for those who did not adequately avail of the antenatal and postnatal services. ### Conditions - Prenatal Care - Food Insecurity - Pregnancy Outcome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational study ### Outcomes Primary Outcomes - Percentage of women who availed at least three Antenatal Care (ANC) visits - Percentage of women who had contact with ASHA worker during pregnancy - Percentage of women who consumed at least 100 Iron Folic Acid tablets - Percentage of women who consumed deworming tablets at least once during pregnancy - Percentage of women who underwent delivery preparedness - Percentage of women with knowledge of key danger signs during pregnancy - Percentage of women who delivered at institution - Percentage of women who stayed at a facility for at least 24 hours post-delivery - Percentage of women who received post-natal care within a week of delivery Secondary Outcomes - Association of demographic characteristics and household food insecurity scores with the indicators of utilization of healthcare services ### Location - Facility: Hirabai Cowasji Jehangir Medical Research Institute, Pune, Maharashtra, 411001, India @@
## Parameters of the General Health Status of Prison Officers - NCT ID: NCT06313099 - Study ID: SakaryaAppliedSciencesUPNSC - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2021-03-02 - Lead Sponsor: Pakize Nurgul Sen ### Study Description Introduction The working conditions of prison officers are very stressful. Today, it is known that stress affects the health status of individuals in many ways. In this study, it was aimed to evaluate the musculoskeletal system problems, fatigue severity, depression levels, and quality of life of prison officers and to examine the relationship between these parameters and the socio-demographic characteristics of the participants.Method The study included a total of 141 volunteers. The musculoskeletal problems of the participants were evaluated with the Cornell Musculoskeletal Disorders Questionnaire, fatigue levels were evaluated with the Fatigue Severity Scale, depression levels were evaluated with the Beck Depression Inventory, and quality of life was evaluated with the Nottingham Health Profile. ### Conditions - Musculoskeletal Pain - Fatigue - Depression - Quality of Life ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - Cornell Musculoskeletal Disorders Questionnaire Secondary Outcomes - Fatigue Severity Scale - Sleep Quality: Virtual Analog Scala: VAS - Beck Depression Inventory - Nottingham Health Profile ### Location - Facility: Muğla E Type Closed Prison, Muğla, Menteşe, 48000, Turkey @@
## DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer - NCT ID: NCT06313086 - Study ID: SYSA1501-009 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-02 - Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. ### Study Description A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer ### Conditions - HER2-positive Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DP303c - trastuzumab emtansine ### Outcomes Primary Outcomes - Progression-free survival (PFS) by BIRC Secondary Outcomes - Progression-free survival (PFS) by investigator - Overall Survival (OS) - Objective response rate (ORR) - Duration of response (DoR) - Incidence and severity of adverse events (AEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neoadjuvant Radiotherapy for Breast Cancer - NCT ID: NCT06313073 - Study ID: CHFL-BC-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-02-15 - Lead Sponsor: Changhai Hospital ### Study Description The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer.The main questions it aims to answer are:* The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens.* Evaluate the acute and late toxicity of preoperative radiotherapy Participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group. ### Conditions - Neoadjuvant Radiotherapy - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neoadjuvant radiotherapy - adjuvant radiotherapy ### Outcomes Primary Outcomes - pCR Secondary Outcomes - RCB ### Location - Facility: Changhai hospital, Shanghai, Shanghai, 200433, China @@
## Efficacy of Carbonated Beverages in the Resolution of Alimentary Esophageal Impaction - NCT ID: NCT06313060 - Study ID: 010 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-01-01 - Lead Sponsor: Hospital del Río Hortega ### Study Description Objectives: To evaluate the efficacy of the administration of carbonated beverages in the resolution of dietary esophageal impaction, and to identify subgroups in which their effectiveness may be different: patients with/without esophageal diseases, with/without a history of impaction.Methods: A clinical trial was conducted randomizing consecutive patients with a clinical diagnosis of dietary esophageal impaction to receive 200cc of carbonated drink or not at all, excluding patients with a previous diagnosis of non-esophageal stenosis that could not be overcome with a gastroscope and suspected impaction by non-alimentary foreign bodies, spines or bones. Subsequently, an endoscopic evaluation will be carried out in all cases, checking the presence or absence of a foreign body and removing it if necessary, as well as assessing and recording the possible underlying esophageal pathology.A telephone follow-up will be carried out after 7 days, recording possible adverse events. ### Conditions - Esophagus Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Coca-cola ### Outcomes Primary Outcomes - Efficacy of carbonated beverage for disimpaction Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacogenetic of Doxorubicin in HCC. - NCT ID: NCT06313047 - Study ID: Doxorubacin in HCC - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-12-30 - Lead Sponsor: Rehab Werida ### Study Description The study included 81 HCC patients, both male and female. Prior to being assessed for eligibility, each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results. Every research participant take part in the experiment and provided written informed consent. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Doxorubicin ### Outcomes Primary Outcomes - GSTP1 - CYP2B6 Secondary Outcomes ### Location - Facility: King Abdullah bin Abdulaziz University Hospital, Riyadh, N/A, N/A, Saudi Arabia @@
## The Effect of Breastfeeding Training Given to Mothers With Vaginal Birth by Motivational Interview Technique - NCT ID: NCT06313034 - Study ID: GU-SBF-OPA-02 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-03-15 - Lead Sponsor: Gümüşhane Universıty ### Study Description This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial. ### Conditions - Breastfeeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breastfeeding education based on motivational interviewing technique ### Outcomes Primary Outcomes - Mother Introductory Information Form - Primipara Breastfeeding Motivation Scale - Breastfeeding Self-Efficacy Scale Short Form - Mother-Baby Attachment Scale Secondary Outcomes ### Location - Facility: Gümüşhane University, Gümüşhane, N/A, N/A, Turkey @@
## Turkish Version of the Brief Assessment of Cognitive Impairment in Individuals With Stroke Scale - NCT ID: NCT06313021 - Study ID: 2023.12.03 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-05-15 - Lead Sponsor: Ataturk University ### Study Description Cognitive processing involves many interrelated cognitive domains, such as performing daily tasks, attention, language, and memory. 70% of individuals with stroke experience cognitive problems. Due to cognitive problems, individuals with stroke have difficulty processing and planning information. This situation negatively affects daily living activities and returning to work. Cognitive disorders that occur after stroke negatively affect the functional independence of individuals. At the same time, individuals with stroke have difficulty structuring and organizing information. The individual may not be able to pay sufficient attention during the activity in terms of planning, automatic attention and adaptation to the stages required by the job.Cognitive evaluation should include cognition, orientation, and higher cortical functions because the cognitive process is a very complex process. Assessment methods frequently used in cognitive evaluation of stroke patients; Scales and tests such as Simple Mental Test, Mini Mental State Test, Montreal Cognitive Assessment Scale, Wechsler Memory and Intelligence Test are used. General problems with these evaluations; Some of them have a long application period, some of them have problems in perception of the patients, and some of them have a low power to distinguish the cognitive problems of the patients. When the Brief Assessment of Cognitive Impairment Scale, a newly introduced scale in the literature, is examined; It attracts attention because the items are very simple for patients to perceive, combine cognitive tests and cognitive questionnaires, have a short application period, and have not shown a ceiling or floor effect in previous studies. For all these reasons, this study was planned to conduct the Turkish validity and reliability study of the Brief Assessment of Cognitive Impairment Scale. ### Conditions - Stroke - Cognition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Reliability and Validity Study ### Outcomes Primary Outcomes - Brief Assessment of Cognitive Impairment Scale Secondary Outcomes - Mini Mental State Test - Sociodemographic Assessment ### Location - Facility: Ataturk University, Erzurum, N/A, N/A, Turkey @@
## Empagliflozin Versus Vildagliptin in CAD Patients With T2DM - NCT ID: NCT06313008 - Study ID: EMBA-VILDA-Response trial. - Status: RECRUITING - Start Date: 2023-08-10 - Completion Date: 2024-06-10 - Lead Sponsor: Damanhour University ### Study Description We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM). ### Conditions - Coronary Artery Disease - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Empagliflozin 10 MG - Vildagliptin 50 MG ### Outcomes Primary Outcomes - LVEF % - Sortilin (ng/ml) - LDL (mg/dl) Secondary Outcomes - hsCRP (mg/L) - HbA1c % - FBG (mg/dl) ### Location - Facility: Rehab Hussein Werida, Damanhūr, Elbehairah, 31527, Egypt @@
## Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients - NCT ID: NCT06312995 - Study ID: T3DDY02 - Status: RECRUITING - Start Date: 2022-03-14 - Completion Date: 2025-06-14 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Single-centre, randomised, controlled, non-profit study on a custom-made medical device for immobilisation of radius and ulna fracture in paediatric patients.The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster. ### Conditions - Fractures, Bone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - T3DDY01 - PLASTER ### Outcomes Primary Outcomes - Fracture Healing Secondary Outcomes - Adverse event - Comfort of use of devices - Presence of skin lesions or other manifestations of intolerance to the device - Pain evaluation - Acceptance of the device - Structural analysis of devices - Usability for design purposes of the controlate ### Location - Facility: Meyer Children's Hospital IRCCS, Florence, N/A, 50139, Italy @@
## A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study - NCT ID: NCT06312982 - Study ID: BFH-niCRT-04 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-12 - Lead Sponsor: Beijing Friendship Hospital ### Study Description The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer.The main questions it aims to answer are:To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart. ### Conditions - Locally Advanced Rectal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tislelizumab ### Outcomes Primary Outcomes - CR Secondary Outcomes - AE rate - NAR score - ORR - OPR - immune-related adverse event rate ### Location - Facility: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China @@
## Technological Gaming in Cancer Survivors (WINNERS) - NCT ID: NCT06312969 - Study ID: 2022.301 - Status: RECRUITING - Start Date: 2023-02-23 - Completion Date: 2025-02 - Lead Sponsor: Antonio Pérez Martínez ### Study Description HYPOTHESIS1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.VARIABLES1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.2. Statistically significant changes in neuroimaging tests.3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT). ### Conditions - Survivors of Childhood Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Video game based training ### Outcomes Primary Outcomes - SDMT Test - Change in SDMT Test - Change in SDMT Test - "DIGITOS" Test - Change in "DIGITOS" Test - Change in "DIGITOS" Test - "TONI-4" test - Change in "TONI-4" test - Change in "TONI-4" test - "ROCF" test - Change in "ROCF" test - Change in "ROCF" test - "TFV" test - Change in "TFV" test - Change in "TFV" test - "STROOP" test - Change in "STROOP" test - Change in "STROOP" test - "TAVECI" test - Change in "TAVECI" test - Change in "TAVECI" test - "CPT3" - Change in "CPT3" - Change in "CPT3" - "BRIEF" survey - Change in "BRIEF" survey - Change in "BRIEF" survey - "BASC" survey - Change in "BASC" survey - Change in "BASC" survey - Statistically significant changes in neuroimaging tests - Statistically significant changes in neuroimaging tests - Immune and inflammatory biomarkers - Statistically significant changes in immune and inflammatory biomarkers - Statistically significant changes in immune and inflammatory biomarkers Secondary Outcomes - Prevalence - Perception of the family measured by satisfaction survey ### Location - Facility: Hospital La Paz, Madrid, N/A, 28046, Spain @@
## Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy - NCT ID: NCT06312956 - Study ID: 21C403 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2026-02 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description This observational study aims to evaluate multiple dimensions of health in patients with Obstructive Sleep Apnea Syndrome (OSAS), before and after three weeks of ventilotherapy.Specifically, the study aims to identify pre- vs post-treatment differences in the following domains:* cognitive performance* blood expression of biomarkers related to neurodegeneration* psychosocial wellbeingThus, patients will complete the following evaluations before (T0) and after (T1) ventilotherapy:* neuropsychological standard assessment* blood sampling* psychosocial self-reported questionnaires ### Conditions - Obstructive Sleep Apnea - Sleep Disorder - Well-Being, Psychological - Cognitive Impairment - Cognitive Change - Neurologic Signs ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Continuous Positive Airway Pressure Ventilotherapy ### Outcomes Primary Outcomes - Overall cognitive functioning - Selective attention - Memory and learning - Visuo-spatial abilities - Inhibition - Planning - Decision making Secondary Outcomes - biomarkers of neurodegeneration - psychosocial wellbeing and satisfaction - Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction) ### Location - Facility: IRCCS Istituto Auxologico Italiano, Piancavallo, VCO, 28824, Italy @@
## "Translating Articular Biomarkers Into Diagnoses" - NCT ID: NCT06312943 - Study ID: APHP180414 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-09 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Early diagnosis is a key factor in the prevention and management of rheumatic diseases. Rheumatic diseases are classically diagnosed based on criteria combining clinical, biological and radiological features. However, in up to 20% of the cases, diagnoses remain unstated and underlying rheumatic diseases unclassified, which might lead to delayed specific treatment and unfavourable clinical outcomes. In addition, conventional methods could lack sensitivity and specificity for early diagnosis. Biological samples are attractive targets for the early detection of articular damage because they allow for collection of multiple levels of information from the clinic and the laboratory\]. Biological samples most frequently collected from patients with rheumatic diseases are synovial fluid by joint aspiration, blood by venous puncture and tissue specimen by surgery. The investigators hypothesize that in challenging situations, novel biomarkers detected from synovial fluid or articular tissues using both conventional (e.g. histology, immunodetection, PCR) and innovative (e.g. Raman spectroscopy, nanospectroscopy) laboratory tests may help refining diagnosis and better classifying patients with rheumatic diseases. ### Conditions - Inflammatory and Non-inflammatory Bone and Joint Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collection of joint fluid or tissue sample ### Outcomes Primary Outcomes - Tissues and biofluid spectra using surface-enhanced Raman spectroscopy - Protein expression using immunodetection techniques and RNA expression using PCR Secondary Outcomes - Tissues and biofluid spectra using surface-enhanced Raman spectroscopy - Protein expression using immunodetection techniques and RNA expression using PCR ### Location - Facility: Service de Médecine Physique et de Réadaptation, Hôpital Cochin, Paris, IDF, 75014, France @@
## Transcranial Pulse Stimulation on Motor Cortex - NCT ID: NCT06312930 - Study ID: HSEARS20220816001-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-08-20 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer's disease and depression. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, double-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior. ### Conditions - Healthy Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Transcranial pulse stimulation ### Outcomes Primary Outcomes - Change in movement time in nine-hole peg test after TPS - Change in reaction time in Deary-Liewald reaction time task after TPS Secondary Outcomes - The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS task performance measured by nine-hole peg test and Deary-Liewald reaction time task ### Location - Facility: Georg Kranz, PhD, Hong Kong, N/A, N/A, Hong Kong @@
## Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer - NCT ID: NCT06312917 - Study ID: 2023PHB183 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-02-01 - Lead Sponsor: Peking University People's Hospital ### Study Description This study evaluated the clinical outcome of exercise management on patients with endometrial cancer treated with fertility preservation, including the effect of complete response rate, complete response time, recurrence rate, recurrence time, etc., and physical composition, to evaluate the effectiveness of physical activity on weight management. ### Conditions - Endometrium Cancer - Physical Activity - Weight Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical activity ### Outcomes Primary Outcomes - Body weight - BMI - physical activity level Secondary Outcomes - serum total cholesterol - Waist Hip Ratio - triglyceride ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, N/A, China @@
## Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP - NCT ID: NCT06312904 - Study ID: 2023-GSP-QN-7 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-12-30 - Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital ### Study Description This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - paravertebral block - Local infiltration anesthesia ### Outcomes Primary Outcomes - opioid consumption during the first 24h after surgery Secondary Outcomes - FPS-R scale recorded at 6, 12, 18 and 24h postoperatively - The rate of opioid treatment for remedial analgesia between groups ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Value of Heart Rate Lowering Therapy in Acute Myocarditis - NCT ID: NCT06312891 - Study ID: VOHRLTIAM - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-01 - Lead Sponsor: Assiut University ### Study Description To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction. ### Conditions - Myocarditis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ivabradine ### Outcomes Primary Outcomes - Value of Heart Rate Lowering Therapy in Acute Myocarditis Secondary Outcomes ### Location - Facility: Heart Hospital, Assiut, N/A, N/A, Egypt @@
## CT Features of Interrupted Inferior Vena Cava With Azygous Continuation - NCT ID: NCT06312878 - Study ID: IRBN052024/CHUSTE - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-03-31 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired.The origins of these anomalies are not entirely clear, and their incidence is uncertain.Imaging plays a pivotal role in diagnosis to prevent misinterpretation. CT scan is a quick, available, and suitable imaging modality in emergency setting.The aim of this retrospective monocentric study was of describe CT features of interrupted suprarenal inferior vena cava with azygous continuation. ### Conditions - Anatomical Variant of the Inferior Vena Cava ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Describe the anatomy of the IVC in the case of an anatomical variant ### Outcomes Primary Outcomes - Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation Secondary Outcomes - Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation - Describe association with polysplenic syndrome - Describe association with polysplenic syndrome - Describe association with polysplenic syndrome - Describe association with polysplenic syndrome - Describe association with polysplenic syndrome - Describe association with polysplenic syndrome - Describe circumstances of discovering the interrupted IVC - Describe circumstances of discovering the interrupted IVC ### Location - Facility: CHU de Saint-Etienne, Saint-Priest-en-Jarez, N/A, 42270, France @@
## Intermittent Exotropia in Egyptian Population - NCT ID: NCT06312865 - Study ID: IXTEGYPT - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: Assiut University ### Study Description Strabismus is one of the most frequent ocular problems among developmentally normal children. The prevalence of strabismus varies among different regions, ranging from 0.06% in Japan to 5.65% in China. Exotropia is reported to be the most prevalent type of deviation in many of these studies. About 48-92% of the exotropic patients have intermittent exotropia (IXT). Jenkins reported that the prevalence of exodeviation was higher in countries near the Equator. Its prevalence is also higher in subequatorial Africa, the Middle East, and East Asia (where there is plenty of sunshine) in comparison to the USA and Central Europe. Intermittent exotropia is a disorder of binocular eye movement control, where one eye intermittently turns outward. The outward deviation is greatest and likely occurs at far distances viewing, when the oculomotor convergence effort is weakest, and occurs frequently when the patient is under stress, tired, ill, or in particular test situations. X(T) can also occur at near as convergence insufficiency. ### Conditions - Exotropia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ophthalmic exam ### Outcomes Primary Outcomes - The difference in demographic criteria in Egyptian population Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Antenatal Steroids on Coagulation. - NCT ID: NCT06312852 - Study ID: Antenatal steroids & clotting - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05 - Lead Sponsor: Assiut University ### Study Description Aim of the research :1- Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers. ### Conditions - Corticosteroids Adverse Reaction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Antenatal corticosteroids impact on Coagulopathy Secondary Outcomes - Follow up for cases on corticosteroid therapy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning - NCT ID: NCT06312839 - Study ID: IRBN032024/CHUSTE - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description This retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. Two groups were included : a surgery-alone group (control group) and a PreopAE group (study group) treated with an embolization procedure before esophagectomy. Collected data included patient characteristics, embolization procedure details, surgical outcomes, and postoperative complications.The primary outcome was the efficacy of preoperative ischemic conditioning in preventing anastomotic leakage, assessed through CT scans. Secondary outcomes included analyzing safety of ischemic gastric conditioning, hypertrophy of the gastroepiploic artery in embolized patients and comparing hospital stay length and postoperative mortality. ### Conditions - Esophageal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collecting data from the medical record ### Outcomes Primary Outcomes - Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. Secondary Outcomes - Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. - Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. - Safety of ischemic gastric conditioning - Hypertrophy of the gastroepiploic artery - Comparing hospital stay length - Comparing postoperative mortality ### Location - Facility: CHU de Saint-Etienne, Saint-Priest-en-Jarez, N/A, 42270, France @@
## Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk - NCT ID: NCT06312826 - Study ID: KCT0007417 - Status: RECRUITING - Start Date: 2022-08-26 - Completion Date: 2027-12 - Lead Sponsor: So Yeon Kim ### Study Description Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design.Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate. ### Conditions - Liver Cirrhosis - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Abdominal US - AMRI ### Outcomes Primary Outcomes - Detection rate of patients with early stage HCC Secondary Outcomes - Detection rate of patients with very early stage HCC - False referral rate of patients with early stage HCC - False referral rate of patients with very early stage HCC ### Location - Facility: Asan Medical Center, Seoul, Songpa-gu, 05505, Korea, Republic of @@
## Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea - NCT ID: NCT06312813 - Study ID: 2023-296 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2028-12 - Lead Sponsor: Wright State University ### Study Description Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea. ### Conditions - Rosacea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Imipramine - Amitriptyline - Vehicle ### Outcomes Primary Outcomes - Ultraviolet B induced erythema change with 4% imipramine - Ultraviolet B induced erythema change with 4% imipramine - Ultraviolet B induced erythema change with 4% imipramine - Ultraviolet B induced erythema change with 4% imipramine - Ultraviolet B induced erythema change with 4% amitriptyline - Ultraviolet B induced erythema change with 4% amitriptyline - Ultraviolet B induced erythema change with 4% amitriptyline - Ultraviolet B induced erythema change with 4% amitriptyline Secondary Outcomes - Tolerability of 4% imipramine on facial skin - Tolerability of 4% imipramine on facial skin - Tolerability of 4% imipramine on facial skin - Tolerability of 4% imipramine on facial skin - Tolerability of 4% amitriptyline on facial skin - Tolerability of 4% amitriptyline on facial skin - Tolerability of 4% amitriptyline on facial skin - Tolerability of 4% amitriptyline on facial skin ### Location - Facility: Wright State Physicians, Fairborn, Ohio, 45324, United States @@
## Acamprosate and Methazolamide for Essential Tremor - NCT ID: NCT06312800 - Study ID: LeWitt02 - Status: WITHDRAWN - Start Date: 2016-03 - Completion Date: 2017-12 - Lead Sponsor: Henry Ford Health System ### Study Description This is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET). ### Conditions - Essential Tremor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Acamprosate - Placebo - Methazolamide ### Outcomes Primary Outcomes - Fahn-Marin-Tolosa rating scale (FMTRS) Part A Secondary Outcomes ### Location - Facility: Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, 48322, United States @@
## A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation - NCT ID: NCT06312787 - Study ID: VX23-118-002 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-05 - Lead Sponsor: Vertex Pharmaceuticals Incorporated ### Study Description The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - VX-118 ### Outcomes Primary Outcomes - Maximum Observed Plasma Concentration (Cmax) of VX-118 - Area Under the Concentration Versus Time Curve (AUC) of VX-118 Secondary Outcomes - Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) ### Location - Facility: Celerion - Lincoln, Lincoln, Nebraska, 68502, United States @@
## Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia - NCT ID: NCT06312774 - Study ID: IRAS 333853 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2027-01-04 - Lead Sponsor: University College, London ### Study Description Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life.The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia.The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study. ### Conditions - Sarcopenia - Chronic Lung Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - This is observational study ### Outcomes Primary Outcomes - Sarcopenia Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 - NCT ID: NCT06312761 - Study ID: Oral T-12 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Washington ### Study Description This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix, which is approved for the treatment of prostate cancer, and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose. ### Conditions - Hypogonadism, Male ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Relugolix 120Mg Tab - Curcumin - Testosterone Undecanoate 237 MG Oral Capsule ### Outcomes Primary Outcomes - average serum testosterone after dosing on day 2 - average serum testosterone after dosing on day 3 - Maximum concentration - time to maximum concentration - area-under-the curve - elimination phase half-life Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Novel Approaches for Improving Vascular Function in Veterans With HFpEF - NCT ID: NCT06312748 - Study ID: 138675 - Status: RECRUITING - Start Date: 2021-05-19 - Completion Date: 2030-09-30 - Lead Sponsor: D. Walter Wray ### Study Description This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF). ### Conditions - HFpEF - Heart Failure With Preserved Ejection Fraction - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - L-Citrulline - Placebo for L-Citrulline - BH4 - Placebo for BH4 - Atorvastatin - Placebo for Atorvastatin ### Outcomes Primary Outcomes - Flow-mediated dilation (FMD) Secondary Outcomes - Passive Limb Movement (PLM) ### Location - Facility: George E. Whalen VA Medical Center, Salt Lake City, Utah, 84128, United States @@
## VR for Patients With Chronic Pain (Wait & Work) - NCT ID: NCT06312735 - Study ID: 230405 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-09-30 - Lead Sponsor: University of Twente ### Study Description This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VR (Reducept) ### Outcomes Primary Outcomes - Change in quality of life measured using the short-form 12 (SF-12) Secondary Outcomes - Change in pain intensity measured using the numeric pain rating scale (NPRS) - Change in pain catastrophizing measured using the pain catastrophizing scale (PCS) - Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ) - Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8) - Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS) - Change in quality of care measured using the client satisfaction questionnaire (CSQ-8) - Change in medication use measured using an open-ended question ### Location - Facility: Revalidatie Friesland, Emmeloord, Friesland, 8303BX, Netherlands @@
## Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study - NCT ID: NCT06312722 - Study ID: PR1309 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2031-02-07 - Lead Sponsor: Urotronic Inc. ### Study Description The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. ### Conditions - Benign Prostatic Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Optilume® BPH Catheter System ### Outcomes Primary Outcomes - The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. Secondary Outcomes - Semen Sub-Study Safety Secondary Endpoint ### Location - Facility: Urotronic, INC, Plymouth, Minnesota, 55441, United States @@
## teleABLE to Reduce Post-Stroke Sedentary Behavior - NCT ID: NCT06312709 - Study ID: STUDY00021288 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2026-07-31 - Lead Sponsor: University of Minnesota ### Study Description The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.Participants in this study will:* Complete questionnaires at Weeks 1, 8, and 24* Wear an activPAL monitor at Weeks 1, 8, and 24* Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions)* Complete an interview at Week 24 ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) - Health Education ### Outcomes Primary Outcomes - Between-group difference in change scores on health-related quality of life - Between-group difference in change in sedentary behavior Secondary Outcomes - Between-group difference in change in sedentary behavior - Between-group difference in change scores on health-related quality of life ### Location - Facility: School of Kinesiology, University of Minnesota, Minneapolis, Minnesota, 55455, United States @@
## Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy - NCT ID: NCT06312696 - Study ID: SMT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: University of Minnesota ### Study Description The broad long-term objective is to develop an objective biomarker for spinal health based on aberrant or abnormal movement patterns during functional activities to better target spinal manipulation therapy (SMT) and other conservative treatments. The central hypotheses are a) that aberrant spinal motions and their location (area and level) are indicative of underlying spinal dysfunction, and b) that quantified 3D cervical spine intersegmental and global motion patterns during functional tasks can be used as a biomarker for subsequent clinical studies aimed at normalizing cervical kinematics.Specific Aim: Determine the extent to which SMT can modulate, or normalize, intersegmental motion in patients with neck pain. Rationale: SMT is a force-based biomechanical event whose hypothesized mechanism of action relies on moving the segment into the para-physiological zone, resulting in normalization of spinal kinematic function. Hypothesis: Severity of abnormal or aberrant motion, identified in those with NP, will improve following SMT. Approach: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention. ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - SMT - Light Massage ### Outcomes Primary Outcomes - Intersegmental and Global Range of Motion Secondary Outcomes - Neck pain intensity - Neck disability - physical function - depression - sleep disturbance - Pain interference - Fear of pain assessment - Overall function assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rifaximin for the Secondary Prevention of Recurrent Pouchitis - NCT ID: NCT06312683 - Study ID: 23-2111 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis. ### Conditions - Pouchitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Rifaximin 550 MG Oral Tablet [XIFAXAN] ### Outcomes Primary Outcomes - Percentage of Participants Who Develop Recurrent Pouchitis Secondary Outcomes ### Location - Facility: University of North Carolina, Chapel Hill, North Carolina, 27599, United States @@
## Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer - NCT ID: NCT06312670 - Study ID: CASE2823 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2026-03-01 - Lead Sponsor: Pedro Barata, MD, MSc ### Study Description The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks. ### Conditions - Metastatic Hormone-sensitive Prostate Cancer (mHSPC) - Prostate Cancer - Prostate Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - EPI-7386 - Enzalutamide - Androgen Deprivation Therapy (ADT) ### Outcomes Primary Outcomes - Biochemical response rate - PSA progesterone-free survival (PFS) - Radiographic PFS (rPFS) - ORR (confirmed) Secondary Outcomes - AUC0-24 - Maximum concentration (Cmax) - Predose Plasma Concentration - Time to reach Cmax (Tmax) - Terminal elimination half-life - Volume of distribution at steady state after extravascular administration - Clearance after extravascular administration - Treatment-emergent adverse events - Rate of abnormalities in clinical laboratory parameters - Rate of abnormalities in vital sign measurements - Rate of bnormalities in electrocardiograms (ECGs) - Changes in Eastern Cooperative Oncology Group (ECOG) performance status ### Location - Facility: University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States @@
## Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice - NCT ID: NCT06312657 - Study ID: 81971 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-03-28 - Lead Sponsor: Joshua A. Lile, Ph.D. ### Study Description The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Drug Cue - Money - Withdrawal ### Outcomes Primary Outcomes - Task choices Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Ultomiris® (Ravulizumab) Safety in Pregnancy - NCT ID: NCT06312644 - Study ID: D9289C00007 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2033-10-21 - Lead Sponsor: Alexion Pharmaceuticals, Inc. ### Study Description The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk. ### Conditions - Ultomiris-exposed Pregnant/ Postpartum - Pregnancy - Paroxysmal Nocturnal Hemoglobinuria (PNH) - Atypical Hemolytic Uremic Syndrome (aHUS) - Generalized Myasthenia Gravis (gMG) - Neuromyelitis Optica Spectrum Disorder (NMOSD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultomiris ### Outcomes Primary Outcomes - Number of Pregnancy Complications - Number of Maternal Complications - Fetal/Infant Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults - NCT ID: NCT06312631 - Study ID: RC31/21/0342 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: University Hospital, Toulouse ### Study Description On a functional level, performing the actions of daily life requires coordinated activity of the muscles of the upper limbs. The quality of motor recovery and/or technical assistance aimed at compensating for the movement deficit of the paretic upper limb (MSP) determines the possibilities of using the upper limb (MS) in activities of daily life.Interventions in the chronic phase of stroke aim to return home. The integration of the paretic upper limb into daily life activities is a major issue regarding the prognosis of recovery of use of the upper limb. Independence in daily life becomes an ultimate goal to take charge of.Our study focuses on a new technical aid device, standard orthosis type, expanding the range of gripping gloves: the SaeboGlove in everyday environments. These MS orthoses help improve the use and function of the MSP in post-stroke adults as well as their independence and participation in society. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Putting on the gripping glove - ULPA questionnaire - Motor Activity Log (MAL) Questionnaire - Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire - Score Action Arm Research Test - EuroQol five-level (EQ-5D-5L) questionnaire - Quebec User Evaluation of Satisfaction with Assistive Technology - Psychosocial Impact of Assistive Devices Scale (PIADS) - Goal Attainment Scale (GAS) - installation and collection of accelerometers ### Outcomes Primary Outcomes - Evaluation of the effectiveness of the gripping glove Secondary Outcomes - Evaluation of the performance of an activity in the real context of the patient - Evaluation of factual spontaneous use of the upper limb in daily life - Evaluation of the perceived performance of the use of the paretic upper limb - Assessment of the quality of voluntary motor skills of the upper limb - Assessment of gripping abilities - Quality of life assessment - Evaluation of satisfaction and tolerance - Evaluation of the psycho-social impact ### Location - Facility: Claire VILLEPINTE, Toulouse, CHU De Toulouse, 31059, France @@
## Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation - NCT ID: NCT06312618 - Study ID: FMASU MD292/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-10-15 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane. ### Conditions - Emergence Agitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Propofol - Dexmedetomidine ### Outcomes Primary Outcomes - the overall incidence of postoperative Emergence Agitation Secondary Outcomes - Vital signs change. - Vital signs change. - Vital signs change. - Proportion of patients with adverse events in the PACU - Proportion of patients with Post Operative Nausea and Vomiting (PONV) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial) - NCT ID: NCT06312605 - Study ID: 230620 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-08 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question\[s\] it aims to answer are:* Pigment recurrence after one year.* Patient satisfaction and histological response of tissues.Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen.Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each. ### Conditions - Gingival Pigmentation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Injectable applied vitamin C - Topical applied Vitamin C - Surgical depigmentation only ### Outcomes Primary Outcomes - Pigmentation scores - Assessment of pigment surface area (SA) - Assessment of pigment intensity in terms of mean darkness value (MDV) Secondary Outcomes - Patient satisfaction - Histological response ### Location - Facility: Faculty AinShams University, Cairo, N/A, N/A, Egypt @@
## GBV Prevention, Mitigation, and Response in Colombia - NCT ID: NCT06312592 - Study ID: FWA00015367 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-09-01 - Lead Sponsor: Washington University School of Medicine ### Study Description As of August 2021, Colombia hosts the vast majority of Venezuelan refugees and migrants (UNHCR, 2022). For vulnerable refugees and migrants in Colombia, and especially for women, gender-based violence (GBV) is present during transit and continues in their new homes where xenophobia, lack of accessible and adequate services, lack of safe economic opportunities, and lack of information on access to services, further increase risk. Lack of livelihood opportunities also affect vulnerable refugees and migrants, especially women, with barriers to employment including lack of information; precarious working conditions with lower payments and longer working days with increasing risks of labor exploitation; xenophobia and discrimination; limited access to formal labor markets; lack of access to financial services, among others. To address these issues, the investigators are conducting a pilot randomized-controlled trial (RCT) of HIAS' Entrepreneurship School with Gender Lens (ESGL), a methodology that targets GBV survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. The pilot RCT will be conducted within three cities in Colombia; approximately 80 eligible participants will be enrolled in each city and randomized to a treatment or control arm. Survey questionnaires will be administered to participants at baseline, eight months following baseline (endline), and 3-4 months after endline. Outcomes of interest include household self-reliance, mental health, empowerment, decision-making, and GBV risk and knowledge. ### Conditions - Refugee Self-reliance - Mental Health Issue - Empowerment - Gender Based Violence Knowledge and Perceived Risk - Decision Making ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Entrepreneurship School with Gender Lens ### Outcomes Primary Outcomes - Self-Reliance Index Secondary Outcomes - Patient Health Questionnaire (PHQ-9) - Brief Scale of Resilient Strategies - Multidimensional Women's Empowerment Index - GBV perceived risk ### Location - Facility: Los Andes University, Bogotá, N/A, N/A, Colombia @@
## At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers - NCT ID: NCT06312579 - Study ID: E4897-P - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2026-03-31 - Lead Sponsor: VA Office of Research and Development ### Study Description Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility.People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical.This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control. ### Conditions - Diabetic Foot Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 12-week home based exercise - 12-week standard of care ### Outcomes Primary Outcomes - Gait speed Secondary Outcomes - Feasibility- Recruitment - Physical Activity - Acceptability- Usage Rating Profile-Intervention - Muscular strength - Perfusion - Glycemic control - Mobility - Acceptability - Adherence to the exercise regimen - Feasibility- Retention - Community mobility ### Location - Facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, 21201, United States @@
## A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants - NCT ID: NCT06312566 - Study ID: EP0231 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-10-25 - Lead Sponsor: UCB Biopharma SRL ### Study Description The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants. ### Conditions - Healthy Study Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - brivaracetam (BRV) tablet - brivaracetam (BRV) dry syrup ### Outcomes Primary Outcomes - Maximum plasma concentration at steady state [Cmax(ss)] after multiple doses of brivaracetam - Area under the curve during a dosing interval at steady state [AUC(tau)] after multiple doses of brivaracetam Secondary Outcomes - Percentage of study participants with treatment-emergent adverse events (TEAEs) - Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs) - Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation ### Location - Facility: Ep0231 001, Sumida- Ku, Tokyo, N/A, Japan @@
## Remotely Delivered Mindfulness-Based Diabetes Education - NCT ID: NCT06312553 - Study ID: IRB-300012515 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-06-30 - Lead Sponsor: University of Alabama at Birmingham ### Study Description Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing remotely delivered Mindfulness-Based Diabetes Education plus remote patient monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black adults with type 2 diabetes and elevated diabetes distress who receive care within federally qualified health centers to assess feasibility and acceptability. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring - Standard Diabetes Self Management Education ### Outcomes Primary Outcomes - Feasibility: percentage of screened participants who are eligible - Feasibility: percentage of eligible participants who enroll - Feasibility: ability to randomize participants to study arms - Feasibility: distribution of participants by demographics - Feasibility: percentage of sessions attended - Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities. - Feasibility: barriers to participation in intervention sessions or completing study activities at home - Feasibility: reasons for dropping out - Feasibility: overall study retention - Acceptability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PERSonalized rObotic NeurorehAbilitation for Stroke Survivors - NCT ID: NCT06312540 - Study ID: PERSONA - Status: RECRUITING - Start Date: 2020-09-02 - Completion Date: 2024-09-01 - Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana ### Study Description The aim is to carry out a first clinical study, to expand existing knowledge about the neurophysiological mechanisms underlying post-stroke recovery. The information acquired during this phase will be used as building blocks to develop customized protocols. Understanding the mechanisms underlying stroke-induced motor deficits and motor recovery is mandatory to improve clinicians; ability to guide the repair of the affected neural structures. The motor system comprises a network of cortical and subcortical areas interacting via excitatory and inhibitory circuits, thereby governing motor behaviour. Stroke lesions cause neural dysfunction both at the lesion site and in remote brain regions. Abnormal interactions among cortical regions within the motor network contribute to the motor impairment after stroke. Longitudinal analysis of neural activity and connectivity can help to understand the pathophysiology mechanisms underlying functional impairment and recovery after stroke. Analysis of the data will try to extract biomarkers of plasticity and recovery that will be used to design customized therapeutic interventions. ### Conditions - Stroke Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Brain activity - Functional evaluation Secondary Outcomes - Clinical scale - Spasticity assessment ### Location - Facility: AOUPisana, Pisa, Pi, 56124, Italy @@
## Mepiform in Simultaneous Bilateral TKA - NCT ID: NCT06312527 - Study ID: TUH Mepiform TKA - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-07 - Completion Date: 2024-05-31 - Lead Sponsor: Thammasat University Hospital ### Study Description The goal of this RCT is comparing efficacy of silicone dressing in scar preventing after simultaneous bilateral total knee arthroplasty.The main question\[s\] it aims to answer are:* Does silicone dressing can prevent scar formation after total knee arthroplasty?* Does silicone dressing have similar functional outcomes and complications after total knee arthroplasty? Participants will apply silicone dressing after wound healed and apply for 10 weeks. Researchers will compare to the other side that is no intervention. ### Conditions - Scar Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Silicone dressing ### Outcomes Primary Outcomes - Vancouver Scar Scale Secondary Outcomes - Range of motion - Forgotten joint score - modified WOMAC score - Scar pain - Scar itching - Complications ### Location - Facility: Thammasat University, Khlong luang, Pathum Thani, 12120, Thailand @@
## Lafiya HIV-status Neutral Study - Protocol - NCT ID: NCT06312514 - Study ID: STUDY00008615 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2028-08-29 - Lead Sponsor: University of Rochester ### Study Description The primary objective of this study is to adapt and evaluate the feasibility of "Lafiya," which means "Wellness" in Hausa, a multilevel intersectional stigma \& discrimination (ISD) and HIV testing intervention, to a status-neutral intervention to increase HIV testing, PrEP, and ART Uptake (HPART) among young gay, bisexual, and other men who have sex with men in Ghanaian slums. Specific objectives include, Assessing intersectional stigma and options for HPART implementation, Adapting Lafiya to a status-neutral intervention to address intersectional stigma and increase HPART uptake among YGBMSM, Test acceptance, feasibility, appropriateness, and preliminary efficacy of Lafiya to address intersectional stigma and increase HIVST uptake. ### Conditions - HIV Prevention and Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - LAFIYA ### Outcomes Primary Outcomes - Change in HIV testing. - Change in PrEP Adherence. - Change in ART Adherence - Change in Treatment Self-Efficacy. Secondary Outcomes - Percentage change in HIV stigmatizing attitudes. - Percentage change in reported sexual behavior stigma. - Percentage change in gender nonconformity stigma - Percentage change in PrEP-related stigma - Neighborhood stigma - Mean change in the Basic Needs Satisfaction - Percentage of participants that reported healthcare climate stigma. - Percentage of participants that reported Brief Resilience - Changes in Healthcare facility Intersectional stigma and discrimination. ### Location - Facility: University of Ghana, Accra, N/A, N/A, Ghana @@
## Remote Patient Monitoring for Patients With Heart Failure in France - NCT ID: NCT06312501 - Study ID: 2021-0020 TELESAT - Status: COMPLETED - Start Date: 2018-08-01 - Completion Date: 2022-12-31 - Lead Sponsor: Satelia ### Study Description The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survivalParticipants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.Researchers will compare the following cohorts to see if RPM can improve their condition:* Cohort 1: using RPM for follow-ups.* Cohort 2: conventional care and not using any devices and solutions for the follow-ups. ### Conditions - Heart Failure - Patient Empowerment - Cardiac Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Satelia®Cardio - Conventional care ### Outcomes Primary Outcomes - Number of All Causes Deaths Secondary Outcomes - Number of unplanned heart failure Hospitalization - Number of All Causes Deaths in elderly patients - Number of unplanned hospitalization for heart failure in elderly patients ### Location - Facility: NP Medical, Bordeaux, N/A, 33000, France @@
## Point of Care Evaluation of Fibrinolysis in Sepsis - NCT ID: NCT06312488 - Study ID: 4097 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2025-08-31 - Lead Sponsor: Policlinico Hospital ### Study Description Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers. ### Conditions - Fibrinolytic Defect - Sepsis - Critical Illness ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Clot Pro ### Outcomes Primary Outcomes - Prevalence of impaired fibrinolysis Secondary Outcomes - Correlation between impaired fibrinolysis and changes in coagulation standard tests - Correlation between impaired fibrinolysis and inflammation markers - Correlation between impaired fibrinolysis and multiorgan failure - Correlation between impaired fibrinolysis and ICU lenght of stay - Correlation between impaired fibrinolysis and ICU mortality ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, MI, 20100, Italy @@
## Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors - NCT ID: NCT06312475 - Study ID: KN057-A-301 - Status: RECRUITING - Start Date: 2024-01-09 - Completion Date: 2025-12-15 - Lead Sponsor: Suzhou Alphamab Co., Ltd. ### Study Description The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B with inhibitors and is safe to use. Successfully screened participants will be randomly assigned to KN057 Prophylaxis (Arm 1) versus No Prophylaxis (Arm 2) at a ratio of 2:1. Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.The trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration. ### Conditions - Hemophilia A With Inhibitor - Hemophilia B With Inhibitor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - KN057 ### Outcomes Primary Outcomes - Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2. Secondary Outcomes - ABR calculated based on bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1 and Arm 2. - ABR calculated based on bleeding episodes and treated bleeding episodes respectively in Arm 2. - ABR calculated based on bleeding episodes, treated bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1. - Change from baseline in Hemophilia Joint Health Score (HJHS) scores in Arm 1 and Arm 2. - Change in HJHS scores from baseline in Arm 1 and from the 26th week in Arm 2. - Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) in Arm 1 and Arm 2. - Change in EQ-5D-5L from baseline in Arm 1 and from the 26th week in Arm 2. - Incidence of TEAE, TEAE related to the experimental drug and SAE. - Incidence of thromboembolic events, TMA and DIC. - Incidence of hypersensitivity type reactions. - Incidence of injection site reactions. - Incidence of clinically significant laboratory value abnormalities. - Number of participants with clinically significant changes from baseline in physical exam. - Number of participants with clinically significant changes from baseline in electrocardiograms. - Number of participants with clinically significant changes from baseline in vital signs. - KN057 plasma trough concentration. - Levels of Free TFPI. - Levels of prothrombin fragment 1+2 (PF1+2). - Incidence of anti-KN057 antibody (ADA) and neutralizing antibody (Nab). ### Location - Facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, 300020, China @@
## Health Education Model Led by Community Health Volunteers. - NCT ID: NCT06312462 - Study ID: PembaMoH - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-05 - Lead Sponsor: Pemba Ministry of Health Zanzibar ### Study Description The goal of this intervention study is to investigate the level of knowledge, attitudes, and behaviors of students on schistosomiasis in Pemba Island. It aims to test the effectiveness of establishing a widely applicable Community Health Volunteers model in the Zanzibar region and explore the feasibility of promoting this model in other areas of Africa. This study also aims to provide valuable insights and references for global schistosomiasis prevention and control efforts. ### Conditions - Schistosomiasis - Health Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - health education ### Outcomes Primary Outcomes - change in infection rate - Change in Knowledge Level - Attitudes Changes - Behaviors Changes Secondary Outcomes - Student satisfaction survey ### Location - Facility: Neglected tropical diseases in Pemba, Pemba, CharkChark, P.O.BOX 98, Tanzania @@
## Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes - NCT ID: NCT06312449 - Study ID: 2211110001 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-09-23 - Lead Sponsor: Tung Yu-Ching ### Study Description This study aims to explore the use of peanut balls during the second stage of labor. It compares three different positions: traditional lithotomy position, lateral position, and lateral position with peanut ball in terms of women's perceived pushing effort experiences, fatigue, and birth outcomes. ### Conditions - Other ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - The side-lying position with the peanut ball during the second stage of labor. - During the second stage, the patient is placed in a lateral position ### Outcomes Primary Outcomes - The duration of the second stage of labor of women who use side-lying with peanut balls. - The pushing time of women in the second stage of labor who use side-lying with peanut balls. - lateral position with peanut ball in terms of women's perceived pushing effort experiences. - Parturients using the side-lying position with a peanut ball for experience levels of fatigue. Secondary Outcomes ### Location - Facility: Yu-Ching Tung, Taoyuan City, N/A, N/A, Taiwan @@
## The AT-REBOA Target Trial - NCT ID: NCT06312436 - Study ID: AT-REBOA - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-01-01 - Completion Date: 2024-03 - Lead Sponsor: Medical University of Graz ### Study Description Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers. ### Conditions - Hemorrhage - Shock, Traumatic - Cardiac Arrest Due to Trauma - Polytrauma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) ### Outcomes Primary Outcomes - 30-day in-hospital mortality Secondary Outcomes - 3-hour mortality - 6-hour mortality - 24-hour mortality - 90-day mortality - Intensive Care Unit length of stay - Hospital length of stay - Blood product use - Use of whole body computed tomography - damage control procedure performed - Time to damage control procedure - Rate of complications - Cause of death ### Location - Facility: University Medical Centre Graz, Graz, Styria, 8036, Austria @@
## Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer - NCT ID: NCT06312423 - Study ID: ECDA000/02 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-12-30 - Lead Sponsor: Ministry of Public Health of the Province of La Rioja ### Study Description Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers. ### Conditions - Immune System ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Oligonucleotides, Phosphorothioate ### Outcomes Primary Outcomes - Safety: Local and systemic reaction after administration of each dose of the investigational drug - Safety: Serious adverse event - Safety: Variations in the Laboratory results - Pharmacokinetics: IMT504 level in Serum - Pharmacokinetics: IMT504 level in Serum - Pharmacokinetics: IMT504 level in Serum - Pharmacokinetics: IMT504 level in Serum - Pharmacokinetics: IMT504 level in Serum Secondary Outcomes - Pharmacodynamics: Interleukin - 35 ### Location - Facility: CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar, Buenos Aires, N/A, 1702, Argentina @@
## The VIA Family 2.0 - a Family Based Intervention for Families With Parental Mental Illness - NCT ID: NCT06312410 - Study ID: H-23067714 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2028-12-31 - Lead Sponsor: Mental Health Services in the Capital Region, Denmark ### Study Description VIA Family 2.0 - a Family Based Intervention for families with parental mental illnessBackground: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.A collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine. ### Conditions - Child - Parents - Mental Disorder - Child of Impaired Parents - Preventive Health Services ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - VIA Family 2.0 ### Outcomes Primary Outcomes - Change in Strengths and Difficulties Questionnaire (SDQ) - Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development - Change in Family Assessment Device - General Function Scale (FAD-GF) - Change in Parental Stress Scale (PSS) Secondary Outcomes - Change in Home Observation for Measurement of the Environment (HOME) - Change in Parenting and Family Adjustment Scales (PAFAS) - Change in Children's Global Assessment Scale (CGAS) - Change in Perceived Stress Scale (PSS) - Client Satisfaction Scale (CSQ) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect on Back Pain and Fatigue Level of Acupressure - NCT ID: NCT06312397 - Study ID: MU-HF-BVD-01 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-08-30 - Lead Sponsor: Mersin University ### Study Description This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography. ### Conditions - Coronary Angiography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Acupressure - Sham acupressure ### Outcomes Primary Outcomes - Visual Analog Scale for Pain - Visual Analog Scale for Fatigue Secondary Outcomes ### Location - Facility: Birgül VURAL DOĞRU, Mersin, N/A, 33110, Turkey @@
## The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation - NCT ID: NCT06312384 - Study ID: A04080622 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-07-01 - Completion Date: 2024-06 - Lead Sponsor: Mansoura University ### Study Description Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation. ### Conditions - Bone Deformity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation - conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation ### Outcomes Primary Outcomes - Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans Secondary Outcomes ### Location - Facility: Faculty of Dentistry-Mansoura University, Mansoura, N/A, 35516, Egypt @@
## Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients - NCT ID: NCT06312371 - Study ID: Feeding Hesitancy - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Muhammad ### Study Description The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding ### Outcomes Primary Outcomes - Swallowing Quality of Life questionnaire Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Expanding the Infant Achievements Intervention Through Community Partnerships - NCT ID: NCT06312358 - Study ID: IRB00408654 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. ### Study Description The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are:1. Does teacher participation in a PD intervention improve the use of evidence-based practices from pre- to posttest?2. To what extent is the PD intervention feasible to implement in an established child care program?3. To what extent is the PD program acceptable to teachers?Participants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study. ### Conditions - Child Development - Infant Development - Developmental Delay - Language Development ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Building Capacity for Infant Achievements in Child Care ### Outcomes Primary Outcomes - Classroom Quality (as assessed by scores on the TPITOS) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ciprofol Versus Propofol for Anesthesia Induction in Cardiac Surgery: A Randomized Double-blind Controlled Clinical Trial - NCT ID: NCT06312345 - Study ID: 2024.3.10-2024.5.1 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-05-10 - Lead Sponsor: Le Yu ### Study Description Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Drug: ciprofol injection ### Outcomes Primary Outcomes - Mean arterial pressure - Mean arterial pressure - Mean arterial pressure - Mean arterial pressure - Heart beats - Heart beats - Heart beats - Heart beats Secondary Outcomes - Oxygenation index - Oxygenation index - Injection pain ### Location - Facility: Shanghai East Hospital of Tongji University, Shanghai, Shanghai, 200120, China @@
## Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE) - NCT ID: NCT06312332 - Study ID: HUM00220089 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-08 - Lead Sponsor: University of Michigan ### Study Description This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions. ### Conditions - Pulmonary Embolism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Pulmonary Embolism (PE) Care in Emergency Department (ED) ### Outcomes Primary Outcomes - Change in proportion of patients discharged home from Emergency Department (ED) Secondary Outcomes ### Location - Facility: Michigan Emergency Department Improvement Collaborative partners, Ann Arbor, Michigan, 48109, United States @@
## Home-based Respiratory Training on Swallowing in Stroke - NCT ID: NCT06312319 - Study ID: DF0001 - Status: RECRUITING - Start Date: 2023-08-20 - Completion Date: 2024-06-20 - Lead Sponsor: Universidad de Granada ### Study Description The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Respiratory training - Orofacial exercises ### Outcomes Primary Outcomes - Gugging Swallowing screen - Swallowing quality of life questionnaire - cough peak flow Secondary Outcomes - Forced vital capacity - Forced expiratory volumen in the first second - FEV1/FVC ratio - Respiratory Pressure Meter ### Location - Facility: Faculty of Health Sciences, Granada, N/A, 18016, Spain @@
## Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke - NCT ID: NCT06312306 - Study ID: TDCS vs pilates in stroke - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-09 - Lead Sponsor: Cairo University ### Study Description The goal of this clinical trial is to compare the effects of transcranial direct current stimulation and pilates based core stability training on gait and balance in stroke patients. The main question\[s\] it aims to answer are:* is there an effect of transcranial direct current stimulation and pilates based core training on gait and balance* Is there a significant effect of tDCS over Pilates-based core trainingParticipants will be assigned to three groups:* Group 1: will receive 18 sessions(3 sessions/week 20 minutes each) of anodal tDCS in addition to conventional physical therapy exercises* Group 2: Will receive 18 Pilates exercise sessions over a period of 6 weeks (3 sessions / week) in addition to conventional physical therapy exercises.* Group 3: Will receive conventional physiotherapy programResearchers will compare the transcranial direct current stimulation group with the pilates exercise group to see if one of them is superior to the other on balance and gait. ### Conditions - Stroke - Cerebrovascular Accident ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial direct current stimulation - Pilates based core training - conventional physiotherapy program ### Outcomes Primary Outcomes - Gait kinematics - The Biodex Balance System Secondary Outcomes - Stroke Impact Scale (SIS) ### Location - Facility: Faculty of physical therpay cairo university, Dokki, Giza, 12613, Egypt @@
## Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation - NCT ID: NCT06312293 - Study ID: STUDYAP0004 - Status: COMPLETED - Start Date: 2023-09-15 - Completion Date: 2023-12-30 - Lead Sponsor: Bahçeşehir University ### Study Description The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases. ### Conditions - Vagus Nerve Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Transcutaneous Vagus Nerve Stimulation ### Outcomes Primary Outcomes - Heart Rate Variability Secondary Outcomes ### Location - Facility: Igdir University, Igdir, Central, 76000, Turkey @@
## Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity - NCT ID: NCT06312280 - Study ID: CE342/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-11-30 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk.The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition. ### Conditions - Pediatric Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mediterranean diet ### Outcomes Primary Outcomes - Change in Body composition Secondary Outcomes - Dietary compliance with questionnaires - Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome) ### Location - Facility: SCDU Pediatria, AOU Maggiore della Carità, Novara, N/A, 28100, Italy @@
## Reducing Wound Infections Using Bioelectric Wound Dressings - NCT ID: NCT06312267 - Study ID: 1840655 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-03-01 - Lead Sponsor: AdventHealth ### Study Description The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation. ### Conditions - Surgical Site Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Bioelectric dressing ### Outcomes Primary Outcomes - Quantitative bacterial count Secondary Outcomes ### Location - Facility: AdventHealth Celebration, Kissimmee, Florida, 34747, United States @@
## Pharmacological Modulation of Peripheral Nerve Excitability - NCT ID: NCT06312254 - Study ID: N-20230071 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-08 - Lead Sponsor: Aalborg University ### Study Description The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo). ### Conditions - Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Topical lidocaine 5% - Topical Phenytoin 10% - Topical Mepyramine 2% - Topical Placebo ### Outcomes Primary Outcomes - Change in PTT-value Secondary Outcomes ### Location - Facility: Center for Neuroplasticity and Pain, Aalborg, N/A, N/A, Denmark @@
## Metacognitive Training-Silver BeWell in Older Adults - NCT ID: NCT06312241 - Study ID: MCT-Silver BeWell - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2025-12 - Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf ### Study Description The present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.). ### Conditions - Depressive Symptoms - Well-Being, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Metacognitive Training-Silver BeWell ### Outcomes Primary Outcomes - Number of sessions attended Secondary Outcomes - Participants' appraisal of the training - Negative effects questionnaire (NEQ) - Depression (Beck Depression Inventory - II) - Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale) - Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale) - Resilience (Resilience Scale) - Rumination (Ruminative Responses Scale) - Loneliness (UCLA Loneliness scale) - Self-rated health (EQ5D5L Visual Analog Scale ) - Session-specific effects ### Location - Facility: University Medical Center Hamburg-Eppendorf, Hamburg, N/A, 20246, Germany @@
## The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination - NCT ID: NCT06312228 - Study ID: 2023/05 - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2023-10-02 - Lead Sponsor: Tarsus University ### Study Description Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023. Data Collection Form, Wong-Baker pain scale, Fear scale and Buzzy® device were used as data collection tools. Buzzy® and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection, while routine vaccine injection was applied to the children in the control group. Children's pain and fear responses were evaluated by the nurse and parents before and after vaccine injection, and physiological parameters were evaluated by the nurse before and after vaccine injection. ### Conditions - Child, Only ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Helfer Skin Tap - Buzzy ### Outcomes Primary Outcomes - Child Information Form - Wong-Baker Scale (Pain Facial Expression Scale) - Child Fear Scale Secondary Outcomes ### Location - Facility: Tarsus University, Mersin, N/A, 33400, Turkey @@
## Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services - NCT ID: NCT06312215 - Study ID: 1763831 - Status: COMPLETED - Start Date: 2023-05-26 - Completion Date: 2023-10-02 - Lead Sponsor: Tarsus University ### Study Description The study was conducted as a randomized controlled experimental research to examine the effects of open and closed system peripheral catheters on the success of insertion, duration of stay, and development of complications in children aged 1-18 years in pediatric services. The population of the study consisted of children admitted to the Pediatric Services of the Istanbul Faculty of Medicine, and the sample included a total of N=80 children who met the sample criteria and underwent catheter insertion between May 2023 and October 2023. The sample was divided into two groups: closed system peripheral venous catheter group (n=40) and open system peripheral venous catheter group (n=40). The data of the study were collected using a Data Collection Form, Peripheral Venous Catheter Monitoring Form, Visual Infusion Phlebitis Detection Scale, and Pediatric Peripheral Intravenous Infiltration Scale ### Conditions - Child, Only - Catheter Infection - Catheter Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Closed-system catheter ### Outcomes Primary Outcomes - Patient Identification Form - Daily Monitoring Form - Visual Infusion Phlebitis Assessment Scale, Staging Key - Peripheral IV'sVIPAS - Pediatric peripheral intravenous infiltration assessment tool Secondary Outcomes ### Location - Facility: Tarsus University, Mersin, N/A, 33400, Turkey @@
## Drowning Incidents in Danish Harbours - NCT ID: NCT06312202 - Study ID: DROWN_HARBOUR - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning. ### Conditions - Drowning - Drown - Drowning; Anoxia - Drowning, Near - Drowning; Asphyxia - Drowning and Nonfatal Submersion - Drowning or Immersion of Unknown Intent - Drowning and Submersion, Undetermined Intent - Drowning and Submersion While in Natural Water - Drowning and Submersion Due to Sailboat Sinking - Drowning and Submersion Due to Fall Off Ship ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drowning ### Outcomes Primary Outcomes - Yearly incidence of drowning incidents - Fatal to non-fatal drowning ratio Secondary Outcomes - Assess risk factors associated with 30-day mortality ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada - NCT ID: NCT06312189 - Study ID: NBI-98854-HD3022 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Neurocrine Biosciences ### Study Description This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada. ### Conditions - Chorea, Huntington ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Valbenazine ### Outcomes Primary Outcomes - Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Secondary Outcomes ### Location - Facility: Neurocrine Clinical Site, Vancouver, British Columbia, V6T 2B5, Canada @@
## A Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) - NCT ID: NCT06312176 - Study ID: 2870-010 - Status: RECRUITING - Start Date: 2024-04-13 - Completion Date: 2031-04-12 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The purpose of this study is to compare MK-2870 as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.The primary hypotheses are that MK-2870 as a single agent and MK-2870 plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants. ### Conditions - Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MK-2870 - Pembrolizumab - Paclitaxel - Nab-paclitaxel - Capecitabine - Liposomal doxorubicin ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) (MK-2870 versus treatment of physician's choice [TPC]; MK-2870 + pembrolizumab versus TPC) Secondary Outcomes - Overall Survival (OS) - Progression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870) - Objective Response Rate (ORR) - Duration of Response (DOR) - Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) - Change from baseline in physical functioning score, on the EORTC QLQ-C30 - Change from baseline in emotional functioning score, on the EORTC QLQ-C30 - Change from baseline in fatigue score, on the EORTC QLQ-C30 - Change from baseline in diarrhea score, on the EORTC QLQ-C30 - Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30 - TTD in physical functioning score, on the EORTC QLQ-C30 - TTD in emotional functioning score, on the EORTC QLQ-C30 - TTD in fatigue score, on the EORTC QLQ-C30 - TTD in diarrhea score, on the EORTC QLQ-C30 - Number of participants who experience one or more adverse events (AEs) - Number of participants who discontinue study treatment due to an AE ### Location - Facility: Rambam Health Care Campus-Oncology Division ( Site 1452), Haifa, N/A, 3109601, Israel @@
## Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network - NCT ID: NCT06312163 - Study ID: EHRD1001 - Status: COMPLETED - Start Date: 2022-06-06 - Completion Date: 2023-12-15 - Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust ### Study Description The goal of this Prospective, single-site, cohort study is to validate rigid gas permeable corneal contact lens (RGP) designs for keratoconus derived from combining the data from corneal topography scans and contact lenses ordered in patients with keratoconus (KC) attending a UK tertiary NHS Hospital contact lens clinic. The main questions it aims to answer are:* Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients' own lens?* Is the number of trial lenses required to fit a patient is reduced compared to standard practice?* Is the time taken to fit a contact lens is reduced compared to standard practice?* Is there user acceptance of the new lens?* Are the Axial ege lift (AEL) changes clinically significant?There will be 3 work packagesWP1: For each participant data collection will take place over two visits.• Visit 1: Pentacam topography scans and optimal 'virtual' lens selection will take place. • • Visit 2: Participants are fitted with 4 contact lenses (i) the optimal lens design as specified by the virtual fitting module, (ii) a contact lens with a clinically significant step flatter AEL (iii) a contact lens steeper in axial edge lift (AEL) (iv) the participant's own contact lens.Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), Anterior segment OCT MS39) (CSO Hansom Instruments, UK) and best-corrected visual acuity with each lens design using high-contrast logMAR .WP2. Participants will attend one appointment where a traditional lens fit, and a lens fitted using the topography guided 'virtual' module will be undertaken (with the fitting method selected for each eye randomised). For each fitting method the total fitting time will be measured and the total number of trial contact lenses used. Patients will be invited to complete a questionnaire that probes their satisfaction of this process.WP3. Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool. ### Conditions - Keratoconus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design). A CE (UKCA) marked class 2 medical devices. ### Outcomes Primary Outcomes - Rigid gas permeable contact lens fit Secondary Outcomes - The changes in contact lens fit from increased and decreased Axial Edge lift - Best corrected Visual Acuity - Clinician Usability Assessment ### Location - Facility: Moorfields Eye Hospital NHS Foundation Trust, London, N/A, EC1V 2PD, United Kingdom @@
## Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours - NCT ID: NCT06312150 - Study ID: BETA 3 2019 - Status: RECRUITING - Start Date: 2019-12-17 - Completion Date: 2025-12 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Childhood cancers are the third leading cause of death among children between the ages of 1 and 4, and the second leading cause of death among children aged 5-14 years. Biologically, it has been demonstrated that tumour aggressiveness and invasive capacity are caused by genetic modifications and cellular microenvironmental factors in a sequential and multifactorial process. The search for genetic alterations, proteins, or entire intracellular signalling pathways involved in the process of carcinogenesis and metastatisation is always evolving in order to identify new prognostic factors or potential therapeutic targets. In recent years, β-adrenergic receptors (β-ARs) have been associated with tumour progression.This is a multicentre biological samples study which main aim is to evaluate the β3 receptor expression in the peripheral blood of patients with solid tumours compared to a healthy control group. The biological samples collected during the study are: peripheral blood sample, bone marrow aspirate and fresh or fresh paraffin biopsy tumour. ### Conditions - Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Analysis of peripheral blood (control group) - Analysis of biological sample (Substudy-solid neoplasms) - Analysis of biological sample (substudy-leukaemia patients) ### Outcomes Primary Outcomes - Evaluation of β3 receptor expression in the peripheral blood, bone marrow and bioptic samples of patients with solid tumours compared to a healthy control group - Assessment of oxidative stress in peripheral blood samples from enrolled patients Secondary Outcomes - Evaluation of the role of the β3 receptor in apoptosis resistance (substudy) ### Location - Facility: Ospedale San Donato di Arezzo, Arezzo, N/A, N/A, Italy @@
## A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) - NCT ID: NCT06312137 - Study ID: 2870-019 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2034-10-23 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR). ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sacituzumab tirumotecan - Pembrolizumab - Cisplatin - Pemetrexed - Gemcitabine - Carboplatin - Paclitaxel ### Outcomes Primary Outcomes - Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) Secondary Outcomes - Overall Survival (OS) - Distant metastasis-free survival (DMFS) as assessed by investigator - Disease-Free Survival (DFS) as assessed by investigator - Lung Cancer Specific Survival (LCSS) - Number of Participants Who Experience at least One Adverse Event (AE) - Number of Participants Who Discontinue Study Intervention Due to AEs - Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30) - Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5) - Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7) - Change from Baseline in Dyspnea scores (QLQ-C30 Item 8) - Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52) - Change from Baseline in Chest pain scores (QLQ-LC24 Item 40) ### Location - Facility: Mid Florida Hematology and Oncology Center ( Site 0018), Orange City, Florida, 32763, United States @@
## A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer - NCT ID: NCT06312124 - Study ID: 24-006 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2028-03-08 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic. ### Conditions - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - Educational Module - Salpingectomy ### Outcomes Primary Outcomes - Rate of Opportunistic Salpingectomy/OS after completion of educational module Secondary Outcomes ### Location - Facility: Johns Hopkins University (Data Collection Only), Baltimore, Maryland, 21287, United States @@
## Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension (Ph-PAH) - NCT ID: NCT06312111 - Study ID: 62/2021 - Status: COMPLETED - Start Date: 2021-04-22 - Completion Date: 2022-07-17 - Lead Sponsor: Centre of Postgraduate Medical Education ### Study Description Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH) ### Conditions - Pulmonary Arterial Hypertension - Physical Inactivity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - recommendation to increase physical activity ### Outcomes Primary Outcomes - Number of steps per day Secondary Outcomes - Change in 6-minute walk distance - Change in quality of life (SF-36) - Change in the hospital anxiety and depression scale (HADS) - Change in the acceptance of illness (AIS) - Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP) - Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD - Compliance with counting steps ### Location - Facility: Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education, Otwock, Borowa 14/18, 05-400, Poland @@
## Perioperative Factors and Living Donor Liver Transplantation - NCT ID: NCT06312098 - Study ID: KC21RISI0576 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Min Suk Chae ### Study Description Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease. ### Conditions - Liver Transplant Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - remote ischemic preconditioning (RIPC) ### Outcomes Primary Outcomes - Incidence of postreperfusion syndrome Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material. - NCT ID: NCT06312085 - Study ID: EF_5301_V1.0_CIP - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Lumendo AG ### Study Description The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answers is1. To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period.2. To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure.The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year. This is a single-arm study with no comparison groups. ### Conditions - Endodontic Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endofill ### Outcomes Primary Outcomes - Effectiveness of root canal treatment using Endofill Secondary Outcomes - Safety of root canal treatment using endofill ### Location - Facility: Medipol University, Istanbul, N/A, N/A, Turkey @@
## Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi - NCT ID: NCT06312072 - Study ID: 23-019 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2025-12 - Lead Sponsor: Liverpool School of Tropical Medicine ### Study Description Worldwide, the number of people living with long-term health conditions, including chronic kidney disease (CKD), is increasing. CKD is usually asymptomatic in early stages but can progress to advanced disease, including kidney failure, causing significant morbidity and mortality.In low-income countries of sub-Saharan Africa, including Malawi, treatments for kidney failure are not yet widely available and are prohibitively expensive . It is therefore vital to:(a) Prevent development of CKD in the first place (b) Detect CKD earlier so that more cost-effective treatments can be given to slow progression.There is little evidence on factors that drive CKD progression in Malawi, or on interventions that may be cost-effective for improving detection and slowing disease progression in this setting. This PhD will address these knowledge gaps, through the following aims:1) Determine the mortality associated with CKD, and the risk factors driving its development and progression in Malawian adults 2) Investigate the impacts of different models for integrating screening and prevention strategies for CKD and its risk factors into health services for other long-term conditions in low- and middle-income countries 3) With patients, carers, healthcare workers and policy makers, evaluate the feasibility and acceptability of different potential models for integrating CKD screening and prevention strategies into health services for high-risk patient groups in Malawi ### Conditions - Chronic Kidney Diseases - Non-Communicable Chronic Diseases - Non-communicable Disease - Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention; observational study ### Outcomes Primary Outcomes - Aim 1, objective 3 primary outcome measure - Aim 1, objective 2 primary outome measure - Aim 1, objective 1 primary outcome measure: Secondary Outcomes - Aim 1, objective 3 secondary outcome measure 1: - Aim 1, objective 3 secondary outcome measure 2: - Aim 1, objective 3 secondary outcome measure 3: - Aim 1, objective 3 secondary outcome measure 4: - Aim 1, objective 3 secondary outcome measure 5: - Aim 1, objective 3 secondary outcome measure 6: - Aim 1, objective 2 secondary outcome measure: - Aim 1, objective 1 secondary outcome measure: ### Location - Facility: Malawi Epidemiology and Intervention Research Unit, Chilumba, Karonga, P.O. Box 46, Malawi @@
## Goat or Cow Milk Based Infant Formula GMS - NCT ID: NCT06312059 - Study ID: KNC-GMS-002 - Status: RECRUITING - Start Date: 2023-12-14 - Completion Date: 2024-08-15 - Lead Sponsor: Kendal Nutricare Ltd ### Study Description This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF). ### Conditions - Growth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - "Similac® Advance Infant Formula Powder - "Kendamil Cow milk test product - "Kendamil goat milk test product ### Outcomes Primary Outcomes - Growth as compared against WHO growth charts Secondary Outcomes - Safety ### Location - Facility: ObvioHealth USA, Inc., New York, New York, 10001, United States @@

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