cyrilzakka/clinical-trials huggingface dataset:
RESISTance Exercise for Depression Trial

Depression is a leading cause of disability worldwide and current treatments are ineffective for many people. This trial will investigate the efficacy of a 16-week high vs low dose resistance exercise training program for the treatment of Major Depressive Disorder (MDD) in 200 adults.

Frontline treatments for major depressive disorder (MDD), including psycho- and pharmacotherapy, have limited effectiveness, and there is a critical need to develop and test novel, efficacious treatments for MDD and simultaneously work to optimize its benefits. Resistance exercise training (RET) is a promising but understudied treatment approach. This trial will investigate the efficacy of RET for treatment of MDD in a 1:1 randomized controlled trial (n=200) of 16 weeks of high vs low progressive RET in adults with DSM-5 diagnosed MDD. Further, this project will explore potential mechanisms leading to symptom improvement, including changes in cerebrovascular function (i.e., cerebral blood velocity and pulsatility) and self-efficacy, while also using supervised machine learning tools to predict depression changes, cerebrovascular changes, and participant adherence. Upon completion, this study will build towards identifying and translating mechanistically driven behavioral treatments to reduce the global burden of mental illness.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with DSM-5 MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID).
* Have current depressive symptoms of at least mild severity defined by the Hamilton Rating Scale of Depression 17 greater than or equal to 8 (HAMD; using the GRID-HAMD evaluated by trained, masked raters)
* Be ages 18-65
* EITHER not taking any mental health medications or seeking other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and be willing to maintain that regimen for the duration of the study
* Safe to exercise based on physician clearance
* Willing to be randomized to either condition

Exclusion Criteria:

* Currently pregnant, nursing, or planning to become pregnant during the trial
* Class III+ obesity
* Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
* Diagnosed with current Substance Use Disorder, via the SCID
* Active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale), which would necessitate immediate emergent care
* Exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as assessed by clinical research personnel
* Currently meets resistance exercise recommendations (2 days per week) for the last 8 weeks
* Concussion/traumatic brain injury within the last 3 months
Persistence of Protection by Shingrix

The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

The primary endpoint of this study was the area under the concentration/time curve of quantitative VZV DNA in plasma. However, all the VZV DNA measurements were below the lower limit of quantitation of the assay. Due to this unexpected outcome, we performed a qualitative analysis of presence or absence of VZV DNA in plasma at Day ≥3 after the vOka challenge.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-85
* General good health
* Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
* ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
* ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
* ARM 3 ONLY: Have never received any shingles vaccination

Exclusion Criteria:

* Prior history of herpes zoster (HZ)
* Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.
* Significant immune suppressive illness or therapy
* Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.
* Women of childbearing potential.
* Pregnancy or breastfeeding.
* Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.
Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer

This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.

The combination of PTX and vit E appears as the standard treatment of radiation induced fibrosis. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective. This combination was also positively evaluated in the treatment of osteoradionecrosis, radiation-induced pelvic neuropathies, pneumoniae as well as bowel pathologies.

Spa cares are part of the standard treatment of burn scars. Two spa treatments per year enable the mitigation or disappearance (after several treatments) of pruritus, dysesthesia, local inflammation, hypertrophy and sclerosis. They promote the healing of chronic superficial erosions. The spa treatment combines baths, sprays and especially filiform showers with thermal water jets under high pressure for a few minutes.

Eligibility Criteria:
Inclusion Criteria:

* women
* age ≥ 18 and \<80 years old
* invasive or in situ breast carcinoma
* non-metastatic disease.
* postoperative radiotherapy completed since at least 6 months
* unilateral breast radiotherapy
* grade \> 2 dermal and/or soft tissue toxicity (CTCAE v4.0)
* no inflammatory ou infectious flare on the breast at the time of inclusion
* ability to provide an informed written consent form
* affiliation to a social security system

Exclusion Criteria:

* age \<18 or ≥ 80 years old
* evolutive cancer
* Metastatic Disease
* Patient undergoing specific treatment for breast cancer (except adjuvant endocrine therapy and / or adjuvant Herceptin) at the time of inclusion
* bilateral Breast/chest wall Radiotherapy
* breast prosthesis bearer
* Body Mass Index \> 40 or \<18.5
* chronic skin ulceration within the treated breast at the time of inclusion
* contraindications to spa care :

  * inflammatory disease in flare at the time of inclusion
  * active infections
  * heart failure (NYHA class\> 1)
  * chronic respiratory failure
  * labile blood pressure
  * bullous dermatitis
* evolutive chronic skin disease
* hypersensitivity to pentoxifylline or any of the excipients
* acute myocardial infarction
* ongoing hemorrhage or major bleeding risk
* use of oral anticoagulants
* pregnant or likely to be in 6 months or breastfeeding
* patients deprived of liberty or under supervision
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Treated with a stable dose of one of the following for at least 3 months prior to screening: \* \>=1000 mg/day immediate-release metformin; or metformin \>=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
* HbA1c between 7.1% and 11.0%, inclusive.
* Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2.

Exclusion Criteria:

* Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
* Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
* Have characteristics contraindicating metformin or sulfonylurea use.
* Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
* Have used drugs for weight loss within 1 month of screening.
Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS

The significance of this study is that it may improve the premenstrual symptoms like pain and anxiety in females with premenstrual syndrome and improve their quality of life. This study may add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy. Therefore, the study will be done to compare the effects of Pilate exercises and aerobic exercises on pain, anxiety and quality of life in females with premenstrual syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Unmarried
* Age between 18-30 years
* Patients with at least 5 of 11 symptoms on premenstrual syndrome questionnaire

Exclusion Criteria:

* Patients suffering from Any Disability.
* Patients suffering from diabetes or hypertension or any other Chronic Illness.
* Spine fracture or history of Any Previous Surgery.
A Behavioral Intervention to Improve Work Outcomes

This research has been designed to learn whether getting regular and specific feedback about work performance with small rewards for meeting goals helps people to improve their job performance and leads to better work outcomes, improved mental functioning, and better quality of life

This study is designed to test whether systematic work performance feedback with weekly goal setting, combined with small rewards given for goal achievement, leads to improved vocational, health, and quality of life outcomes for veterans enrolled in the various work service programs at this medical center. The long-term goal of this project is to determine the effectiveness of these interventions at this medical center and to use this experience for a multi-site cooperative study proposal.

Research Design and Methods: One hundred and fifty subjects accepted into work services at this medical center will be randomly assigned to one of two conditions: Work Feedback with Small Rewards, or Usual Services. In the Work Feedback with Small Rewards condition, participants attend a weekly workers meeting where they receive specific feedback based upon the Work Behavior Inventory and set weekly goals. They also receive small rewards for goal achievement that equal $10 per month. Participants in the Usual Services condition do not get specific work feedback but receive all the usual work services normally provided. They also receive $10 per month for active participation. Assessments include baseline evaluations of mental and physical health, social function, cognitive function, and quality of life. Evaluations of mental health, quality of life, and job satisfaction will occur at two months and four months. Six-month and twelve month evaluations will repeat the baseline assessment. Outcome measures will include biweekly work performance assessments, vocational outcomes, mental and physical health status, social and cognitive function, and quality of life

Eligibility Criteria:
Inclusion Criteria:

* Veterans participating in a work program at the VA Connecticut Healthcare System; English-speaking

Exclusion Criteria:

* No exclusion criteria based upon diagnosis, although VA work programs have pre-existing requirements such as a demonstrated need for services, a referral from a clinician, and an interest in work rehabilitation
Improving Biopsy Experiences Study for Women

The goal of this study is to examine whether a guided meditation intervention will reduce anxiety and distress as compared to a music intervention or radiologist supportive dialogue in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation and music interventions are administered through use of headphones during routine outpatient imaging-guided core needle breast biopsies. Women in the guided meditation and music conditions will be given a CD with instructions for home practice. Women complete follow-up questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is examined for 60 months.


Eligibility Criteria:
Inclusion Criteria:

* 21 years old or older
* Undergoing imaging guided core needle biopsy
* Mammography or ultrasound Breast Imaging - Reporting and Data System(BI-RADS) final assessment category 3,4a-c, or 5
* Able to speak and read English
* Able to provide meaningful consent

Exclusion Criteria:

* significant hearing impairment
Oxygen Consumption, Hypoperfusion and Organ Injury After Cardio-pulmonary Bypass

The goal of this observational study is to understand how oxygen consumption after heart surgery relates to blood flow problems and organ injury. The study focuses on patients over 18 years old who are having planned heart surgery with a heart-lung machine (cardiopulmonary bypass).

The main questions the study aims to answer are:

1. How does oxygen consumption in the early hours after surgery relate to lactate levels (a sign of low oxygen supply to the tissues)?
2. How is oxygen consumption linked to signs of poor blood flow and organ injury (such as heart, kidney, liver, brain, and gut damage)?

Researchers will measure oxygen consumption after surgery using a technique called indirect calorimetry. They will also track blood flow and oxygen use during surgery and check for signs of organ injury the day after the procedure. The study will include 65 participants. People with certain health conditions, like severe anemia, high lactate levels before surgery, or needing intensive care or extra oxygen supply before surgery, will not be included. By understanding how oxygen consumption relates to blood flow and organ injury, this research may help to better manage patients after heart surgery and reduce complications.


Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* Combined, redo or annuloplasty procedures
* Surgical procedures involving other vascular cannulation than standard direct, such as bicaval or femoral cannulation
* Preoperative hyperlactatemia (\>2mmol/L) or anaemia (Hb \<90 g/dL)
* Preoperative need for supplementary oxygen or ICU care
* Consent not obtainable.
The Role and Effect of Anemia in Children With Pneumonia

This study will measure the effect of anemia on the outcomes of hospitalized children with severe pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 59 months
* WHO-defined severe pneumonia

Exclusion Criteria:

* Congenital heart disease
Evaluation of the SHARE! Peer Toolkit Training

SHARE! the Self-Help and Recovery Exchange will engage peer workers in their Peer Toolkit training, which is designed to improve the performance of peer workers in their provision of peer support. The Peer Toolkit training currently has a waitlist of peer workers interested in taking the course for professional development purposes. These peer workers and their supervisors will be invited to complete a web-based survey at baseline and 4-month follow-up. Peer workers will be randomly assigned to enroll in the Peer Toolkit training immediately or after the follow-up survey. Analyses will compare participants who had the opportunity to complete the training to those still waiting to start the training. This study will inform the use of the Peer Toolkit as a training mechanism to build the capacity of peer workers in the mental health workforce.

SHARE! the Self-Help and Recovery Exchange will engage peer workers in their Peer Toolkit training, which is designed to improve the performance of peer workers in their provision of peer support. The training covers each of the 12 tools in the Peer Toolkit, which are taught through brief presentations followed by group discussions and interactive exercises to help people competently use each of the tools. The training is offered both online and in-person, requires 60 hours of time, and is typically completed over the course of 4 months. Participation in the training is optional.

The Peer Toolkit training currently has a waitlist of peer workers interested in taking the course for professional development purposes. These peer workers and their supervisors will be invited to complete a web-based survey at baseline and 4-month follow-up. Peer workers will be randomly assigned to enroll in the Peer Toolkit training immediately or after the follow-up survey. Analyses will compare participants who had the opportunity to complete the training to those who are still waiting to start the training. This study will inform the use of the Peer Toolkit as a training mechanism to build the capacity of peer workers in the mental health workforce.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be employed as a peer worker or as the supervisor of a peer worker participating in the study.
* Participants must be willing to attend the SHARE! Peer Toolkit Training, which takes 60 hours to complete.

Exclusion Criteria:

* Peer workers who do not receive pay and volunteer for less than 15 hours per week
Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice

The study will assess the recovery and performance of young athletes suffering from muscle damage induced by physical exercise. Model by comparing the safety and efficacy of ReWin(d) supplemention during 4 weeks to placebo over 72 hours post exercice.

Double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study.

40 healthy young male athetes were randomly assigned to the ReWin(d) or Placebo group. After 4 weeks supplementation (either 2 g daily of ReWin(d) capsules or placebo capsules). the participants were subjected to a 1 hour plyometric exercise session to induce DOMS. At 0 hours, 24 hours, 48 hours and 72 hours post exercise, the volunteers have been assessed to determine: (i) pain perception, (ii) fatigue rate, (iii) sport performance (effectiveness of a jump) and (iv) muscle damage and inflammation by I-R thermography and biomarkers

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Young athletes
* Training at least 3 times per week
* Agree not to initiate any new exercise or diet programs during the entire study period
* Agree not to change their current diet or exercise program during the entire study period
* Agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment for the duration of the trial.

Exclusion Criteria:

* Previous history of upper extremity injury or knee joint pain
* Use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study
* Daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
* Antibiotic use in past 3 months
* Chronic disease
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A ((FVIII:C \<= 1%)
* Male subjects \>= 12 years of age
* Previously treated with FVIII concentrate, at least 50 EDs
* Immunocompetent (CD4+ count \> 200/ul)
* Negative for anti- HIV; if positive, viral load \< 200 particles/u; or \<400,000 copies/mL

Exclusion Criteria:

* Other coagulation disorder than hemophilia A
* Present of past FVIII inhibitor activity (.= 0.6 BU)
* Severe liver and kidney disease
* Receiving of scheduled to receive immuno-modulating drugs
The Value of Amniopatch in Preterm Premature Rupture of Membranes

A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into 2 groups. Group I in which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen plasma in addition to the routine management used in the control group. Group II were treated with routine management including antibiotics and corticosteroids

All patients were started on a regimen of hospital bed rest and received antibiotic prophylaxis consisting of ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days . Antenatal corticosteroids were given in the form of dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses.

Fifty to two hundred ml of normal saline was infused to create an adequate pocket in which the infusion needle can be stabilized. After injection of normal saline, alternate infusions of 20 mL of platelets, normal saline (which does not contain Calcium, needed for the clotting process), and 20 mL of (FFP). The infused substances were warmed to a temperature of 37°c. Avoiding contact between the blood products prevents clotting in the lines.

During infusion, the fetal heart rate as well as the accumulation of amniotic fluid was monitored by ultrasound. Usually a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure

Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women
* gestational age of 24 to 34 weeks (calculated by the sure dates of the last menstrual period and confirmed by early 1st trimesteric ultrasound).

All women carried a normal healthy singleton fetus

Exclusion Criteria:

* established preterm labor at admission
* those with symptoms or signs suggestive of clinical chorioamnionitis.
* women with uncontrolled medical disorder e.g. severe hypertension, uncontrolled diabetes, chronic renal impairment
* women with vaginal bleeding regardless its cause.
* Pregnancies associated with major congenital fetal malformations
* placental insufficiency or anomalies
* anterior position of the placenta
* iatrogenic PPROM