cyrilzakka/clinical-trials huggingface dataset:
Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Vascular comorbidities, such as high cholesterol, obesity, high blood pressure, and diabetes, are common among people with multiple sclerosis (MS), and can negatively impact disease diagnosis, treatment, and progression. Physical inactivity may be one possible reason for this increased risk and may occur through changes in cardiorespiratory fitness (the ability of the body to transport and use oxygen during sustained physical activity). While exercise training is effective for improving fitness, factors such as accessibility to facilities and financial cost may not make it a viable option for most people with MS. An alternative approach for improving fitness is by increasing daily physical activity levels. The research team has developed and tested an Internet-delivered lifestyle physical activity intervention that has been shown to improve physical activity levels among people with MS. This lifestyle intervention is a promising approach for also increasing fitness and managing vascular comorbidity risk in persons with MS. This randomized clinical trial will examine the efficacy of a 6-month lifestyle physical activity intervention on cardiorespiratory fitness and vascular comorbidity risk in persons with MS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Relapse-free in the past 30 days
* Stable course of disease modifying therapy over the past 6 months
* Being non-active, defined as not engaging in regular exercise (i.e., ≥30 minutes/day on \>2 days/week during the last 6 months)
* Internet access
* Ability to comprehend study materials and communicate in English
* Expanded Disability Status Scale (EDSS) score \<6.0
* Willingness to complete three testing sessions at the University of Ottawa separated by 6 months
* Willing to undergo randomization to a lifestyle physical activity condition or general wellness condition for 6 months
* Intermediate risk level for cardiovascular disease based on the Framingham Cardiovascular Disease Risk Score calculator
* Asymptomatic (i.e., no major signs or symptoms of acute or uncontrolled cardiovascular, metabolic, or renal disease; e.g., chest pain) based on the Get Active Questionnaire and the health history section of the American Heart Association (AHA)/American College of Sports Medicine (ACSM) Health/Fitness Facility Pre-participation Screening Questionnaire
* Physician approval for participation

Exclusion Criteria:

* Pregnancy
* Previous enrollment in lifestyle physical activity behaviour interventions
Natural History Study of Serious Medical Events in PWS

PATH for PWS is a study to help researchers better understand serious medical events in PWS over a 4-year period, as well as evaluate how PWS-related behaviors change over time. The data from this study is intended to inform the development and clinical trial design of potential new treatments.

Every 6 months, participants or their caregivers will be asked to update online surveys about medical problems and serious medical events, as well as provide information about conditions and behaviors often associated with PWS such as hyperphagia. Because this is an observational study, no study drug will be provided and no visits to a doctor or clinic are required.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria:

* Confirmed diagnosis of PWS
* At least 5 years of age
* Live in the United States, Canada, Australia, or New Zealand
* Must be enrolled or willing to enroll in the Global PWS Registry (https://pwsregistry.org)

Participants or their caregiver must also meet all of the following criteria:

* Have access to the internet to complete online surveys at least every 6 months
* Agree to receive reminders to complete online surveys
* Allow the staff to ask questions about survey responses if more information is needed and to enter data into the surveys

Exclusion Criteria:

Participants or their caregiver meeting any of the following criteria will be excluded:

* Is not able to read and understand English
Internet Weight Control for Bingeing Adolescents

The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.

The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.

Eligibility Criteria:
Inclusion Criteria:

* Female and male high school students in Hayward Unified School District or Meridian School District
* 85th or greater percentile for age-adjusted weight
* Objective binge eating one or more times weekly for a duration of ≥ 3 months
* Access to a computer with internet access
* English literacy at a sixth grade reading level

Exclusion Criteria:

* Current (or history of) diagnosis of anorexia or bulimia nervosa
* Active suicidal ideation
* Current enrollment in a formal weight loss or binge eating program (e.g., Weight Watchers)
* Any medical condition in which the actual condition or treatment affects weight and/or appetite (i.e., cancer, diabetes)
HYPNOSIS DURING PERIOPERATIVE CARDIAC SURGERY

Evaluation of practices: retrospective and prospective monocentric survey on the satisfaction of patients undergoing Cardiac Surgery who were able to benefit from additional management by Ericksonian Medical Hypnosis during their stay.

Since 2018, additional care using Ericksonian Medical Hypnosis has been offered to patients undergoing cardiac surgery. Cardiac surgery is one of the most complex and high-risk procedures, requiring a general anaesthetic and a stay in intensive care.

Its aim is to reduce pre-operative stress and anxiety, which are always present to varying degrees before this type of treatment. The aim is to put the patient back at the centre of his or her care by making them active and active participants throughout the treatment process.

Many studies have demonstrated the benefits of hypnosis in reducing anxiety, depression, pain perception, sedation and comfort during hospitalisation. However, very few studies have looked at the quality of life of these patients for up to a year.

Hypnosis support is subject to the number and presence of trained nursing staff.

In order to assess the feelings of patients who have benefited from this additional treatment, and to improve our practices, we would like to carry out a satisfaction survey using questionnaires including the EQ5D-5L quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Patients undergoing major cardiac surgery
* Patients who have had perioperative hypnosis sessions.

Exclusion Criteria:

* Opposition of the patient to the conservation of data
* Subject under guardianship or subject deprived of liberty, as referred to in articles L1121-5 to L1121-8 of the CSP (French Public Health Code)
* Pregnant or breast-feeding women
* Contraindication to the practice of hypnosis
A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed/refractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
* Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed/metastatic Non-Driver Mutation NSCLC, relapsed/refractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma);
* Adequate organ function;

Exclusion Criteria:

* Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy;
* Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies;
* Prior other specific T cell targeting agents;
* Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg/day prednisone or equivalent) two weeks prior to start of treatment.
* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine;
* Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
* Pregnancy or lactation;
* Other conditions considered not appropriate to participate in this trial by the investigators.
NTLA-3001 in Adults with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease

This study will be conducted to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of NTLA-3001 in adults with alpha-1 antitrypsin deficiency (AATD) -associated lung disease

This study consists of 2 parts: Phase 1 is an open-label, single-arm ascending dose study to characterize the safety and activity of NTLA3001 and identify the dose for evaluation in Phase 2. Phase 2 will follow as an open-label, dose expansion study to further characterize the safety and clinical activity of NTLA-3001 and provide an initial assessment of the effect of NTLA-3001 on clinical measures of pulmonary function.

Eligibility Criteria:
Inclusion:

1. Age 18 years to 75 years
2. Diagnosis of AATD ZZ/ZNull genotypes
3. FEV1 ≥35% and ≤65%
4. No evidence of liver cirrhosis
5. Adequate chemistry and hematology measures at screening
6. Participants must agree not to participate in another interventional study for the duration of this trial.
7. Participants must be capable of providing signed informed consent

Exclusion Criteria:

1. AATD genotypes outside of ZZ or ZNull
2. Participants with total antibodies to adeno-associated virus (AAV) serotype above laboratory assay cut off
3. Participants who have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component.
4. Any condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
5. Unwilling to comply with study procedures.
Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders

Participants will undergo a single session of functional magnetic resonance imaging (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their ability to regulate motivational networks of the brain during the exposure to alcohol cues and evaluate immediate effects on craving and cognitive bias for alcohol by administering a questionnaire and a Stroop task before and after the session.


Eligibility Criteria:
Inclusion Criteria:

* History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol per week (female participants)

Exclusion Criteria:

* MRI safety exclusion criteria
Effects of Sensory Motor Training and Kinesthetic Exercises in Knee Osteoarthritis.

In this study i will see the effects of kinesthetic exercises and sensory motor training on pain and range of motion in patients with knee OA.

In 2022 a A Pilot Randomized Trial of Different Weekly Applications of Kinesthesia, Balance and Agility Exercise Program for Individuals with Knee Osteoarthritis was conducted.In 2023 A critically appraised research was conducted on Sensorimotor or Balance Training to Increase Knee-Extensor and Knee-Flexor Maximal Strength in Patients With Knee Osteoarthritis.

In past there is no study that compares the effects of SMT and kinesthetic exercises in knee OA.

Eligibility Criteria:
Inclusion Criteria:

* patients having osteophytes and definite joint space reduction confirmed by radiographs
* Patients having age 40-60 years or both gender are included

Exclusion Criteria:

Rheumatoid arthritis. Hip or ankle instability Hip or knee replacement Unresolved balance disorder Patients with active synovitis
Interoceptive Intervention for Pulmonary Hypertension

Background Pulmonary hypertension is a rare and incurable condition characterised by fatigue and breathlessness. The effects of pulmonary hypertension has a significant impact on an individual's emotional wellbeing and there are currently no established psychological interventions to improve this. Interoception is defined as the ability to perceive the internal state of the body and emerging research suggests that interventions to improve interoception can improve well-being.

Aims The project aims to develop an interoceptive based intervention for those with pulmonary hypertension and examine the feasibility and acceptability of this. Additional aims are to explore the preliminary results of the intervention.

Methods A randomised control feasibility trial will be used. Thirty-two participants will be included. Participants will be patients within the Scottish Pulmonary Vascular Unit diagnosed with pulmonary hypertension and randomly assigned to either the intervention or control (waitlist) group. The intervention will be an eight-session online group and participants will complete measures for interoception, anxiety, depression, health related quality of life, as well as a feasibility and acceptability questionnaire. Quantitative analysis will include descriptive statistics and T-tests (including non-parametric versions) to analyse the feasibility and gain a preliminary understanding of the intervention.

Practical Applications It is hoped that the findings will identify a sample size for a larger trial whilst also informing future clinical practice. This project will be written up for a suitable journal and will be presented at an appropriate conference.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be patients under the care of the Scottish Pulmonary Vascular Unit (SPVU) at the Golden Jubilee University National Hospital (GJUNH).
* Diagnosed with any type of PH.
* Adults over 18 years.
* Fluent in English.
* Able to commit to the duration of the research (expected to be three months from initial recruitment to the end of treatment).

Exclusion Criteria:

* Individuals with current thoughts of self-harm or suicide.
* Presenting with comorbid alcohol or substance misuse.
* Currently engaging in any additional psychological interventions at the time of the study.
Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.

The patients will be evaluated at baseline and after three months of treatment with placebo or product.


Eligibility Criteria:
Inclusion Criteria:

1. uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
2. eligible for surgery
3. symptoms like menometrorrhagia or pelvic pain

Exclusion Criteria:

1. BMI\>30
2. currently pregnant or breastfeeding
3. diabetic
4. suspect of malignancy
5. diagnosis of cancer
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.

The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
* Has had all urothelial cell carcinoma tumor resected within the past 12 months
* Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
* Able to provide legally effective informed consent
* Able to produce 45mL of urine

Exclusion Criteria:

* Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
Efficacy of Prontosan Solution on Chronic Ulcers

The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough
* Braden index at baseline\>=10
* Ulcer area\<80 cm2
* Ability to give an informed consent

Exclusion Criteria:

* Braden index at baseline\<10
* Current therapy with corticosteroids or immunosuppressor or radiotherapy
* Sensitivity to any of the components of Prontosan® Solution
* Diabetic foot ulcer
* Current use of local antiseptics on the wound bed
* Previous recruitment of another ulcer in the trial
Candesartan in the Prevention of Relapsing Atrial Fibrillation

The purpose of this study is to test the hypothesis that treatment with the angiotensin II type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion.

Background: The most effective procedure to restore sinus rhythm in patients with persistent atrial fibrillation (AF) is electrical cardioversion, but AF recurs in 60-80% of the patients during the first year. AF is associated with electrical and anatomical remodelling of the atria, and angiotensin II is involved in the remodelling process. Studies have indicated that the angiotensin II type 1 receptor antagonist candesartan may counteract both electrical and anatomical remodelling induced by AF. The investigators therefore hypothesised that treatment with candesartan may reduce the recurrence rate of AF after electrical cardioversion.

Study design: 171 patients with persistent AF scheduled for electrical cardioversion are randomised in a double blind, placebo-controlled study. The patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion, and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion. The study medication is discontinued if electrical cardioversion is unsuccessful or if AF recurrence is documented. Primary endpoint is recurrence of AF. Clinical, electrocardiographic, echocardiographic and biochemical markers will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation, diagnosed electrocardiographically, of more than 48 hours duration in whom direct current (DC) cardioversion is planned.

Exclusion Criteria:

* Patients with a history of known hypersensitivity or contraindication to any angiotensin II receptor blocker or any angiotensin-converting enzyme (ACE) inhibitor.
* Patients currently receiving an ACE inhibitor or angiotensin II antagonist because of heart failure or other strong indication.
* Patients currently receiving any antiarrhythmic medication including sotalol. Other beta-blockers will not be regarded as specific antiarrhythmic agents.
* Significant renal artery stenosis and any medical condition in which administration of a vasodilator is contraindicated; serum creatinine \> 225 micromol/L; or serum potassium \> 5.5 mmol/L; or serum sodium \< 128 mmol/L.
* Patients with severe hepatic dysfunction.
* Life-limiting disease or substance abuse which may affect participation.
* Patients unwilling to participate.
* Patients who have previously undergone DC cardioversion for atrial fibrillation within the last month.
* Thyrotoxicosis.
* Patients with a systolic blood pressure of \< 100 mm Hg.
* Hypertensive patients requiring intensified treatment prior to DC cardioversion.
* Pregnancy or lactation.
Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix

Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine cervix can differentiate between grades of pre-invasive and invasive cervical disease and cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to detect pre-invasive cervical disease and cervical cancer.

B. Specific Aims

1. Primary. To determine the sensitivity, specificity, positive and negative predictive values for Niris 1300e OCT enhanced gynecologic examination (VIA-OCT vs.colposcopy-biopsy) for the detection of lesions equal or greater than cervical intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation.
2. Secondary. To examine the ease of use of Niris 1300e OCT in a real time clinical setting in order to assess its potential application during a "see and treat" or "single episode of care" clinic visit.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects \> 18 years of age
2. Subject must voluntarily sign a Patient Informed Consent Form specific to the study.
3. Subject must be physically and mentally willing to comply with all study requirements, especially conduct of a colposcopy exam.
4. Participant must be attending the Center for Cervical Diagnosis.

Exclusion Criteria:

1. Based on clinical history, physical exam and patient presentation, the subject is unable to provide adequate informed consent and/or comply with the study requirements.
2. Subject is a prisoner.
3. Subject is pregnant.
4. Subject has had a hysterectomy
5. Subject has received prior pelvic radiotherapy.