cyrilzakka/clinical-trials huggingface dataset:
Pecha Kucha Method Effects on Posttraumatic Growth and Psychological Resilience

This study was planned to investigate the effect of the training given to breast cancer patients receiving chemotherapy with pecha kucha method on posttraumatic growth and psychological resilience.

This study is a randomized controlled trial planned to investigate the effect of the training given to breast cancer patients receiving chemotherapy with the pecha kucha method on posttraumatic growth and psychological resilience.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* At least one course of adjuvant chemotherapy prior to treatment,
* Literacy
* Communicable patients
* Patients who agreed to participate in the study

Exclusion Criteria:

* With a psychiatric diagnosis,
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions (eMouve2)

The aim of this study was to validate functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

There is a growing interest in evaluating physical activity and energy expenditure (EE) to provide feedback to the user. The use of mass-market sensors such as accelerometers offers a promising solution for the general public due to the growing smartphone market over the last decade.

Thus, the proposed EE estimation function has been created using accelerometry data collected from 10 volunteers equipped with a smartphone and two research sensors (Armband and Actiheart) used to estimate EE during several controlled activities. The research sensors' data serves as reference during the creation and evaluation of the proposed function.

It has been evaluated with data of 6 other volunteers in free-living conditions in the previous eMouve project.

eMouve2 consists in acquiring more data from 24 new volunteers in order to validate the function in free-living conditions.

This EE estimation function using the smartphone technology is dedicated to light- and moderate-intensity activities, and we believe it can be a new way to help people controlling their daily physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* age: 18-60 years
* BMI between 18.5 and 25 kg/m²
* subject considered as healthy after clinical examination and medical questionnaire
* women of childbearing age: use of a contraceptive method
* subject with normal rest electrocardiogram (validated by a cardiologist)
* subject with normal blood pressure (\<140/90 mm Hg) with or without medical treatment
* subject with no foot pad problem
* subject giving his/her written informed consent
* subject willing to comply with study procedures
* affiliated to National Health Insurance

Exclusion Criteria:

* respiratory failure or cardiovascular problem
* known cardiac decompensation or myocardial infarction
* surgery made less than 6 months before the study beginning
* pregnant women and nursing mother
* current infectious pathology
* abnormal electrocardiogram
* not affiliated to national health insurance people
* under legal guardianship
* refusal to sign informed consent
* refusal to be registered on the national volunteers data file
* currently participating or who having got 4500€ in this year before to have participated in another clinical trial
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants

The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.

Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients' immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs.

The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective, multicenter clinical trial. MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.

Eligibility Criteria:
Inclusion Criteria:

Recipient Inclusion Criteria:

* Past recipient of a first kidney allograft from an HLA-matched, living related donor
* Age ≥18 and ≤70 years
* Single solid organ recipient (kidney only)
* ABO compatibility with donor

Donor Inclusion Criteria:

* HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling, half sibling) relative of the prospective recipient participant
* Age ≥18 and ≤70 years
* Past living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells

Exclusion Criteria:

Recipient Exclusion Criteria:

* Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
* Baseline positive donor-specific anti-HLA antibody testing
* Is taking immunosuppressive therapy
* Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)

Donor Exclusion Criteria:

* History of autoimmune disorders
* History of type 1 or type 2 diabetes mellitus
* Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
* History of infection with Zika virus
Patient Experience Study of Deoxycholic Acid Injection

The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.

Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.

Eligibility Criteria:
Inclusion Criteria:

1. Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
2. Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
3. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
4. Acceptable skin laxity as determined by the investigator
5. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
2. Absence of clinically significant health problems
3. Body mass index \> 40.0 kg/m² as determined prior to randomization.
4. History of drug or alcohol abuse.
Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.

Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed

Eligibility Criteria:
Inclusion Criteria:

* Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
* Intermediate or high risk, clinically localized disease
* Adequate organ function
* Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
* Select imaging to rule out metastasis will be done as clinically indicated
* Signed and date informed consent document

Exclusion Criteria:

* Prior treatment for prostate cancer
* Major surgery or radiation therapy within 4 weeks of starting the study treatment
* NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
* History of or known metastatic prostate cancer
* Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
* QTc interval \> 500 msec on baseline EKG
* Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy).
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
* Known active infection
* Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies

The purpose of this prospective and observational study is to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies

Chimeric antigen receptor T-cell (CAR-T) therapy has shown impressive efficacy in hematological malignancies. However, response rates and associated immune-related adverse effects widely vary among patients. And no biomarkers have been identified to predict the efficacy and associated toxicities after CAR-T therapy in patients. Several preclinical experiments and clinical studies have shown that gut microbiota was associated with the efficacy of T cell-driven cancer immunotherapies and their toxicities. In hematologic malignancies, gut microbiota was associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the potential correlation between gut microbiota and the effificacy and toxicity of CAR-T therapy is unclear. Therefore, in this study, we aim to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16-65 years.
2. Hematologic malignancies intended for CAR-T therapy.
3. Expected survival time ≥ 3 months (according to investigator's judgement).
4. Left ventricular ejection fractions ≥ 55% by echocardiography.
5. ALT / AST \<3 times of normal amounts.
6. Creatinine\<2.0mg/dl.
7. PT and APPT \<2 times of normal amounts.
8. Karnofsky performance status ≥ 60.
9. The ECOG score ≤2 points.

Exclusion Criteria:

1. Pregnant (or lactating) women;
2. Uncontrolled active infection；
3. Active infection of hepatitis B virus or hepatitis C virus；
4. Human immunodeficiency virus (HIV) positive；
5. Patients with a history of myocardial infarction or severe arrhythmia within six months or those with class III or IV cardiac function according to the New York classification；
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.

According to Cochrane group trials , abdominal approaches centered on sacral colpopexy is associated with lower risk of awareness of prolapse, repeat surgery for prolapse and dyspareunia than a variety of vaginal interventions. However, these trials weren't statistically significant and have focused on the effects in terms of anatomy and lacked the effect on functional outcomes, the quality of life, perioperative complications and the operative duration.

In this study, We hypothesize that prolonged operative duration will be associated with a greater risk of developing complications and so may guide us to a minimally invasive approach with better functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  1. Symptomatic apical descent stage II or more.
  2. Eligible for both surgical procedures
  3. No uterine or cervical pathology.
  4. Able to consent to participate in the trial.

Exclusion Criteria:

1. Women with contraindication to any surgical procedures.
2. Women with previous apical prolapse surgery.
3. One of the two surgical approaches is not feasible.
4. Women with concomitant surgical procedures apart from correction of the prolapse.
5. Women who prefer to have hysterectomy.
Coronary Artery Calcium, Exercise Tests, and CHD Outcome

To investigate coronary artery calcium (CAC), detected by electron beam computed tomography (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and all-cause mortality in a historical cohort epidemiological study.

BACKGROUND:

Dramatic advances in medical and interventional treatment of clinically overt CHD have contributed substantially, perhaps predominately, to the decline over the past three decades in CHD mortality that has occurred despite relatively unchanged rates of myocardial infarction. By analogy, it is attractive to assume that substantial benefit could also be given to individuals with significant but asymptomatic coronary artery disease if only they could be accurately diagnosed. In this context, research to determine whether or not a non-invasive method like EBCT has sufficient independent predictive value for CHD events to play a useful role in this process has potentially considerable clinical and public health importance.

DESIGN NARRATIVE:

Follow-up of the 5,400 women and 12,600 men will be for an average of about 2.75 years with approximately 15,000 woman-years and 35,000 man-years of observations being available for analyses by June 30, 2000. An important strength of the study is the self-reported key health variables at baseline for all study participants. In addition, objective measures of blood pressure, total cholesterol, HDL- cholesterol, triglyceride, plasma glucose, resting and exercise electrocardiograms (ECG), maximal health rates, cardiorespiratory fitness, and other clinical and biochemical measurements are available for about half of the participants. CAC by EBCT has been associated with prevalent CHD and with incident CHD in recent small prospective studies. However, it is unclear whether CAC is predictive of MI or CHD deaths, because currently available studies had few individuals with evidence of hard CVD endpoints. The large cohort with CAC measurements provides the power to investigate an association between CAC and CHD morbidity, stroke, and all- cause mortality in terms of thresholds or dose-response effects. Exercise test results and measures of conventional CHD risk factors, including several health behaviors and biochemical markers, are available for about 50 percent of the participants. This will allow evaluation of the separate and independent predictive value of CAC and exercise test results and the combination of these two exposures in relation to study outcomes. Furthermore, CAC scores, exercise test results, and the presence of conventional risk factors will be used together to identify participants at the highest risk of developing CHD outcomes.

Eligibility Criteria:
No eligibility criteria
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.

Parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, term (37-42 weeks gestation), singleton infant at birth.
* Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.
* At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.

Exclusion Criteria:

* Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment.
* Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.
Heart Failure Optimization Study

This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be used to observe the rate of recovery of ventricular function (EF\>35%) between 90 and 180 days in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge, with the option for longer use under physician discretion. Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study.

Eligibility Criteria:
Inclusion Criteria:

Phase 1 (Registry phase)

* Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD for no more than 30 days.
* Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times).

Phase 2 (Study phase)

* Patients who completed Phase 1 and used a WCD for 90 ± 14 days.

Exclusion Criteria (both phases):

* Patients under 18 years old.
* Patients who have an active unipolar pacemaker.
* Patients with a physical or mental condition that could impair their ability to properly interact with the device.
* Patients currently participating in another clinical study.
* Patients with any skin condition that would prevent wearing the device.
* Patients with an advanced directive prohibiting resuscitation.

Exclusion criteria (Phase 2)

* Patients who have a QRS duration of ≥135 ms and are planned for cardiac resynchronization therapy.
* Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).