cyrilzakka/clinical-trials huggingface dataset:
Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis

This research study is studying a possible test which may help doctors diagnose women with ovarian cancer.

This research study is a Feasibility Study, to try to evaluate whether or not culdocentesis can detect tumor associated cell free DNA. Although this is the first time investigators are using this type of procedure to detect cell free DNA, culdocentesis is not a new procedure. It used to be done routinely in the past to examine pelvic fluid. The investigator's goal is to develop a test to detect ovarian cancer in women before they develop any signs or symptoms of the disease. Currently, there is no screening test for ovarian cancer.

This study uses a technique called "culdocentesis" to detect DNA released by ovarian cancer cells into pelvic fluid. During culdocentesis, a small needle is inserted through the vagina into an empty space between the uterus and the rectum called the "cul-de-sac." Fluid is withdrawn from this space and sent for analysis. Culdocentesis is a technique that has been used for many years to examine pelvic fluid and determine its composition, but it has not previously been studied as a technique for examining cell-free DNA to detect ovarian cancer. The investigators suspect that this may be a useful way to detect cell-free DNA from ovarian cancer cells because the ovaries are very close to the cul-de-sac space.

In this study, the investigators will compare our ability to detect cell-free DNA in fluid from the cul-de-sac with our ability to detect cell-free DNA from a vaginal swab (similar to a Pap smear), a blood test, and in the tissue specimens collected at the time of surgery. The investigators are hoping to learn from this study whether developing a cell-free DNA test to screen for ovarian cancer involving culdocentesis would be an effective strategy.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 18
* Able to give informed consent
* Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and carcinomatosis)
* Post-menopausal or negative urine and/or blood pregnancy test
* Measurable disease on preoperative imaging

Exclusion Criteria:

* Male
* Age \< 18
* Unable to give informed consent
* Not planned for surgical intervention
* Active malignancy other than ovarian cancer
* Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation)
* Known or suspected active pelvic infection
* Pregnancy
* No measurable disease or suspected Stage I or II ovarian cancer on preoperative imaging
Iron Intravenous Therapy in Reducing the Burden of Severe Arrhythmias in Heart Failure With Reduced Ejection Fraction

An open label,single-center, non-interventional prospective study with the aim on investigating the effect of intravenous ferric carboxymaltose in restoring iron status and reducing the risk of severe arrhythmic events in participants with iron deficiency and a reduced ejection fraction (HFrEF).

Patients with HFrEF already scheduled to receive IV FCM to treat iron deficiency will be included in this registry trial. These patients undergo clinical examination, echocardiography, blood testing, 6-minute walking testing, cardiopulmonary exercise testing, cardiac implantable device interrogation, 24-hour Holter monitoring and quality of life quantification as part of standard clinical practice. This database will be extracted from clinical databases and stored on a separate, registry database. The study will examine the effect of IV FCM on patients' iron stores, arrhythmic burden, hospitalizations and clinical, echocardiographic, exercise-testing-derived and biological markers of disease severity such as 6-minute walking distance, peak VO2 consumption, LVEF and LV global longitudinal strain and NT-proBNP.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HFrEF (LVEF≤40%)
* Implanted cardiac implantable electronic device with at least 3 months of recorded arrhythmic history
* Patient is scheduled to receive IV ferric carboxymaltose to treat diagnosed iron deficiency

Exclusion Criteria:

* Myocardial infarction, acute heart failure or life-threatening arrhythmias in the preceding 15 days
* Autoimmune disorders, cancer or other diseases other than heart failure that significantly affect patients' life expectancy, appetite and emotional status
* Known allergic reaction to ferric carboxymaltose.
VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions

To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered, it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling early cancer visualization using a newly developed fluorescent NIR fiber-bundle. This hypothesis will be tested in this pilot intervention study.


Eligibility Criteria:
Inclusion Criteria:

* Identified HGD or intramucosal EAC (T1) and therefore candidate for endoscopic mucosal resection therapy
* Mentally competent person, 18 years or older.
* Written informed consent.
* Adequate potential for follow-up.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Submucosal and invasive EAC; EAC with tumor-classification other than T1.
* Concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure.
* Previously performed therapeutic endoscopic procedures.
* Pregnancy or breast feeding.
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities

This study seeks to implement a sexual health promotion intervention for male sex workers in Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. At the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.

The intervention is administered in community and clinic settings. The full intervention consists of seven core modules: Sexual Health, Sexual Diversity, HIV/STI Transmission, Behavioral Risk and Risk Reduction, Alcohol and Drugs, Stigma, and HIV/STI and Health Seeking Practices. In the community, outreach is conducted by Health Educators to deliver the intervention modules that young men express and interest in, as well as to provide risk reduction materials including condoms and lubricant. Study interviewers conduct a cross-sectional interview of young male sex workers in community venues (the interviewers and health educators are never present in a venue at the same time), and a random sample of interviewees are invited to a local clinic, where they receive a more detailed interview, the full intervention (delivered one on one by a Health Educator and including all seven modules), a clinical exam, testing for HIV and other STIs (HBV, HCV, gonorrhea, syphilis, chlamydia), onsite treatment, vaccination and referral, and a post-intevention assessment.

Eligibility Criteria:
Inclusion Criteria:

* Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days

Exclusion Criteria:

* inability to provide informed consent
Ventilation Strategies During Spontaneous Breathing Trial

Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.

Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or more
* intubated and mechanically ventilated for at least 24 consecutive hours
* staying in the medical ICU at the Croix Rousse Hospital, Lyon, France
* pressure support ventilation 10-15 cm H2O, total respiratory rate 25-35 breaths/min, expired tidal volume 6-8 ml/kg predicted body weight
* meeting criteria for spontaneous breathing trial (able to answer simple questions, no ongoing intravenous sedation, norepinephrine ≤ 1 mg/H, dobutamine ≤ 20 mg/h, fraction of inspired oxygen (FIO2 ≤ 50%), PEP ≤ 5 cm H2O, respiratory rate ≤ 35 breaths/min, saturation in oxygen (SpO2) ≥88%)
* under Dräger Evita XL ou V500 ICU ventilator
* agreement to participate from the patient or next of kin

Exclusion Criteria:

* Chronic respiratory failure under long term home oxygen therapy and/or non invasive ventilation before ICU admission
* Tracheotomy
* nasogastric tube contra-indicated
* thoracic tube in place
* no agreement to participate
* under justice protection
* deprived of freedom
* pregnant or breastfeeding
* not affiliated to social insurance
* involved into another study that may interfere with present study
The Impact of Night Float on Anesthesiology Resident Sleep Patterns

Residency training requires hospital presence twenty-four hours a day. At times this necessitates working extended shifts, including night shifts, resulting in altered sleep patterns and sleep deprivation. Since 2003, the Accreditation Council for Graduate Medical Education (ACGME) has enforced duty hour regulations limiting shift length, the amount of weekly hours worked, and other variables governing shift work. Numerous studies have sought to determine the impact of duty hour regulations on the quality of patient care and resident education.

In addition to affecting patient care, medical resident sleep deprivation also has the potential to affect residents' well-being and their ability to perform basic tasks. A study in surgical residents showed reduced efficiency and safety in performing simulated laparoscopy following a period of sleep deprivation that was worse with novices compared to experienced residents. Recently, UVA found that resident physicians have greater difficulty controlling speed and driving performance with increased reaction times and minor and major lapses in attention in the driving simulator following six consecutive night shifts.

To comply with duty hour restrictions, residency programs have adopted various strategies including the creation of night float systems where residents are required to work multiple nights in a row. Reduced shift length has been associated with decreased medical errors, motor vehicle collisions, and percutaneous injuries.Surgical residents who transitioned to a night float system from 24-hour call every 3rd day reported reduced fatigue, more time for sleep and independent reading and increased family time, while nurses and patients reported improved communication and quality of patient care. In a pilot study of urology residents assigned to a 12-hour day shift (Monday-Friday), 12-hour night float (Sunday-Friday) or 24-hour home call, actigraphy was used to measure total sleep time, sleep latency and depth of sleep. Night float did not impact total sleep time or quality of sleep. However, these studies did not establish the optimal shift duration

Participants wear a portable EEG monitor and a FITBIT activity monitor while attempting to sleep while on night call and at home for a baseline reading

Eligibility Criteria:
Inclusion Criteria:

* postgraduate year (PGY) 2, 3, and 4 Anesthesia residents

Exclusion Criteria:

* history of pacemaker or other medical device
* unable or unwilling to consent and comply with the protocol
* history of sleep disorder
Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.

The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type A, B, C fractures of AO classification of distal radius fractures
* Patents aged between 18 and 75 years,
* Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living

Exclusion Criteria:

* Patients with open fractures
* Patients with mental disorders (dementia, alcoholism, etc.),
* Patient dependent for basic activities of daily living
* Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO),
* Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).
Effect of Pre-operative Training Using Surgical Videos on Resident Performance of Unilateral Salpigo-oophrectomy

There is a need for the development and validation of new teaching strategies and resources for surgical training that can occur outside of the operating room. The use of surgical videos is not novel however it has not been validated as an effective approach for gynecologic surgical training. The goals of our study are to (1) develop an educational surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the effectiveness of this tool in preparing residents for performance in the operating room.

In the rapidly changing face of surgical education and with a pressure to adopt competency-based training and assessment nationwide, obstetrics and gynecology residency programs will be forced to implement effective strategies to ensure that learners acquire the skill set required to become competent gynecologists. However, very few instructional tools have been validated in gynecologic surgery. The use of surgical videos as a teaching strategy may be one piece to this puzzle. Surgical videos are becoming increasingly popular, however, their value as an effective instructional technique has yet to be validated. Should surgical videos prove to be of benefit in surgical training it would offer an alternate modality to optimize operating room experiences and learning for gynecology residents.

Obstetrics and gynecology residents in years one and two of their training (junior residents), will view a teaching video about LSO (intervention group) compared to not watching a video (control group) to assess if our intervention results in better performance in the operating room for this procedure as rated by an objective structured assessment of technical skills tool (OSAT) (primary outcome). Secondary outcome measures will include a self-administered questionnaire grading knowledge and confidence, and a 5-point Likert scale grading resident satisfaction with the video.

Eligibility Criteria:
Inclusion Criteria:

* Novice OBGYN residents who have performed \<10 LSO surgeries as the primary surgeon

Exclusion Criteria:

* OBGYN residents who have performed \> 10 LSO surgeries as the primary surgeon.
Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis

The present study aims to compare the efficacy of assisted rehabilitation treatment, in terms of improvement of pain and shoulder articulation, in patients with stage 2 adhesive capsulitis compared with unassisted home rehabilitation treatment. This evaluation is performed following the glenohumeral capsular hydrodistension procedure performed under ultrasound monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged between 18 and 65 years;
* Stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound.

Exclusion Criteria:

* Patients unable to give consent;
* Pregnant women;
* Patients with poly-drug allergies (anesthetics, corticosteroids); 3.
* Patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).
Impact of Education During Pregnancy in Overweight Pregnant Women

Metabolic environment of the foetus during pregnancy in obese women is altered and the child exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is associated with subsequent obesity.

The purpose of the study is to test the efficacy of an educational intervention during pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the two first years of life.

In a first time, we propose to pregnant overweight women to participate a study based on the follow up of their pregnancy and of their child during the two first years of life. Women in agreement with the study sign a consent form and fill in a questionnaire about their quality of live.

We secondly randomized the women in two groups:

Group A: in this group an intervention is delivered. It provide education, at regularly scheduled sessions (20 weeks, 28 weeks, 35 weeks, and 2 month after delivering) and two dietary consulting. The sessions that stress about healthy eating and modest exercise assemble several women (no more than 10). Women in agreement with this intervention sign a consent form.

Group B: in this group, pregnant women are managed with standard care (at least one dietary consulting is proposed around 26 weeks).

Risk factors for child obesity are researched by questionnaire (parents smoking habit, mother and father level of education, family history of obesity, risk factors for gestational diabetes...). Mother weight measured at every clinic visit, is recorded as complications during pregnancy (HTA, preeclampsia, diabetes, fetal malformation ...) and during delivery. Mother glycosylated haemoglobin is measured at birth.

Variables of interest for the children included at birth: gestational age, sex, neonatal pathology, hospitalisations and hypoglycaemia episode. Measurement, and method of infant feeding are recorded at birth, and by phone call every 2 months during 6 months, at 9 month, 1 year, 18 months and 2 years. At 4 months the mother fill in a questionnaire about the amount of milk or other foods eaten by the child.

A visit is planed at 2 years for:

* clinical examination of the child,
* recording of his nutritional and exercise habits
* questionnaire about quality of life of the mother and her health
* measurement of her BMI, arterial pressure, glycaemia before and after 75 g oral glucose-tolerance test, glycosylated hemoglobin, and lipid test.

Eligibility Criteria:
Inclusion criteria :

* Pregnant women who agree the study
* BMI \> 25 kg/m². BMI is based on retrospective self reported weight of the patient before pregnancy.
* No more that 21 weeks of gestation.
* Social security

Exclusion criteria :

* women younger than 18 yrs,
* multiple gestation,
* high risk pregnancy,
* psychiatric pathology,
* diabetes diagnosed before the inclusion
* fetal malformation
* history of obesity surgery
* Women with no understanding of French language
* Women planning to move to another area.
Novel Methodology to Measure Protein Accumulation

Accumulation of damaged proteins is thought to underlie many degenerative conditions, including aging, diabetes, Alzheimer's disease, cataracts, and others. Over time, proteins can be irreversibly damaged by a variety of factors, such as reactive oxygen species, and without timely degradation they can accumulate and aggregate. We believe this can contribute to the development of chronic degenerative disorders.

The purpose of this study is to develop a novel methodology for measuring protein accumulation and test it in two groups of people: young (18-30 years) and old (≥65 years). This methodology will require that people drink a solution of essential amino acids that includes isotopically labeled L\[ring-13C6\]phenylalanine. We will then collect blood and muscle samples, to isolate plasma and skeletal muscle proteins. Participants will return to the study center four more times on a weekly interval.

We hypothesize that older proteins, which persisted in circulation and accumulated over time, will have a higher degree of post-translational oxidative damage than newly synthesized proteins.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years
* Age greater than 65 years

Exclusion Criteria:

* Active or uncontrolled cardiovascular disease
* Chronic kidney disease with serum creatinine ≥ 1.4 mg/dL for women and ≥ 1.5 mg/dL for men
* Chronic liver disease (elevation in serum transaminases ≥ 3 times the upper limit of normal)
* Any debilitating chronic illness, including malignancy
* Significant malabsorptive state, including prior gastric bypass surgery or inflammatory bowel disease
* Diabetes mellitus (types 1 or 2) or glucose ≥ 110 mg/dL.
* Obesity (BMI ≥ 31 kg/m2)
* Anticoagulant therapy (warfarin or heparin) or bleeding disorder that increases risk of bleeding during a muscle biopsy.
* Anemia (hemoglobin ≤ 11 g/dL)
* Use of medications known to modulate protein synthesis, mitochondrial function, and/or glucose homeostasis (including β-blockers and corticosteroids).
* Participation in another study where the 13CPhe was administered during the past 6 months.
* Moderate or high level of structured exercise (on average, ≥ 30 minutes per day and ≥ 2 days per week)
* Pregnancy
* Daily use of tobacco products (smoking or chewing); or smoking ≥7 cigarettes per week, on average. Abstinence from tobacco for ≥3 months is required before enrollment in the study.