cyrilzakka/clinical-trials huggingface dataset:
Precision of OCT and OCTA-based Ocular Measurements

Precision of OCT- and OCTA-based Ocular Measurements

The purpose of this study is to assess precision of measurements of vascular structures and the anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to assess measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Eligibility Criteria:
Inclusion Criteria:

* Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
* Glaucoma - Have glaucoma and no history of other retinal pathology.
* Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
* Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria:

* Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
* Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
* Retina - Unable to complete required exams.
* Cornea - Unable to complete required exams.
Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Medicaid coverage and similar state-supported insurance are robust predictors of CR non-participation. There is growing recognition of the need to increase CR among patients with this form of insurance and other economically disadvantaged patients, but there are no evidence-based interventions available for doing so. In the present study we are examining the efficacy of using financial incentives for increasing CR participation among Medicaid patients. Financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study are randomizing 130 CR-eligible Medicaid enrollees to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions or to a "usual-care" condition where they will not receive these incentives. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, decision making and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing CR initiation and adherence. Should this intervention be efficacious and cost-effective, it has the potential to substantially increase CR participation and significantly improve health outcomes among low-income cardiac patients.


Eligibility Criteria:
Inclusion Criteria:

* A recent myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, heart valve replacement or repair, or stable heart failure.
* Enrolled in a state-supported insurance plan for low income individuals
* Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden County) for the next 12 mos.

Exclusion criteria:

* Dementia (MMSE\<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
* Non-English speaking
* Prior participation in cardiac rehabilitation
* Advanced cancer, advanced frailty, or other longevity-limiting systemic disease that would preclude CR participation
* Rest angina or very low threshold angina (\<2 METS) until adequate therapy is instituted
* Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
* Class 4 chronic heart failure (symptoms at rest)
* Exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe lung disease
An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults

Research has demonstrated the positive effects of chronic exercise on cognitive functioning and performance of Activities of Daily Living (ADLs). However, minimal research exists regarding the effects of acute exercise. To address this gap in the literature, the present study investigated the effect of an acute bout of exercise on executive functions, balance, and ADLs among healthy older adults. Based on the current literature, we expected participants in the exercise group to perform better on executive function tasks and ADLs compared to participants in the control group.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 60.

Exclusion Criteria:

* health complications preventing the ability to cycle on a recumbent bike and walking at moderate intensity as indicated by the health history questionnaire, taking anti-depressant medication, or having color blindness.
Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers

The purpose of this study was to compare the effects of high voltage pulsed current and low level laser therapy on the healing process of diabetic foot ulcers.

Based in the literature review we concluded that LLLT and HVPC are effective in the healing wound. We did not meet outcomes of previous clinical studies, where compare the effectivity of two physical technologies. For the high prevalence of diabetic foot ulcers, the amputation risk and the consequent impairment and dysfunction in the quality of life, and the associated high costs for this health problem, it is important that new studies that identified effective treatment alternatives for promoting wound closure.

Eligibility Criteria:
Inclusion Criteria:

* Ages 30 - 75 years
* Ulcer located on the legs or feet, stage I or II (Wagner Classification System)
* Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, two random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)

Exclusion Criteria:

* Uncontrolled diabetes
* Ulcer infection
* Lower limb amputation
* Orthopedic or neuromuscular pathologic conditions
Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

Exclusion Criteria:

known allergy to any of the study drugs, significant cardiovascular disease vomiting.
Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study

While interdisciplinary weight loss intervention have been shown successful among adolescents with obesity, a weight regain is most of the time observed within the following weeks or months. The aim of the present project will be to better identify the independent role played by both the metabolic and mechanical load and their modification during weight loss, on the energy expenditure and energy metabolism of adolescents with obesity.

A total of 28 adolescents with obesity will be recruited from our local inpatient pediatric obesity centers. Before their weight loss intervention the adolescents will complete two experimental visits. During the first visit, anthropometric and body composition measurements will be performed. Then the participants will be asked to complete a walking exercise on a treadmill during the second visit. Their energy expenditure and substrate oxidation will be assessed by indirect calorimetry. They will have to walk at 5 different walking speeds. Then, they will follow a 12-week weight loss intervention. By the end of this intervention, their body composition will be assessed and they will be asked to perform the same walking exercise. On a separate occasion (randomly assigned) they will have to repeat this walking exercise while carrying a load corresponding of their weight loss.

Eligibility Criteria:
Inclusion Criteria:

* being aged 12-16 years old
* no contraindication to physical exercise
* no cardiovascular disease
* BMI above the 97th percentile
* candidate to a weight loss intervention

Exclusion Criteria:

* surgery and medical conditions preventing them to perform the intervention
* Weight loss during the previous 6 months
* medication that could interfere with energy metabolism.
* pregnancy
* regular tobacco and alcool use
The Anti-Inflammatory Effects of Exercise and Peanut Consumption

This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. The study will test and compare the effect of peanuts and exercise on inflammation and heart rate variability as indicators of heart health. Specifically, the study will measure inflammation in the blood because there is evidence that higher inflammation is found in heart disease patients. There is also evidence that inflammation is related to death as a result of heart disease in healthy individuals. Finally, there are ongoing trials targeting these markers to improve heart health. The study hypothesizes that peanuts and exercise will reduce inflammation. It is also expected to find less inflammation because exercise and peanut consumption activate a part of the nervous system that has been shown to cause a similar effect.

Additionally, previous studies show that inflammation involves the mitochondria in the cell, the part of the cell that produces energy. For this reason, it is expected that exercise and peanuts will cause changes in the mitochondria. The study will test and compare mitochondrial activity in response to peanut consumption and exercise.


Eligibility Criteria:
* INCLUSION CRITERIA

  1. Of either sex,
  2. age 21-45 years
  3. English-speaker
  4. Overweight or obese
  5. sedentary
* EXCLUSION CRITERIA

  1. Cardiovascular disease
  2. Uncontrolled high blood pressure (blood pressure ≥ 140/90). Individuals with controlled hypertension (i.e. under medical treatment) and blood pressure lower than 140/90 will not be excluded.
  3. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. Prostatic carcinoma will not be grounds for exclusion.
  4. Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II).
  5. HIV infection
  6. Pregnant or lactating (participation allowed 3 months after ceasing lactation).
  7. Medications that alter inflammation or autonomic nervous system activity.
  8. Any history of psychosis or ECT
  9. Psychotic disorder (lifetime)
  10. Current or recent (past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety disorder
  11. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  12. Probiotic and dietary supplements that affect inflammation or the ANS
  13. Physically active
  14. Peanut allergy in subject or in family of subject. Subjects who are unsure of their allergy status will be excluded.
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.

Eligibility Criteria:
Inclusion Criteria:

* Patients on the waiting list for a total hip arthroplasty
* Primary osteoarthritis
* Osteoarthritis secondary to congenital dislocation of the hip

Exclusion Criteria:

* Rheumatoid arthritis
* Bisphosphonate treatment
* Osteomalacia
* Hypocalcemia
* Previous surgery of the affected hip
Fermented Dairy Products and The Metabolic Syndrome

The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 30-70 years
* BMI of 28-45 kg/m2
* Abdominal obesity (defined as waist circumference \>102 cm)
* Provided voluntary written informed consent

Exclusion Criteria:

* Body weight changes +/- 5% in the past three months
* Any diet, allergy or intolerance which results in not being able to follow the study protocol
* Contraindications related to MRI (pacemaker, stent, magnitic metal in the body, claustrophobia, physiological diseases or a body weight \>160 kg)
* History or diagnosis of diabetes
* History or diagnosis of heart, liver, gastrointestinal or kidney disease
* History or diagnosis of illness related to energy balance
* History or diagnosis of eating disorders
* Simultaneous blood donation for other purpose than this study (and one month before initiating the study)
* Simultaneous participation in other clinical intervention studies
* Any other condition that judged by the investgator may interfere with the adherence to the study protocol
Cannabidiol in Youth Alcohol Use Disorder

The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 50 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month.


Eligibility Criteria:
Age 16 to 22. Does or does not drink alcohol.
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes

This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month, or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
A Phase 1 Study Evaluating Safety and Tolerability of RCT2100 in Healthy Participants and in Participants With CF

This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.

This is a multi-part study to assess the safety, tolerability, and biodistribution of a single ascending dose of inhaled RCT2100 administered via nebulizer to healthy participants (Part 1) and multiple-ascending doses of inhaled RCT2100 administered to participants with CF (Part 2).

Eligibility Criteria:
Part 1 Major Inclusion Criteria:

* Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
* Body weight greater than or equal to 50 kg and body mass index (BMI) between 16-32 kg/m2, inclusive
* The participant has a forced expiratory volume in one second (FEV1) of at least 80% predicted
* The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
* Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

Part 1 Major Exclusion Criteria:

* History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
* The participant has supine blood pressure (BP) \>150 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least 5 minutes of supine rest.
* The participant has abnormal clinical laboratory tests at screening, as assessed by the study-specific laboratory.
* The participant is a smoker or has used nicotine or nicotine-containing products 6 weeks before the first dose of study drug. Former smokers with greater than 10 pack years of smoking history are excluded.

Part 2 Major Inclusion Criteria:

* Confirmed diagnosis of CF
* Forced expiratory volume in 1 second ≥40% and ≤100% of predicted mean value for age, sex, and height
* a) Not eligible for CFTR modulators based on having mutations of CFTR gene on both alleles that are not responsive to CFTR modulator therapy OR
* b) Eligible for CFTR modulators (based on local prescribing information) but not using CFTR modulators due to intolerance or contraindications

Part 2 Major Exclusion Criteria:

* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for sinopulmonary disease within 4 weeks before the first dose of study drug
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Arterial oxygen saturation on room air less than 94% at screening
* Values of AST, ALT, alkaline phosphatase, or gamma-glutamyl transferase (GGT) ≥3×ULN
* Treatment with a CFTR modulator (Kalydeco, Trikafta, Symdeko, or Orkambi) within 12 weeks of Screening

Other protocol defined Inclusion/Exclusion criteria may apply.
Criteria Associated With Patient Willingness to Participate in Biomedical Research

The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).

The secondary objectives of this study are:

* To compare patient acceptance rates for participation in a clinical research protocol before and after January 15, 2016.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before January 15, 2016.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after January 15, 2016.
* To describe the patient population seen during pneumology consultations.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution.
* Construct clusters (homogeneous groups) of patients seen during the pneumology consultations.

Eligibility Criteria:
Inclusion Criteria:

* The patient was informed about the study.
* The patient is scheduled for a consult in the pneumology department

Exclusion Criteria:

* The patient is under judicial protection or is an adult under any kind of guardianship
* The patient expresses opposition to the study
* It is impossible to correctly inform the patient about the study
* The patient cannot fluently read French
* The patient is pregnant
* The patient is breastfeeding
* The patient has cancer
* The patient is consulting in tabaccology
Development of a Multi-omics Prediction Model for Immunotherapy Response in Triple-Negative Breast Cancer Subtypes

This study aims to collect clinical samples from breast cancer patients who have undergone or are expected to undergo immunotherapy at our institution. The samples, including fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data, will be used to build a predictive model for immunotherapy efficacy. The research will employ proteomics, transcriptomics, metabolomics sequencing, imaging mass cytometry (IMC), and spatial transcriptomics to construct a multi-omics, multi-dimensional (temporal and spatial) model to predict the effectiveness of immunotherapy.

This research will utilize a comprehensive approach by analyzing various types of clinical samples from breast cancer patients treated with immunotherapy. The integration of proteomic, transcriptomic, and metabolomic data, along with advanced imaging techniques like IMC and spatial transcriptomics, will allow for a detailed understanding of the tumor microenvironment and its response to immunotherapy. This multi-dimensional analysis aims to enhance the accuracy of predicting immunotherapy outcomes, thereby aiding in personalized treatment strategies for breast cancer patients. The study adheres strictly to ethical guidelines, ensuring patient confidentiality and welfare are maintained throughout the research process.

Eligibility Criteria:
Inclusion Criteria:

- Female, aged ≥ 18 years.

Pathologically confirmed diagnosis of breast cancer.

Patients who received immunotherapy/neoadjuvant immunotherapy at our institution between January 1, 2015, and September 30, 2023 (retrospective cohort), or patients who may receive immunotherapy/neoadjuvant immunotherapy starting from October 1, 2023 (prospective cohort).

Availability of sufficient tumor tissue samples (e.g., fresh biopsy tissue, residual tumor tissue post-surgery).

Availability of blood samples and imaging data.

Signed informed consent (for the prospective cohort).

Exclusion Criteria:

* Male breast cancer patients.

Inability to provide sufficient tumor tissue samples or other clinical data.

Presence of severe comorbidities (e.g., active infections, severe cardiac, hepatic, or renal dysfunction) that may affect the safety assessment of immunotherapy.

Lack of signed informed consent (for the prospective cohort).