cyrilzakka/clinical-trials huggingface dataset:
Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients

The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max.

The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The non-probability convenient sampling technique, followed by random allocation using a lottery method, ensures a diverse yet unbiased sample. Will be conducted at the Sialkot Medical and Physiotherapy Centre, the inclusion criteria will focus on post-PCI patients aged 40-60, presenting with a BMI of 30 or higher. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max. The aerobic exercise group undergoes sessions three times a week, progressively increasing in duration and intensity, emphasizing activities like brisk walking and cycling. The resistance exercise group follows a similar schedule, engaging in full-body resistance exercises targeting major muscle groups. Both groups undergo assessments using cardiopulmonary exercise testing (CPET) to determine exercise tolerance accurately.

Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be between 40 and 60 years old.
* Gender: Male and female both.
* Cardiovascular Status: Post Percutaneous Coronary Intervention (PCI) patients with a documented history of coronary artery disease
* Participants who are at least three months post PCI to ensure stabilization of their cardiovascular condition.
* Obesity: Participants must have a Body Mass Index (BMI) equal to or greater than 30 kg/m², indicating obesity.
* Health Status: Participants should be in stable health condition to participate in moderate physical activities.
* Willingness to Participate: Participants must provide informed consent and be willing to comply with the study protocol, including attending scheduled exercise sessions and follow-up assessments.
* Participants capable of engaging in either aerobic or resistance training, were assessed by a physical activity readiness questionnaire (PAR-Q).

Exclusion Criteria:

* Participants with severe physical limitations, disabilities, or musculoskeletal disorders that would prevent them from engaging in aerobic and resistance exercises.
* Individuals with a history of substance abuse or current substance abuse issues that might interfere with their ability to participate or adhere to the study protocol.
* Patients with Neurological diseases
* Patients with severe or unstable heart conditions, recent heart attack, or heart failure
Effectıveness of The Sexually Transmıtted Dıseases Educatıon Program for Adolescents

The World Health Organization has defined the period between the ages of 10-19 as adolescence, 15-24 years as youth and 10-24 years as youth period. Adolescence is divided into 3 periods: early adolescence (10-13 years), middle adolescence (14-16 years) and late adolescence (17-21 years). HIV virus and AIDS, which have become a problem among sexually transmitted diseases all over the world, have increased the importance of controlling sexually transmitted diseases. There is a strong correlation between the spread of STDs through traditional means and the transmission of HIV; and sexually transmitted diseases have been found to increase the risk of sexual transmission of HIV. According to WHO data, 340 million treatable STDs, millions of incurable STDs and 5 million HIV cases occur worldwide each year.

People in the 15-49 age group who are sexually active are the most likely to contract sexually transmitted diseases. The prevalence of STDs is higher in developing countries than in developed countries. These diseases are among the top 5 etiologic factors that cause loss of years of "healthy productive life" in developing countries. As in other countries, sexually transmitted diseases are of great importance in terms of complications and sequelae in Turkey

One out of 20 young people is infected with STDs every year. In our country, the age of sexual maturation has shifted earlier. In addition, the age of sexual experience of young people has also shifted earlier. Young people's understanding of freedom and their inability to access FP methods whenever they want negatively affect their sexual health behaviors. Impact on Society STDs cause a lot of economic and social damage to society. STDs may disrupt the normal functioning of family, community and health institutions and leave these institutions under a heavy economic burden. STDs reduce the productivity of men and women at the most productive ages of their lives. In addition, when outbreaks of these infections are not controlled, the costs to society will increase.

Translated with DeepL.com (free version)

Eligibility Criteria:
Inclusion Criteria:

* At a Foundation University located within the borders of Istanbul Province 1.2.3. and 4th grade students

Exclusion Criteria:

-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects

This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.

Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10 subjects will be enrolled in each cohort and will be randomly assigned to receive a single oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review all available safety data in a blinded manner following the completion of each cohort to determine the next dose level to be evaluated in the next cohort.

Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an adequate number of days to reach steady state (the number of days will be determined based on the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the SRT.

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18 to 30 kg/m\^2
* Negative serum pregnancy test (females); females of childbearing potential and males must agree to use acceptable contraception

Key Exclusion Criteria:

* Pregnant or lactating (females)
* Clinically significant past or current medical or surgical history
* Clinically significant illness or abnormality on physical examination, 12-lead ECG, laboratory values
* Participation in an investigational drug or device study within 30 days prior to Screening
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation

In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.

COVERAGE France is Multicenter, randomized, controlled clinical trial with for each drug :

* A safety study pilot phase.
* An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase.
* Pilot phase will evaluate the tolerance of experimental treatments for drugs given for the first time ("first in home-based care") in ambulatory individuals with COVID-19 with aggravating risk factors.
* Efficacy Phase: To estimate the effectiveness of experimental ambulatory treatments, compared to vitamin supplementation, in reducing the risk of hospitalization, oxygen therapy indication or death in ambulatory individuals with COVID-19 with aggravating risk factors.

The trial is a national platform with the vocation to open as many centers as possible, subject to criteria set by the Scientific Advisory Board.

Eligibility Criteria:
Inclusion Criteria:

* Clinical picture suggestive of COVID-19 dated 7 days or less.
* Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
* Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
* Age :

  * greater than or equal to 60 years of age without any risk factor
  * or between 50 and 59 years of age and the presence of at least one of the following risk factors :

    * Arterial hypertension under treatment (all stages)
    * Obesity (BMI ≥30 kg/m2)
    * Diabetes under treatment (all types)
    * Ischemic heart disease (all stages)
    * Heart failure (all stages)
    * Stroke History
    * Chronic Obstructive Pulmonary Disease (all stages)
    * Stage 3 chronic renal failure (30 ≤ Estimated GFR \< 60 mL/min/1.73 m²)
    * Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.
    * Immunodeficiency
* of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids \> 15 mg/d of prednisone equivalent taken for at least 2 months);
* HIV infection with CD4\<200/mm3.
* Valid, ambulatory person, fully able to understand the issues of the trial
* Beneficiary of a Social Security scheme
* Signed informed consent

Exclusion Criteria:

* Asymptomatic person
* Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)
* Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.
Long-term Follow-up of Subjects Treated with CAR T Cells

This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (DF/HCC# 22-175) and NCT06026319 (DF/HCC# 23-474).

This is a long-term safety and efficacy follow-up study for subjects who have been treated with CAR T cells in corresponding Phase I main studies that evaluated the safety and efficacy of CAR T cells in subjects.

No investigational treatment will be administered in this study.

The FDA (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (AEs), as well as durability of clinical response.

Therefore, after monitoring of subjects in the main studies has been completed (24 months after CAR T cells infusion, or \<24 months after CAR T cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (LTFU).

Subjects will be followed for up to 15 years following their last CAR T cells infusion in the corresponding main study.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be asked to participate leading up to the last DF/HCC corresponding main study visit.

Subjects meeting the following criteria are eligible for study participation:

* Provision of voluntary written informed consent by subject
* CAR T cells were administered in DF/HCC IRB corresponding main study

Exclusion Criteria:

Subjects meeting the following criterion are to be excluded from study participation:

- Subject unable to comply with study requirements
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

This is a substudy (Part 2) of a larger two-part clinical trial including both observational and therapeutic (interventional) cohorts to assess the progression free survival ratio of patients treated with a targeted therapy based on genomic analysis results and recommendation by the Markey Cancer Center Molecular Tumor Board (MCC MTB).

This prospective, single-arm trial in patients with refractory metastatic cancer will compare the Progression Free Survival (PFS) using a treatment regimen selected by the MCC MTB with the PFS (time to tumor progression) for the most recent regimen on which the patient had experienced progression (i.e., using patients as their own control).

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically suspected or histologically confirmed solid or hematological malignancy who have undergone or will undergo genetic testing of their tumor
* Patients must have failed first-line therapy for their disease (refractory) or have no options for curative therapies.
* Patients must have either measurable or non-measurable disease.
* Age ≥18 years.
* Eastern Cooperative Oncology Group performance status ≤3.
* Patients with brain metastasis must have had treatment of their brain metastasis completed at least 1 day prior to enrollment and be on stable dose of steroids or off steroids at the time of enrollment.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
* Pregnant women are excluded from this study.
* HIV positive patients with CD4 counts below 500 OR who are not on a stable dose of antiretroviral therapy (for at least 1 month prior to registration) are ineligible.
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds

The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds

Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.

Eligibility Criteria:
Inclusion Criteria:

* Acute wounds in granulation phase with a minimum surface of 100cm2
* ≥ 18 years
* signing informed consent form
* guarantee adherence to protocol

Exclusion Criteria:

* chronic arterial insufficiency
* pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method
* involved in other assay
* previous disease; kidney, heart, hepatic, systemic or immune
* inability to understand informed consent form
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long coronary lesions.

Following angiography, patients with significant diameter stenosis \>50% and lesion length (\> 25mm) requiring single or multiple long-stent placement (total stent length\>28mm) by visual estimation and eligible for LONG-DES IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be at least 18 years of age.
* Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm)
* Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
* Acute ST-segment-elevation MI or cardiogenic shock
* Terminal illness with life expectancy \<1 year
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted)
* Patients with EF\<30%.
* Serum creatinine level \>=3.0mg/dL or dependence on dialysis.
* Patients with left main stem stenosis (\>50% by visual estimate).
Interest of HI-RTE Elasticity in Obstetric

In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.

If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.

The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.

Its contribution in obstetric must be estimated to improve patients minimum fare.

The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women


Eligibility Criteria:
Inclusion Criteria:

* Unique(only) or multiple pregnancy about is the term presenting an intra Utérine pregnancy in the 1st quarter ·
* Signed lit(enlightened) consent ·
* Patient of more than 18 years old

Exclusion Criteria:

* Suspicion of pregnancy extra utérine, hémodynamique unstable, important métrorragies, maternal diabetes, arterial high blood pressure

  * impossibility to receive the consent lit(enlightened) by the patient · patient old under age 18
STORIES-Stories to Communicate Risk About Tobacco

The purpose of this study is to develop and test an intervention based on literacy-appropriate electronic tools, tailored to the demographics and readiness for change of the user, to promote tobacco smoking cessation in a low-literacy population.

PROJECT STORIES:

STORIES is one of two intervention trials conducted as part of the "Deep South Partnership for the Prevention of CVD Disparities" under the NHLBI Partnership Programs to Reduce Cardiovascular Disparities. STORIES is an innovative approach to smoking cessation programs provided in medical facilities for patients seeking assistance with quitting smoking. Our approach is to provide the patient with counseling prior to being discharged from the hospital in an effort to assist them with quitting smoking. The DVD will include current and previous smokers telling their stories regarding their tobacco use. We feel having the patient see other people similar to them express their views, struggles and successes with quitting smoking will motivate them to quit smoking. The patient will also receive 3 follow up telephone calls to check on their progress. Our hypothesis is that patients exposed to the interactive DVD will be more likely to quit, compared with those not exposed. The specific aims for this health communication project are: (1) to develop a series of interactive, testimonial-base stage of change-matched Health Communication DVD video interventions targeted at low-income, low-literacy African Americans in the Deep South and a health information interactive DVD for the patients selected in the randomized control group; (2) to train a peer health counselor/research assistant to counsel inpatient smokers to quit and assist the community members with learning to use the DVDs and then to follow-up by telephone at two weeks, three months and six months after discharge following enrollment in the project; and (3) to evaluate the impact of the intervention on processes of change and six month cessation rates among smokers using a group-randomized controlled trial.

The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR) record.

Eligibility Criteria:
African American inpatients receiving treatment in the medicine unit who desire to quit smoking.

Inclusion Criteria:

* African Americans
* Patients not previously video/interviewed talking about smoking and health
* Patients willing to provide contact information for follow up
* Patients that are able to hear, view and communicate their input on material

Exclusion Criteria:

* Patients other than African American
* Admitted with issues of alcohol, drugs, and mentally unstable
* Patients leaving the state after hospitalization
* Patients without contact information for follow up
* Patients below age 19
* Non smokers
* Patients that use chewing tobacco
* Patients that are incarcerated
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept


Eligibility Criteria:
Inclusion:

* Patient is between post kidney transplant day 3-7 and no requirement for dialysis

Exclusion:

* Patient is receiving kidney from HLA identical,living donor
* Patient is a multi-organ transplant recipient
* Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control
Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)

The aim of this study is to test a 3D-printed mechanical balancer in a clinical setting during surgery to further evaluate the utility of the device. This will be a pilot prospective study of 50 patients undergoing primary total knee arthroplasty. Surgeons will utilize the device intraoperatively in addition to the standard of care practices of mechanical balancing. It will not guide clinical decision making.


Eligibility Criteria:
Inclusion Criteria:

* Surgical candidates undergoing primary TKA

Exclusion Criteria:

* Patient is unable to provide written consent
Active Surveillance for Cancer of the Prostate (ASCaP)

Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.

This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:

* Imaging studies of the prostate
* Rates of curative intervention
* Measures of tumor recurrence/progression
* Disease specific survival
* Overall survival
* Clinical data to track Quality of Life

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
3. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
4. Patient has elected Active Surveillance as preferred management plan for prostate cancer.
5. Patient consent has been obtained according to local Institutional Review Board .
6. Patient is accessible and compliant for follow-up.

Exclusion Criteria:

1. Unwillingness or inability to undergo serial prostate biopsy.
2. Overall life expectancy less than 2 years
3. Advanced prostate cancer