pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
NCT Number: NCT06477224
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy (CP)
Interventions: OTHER: Scooter Board Activities|OTHER: Routine Physical Therapy
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-07-25

Summary:
This study is a randomized control trial exploring the therapeutic effects of scooter board activities on neck control and dysphagia in children with cerebral palsy (CP). Part of a Master of Science in Physical Therapy program, the research focuses on innovative uses of scooter boards-flat, wheeled platforms that allow children to propel themselves while lying or sitting. This activity is hypothesized to improve neck stability and swallowing functions, which are crucial for posture, movement, and reducing health risks such as malnutrition and aspiration pneumonia.

The trial will employ validated tools like the Eating and Drinking Ability Classification System (EDACS), Schedule for Oral Motor Assessment (SOMA), and Gross Motor Function Measure (GMFM) to assess changes in participants. Conducted over six months at facilities including Rehab Care, Rich Care, and Royal College Hospital, it will involve 22 children, aged 6-10, diagnosed with spastic CP and exhibiting symptoms of dysphagia.

The outcomes of this research could revolutionize therapeutic practices by providing a playful, engaging approach to therapy that enhances both motor and social skills.

Primary Outcome Measures: Gross Motor Function Measure (GMFM), The GMFM will help quantify the extent of improvement in neck control among participants, determining the effectiveness of the scooter board activities compared to routine physical therapy. This measure is crucial as effective neck control is fundamental for posture, movement, and various daily activities, thereby impacting the quality of life and functional independence of children with cerebral palsy. Total the scores from each category. The maximum possible score will depend on the number of categories included and the scoring range for each. A higher overall score generally indicates better oral motor functioning. Low scores in specific areas may indicate the need for targeted intervention., 6 weeks
DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma
NCT Number: NCT06477211
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Adenocarcinoma|Surgery|Prognostic Cancer Model
Sponsor: Nanjing University
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|Peking Union Medical College Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-01
Completion Date: 2024-12
Locations: Nanjing Drum Tower hospital, Nanjing, Jiangsu, 210008, China

Summary:
This study is designed to assess DNA 5-methylcytosine (5mC) methylation modifications in lung adenocarcinoma (LUAD) samples and develop a prognosis-predictive model for LUAD based on cancer tissue DNA 5mC levels. The research will link post-surgical recurrence and survival outcomes to the DNA 5mC profiles of patients. By collaborating with two hospitals in China, this multicentral study will utilize over three years of prognostic data from LUAD patients to validate the model's accuracy. Additionally, the research aims to explore the potential of the model in guiding adjuvant treatment strategies by comparing the differences in outcomes between high-risk patients who receive further treatment and those who do not. This study aspires to enhance future treatment planning for LUAD patients, providing personalized and effective therapeutic options based on precise prognostic predictions.

Primary Outcome Measures: Overall survival, Subjects will be divided into high-risk and low-risk groups based on the DNA methylation model. The overall survival (OS) of these two groups will be compared to determine if there is a significant difference. Additionally, we will analyze whether there are significant differences in OS between high-risk and low-risk groups that received further treatment and those that did not., 4years and/or 5years after surgery completion
Secondary Outcome Measures: Disease-free survival, Subjects will be divided into high-risk and low-risk groups based on the DNA methylation model. The disease-free survival (DFS) of these two groups will be compared to determine if there is a significant difference. Additionally, we will analyze whether there are significant differences in DFS between high-risk and low-risk groups that received further treatment and those that did not., 4-year and/or 5-year after surgery completion
QLB vs ESPB for Lumbar Spinal Surgery
NCT Number: NCT06477198
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbar Disc Herniation
Interventions: OTHER: QLB|OTHER: ESPB|OTHER: Postoperative analgesia management
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2024-10-22
Locations: Istanbul Medipol University Hospital, Istanbul, Bagcilar, 34070, Turkey

Summary:
Ultrasound-guided quadratus lumborum block (QLB) is a fascial plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle to anesthetize the thoracolumbar nerves.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. It has been reported that ESPB provides lumbar analgesia at T10-12, L3.

This study aims to compare US-guided ESPB and posterior QLB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery.

Primary Outcome Measures: Postoperative pain scores (NRS-Numerical Rating Scala), Change from Baseline Pain Scores at Postoperative 24 hours, Postoperative 24 hours period
Secondary Outcome Measures: The use of rescue analgesia (number of participants), Tramadol using, Postoperative 24 hours period|The use of rescue analgesia (rate of tramadol using), Tramadol using, Postoperative 24 hours period
Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures
NCT Number: NCT06477172
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Post Procedural Erythema
Sponsor: Acorn Biolabs Inc.
Sex: ALL
Age: ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2025-02

Summary:
Non-interventional, multi-site, prospective, open-label, observational, real-world study of autologous hair follicle secretome use.

Primary Outcome Measures: Post-Procedure Symptoms, Symptoms of redness, swelling, oozing, pain, tenderness, crusting, itching and discoloration will be measured using a 1-10 likert scale with 0 being best possible and 10 being worst imaginable., 1-7 days|Downtime Questionnaire, Questionnaire asking what activities would they have done, if it were not for their face appearance. Date of end of downtime captured., 1-7 days
Milk Thistle Clinical Trial in Pediatric NAFLD
NCT Number: NCT06477146
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD)
Interventions: DRUG: Milk thistle (MT)|DRUG: Placebo|BEHAVIORAL: Lifestyle Modification|DEVICE: Fibroscan
Sponsor: Thomas J Sferra, MD
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2026-01-31
Locations: University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States

Summary:
Pediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.

Primary Outcome Measures: Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test., Up to 12 weeks|Hepatic Stiffness (kilopascal, kPa) as measured by FibroScan., Normal kPa results are usually between 2 and 7 kPa, with the highest possible result of 75 kPa., Up to 12 weeks|Percent of Hepatic Steatosis as measured by FibroScan., Percentage of steatosis will be correlated with the CAP score- 200 to 400db/m2, Up to 12 weeks
Secondary Outcome Measures: Number of adverse events as measured by patient report., Up to 12 weeks
Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
NCT Number: NCT06477133
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Prostatectomy
Interventions: DRUG: Magnesium sulfate
Sponsor: NYU Langone Health
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2025-06
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
The purpose of this clinical trial is to determine if receiving magnesium sulfate as an adjunctive analgesic for prostate surgery is effective in reducing pain. Subjects will be randomized to receive magnesium or not receive it, as part of a standardized general anesthetic for prostate surgery. The primary objective is to demonstrate improved pain scores in patients receiving magnesium sulfate as an adjunctive analgesic during surgery. Secondary objectives include demonstrating reduced requirements for other opioids, reduced postoperative shivering, improved discharge home and adequate neuromuscular blockade reversal, measured by quantitative train of four monitoring.

Primary Outcome Measures: Pain score, Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain., 30 minutes after awakening from anesthesia
Secondary Outcome Measures: Pain score, Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain., 60 minutes after awakening from anesthesia|Pain score, Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain., 120 minutes after awakening from anesthesia|Number of participants who experienced nausea or vomiting, Up to 120 minutes after awakening from anesthesia|Number of participants who experienced postoperative shivering, Up to 120 minutes after awakening from anesthesia|Number of participants who received analgesics in the post anesthesia care unit (PACU), Through PACU stay, on average 2 hours|Time to administration of analgesics, From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative|Dose of opioid analgesia given, Dose of opioid analgesia given will be measured in milligram morphine equivalents, Through PACU stay, on average 2 hours|Number of patients who were admitted to the hospital, From PACU admission to discharge, up to 120 minutes postoperative|Number of patients who were discharged home, From PACU admission to discharge, up to 120 minutes postoperative|Train-of-four (TOF) ratio, Train- of-four ratio (TOF) is the ratio of the fourth muscle response to the first one., TOF ratios will be measured for the duration of the operation, approximately 3 hours
KLEx Versus FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism
NCT Number: NCT06477081
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia|Astigmatism|Myopic Astigmatism
Interventions: PROCEDURE: FS-LASIK procedure|PROCEDURE: KLEx
Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-03-01

Summary:
FemtoLASIK is a type of laser eye surgery used to correct vision problems such as nearsightedness, farsightedness, and astigmatism. It involves two main steps: creating a flap and reshaping the cornea. Refractive lenticule extraction, (KLEx) is another laser eye surgery method to correct vision issues, which involves creating and extracting a lenticule without the need of a flap. The investigators will evaluate and compare the efficacy and safety of these two procedures.

Primary Outcome Measures: Uncorrected Visual Acuity, Visual acuity without correction after surgery., Day 1, week 1, months 1, 3, 6 & 12th after surgery.
Secondary Outcome Measures: Postoperative spherical equivalent, Overall refractive power that has both spherical and cylindrical components., Day 1, week 1, months 1, 3, 6 & 12th after surgery.|Corrected Distance Visual Acuity, Visual acuity after surgery with refractive correction, Day 1, week 1, months 1, 3, 6 & 12th after surgery.|Loss of 2 or more lines of BCVA, Loss of 2 or more lines of best corrected visual acuity, Day 1, week 1, months 1, 3, 6 & 12th after surgery.|Eyes with 0.5 Diopters within refractive target., Proportion of eye within 0.5 Diopters of refactive target., Day 1, week 1, months 1, 3, 6 & 12th after surgery.
Other Outcome Measures: Adverse events., Dry eye, haze, flap complications, diffuse lamellar keratitis, corneal ectasia, epithelial ingrowth, or any other adverse event., Through study completion, an average of 1 year
Effect of a Medication Reminder Mobile Application
NCT Number: NCT06477068
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility
Interventions: COMBINATION_PRODUCT: Mobile medical reminder application
Sponsor: Hung Vuong Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 387
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2025-02-28
Locations: Hung Vuong, Ho Chi Minh, 70000, Vietnam

Summary:
The goal of this clinical trial is to evaluate of effectiveness when using the "telemedicine medication reminder app on smartphones" at the Infertility Department of Hung Vuong Hospital. The main questions it aims to answer are:

Comparison of the medication forgetting rate between the group of patients using the product and the group of patients not using the app.

Assessment of the level of patient satisfaction when using the app. Comparison of the quantity and quality outcomes of eggs between the group of patients using the app and the group of patients not using the app.

Participants will:

Using or not using " "telemedicine medication reminder app on smartphones" Record the number of cycle cancellations, number of missed doses, satisfaction rates, number of retrieved oocytes, number of mature oocytes, number of immature oocytes, and number of abnormal oocytes.

Primary Outcome Measures: Medication non-adherence rate, Comparison of the medication non-adherence rate (in percentage) between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application.

The medication non-adherence rate is calculated as the number of times the medication was forgotten divided by the total number of prescribed medication doses.

Unit of measure: Percentage (%), 6 months|Grading on Mobile Application Rating Scale, Assessment of the mobile medical reminder application quality will be graded following the Mobile Application Rating Scale (MARS). MARS includes a set of questions that are graded by users. Users will rate the app on a scale from 1 to 5. The average MARS score will be used.

Unit of measure: Quality score (MARS), 6 months
Secondary Outcome Measures: Total retrieved oocytes, The number of oocytes retrieved will be recorded and compared between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application.

Unit of measure: Count (number), 6 months|Total mature oocytes, The number of retrieved mature oocytes will be recorded and compared between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application Unit of measure: Count (number), 6 month|Total abnormal oocytes, The number of retrieved abnormal oocytes will be recorded and compared between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application Unit of measure: Count (number), 6 month
The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer
NCT Number: NCT06477055
Acronym: RAISE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Osimertinib
Sponsor: Hunan Province Tumor Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-06-15

Summary:
This is a phase II, prospective, multicenter, study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC.

Primary Outcome Measures: Recurrence gene profiles, To assess the recurrence gene profiles of adjuvant Osimertinib therapy, Time from first subject dose to study completion, or up to 36 month
Secondary Outcome Measures: Recurrence gene profiles in patients with different recurrence types (local /distant), To explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy, Time from first subject dose to study completion, or up to 36 month|Subsequent treatment patterns, To describe the diverse treatment patterns (Osi or other EGFR TKIs，± chemo) in real clinical practice after the disease progressed, Time from first subject dose to study completion, or up to 36 month
Other Outcome Measures: Recurrence gene profiles per DFS difference, To explore the different recurrence gene profiles associated with clinical efficacy (DFS) in tumour or blood samples, Time from first subject dose to study completion, or up to 36 month
Act on Quality of Life in Patients With aortIc Stenosis
NCT Number: NCT06477042
Acronym: ALPINIST
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Aortic Stenosis
Interventions: OTHER: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2027-09-15
Locations: Service de Cardiologie - CHU Clermont Ferrand, Clermont-Ferrand, 63000, France|Service de Cardiologie, Lille, 59000, France|Service de Cardiologie, Lyon, 69004, France|Service de Cardiologie - Institut Thorax Nantes, Nantes, 44000, France

Summary:
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions. The prognosis is poorly, with survival rates of only 15-50% at 5 years. AS has a major impact on quality of life, with severely limiting symptoms (dyspnea, chest pain,...) often leading to repeated hospitalizations. It is the most common valvular disease in Europe and North America, and its prevalence is increasing as the population ages. In Europe, 17% of the population is aged 65 or over; in France, this proportion will reach 30% by 2030, corresponding to 16 million people. The incidence of aortic valve sclerosis (early stage AS) is around 25% at age 65, rising to 48% after age 75. The prevalence of aortic valve disease is likely to continue to rise, given the expected evolution of the age pyramid.

There is no medical treatment able to slow down the degenerative process of the valve, and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention. Aortic valve replacement has historically been performed surgically, with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis. Now Transcatheter Aortic Valve Implantation (TAVI) has replaced this procedure. This involves inserting a bioprosthesis crimped into a stent via an endovascular route, i.e. without opening the thorax. Deployment of the stent crushes the native valve, leaving the functional bioprosthesis in place.

Initially developed for patients contraindicated to surgery, TAVI is now offered as a first-line treatment for patients aged 75 and over.

Inexistent before 2010, the number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).

Primary Outcome Measures: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score variation between the 2-months visit and inclusion., Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) between the 2-month early visit and inclusion in the poor-prognosis group. The KCCQ-12 contains four subdomains: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status, Day 0 and Month 2
Examination of Transcranial Focused Ultrasound on Brain Activity in Adults
NCT Number: NCT06477029
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Impulsive Behavior
Interventions: DEVICE: tFUS|DEVICE: Sham tFUS
Sponsor: Mary Phillips, MD MD (Cantab)
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 31
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-15
Completion Date: 2026-03-15
Locations: UPMC, Pittsburgh, Pennsylvania, 15213, United States

Summary:
The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity in healthy adults.

Primary Outcome Measures: Ventral striatum (VS) activity to prediction error before receiving tFUS to the VS, Measure of ventral striatum (VS) activity to prediction error before receiving tFUS to the VS, Two visits over up to 8 weeks|Ventral striatum (VS) activity to prediction error after receiving tFUS to the VS, Measure of ventral striatum (VS) activity to prediction error after receiving tFUS to the VS, Two visits over up to 8 weeks
OsciPulse D-dimer Pilot Trial
NCT Number: NCT06477016
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke
Interventions: DEVICE: OsciPulse|DEVICE: Intermittent Pneumatic Compression
Sponsor: University of Pennsylvania
Collaborators: OsciFlex LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-09
Locations: HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
Pilot, randomized, non-blinded clinical trial to generate preliminary data to evaluate the impact of the OsciPulse system on serum d-dimer levels compared to standard of care intermittent compression therapy for DVT prophylaxis in patients admitted in the neuro ICU or intermediate neurological care unit with acute ischemic stroke.

Primary Outcome Measures: Change in serum d-dimer levels., Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge, 7 days
Secondary Outcome Measures: Tolerability of the OsciPulse device in the stroke population, Tolerability defined as the number of patients who stop using the device prior to clinical recommendation and by quantitative scoring of subject experience questionnaires., 7 days|Safety of the OsciPulse device in the stroke population, Comparison of the rate of Adverse Events (AE) between the two groups., 7 days
Food Rx + Community Health Worker
NCT Number: NCT06476990
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Type 2
Interventions: BEHAVIORAL: Healthy food box
Sponsor: University of Kansas Medical Center
Collaborators: Blue Cross Blue Shield
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 47
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-14
Completion Date: 2022-05-03
Locations: University of Kansas Medical Center, Kansas City, Kansas, 66106, United States

Summary:
Food insecurity increases an individual's risk of poor health outcomes from some of the most costly and preventable chronic diseases, including type 2 diabetes. The goal of this interventional pilot study is to see if primary care patients with self-reported food insecurity and a diagnosis of type 2 diabetes who receive 12 weekly home deliveries of fresh produce and diabetes-appropriate, shelf-stable food will have improved diabetes management. Half of these patients also received support from a community health worker (CHW) including nutrition and cooking education and tailored assistance accessing food resources and other social needs (example: transportation). The investigators hypothesized that participants receiving support from a CHW along with food boxes would have greater improvement in health outcomes compared to those participants who received only food.

Primary Outcome Measures: Change from baseline in average blood glucose, as measured by Hemoglobin A1C, Hemoglobin A1C point of care test, Baseline, 3 months, 6 months
Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
NCT Number: NCT06476964
Acronym: StratiKA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Cancer
Interventions: PROCEDURE: skin biopsies
Sponsor: University Hospital, Bordeaux
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-04
Completion Date: 2026-07-31
Locations: University Hospital of Bordeaux - Department of Dermatology, Bordeaux, 33000, France

Summary:
A collection of biological samples (skin) will be created to meet the objectives. Skin biopsies will be taken (excluding on face and fold), in accordance with standard practice.

Primary Outcome Measures: Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue, Evaluation of metabolic changes involved in cSCC progression, Day 1|Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated., Characterization of the immune cells infiltrate Expression of multiple immune cell markers will be assessed in samples from different subtypes of cSCC by single cell RNA sequencing., Day 1
Secondary Outcome Measures: percentage of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10, Evaluation of skin differentiation markers, Day 1|percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index, Evaluation of cSCC aggressiveness markers with the percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index, degree of differentiation, invasion beyond subcutaneous fat, perineural invasion, vascular invasion level of infiltration following immunohistochemistry analyses on formalin-fixed paraffin-embedded tissue sections., Day 1|percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test), Evaluation of cancer proliferative features on skin biopsies with percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test) and cell cycle progression (flow cytometer, western)., Day 1
Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment
NCT Number: NCT06476925
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Open Mitral Cardiac Surgery
Interventions: PROCEDURE: sonar guided stellate ganglion injection|PROCEDURE: sonar guided stellate ganglion block
Sponsor: Minia University
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-02-20

Summary:
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.

Primary Outcome Measures: Number of patients with microscopic myocardial injury, Biopsy from left papillary muscle to investigate microscopic evidence of cellular injury ( cytoplasmic oedema, hemorrhage and necrosis)., intra-operative
Secondary Outcome Measures: Intra-operative arrhythmia, incidence of intraoperative atrial fibrillation, intraoperatively|postoperative arrhythmia, Incidence of post operative atrial or ventricular arrhythmia, first, second and third day after bypass|Troponin I, Serum troponin I to diagnose myocardial injury, before operation, immediately after ICU admission and 3 days post-operative|Myocardial function, Ejection fraction, pre-operative, one week|weaning from mechanical ventilation, Time from ICU admission till successful extubation, 24 hours post-operative|Time of cardiopulmonary bypass, Intraoperative|Length of ICU stay, one week|Need for pacing, intraoperative and one week after
Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Parkinson Disease and Anxiety
NCT Number: NCT06476912
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: weight-shifting exercise
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-13
Completion Date: 2026-07-31
Locations: School and graduate institute of physical therapy, Taipei, Taiwan

Summary:
Postural balance and anxiety are the two critical factors for reducing independence and quality of life in patients with Parkinson's disease (PD). Anxiety would deteriorate balance and gait dysfunction. Especially, relative to non-constraint condition, PD patients with anxiety had greater increases in anxiety level and balance/gait impairment in time-constraint or space-constraint condition than PD patients without anxiety. Presently, the appropriate managements for reducing anxiety in patients with PD had not been comprehensively investigated. Vagus nerve stimulation (VNS) is one kind intervention of neuromodulation. Previous studies showed that VNS could reduce anxiety level for patients with anxiety syndrome. In addition, motor training with VNS could reinforce training benefits due to facilitation of brain plasticity. However, there is no study investigating the effect of VNS on anxiety in PD. Also, the effect of combined exercise training and VNS on balance and gait in PD has not been studied. With the use of behavior performance, skin conductance response, and electroencephalogram (EEG) measurement, the purpose of the 3-year research project is to investigate the effects of VNS on anxiety and balance/gait control in patients with PD. In the first year, we will investigate the immediate effect of VNS on anxiety and weight-shifting performance in conditions with time constraint and space constraint. In the second and third years, we will the investigate long-term effects of combined exercise training and VNS on anxiety level, weight-shifting and walking performance in time constraint condition and space constraint condition, respectively. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of anxiety and balance control with VNS, but to optimize rehabilitation strategy for PD patients with anxiety.

Primary Outcome Measures: EEG relative power, brain excitability, 10 minutes
Secondary Outcome Measures: Weight-shifting tracking error, behavior performance, 10 minutes|Skin conductance level, sweat gland activation, 10 minutes
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy
NCT Number: NCT06476899
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: CLL/SLL
Interventions: DRUG: orelabrutinib|DRUG: FCR/BR|DRUG: BTK inhibitor
Sponsor: Fei Li
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-24
Completion Date: 2026-12-26

Summary:
Prospective, interventional, and practical clinical studies

Primary Outcome Measures: TTNTD rate at 30 months, The proportion of time from the start of treatment to the start of the next treatment or death over a period of 30 months, 30 months
Secondary Outcome Measures: PFS, The time from the start of treatment to the point when the disease progression or death is confirmed by the investigator, 3 years
Substance Use Disorder in Chemsex Practice
NCT Number: NCT06476873
Acronym: TU CHEMSEX
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Addiction Chemical|Use, Substance
Interventions: BEHAVIORAL: Online self-questionnaire.
Sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2025-08-30
Locations: Centre Hospitalier Charles PERRENS, Bordeaux, 33076, France

Summary:
The main aim of this descriptive cross-sectional study is to assess the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire.

Primary Outcome Measures: DSM-5 diagnosis of substance use disorder for chemsex., Assessment of the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire., 1 day
Secondary Outcome Measures: Describing the sociodemographic characteristics of this population, Socio-demographic characteristics, 1 day|Describing the consumption practices of this population, Consumption practices, 1 day|Describing the sexual practices of this population, Sexual practices, 1 day|Explore the existence of chemsex use disorder as a clinical entity in its own right, DSM-5 diagnostic criteria for substance use disorder, adapted to assess chemsex addiction as a single clinical entity, 1 day
Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS
NCT Number: NCT06476860
Acronym: ALBUREA
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis and Septic Shock
Sponsor: Centre Hospitalier Intercommunal André Grégoire
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-23
Completion Date: 2024-06
Locations: CHI Andre Gregoire, Montreuil, 93100, France

Summary:
ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Fluid and sodium inputs in ARDS worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and ICU stay). Predicting ARDS onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.

Primary Outcome Measures: Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock., relationship between proteinuria kinetics in the first 24 hours (H0 and H24) of septic shock and presence of ARDS at H72, 24 hours
Secondary Outcome Measures: measurement of albuminuria urinary IgG at H0 and H24, Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality, 24 hours|measurement of alpha-1-microglobulin at H0 and H24, Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality, 24 hours|measurement of urinary IgG at H0 and H24, Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality, 24 hours
A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
NCT Number: NCT06476834
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Healthy Volunteers
Interventions: DRUG: Deucravacitinib
Sponsor: Bristol-Myers Squibb
Sex: FEMALE
Age: ADULT
Enrollment: 8
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2024-10-26

Summary:
The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.

Primary Outcome Measures: Maximum observed milk concentration (Cmax), Up to 72 hours|Time of maximum observed milk concentration (Tmax), Up to 72 hours|Area under the milk concentration-time curve from time zero to 24 hours (AUC(0-24)), Up to 72 hours|Area under the milk concentration-time curve from time zero extrapolated to infinite time (AUC(INF)), Up to 72 hours|Average milk concentration (Cavg), Up to 72 hours|Amount recovered in milk within 24 hours of dosing (AR(24)), Up to 72 hours|Total amount recovered in milk (AR), Up to 72 hours|Milk-plasma ratio (M/P), milk AUC(0-24)/plasma AUC(0-24), Up to 72 hours|Estimated daily infant dose of deucravacitinib, Estimated Daily Infant Dosage (mg/kg/day) = Mean M/P multiplied by the average maternal plasma concentration (Cavg) multiplied by 200 mL/kg/day, Up to 72 hours|Relative infant dose of deucravacitinib, Relative Infant Dose = Infant Dosage (mg/kg/day)/Maternal Dosage (mg/kg/day) multiplied by 100, Up to 72 hours
Secondary Outcome Measures: Maximum observed plasma concentration (Cmax), Up to 72 hours|Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)), Up to 72 hours|Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)), Up to 72 hours|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)), Up to 72 hours|Time of maximum observed plasma concentration (Tmax), Up to 72 hours|Average plasma concentration (Cavg), Up to 72 hours|Number of participants with Treatment Emergent Adverse Events, Up to Day 30|Number of participants with clinical laboratory test abnormalities, Up to Day 30|Number of participants with vital sign abnormalities, Up to Day 30|Number of participants with physical examination abnormalities, Up to Day 30|Number of participants with electrocardiogram (ECG) abnormalities, Up to Day 30
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
NCT Number: NCT06476808
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: High-grade Serous Ovarian Carcinoma (HGSOC)|Uterine Serous Carcinoma (USC)|Non-small Cell Lung Cancer (NSCLC)
Interventions: DRUG: BMS-986463
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-12-19
Locations: Local Institution - 0003, Los Angeles, California, 90033, United States|Local Institution - 0006, Los Angeles, California, 90067, United States|John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Local Institution - 0026, Vancouver, British Columbia, V5Z 4E6, Canada|Local Institution - 0027, Toronto, Ontario, M5G 2M9, Canada|Local Institution - 0024, Montreal, Quebec, H3T 1E2, Canada

Summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.

Primary Outcome Measures: Number of participants with adverse events (AEs), Up to 108 weeks|Number of participants with serious adverse events (SAEs), Up to 108 weeks|Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria, Up to 108 weeks|Number of participants with AEs leading to discontinuation, Up to 108 weeks|Number of participants with AEs leading to death, Up to 108 weeks
Secondary Outcome Measures: Maximum observed concentration (Cmax), Up to 104 weeks|Area under the concentration-time curve (AUC), Up to 104 weeks|Time of maximum observed concentration (Tmax), Up to 104 weeks|Objective response rate (ORR), Up to 104 weeks|Disease control rate (DCR), Up to 104 weeks|Duration of response (DOR), Up to 104 weeks
The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health
NCT Number: NCT06476795
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Adiposity|Cardiometabolic Syndrome
Interventions: OTHER: Chardonnay Marc
Sponsor: University of California, Davis
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-01
Completion Date: 2025-06-30
Locations: University of California, Davis, Davis, California, 95616, United States

Summary:
Recently a dietary recommendation of 400 - 600 mg/ day has been proposed for the reduced risk of developing cardiovascular disease. Dietary flavanols can be obtained from the intake of foods such as tea, cocoa, wine, berries and apples. Incorporating Chardonnay Marc (the skins and seeds of Chardonnay grapes) into the diet can be an additional source of dietary flavanols. Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.

Primary Outcome Measures: Microvascular function, Microvascular function measured by peripheral arterial tonometry, 12 weeks
Secondary Outcome Measures: Plasma Cholesterol, Circulating levels of plasma lipids, 12 weeks|Cytokines, Pro-inflammatory Th17 cytokines, 12 weeks|short chain fatty acids, Plasma and fecal levels of short chain fatty acids, 12 weeks|plasma bile acids, Circulating levels of primary and secondary bile acids, 12 weeks|blood glucose, fasting levels of blood glucose, 12 weeks|Gene expression, gene expression from whole blood, 12 weeks|insulin, plasma insulin levels after an overnight fast, 12 weeks|zonulin, serum and fecal zonulin as a measure of gut permeability, 12 weeks|lipopolysaccharide binding protein, serum measure of gut permeability, 12 weeks|Metabolomics, plasma levels of untargeted metabolites, 12 weeks
Motor Relearning Program and Aerobic Exercise in Postural Stability and Lower Limb Function in Subacute Stroke Patients
NCT Number: NCT06476782
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Motor Relearning Program(MRP) and aerobic exercise|OTHER: Motor Relearning Program(MRP)
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2024-07-30
Locations: Islam Central Hospital , New life hospital, Sialkot, Punjab, 51040, Pakistan

Summary:
The aim of the study is to determine combined effects of MRP and aerobic exercise in postural stability and lower limb function in subacute stroke patients

Primary Outcome Measures: Postural assessment scale for e, The postural assessment scale for stroke is an outcome measure specifically designed to assess and monitor postural control after stroke.The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36.The higher the score is, the more favourable the balance in stroke patients., 8th week|Lower extremity functional scale, LEF is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. LEFS is scored on a scale of 0 to 80, with higher scores indicating better lower limb function. The interpretation of the scores can be based on the following categories: 0-20: Severe functional limitation. 21-40: Moderate functional limitation., 8th week
Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients
NCT Number: NCT06476769
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: OTHER: blow bottle technique|OTHER: percussion
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2024-07-15
Locations: Wazirabad Institute of Cardiology, Multān, Punjab, 54000, Pakistan

Summary:
It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.

Primary Outcome Measures: Breathlessness cough sputum scale, Breathlessness, Cough and Sputum scale (BCSS) was developed to effectively measure the severity of respiratory symptoms. The BCSS records symptoms in a 5-point Likert like scale in which zero represents improvement symptoms and scores towards 4 indicating worsening of symptoms. It is commonly used in patients with COPD. BCSS provides a simple and robust quantification of symptoms that is sensitive to the effects of treatment and could therefore be used to assess therapeutic interventions. It has good reliability and validity for use in patients with respiratory disorders., 4 weeks|Modified borg RPE scale:, The Modified Borg Dyspnea Scale (MBS) is rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise, one of the most common and frequently used measures to assess the severity of dyspnea., 4 weeks|Incentive spirometry, Incentive spirometry is frequently used after thoracic surgery as an adjunct to physiotherapy. Despite its widespread use, it has remained challenging to demonstrate a clinical benefit in terms of either incidence of pulmonary complications or hospital stay., 4 weeks