pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Dexmedetomidine Improved Oxygenation and Reduced Shunt in One-Lung Ventilation at High-Risk Pediatric Thoracic Surgery
NCT Number: NCT06505772
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: One-Lung Ventilation|Thoracic Surgery
Interventions: DRUG: Dexmedetomidine|DRUG: Normal saline
Sponsor: Damascus University
Collaborators: University Children's Hospital
Sex: ALL
Age: CHILD
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2024-07-01
Locations: University Children's Hospital, Damascus, Syrian Arab Republic

Summary:
Children with high anesthetic risk who underwent Thoracic surgery with OLV (one lung ventilation) technique during general anesthesia were divided into two groups.

The first is an intravenous injection of dexmedetomidine at a rate of 0.4 micrograms/kg/hour as a continuous intravenous infusion. The second group, the placebo group, injected the second with a normal saline solution, an infusion that will pass through the vein, using blinded, unmarked syringes.

Three arterial blood gas (ABG) samples were taken during surgery at designated times. Circulatory PaO2 values were recorded and the Qs/Qt shunt value was calculated.

Primary Outcome Measures: Change in the PaO2, Evaluation of Change in PaO2 During Surgery. PaO2: is Partial Pressure of Arterial Oxygen., four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.|Change in the Qs/Qt, Evaluation of Change in Qs/Qt During Surgery. Qs/Qt: is a Measurement of Pulmonary Shunt. Qs: Blood Flow Through the Shunt, Qt : Total Blood Flow., four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.
Secondary Outcome Measures: Change in the PIP, Evaluation of Change in Peak inspiratory pressure (PIP)., four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.|Change in the MAP, Evaluation of Change in Mean arterial pressure (MAP)., four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.|Change in the HR, Evaluation of Change in Heart Rate (HR)., four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.
Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT
NCT Number: NCT06505759
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Periodontal Pocket
Interventions: DRUG: Bromelain gel|DRUG: chlorhexidine gel|PROCEDURE: SRP
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-07

Summary:
The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis

Primary Outcome Measures: Probing pocket Depth (PPD), measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA, 3 months|Relative attachment level (RAL), (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA), 3 months
Secondary Outcome Measures: Plaque Index, measured on the tooth surface using a probe, 3 months|Gingival index, measured on the tooth surface using a probe, 3 month|Modified Sulcus Bleeding Index, measured on the tooth surface using a probe, 3 months
A Study of Real-world Treatment of Adults With Urothelial Cancer in South Korea and Saudi Arabia
NCT Number: NCT06505746
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Urothelial Cancer
Interventions: OTHER: No intervention
Sponsor: Astellas Pharma Singapore Pte. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2024-10-31

Summary:
Cancer in the bladder lining (urothelial cancer) can be treated in many ways. One way is to directly attack cancer cells. Enfortumab vedotin is a treatment that can do this. Another way is to help the body's immune system find and attack cancer cells. Avelumab is a treatment that can do this. Both treatments were recently approved in some countries.

Doctors have standard clinical practice guidelines to help them treat people with cancer. This study is about collecting information on how adults with urothelial cancer are treated in standard clinical practice. The people in this study will have locally advanced or metastatic urothelial cancer. Locally advanced means the cancer has spread to tissue close by.

Metastatic means the cancer has spread to other parts of the body.

The goal of this study is to learn how people with urothelial cancer receive medical care in clinics in South Korea and Saudi Arabia. The main goals are to learn more about the people receiving treatments, and the treatments they receive.

This study is about collecting information only. The individual's doctor decides on treatment, not the study sponsor (Astellas).

Information will be collected from the people's medical records. This will include 12 months before treatment starts, and during treatment. Also, doctors will answer questions in interviews and surveys about how they care for people with urothelial cancer.

Primary Outcome Measures: Demographics associated with LA/mUC patients at various stages of treatment pathway, Demographics of interest will be recorded., Day 1|Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway, Clinical characteristics of interest will be recorded., Day 1|Therapies received at data collection and any therapies previously received for LA/mUC., Details of current and previous therapies received for LA/mUC will be recorded., Day 1
Secondary Outcome Measures: Healthcare resource utilization of 1L and 2L+ LA/mUC patients, LA/mUC Healthcare resources will be recorded., Day 1|Current molecular/genetic testing patterns in LA/mUC patients, Tumor biomarker, genetic tests results and PD1/PD-L1 expression status will be recorded., Day 1|Current diagnostic tools in LA/mUC patients, Tests and assessments used to diagnosis patient's LA/mUC will be recorded., Day 1
Use of Arthroscopy in Treatment of Acute Pediatric Septic Hip Infection
NCT Number: NCT06505720
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Pediatric Septic Hip Infection
Interventions: PROCEDURE: Arthroscopic management of acute pediatric septic hip infecion|PROCEDURE: Open debridement of acute pediatric septic hip
Sponsor: Hesham Mohamed Elbaseet
Sex: ALL
Age: CHILD
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2027-02-12

Summary:
Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. However, literature is still lacking in actual prospective comparison about the outcome of both methods.

Primary Outcome Measures: Modified Mckay's criteria, Excellent: painless, stable hip; no limp; more than 15 degrees of internal rotation.

Good: painless, stable hip; slight limb or decreased motion , negative Trendelenburg sign Fair: minimum pain; moderate stiffness, positive Trendelenburg sign Poor: significant pain., One Year Follow-up
A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.
NCT Number: NCT06505694
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Stress
Interventions: DIETARY_SUPPLEMENT: Alcohol Alternative Herbal Tincture (Test Product)|DIETARY_SUPPLEMENT: Placebo
Sponsor: Apothekary
Collaborators: Citruslabs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-09
Completion Date: 2024-07-09
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.

Primary Outcome Measures: Improvements in Sleep Quality and Mental Well-Being, Changes in sleep quality, mental well-being, stress, and feelings of anxiety will be assessed using self-assessment questionnaires. Participants will complete these questionnaires at specified intervals throughout the study to evaluate the effectiveness of the herbal tincture compared to the placebo., Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary Outcome Measures: Changes in Sleep Length and Quality, Changes in sleep length and quality will be monitored using a Fitbit sleep tracker. The sleep tracker will collect data on various sleep parameters, including total sleep time and sleep stages, to assess the impact of the herbal tincture compared to the placebo., Baseline, Week 4, and Week 8
Early Diagnosis of Acute Renal Failure by Urine Trehalase Levels.
NCT Number: NCT06505655
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Trehalase Levels|Acute Kidney Injury
Interventions: DIAGNOSTIC_TEST: trehalase levels
Sponsor: Istinye University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-09-15
Locations: Istinye Üniversity, Istanbul, Merkez Mahallesi, 34250, Turkey

Summary:
We think that in surgical patients requiring hypotensive anesthesia, acute kidney injury, which may occur due to intraoperative renal hypoperfusion, can be diagnosed early by evaluating the urine trehalase value using the ELISA method, and thus, early diagnosed acute renal failure can be treated quickly and patients can be protected from subsequent complications in the postoperative period.

Primary Outcome Measures: trehalase levels, urine trehalase levels, 1 month
SOLFA Study to Explore the Thrombogenicity of a Dialyzer
NCT Number: NCT06505616
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End Stage Renal Disease on Dialysis
Interventions: DEVICE: Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it
Sponsor: Fundación Senefro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-17
Completion Date: 2023-05-20
Locations: Hospital Universitario Infanta Leonor, Madrid, 28031, Spain

Summary:
Prospective, multicenter, randomized, crossover, non-masked study to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™.

Primary Outcome Measures: Impact on the thrombogenicity of the haemodialysis circuit by comparing dialyzers, The investigators measure the impact of Solacea membrane on the thrombogenicity of the haemodialysis circuit compared to other high-permeability synthetic dialysers commonly used in clinical practice.

Heparin was progressively reduced until it was discontinued. After each session, investigators carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score. In 8 patients also a scanning technique was carried out., four weeks, carried out in two phases
Secondary Outcome Measures: Effect of heparin reduction or discontinuation, The investigators measure the effect of heparin reduction or discontinuation on vascular access haemostasis time, on dialysis efficacy by measuring KT, on percentage reduction of molecules such as myoglobin or β2-microglobulin, and in the amount of convective volume in patients in OL HDF. During the six sessions of both phases, the dose of heparin was progressively reduced until the last session without heparin. After each session, carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score. In 8 patients also a scanning technique was carried out., four weeks, carried out in two phases
PiMZ Longitudinal Cohort (PiMZ Logic)
NCT Number: NCT06505603
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alpha 1-Antitrypsin Deficiency|Emphysema or COPD
Sponsor: Columbia University
Collaborators: Alpha-1 Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2029-01
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States|University of California- Los Angeles, Los Angeles, California, 90095, United States|National Jewish Health, Denver, Colorado, 80206, United States|University of Chicago, Chicago, Illinois, 60637, United States|Columbia University, New York, New York, 10032, United States

Summary:
Alpha-1 Anti-trypsin Deficiency (AATD) is a genetic disease with lung and liver disease presentations. Presentations are variable in the heterozygous population, the most predominant genotype being PiMZ. The purpose of this study in PiMZ heterozygous patients is to examine the density of the lung as measured by chest computed tomography (CT) and determine if existing emphysema predicts changes in the rate of subsequent emphysema or changes in CT, serum or plasma biomarkers of interest. The overarching goal is to develop biomarkers pertinent to the PiMZ patient that can be used in interventional trials since lung function changes do not typically inform disease progression in AATD.

Primary Outcome Measures: Change in lung density over three years, Change in lung density over three years determined by using the 15th percentile point (PERC-15) of Hounsfield units in inspiratory high resolution CT scans., 3 years|Decline of PERC-15 (15th percentile) over three years, Rate of decline of PERC-15 over three years. PERC-15 provides the Hounsfield unit point below which 15% of all voxels are distributed. The lowest threshold is -1,000 HU. The lower the PERC-15 values are, the more CT-quantified emphysema is present., 3 years
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
NCT Number: NCT06505590
Acronym: STEPPING-STONe
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Diagnosis|Moderate or Severe Score of Cancer-related Fatigue (CRF)
Interventions: DEVICE: Educational content|DEVICE: Educational material plus self-management program - self-administered version|DEVICE: Educational material plus self-management program - guided version with mental health professional
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: University Hospital, Bordeaux|Institut Bergonié
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 372
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-09
Locations: Gustave Roussy, Villejuif, 94805, France

Summary:
Decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of CRF in cancer patients while also gathering data on the implementation strategy.

Primary Outcome Measures: Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient., Compare the effectiveness of standard of care (provided by the patient's cancer center and their treating oncologist) plus three different types of digital aid modalities for the patient (1: educational material; 2: educational material plus self-management program based on a cognitive behavioural therapy strategy - self-administered; 3: educational material plus self-management program based on a cognitive behavioural therapy strategy - guided by a psychologist) in reducing the perceived burden of CRF (cancer-related fatigue), measured as a clinically meaningful change (≥ 6 points) in fatigue scores in the fatigue subscale of the EORTC QLQ C30 questionnaire from baseline to short-term assessments., 3 months and 6 months after the end of the program.
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
NCT Number: NCT06505551
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: HPV-Related Squamous Cell Carcinoma|HPV-Related Cervical Squamous Cell Carcinoma|HPV-Related Vulvar Squamous Cell Carcinoma|HPV-Related Penile Squamous Cell Carcinoma|HPV-Related Vaginal Squamous Cell Carcinoma|HPV-Related Anal Squamous Cell Carcinoma|HPV-Related Head and Neck Cancer
Interventions: BIOLOGICAL: SCG142|DRUG: Cyclophosphamide|DRUG: Fludarabine
Sponsor: SCG Cell Therapy Pte. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-12

Summary:
This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events (Phase 1), Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events., 2 years|Objective response rate (ORR) (Phase 2), The proportion of patients with a complete response (CR) or partial response (PR), 2 years
Secondary Outcome Measures: Objective response rate (ORR) (Phase 1), The proportion of patients with a complete response (CR) or partial response (PR), 2 year|Duration of objective response (DOR) (Phase 1&2), The time from the first occurrence of a confirmed response to disease progression or death from any cause, 2 year|Disease control rate (DCR) (Phase 1&2), The proportion of patients with a CR, PR or stable disease (SD), 2 year|Progression-free survival (PFS) (Phase 1&2), The time from the date of the SCG142 administration to the first occurrence of a progressive disease (PD) or death from any cause, 2 year|Overall survival (OS) (Phase 1&2), The time from date of the SCG142 administration to date of death of any cause, 2 year|Incidence of Treatment-Emergent Adverse Events (Phase 2), TEAEs, 2 years
Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery
NCT Number: NCT06505538
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Symptom Management|Breast Care Nurse|Mobile App|Mobile Health
Interventions: DEVICE: NL-Mapp
Sponsor: Gümüşhane Universıty
Collaborators: Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2019-01-01
Completion Date: 2021-01-01
Locations: Gumushane University, Gumushane, Turkey

Summary:
Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery.

Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate choice to support postoperative self-care.

Methods: This quasi-experimental study aimed to determine the impact of NL-Mapp on breast cancer patients after surgery. The study included 45 patients in the intervention group and 45 patients in the control group. First, NL-Mapp was developed by the research team. Patients were then taught how to use the app to manage their symptoms after breast cancer surgery, and online counseling was provided for patients' questions. The intervention started before surgery, and follow-up visits were made before discharge and in the first month.

Primary Outcome Measures: Function of the affected arm, ASES Shoulder Rating Scale, three months|Body image and sexual adjustment scale, Sexual Adjustment and Body Image Scale, three months|Pain scale, Visual Analog Scale, three months
Secondary Outcome Measures: Quality of life scale, Functional Assessment of Cancer Therapy-Breast, one year
A Study on the Significance of Joint Evaluation of Gastrointestinal Ultrasound Results and Renal Artery Resistance Index for Assessing the Intestinal-renal Syndrome in Sepsis Patients
NCT Number: NCT06505512
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Superior Mesenteric Artery Resistance Index|Renal Artery Resistance Index
Interventions: DIAGNOSTIC_TEST: No intervention
Sponsor: Zhangzhou Municipal Hospital
Collaborators: Climbing project supported by the Doctor's Studio of Zhangzhou Municipal Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-19
Completion Date: 2025-01-31
Locations: Qingjiang Zheng, Zhangzhou, Fujian, 363000, China

Summary:
In this study, the patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. The cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible. To provide reliable objective basis for clinical decision-making, in order to improve the success rate of rescue.

Primary Outcome Measures: superior mesenteric artery resistance index, upon admission into the ICU, and, 24 and 72 hours afterwards|renal artery resistance index, upon admission into the ICU, and, 24 and 72 hours afterwards
Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery
NCT Number: NCT06505499
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy|Gait Disorders in Children
Interventions: OTHER: Gait Profile Score|OTHER: Gait Visual Score
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-06
Completion Date: 2024-12
Locations: Chu de Saint Etienne, Saint Etienne, 42000, France

Summary:
Instrumented three dimensional gait analysis (3DGA) permits to record spatial, temporal, kinetics, kinematics and electromyographic (EMG) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (CP). Nowadays, single-event multilevel surgery in subjects with CP cannot be performed without 3DGA. However, interpretation of multiple and interdependent data remains complex for the clinician. To address this issue, gait statistical index have been developed to give a single measure of the quality of the gait pattern. Among actual index, the Gait Profile Score (GPS), developed by Baker et al (2009), measure the deviation of kinematics parameters from a controlled dataset. The GPS can be divided in nine Gait Variable Score (GVS), corresponding to major lower limb joints: the MAP (Movement Analysis Profile). Many studies have reported the interest of the GPS to analysis gait of subjects with CP: good inter-session reliability, predictor of postoperative kinematic improvement, minimal clinical threshold calculated at 1.6°, significant relationship with clinical data (joint contractures), and sensibility to change after a single-event multilevel surgery.

Primary Outcome Measures: Degrees of Gait Profile Score overall, Analyze Degrees of Gait Profile Score overall, Day 1
Secondary Outcome Measures: Gait Profile Score right, Analyze Gait Profile Score right., Month 2|Gait Profile Score left, Analyze Gait Profile Score left., Year 2
GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC
NCT Number: NCT06505486
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intrahepatic Cholangiocarcinoma
Interventions: DRUG: Gemcitabine-Oxaliplatin Regimen
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2025-07-10
Locations: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangzhou, 510000, China

Summary:
This study aimed to preliminarily evaluate the clinical efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of gemcitabine and oxaliplatin (GEMOX) plus systemic gemcitabine chemotherapy (GEM-SYS) combined with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor in patients with large unresectable intrahepatic cholangiocarcinoma (uICC). Large uICC patients who underwent GEMOX-HAIC (Day 1) and GEM-SYS (Day 8) (3w/cycle) combined with lenvatinib and PD-1 inhibitor between November 2019 and December 2022 were enrolled. Clinical data were retrospectively collected to analyze local tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. AEs were evaluated by the common terminology criteria for adverse events (CTCAE) version 5.0. In this study, OS was the primary endpoint, and progression-free survival (PFS) was the secondary endpoint.

Primary Outcome Measures: Overall survival(OS), OS was calculated as the duration from the date of the first cycle of GEMOX-HAIC+GEM-SYS to the date of death or last date of follow-up., 1-, 2-, and 3-year
Secondary Outcome Measures: Progression-free survival (PFS), PFS was defined as the duration from the date of the first cycle of GEMOX-HAIC+GEM-SYS to tumor lesion progression, death, or last follow-up, whichever came first., 1-, 2-, and 3-year
PICU-related Sleep and Circadian Dysregulation Pilot Study
NCT Number: NCT06505447
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Circadian Dysrhythmia|Sleep Disturbance|Critical Illness|Children, Only
Interventions: OTHER: Daytime light exposure|OTHER: Daytime restricted feeding
Sponsor: State University of New York at Buffalo
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-01-01

Summary:
A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.

Primary Outcome Measures: Feasibility of monitoring the sleep and circadian rhythm of critically ill children, The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays, PICU Day 1 through 4
Secondary Outcome Measures: Feasibility of providing daytime light exposure, Feasibility will be defined by the percentage of days when DLE was implemented and the average hours of DLE provided using a bedside DLE log, PICU Day 2 through 4|Feasibility of restricting nutrition to daytime hours, . The feasibility of daytime restricted feeding will be determined by the percentage of enteral or parenteral nutrition that was provided on each study day outside of the child's daytime feeding period determined by the Intake and Output records in the EMR, PICU Day 2 through 4
A Dynamic Study of Pupil Diameter After Artificial Lens Implantation in Patients With High Myopia
NCT Number: NCT06505434
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cataract
Interventions: PROCEDURE: Cataract surgery
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-01-01

Summary:
Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. With accurate biological measurements and the implantation of appropriate IOLs, most cataract patients can achieve good distance vision after surgery. However, it should not be overlooked that the current global prevalence of myopia is over 28.3% and is expected to reach 49.8% by 2050, while the rate of high myopia will increase from the current 4.0% to 9.8%. The prevalence of cataracts is significantly higher in the highly myopic population than in the orthoptic population.

The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL. It has been shown that the diameter and sensitivity of the pupil in patients with high myopia are also significantly different from those in the orthopneic population, and that there is a correlation with the adjustment status and refractive error. The purpose of this study is to investigate the following: 1. Whether the change of refractive status before and after IOL implantation in highly myopic cataract patients will lead to the change of pupil physiological characteristics, and whether the modification of preoperative measurement parameters can expand the population of myopic patients who can be reasonably applied to the functional IOL and obtain a high degree of satisfaction from patients. 2. Pupil diameter under a single fixed light source is a rough assessment for the screening of the population for functional IOLs, and this study was conducted in a single fixed light source. In this study, we measured the maximum value of pupil diameter, minimum value of pupil diameter, and rate of change of pupil diameter under bright vision and dark vision, and analyzed the correlation between the above three parameters and visual quality to further optimize the objective index of pupil diameter for the screening of functional IOL applicants.

Objectives of the study

1. To observe the dynamic changes of pupil diameter and its visual quality before and after lens extraction combined with IOL implantation in myopic patients, and to analyze the correlation between the changes of pupil diameter and visual quality;
2. To explore the patterns of refractive error and pupil biometric changes in myopic patients before and after IOL implantation, and to make corrections for the evaluation of preoperative biometric indexes for reference.

Primary Outcome Measures: pupil size, pupil size before and after surgery, 1 week ,1 month, 3 months
Eccentric Exercise and Fatigue in Multiple Sclerosis
NCT Number: NCT06505421
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis|Fatigue
Interventions: BEHAVIORAL: Resistance training
Sponsor: Hunter College of City University of New York
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-12-30
Locations: Hunter College, Physical Therapy Department, City University of New York, New York, New York, 10010, United States

Summary:
The goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: is eccentric resistance training more fatiguing than traditional resistance training in persons with MS?. Participants will be asked to come for two sessions for two weeks. In the first week, subjects will undergo a bout of either traditional or eccentric resistance training. The next day they will return to assess their level of fatigue. The following week the subject will return and undergo whatever type of training they did not experience the first week, and it's effects on fatigue will again be assessed. The difference between the subjects level of fatigue for either condition will be compared.

Primary Outcome Measures: 6-Minute walk test, Subject walks at best possible pace with or without assistive device for 6 minutes. Total distance walked as well as distance per minute is measured, Pre-intervention and post intervention for each condition (eccentric and traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition
Secondary Outcome Measures: Visual analog scale of fatigue, Immediately before and after each 6 minute walk subjects will make a mark on a 100mm line indicating their level of fatigue, Pre-intervention and post-intervention for each condition (eccentric vs traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition
A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)
NCT Number: NCT06505395
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastrointestinal Neuroendocrine Pancreatic Tumor
Interventions: DRUG: SYHX2008 injection|DRUG: Sandostatin LAR@
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2028-08-01
Locations: Chinese PLA General Hosptial, Beijing, Beijing, 100853, China

Summary:
The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.

Primary Outcome Measures: Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC), PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first), Up to 1 years following the last patient enrolled
Secondary Outcome Measures: Overall survival (OS), The time from the date of randomization to the date of death due to any cause, Up to 1 years following the last patient enrolled|PFS as assessed by local Investigators, PFS as assessed by local Investigators, Up to 1 years following the last patient enrolled|Overall response rate(ORR), The proportion of patients with best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1, Up to 1 years following the last patient enrolled|Disease control rate (DCR), The proportion of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST 1.1, Up to 1 years following the last patient enrolled|Duration of response (DOR), The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, according to RECIST 1.1, Up to 1 years following the last patient enrolled|Time to Tomor Progression(TTP), TTP is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1, Up to 1 years following the last patient enrolled|Control of cancer-like symptoms (diarrhea and/or flushing), Assess the total occurrences of diarrhea and/or flushing ( cancer-like symptoms): Evaluate every 8 weeks (±3 days) for the first 12 months following the initial dosage, then every 12 weeks (±7 days). This assessment is based on the total instances of diarrhea and/or flushing episodes within the 7 days preceding the assessment visit., Up to 1 years following the last patient enrolled|Incidence of treatment-emergent adverse events, Incidence of treatment-emergent adverse events, Up to 1 years following the last patient enrolled
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association With Disease Stage
NCT Number: NCT06505356
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer|Prostate Inflammation
Interventions: PROCEDURE: Prostate biopsy
Sponsor: Edgaras Burzinskis
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2028-08-30

Summary:
1. Identify the local inflammatory response in prostate tissue and the systemic response in the blood of patients with prostate cancer, depending on the stage of the disease, and evaluate their prognostic value.
2. Identify the spectrum of microorganisms and antibiotic resistance in patients with prostate cancer prior to prostate biopsy, and assess the risk of complications when using Ciprofloxacin and Fosfomycin.
3. Determine the significance of GAS5, JAZF1, and CTBP2 gene polymorphisms in the development of prostate cancer.
4. Evaluate the association of a specific gene polymorphism with the clinical course of the disease in patients with prostate cancer.

Primary Outcome Measures: Inflammatory markers' effect on prostate cancer aggressiveness, Aim: Assess if selected inflammatory markers are linked to prostate cancer aggressiveness by measuring their concentrations and analyzing correlations with disease severity.

Markers:

6Ckine (CCL21) Eotaxin (CCL11) Fractalkine (CX3CL1) IFN gamma IL-2 IL-6 IL-8 (CXCL8) IL-10 IL-18 MIP-3 beta (CCL19) PDGF-BB TNF alpha

Objectives:

1. Measure marker levels in blood samples.
2. Investigate links between marker levels and cancer aggressiveness.
3. Use Gleason score, seminal vesicles invasion, and lymph nodes invasion.

Outcomes:

Identify markers linked to aggressiveness. Develop prognostic tools or therapies. Categorize patients by risk. This study aims to understand inflammation's role in prostate cancer and identify biomarkers for predicting aggressiveness., 2 weeks|Genetic polymorphism markers' effect on prostate cancer aggressiveness, Genetic Polymorphism Markers' Effect on Prostate Cancer Aggressiveness

Objectives:

1. Examine GAS5, JAZF1, CTBP2 polymorphisms and their variations in patients.
2. Measure polymorphism levels and their relationship with cancer aggressiveness.
3. Correlate polymorphisms with Gleason score, seminal vesicles invasion, and lymph nodes invasion.

Expected Outcomes:

* Identify markers linked to aggressiveness.
* Provide insights for genetic tests.
* Understand molecular mechanisms and develop therapies. This study clarifies the role of genetic polymorphisms in prostate cancer aggressiveness, aiding prognosis and treatment., 2 weeks
Effect of Freezing Phenomenon in Patients With Parkinson's Disease
NCT Number: NCT06505343
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Patients With Parkinson's Disease
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-06
Completion Date: 2024-07-10
Locations: Hacettepe University, Ankara, Turkey

Summary:
Although the literature review indicates that plantar pressure may be related to freezing, there are not enough studies examining the effect of freezing phenomenon on pedobarographic pressure distribution and gait parameters. Therefore, the aim of our study is to examine the effect of freezing phenomenon on gait parameters and pedobarographic pressure distribution in patients with Parkinson's Disease.

Primary Outcome Measures: Computerized Gait Evaluation System, This system allows the measurement of spatiotemporal features of gait., Baseline|Pressure distribution measurement platform, This system allows the measurement of dynamic foot pressure distribution with the pressure distribution measurement platform integrated into the system, Baseline|Kinematic analysis, Kinematic analysis of the gait can be performed with the camera support within the system., Baseline|The freezing of gait questionnaire, This scale is a scale that evaluates freezing. This scale is related to patients' experiences, especially in the last week. One article describes the frequency of freezing seen in patients., Baseline
Artificial Intelligence for Early Detection of Peripheral Artery Disease
NCT Number: NCT06505317
Acronym: (AID-PAD)
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Arterial Disease
Interventions: DIAGNOSTIC_TEST: AI-based PAD screening intervention
Sponsor: University of California, San Diego
Collaborators: Stanford University|National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7800
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2026-07-01
Completion Date: 2028-06-30

Summary:
The goal of this clinical trial is to test an AI-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level.

Primary Outcome Measures: PAD Diagnosis Rate, The primary outcome will be counted at a clinic and site level and will include number of new abnormal ABI tests (ABI\< 0.9), and new diagnosis codes, procedures or affirmative text mentions for PAD for patients without a previous diagnosis, During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.
Secondary Outcome Measures: Initiation of secondary prevention measures, New prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level time period., During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.
Long-term Management of Patients With Ruptured HCC
NCT Number: NCT06505291
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Sponsor: University Hospital, Caen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 112
Study Design: Observational Model: |Time Perspective: p
Start Date: 2008-01-01
Completion Date: 2024-04-30

Summary:
The main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008.

Primary Outcome Measures: Survival after rupture of hepatocellular carcinoma, 15 years
A Study to Evaluate Skin and Plasma Pharmacokinetic of Multiple Doses of Povorcitinib After Oral Administration in Healthy Participants
NCT Number: NCT06505265
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: Povorcitinib
Sponsor: Incyte Corporation
Sex: ALL
Age: ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2024-10-05
Locations: Celerion, Inc, Lincoln, Nebraska, 68502, United States

Summary:
The purpose of this study is to measure the effect of multiple doses of orally administered povorcitinib on skin PK and to characterize plasma PK parameters of povorcitinib following multiple doses of orally administered povorcitinib.in healthy participants.

Primary Outcome Measures: Pharmacokinetic (PK) in dermal povorcitinib, Povorcitinib concentration in dermal., Up to Day 17|PK in plasma povorcitinib, Povorcitinib concentration in plasma., Up to Day 17
Secondary Outcome Measures: Number of participants with Treatment-emergent Adverse Events (TEAEs), Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment., Up to Day 30|Additional povorcitinib PK parameters in plasma, Additional povorcitinib concentration in plasma., Up to Day 17
Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study
NCT Number: NCT06505252
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Suppurative Otitis Media
Interventions: PROCEDURE: enoscopic Myringoplasty
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-10-10

Summary:
This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:

1. Evaluation of the graft uptake rate.
2. Evaluation and comparing audiological outcomes.
3. Finding out intraoperative and postoperative morbidity.

Primary Outcome Measures: graft taking, Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly., 3 months
Secondary Outcome Measures: Audiotympanogram, effect on hearing by using Audiotympanogram will be done three months post-operative, 3 months|Otorrhea, presence or absence of otorrhea by history and ear examination, 1 month