cyrilzakka/clinical-trials huggingface dataset:
CLAiR Pivotal Study

This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.

This is a prospective observational clinical study to collect retinal images and clinical biomarker data in order to analyze the performance of the CLAiR SaMD compared to the reference PCE risk score. CLAiR is a deep learning (DL) model that uses retinal photographs and limited demographic data to classify an individual's risk of developing ASCVD over the next 10 years as elevated (≥7.5%) or non-elevated (\<7.5%). For validation, the output of the algorithm can be directly compared to the PCE output, a widely accepted algorithm used by Healthcare Providers to predict ASCVD risk in patients.

The primary hypothesis is that the CLAiR SaMD can achieve high sensitivity and specificity in the binary determination of Yes/No elevated ASCVD risk with PCE risk score ≥7.5% as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 40-75 years
2. Participants must be capable of providing informed consent, demonstrating understanding of the study details, and willingly sign a consent form or verbally confirm their consent in the presence of a witness.
3. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
2. Current use of cholesterol-lowering medication, such as a statin
3. Pregnancy
4. A person who has (in at least one eye):

   * Persistent vision impairment: legally blind when wearing current driving glasses or known VA\<20/400
   * Known pathological myopia
   * Previous treatment or currently under the care for a retinal disease by a specialist (e.g., ophthalmologist)
Treatment of Depression in Adults

This study will determine how certain features of depressed individuals affect their responses to depression treatment.

Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.

This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. Clinical evaluations and questionnaires will be used to assess participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major depression

Exclusion Criteria:

* History of manic or hypomanic episodes
* History of schizophrenia or schizoaffective disorder
* Diagnosis of anorexia nervosa or bulimia nervosa
* Current psychosis
* Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
* Diagnosis of antisocial personality disorder
* Diagnosis of organic affective syndrome and uncontrolled medical illness
* Pregnancy
* Require inpatient treatment for suicidal risk or psychosis
* History of an inability to tolerate any of the study treatments
* Currently receiving treatment with an effective antidepressant
Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis

Sensory impairment is an important problem for patients with Multiple Sclerosis (MS). Although there is no complete loss of sensation in patients, 80% of patients have a significant sensory impairment. The sensory system plays an important role in providing the feedback required to perform motor tasks. Cutaneous sensation, especially in the sole of the foot, is very important in maintaining balance and gait. There are studies showing decreased foot sole sensation in MS patients. Another sensation that is important during motor tasks is the proprioceptive sensation.

The aim of this study is to examine the relationship between the sensation of foot sole and joint position, clinical features, attention, fatigue, body awareness and physical activity level in patients with MS.

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The sensation of foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level will be evaluated.

The investigators will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. In addition, the investigators will examine the correlations between the sensation of the foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level using Pearson bivariate correlations.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Having a diagnosis of "Multiple Sclerosis"
* Relapse free in the last 3 mounts
* Ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No diagnosis of depression

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, and hearing problems that may affect the results of the research
The Effect of Frequency Modulation in TENS on Habituation and Pain Threshold

Purpose

The purpose of this study is to determine whether application of Transcutaneous Electrical Nerve Stimulation (TENS) is effective on habituation to electrical current whether delivered at a fixed frequency of 100 Hz or at patterned frequency. The secondary purposes are to determine the effectiveness on mechanical pressure pain and the subjective perception of the subjects regarding habituation and comfort of the different stimulations.

Low frequency and low intensity TENS showed strong evidence of inefficiency while conventional high frequency TENS (around 100Hz) applied at "strong but comfortable" intensity proved strong evidence of efficacy on pressure pain. In addition, some studies have shown the importance of current intensity in the effect of TENS.

Either in clinical practice and in research, TENS intensity is usually adjusted according to the sensation of the subjects "strong but comfortable" "strong just below the motor threshold", ...). Usually throughout the TENS applications there is a phenomenon called "habituation" that involve a wide decrease of the sensation of the current applied, even though the perception the output-parameters are maintained.

In this sense, It has been seem that adjusting the intensity throughout the TENS intervention produced a greater hypoalgesic effect than when the intensity remained fixed.

On the other hand, most TENS devices offer the possibility of modulating current with the aim of preventing habituation phenomenon. The modulation of the electric current consists of changing the characteristics of the current (pulse width, pulse frequency, ...) every few seconds during the intervention. Nevertheless, the most common pattern used is the frequency modulation. However, there is a lack of evidence regarding what it is the better methods to avoid habituation during a TENS application.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be volunteer healthy students of University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

* Neuromuscular disease. Epilepsy. Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.

Osteosynthesis material in the upper limb. Cancer. Cardiovascular disease. Pacemaker or other implanted electrical device. Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.

Presence of tattoos or other external agent introduced into the treatment or assessment area.

Pregnancy. Sensitivity disturbance in upper limb.
"Effectiveness of Community Health Workers in Breast Cancer Prevention in Jumla: a Cluster Randomized Trials

Breast cancer is the second most prevalent cancer among Nepali females, accounting for 17.1% of cases and 7.7% of female cancer-related deaths. It is more common in younger, premenopausal women, often diagnosed at advanced stages. Raising awareness through community education is crucial for promoting breast cancer screening, particularly in low-resource settings like Nepal, where clinical breast exams are essential early detection tools. Integrating breast cancer education into the health system can enhance knowledge, encourage screening, and promote healthy behaviors for prevention. Early detection significantly improves treatment outcomes and survival rates.

In remote areas, limited access to advanced detection technologies makes breast self-examination (BSE) the most feasible and cost-effective method, particularly in Jumla. This study evaluates the effectiveness of community health worker-led breast cancer prevention through health promotion and education strategies. It follows PROCTOR's framework and the Health Belief Model (HBM) A mixed-methods design will be employed, incorporating an embedded implementation science approach, a cluster-randomized trial, and mixed-method research. The study population includes married women of Jumla, female community health volunteers (FCHVs), and auxiliary nurse midwives (ANMs). Exclusion criteria include married women ≥20 years old with existing cases of cancer, pregnant or lactating women, FCHVs unable to acquire BSE skills, and untrained ANMs. The sample consists of 90 participants in both intervention and control groups.

Acceptability, Appropriateness, and Feasibility will be assessed using the Acceptability of Intervention Measure (AIM) tool. SOP-based checklists will evaluate fidelity, while FGDs and KIIs will collect qualitative data. Quantitative data will be analyzed using frequency, percentage, mean, and standard deviation. A paired t-test and mixed-effect linear regression will assess effectiveness, while qualitative data will undergo thematic analysis. Findings will be reported per CONSORT guidelines.

Ethical approval will be obtained from the Nepal Health Research Council. Expected outcomes include improved breast cancer knowledge, perception, and screening intention, leading to early detection and reduced prevalence. However, selection bias in cluster trials may limit generalizability.


Eligibility Criteria:
Inclusion Criteria:

* Married women \>= 20 years of age group women of CNMP Jumla,
* FCHV, those who can read, write, and understand, and
* ANM

Exclusion Criteria:

* Married women \>= 20 years age group women who had a positive existing case,
* Pregnant and lactating women of CNMP Jumla,
* FCHV those who cannot acquire the minimum skill of breast self-examination,
* ANM who untrained for BSE.
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma

A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids

This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom scores and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised receive treatment with either fluticasone furoate 50 mcg once daily, fluticasone propionate 100 mcg twice daily or placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). Subjects will receive treatment for 24 weeks. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 27 weeks (including screening, treatment and follow-up contact).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
* Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
* Pre-bronchodilator FEV1 of at least 60% predicted
* FEV1 reversibility of at least 12% and 200ml
* Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist

Exclusion Criteria:

* History of life-threatening asthma exacerbation with the past 10 years
* Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
* Current or recent respiratory infection or current oral candida infection
* Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
* Known or suspected allergy to study medication or materials
* Taking another investigational medication or prohibited medication during the study
* Current smokers or former smokers with significant tobacco exposure
* Previous treatment with fluticasone furoate in a phase II or III study
* Children in Care
Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity

Lung cancer is one of the leading cause of cancer related death in China.Different from patients in the US, Chinese patients with lung nodules tend to be less related to smoking, and seem to be more willing to get operation despite of the doctors' suggestion of imaging surveillance.

This study is designed to figure out the risk factors for Chinese lung cancer patients and evaluate the psychosocial status of inpatients with lung nodules.

Smoking is the only determinate risk factor proposed by the NCCN（National Comprehensive Cancer Network） Clinical Practice Guidelines for lung cancer screening. However, it has been estimated that over half of Chinese female lung cancer patients are non-smokers. Thus it might be reasonable to take unique Chinese cooking habit and environment pollution into consideration when it comes to the risk factors for lung cancer in Chinese people.

Lung nodules are reported to exist in 25-70% patients who have undergone LDCT （Low-dose Computed Tomography）examination. However, the prevalence of malignant nodules is reported to be 1.1-3% by different researchers. Even in country with comprehensive medical consulting system and lung nodule management consensus, almost all patients assume their lung nodules to be malignant when detected by LDCT for the first time.The investigators noticed nearly 1/3 of the inpatients are determined to get operation despite the surgeons' suggestion of CT surveillance according to the NCCN guideline in Department of Thoracic surgery in Peking University People's Hospital. As there's no evidence suggesting lung nodules in Chinese people have more possibility of malignancy, the investigators would like to know whether those patients who choose to get operation "ahead of the guideline" has higher level of cancer distress, and figure out whether psychosocial factors should be taken into consideration of lung nodules management when living with an indeterminate tumor has added up to patients' negative emotion and reduced their quality of life.

The investigators do the survey on the first day of admission during the inpatient education, help patients fill in the questionnaire including personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, any past or current environmental exposures and psychological status.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients in Department of Thoracic Surgery in Peking University People's Hospital and Beijing Haidian Hospital.
* Tolerant to surgery with accessible pathology outcome.
* Aged between 18-80.
* Signed Informed Consent Form.

Exclusion Criteria:

* Patients who have difficulty in reading and writing.
* Poor physical status without sufficient respiratory reserve to undergo surgery.
* Unaccessible for surveillance after surgery.
* Refuse to take part.
* Other circumstances which is deemed inappropriate for enrollment by the researchers.
A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors

This is a Phase 1/1b open-label, dose-escalation, and cohort expansion study with BID (tablet) oral dose of MPT-0118 in subjects with advanced or metastatic refractory solid tumors.

The study will be conducted in 3 parts:

* Part A: MPT-0118 dose-escalation
* Part B: MPT-0118 dose-escalation in combination with pembrolizumab
* Part C: Cohort expansion of MPT-0118 in combination with pembrolizumab

MPT-0118 will be administered orally twice daily (BID). Pembrolizumab will be administered intravenously (IV) at a dose of 200 mg every 3 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

1. Has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
2. Is aged ≥18 years at the time of signing the ICF
3. Has provided written informed consent
4. Has an ECOG Performance Status of 0 or 1
5. Has measurable disease per RECIST 1.1
6. Has an adequate tumor sample.
7. Has adequate liver, renal, hematologic, pulmonary, cardiac, and coagulation function.
8. Has a negative serum pregnancy test (for women of child-bearing potential) at Screening and a negative urine pregnancy test on Day 1 prior to the first dose of MPT 0118
9. Ability to swallow and retain and absorb oral medications in tablet or crushed form orally or via feeding tube (e.g., nasogastric feeding tube or percutaneous endoscopic gastrostomy feeding tube)

Key Exclusion Criteria:

1. Has received cytotoxic chemotherapy, biologic agent, investigational agent, checkpoint inhibitors, or radiation therapy ≤3 weeks prior to the first dose of MPT-0118
2. Has received small-molecule kinase inhibitors or hormonal agents ≤14 days prior to the first dose of MPT-0118
3. Has been previously treated with a MALT1 inhibitor
4. Has clinically significant AEs that have not returned to baseline or ≤Grade 1 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
5. Has received systemic immunosuppressive agents within 14 days of the first dose of MPT-0118
6. Has undergone major surgery ≤6 weeks or minor surgery ≤14 days prior to the first dose of MPT-0118
7. Has clinically significant intercurrent disease
8. Part B and Part C: Has previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required dose-interruption, permanent discontinuation, or systemic immunosuppression due to immune-related AEs
9. Has primary central nervous system (CNS) tumors or brain or leptomeningeal metastasis.
10. Has human immunodeficiency virus (HIV) infection
11. Has active hepatitis B or C infection
12. Women who are pregnant or breastfeeding
13. Has an unwillingness or inability to comply with procedures required in this protocol
14. Is currently receiving any other anticancer or investigational agent
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures

The study will elucidate the effectiveness of an educational program in the prevention of osteoporosis and fractures. A random sample of the female population in Southern Finland (Uusimaa region) within the age group of 60-70 years was drawn from the population registry. From 1996 through 2000, 2181 women from the population register were recruited and randomly assigned to the intervention and to the control group. The subjects in the intervention group have been on a multidisciplinary program and the subjects in the control group received osteoporosis prevention information through the media and health care system. An end point is any fracture during the ten-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 60-70 years and living in southern Finland (Uusimaa region)
Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.

Exclusion Criteria:

* Active, clinically significant bleeding (excluding drainage).