cyrilzakka/clinical-trials huggingface dataset:
Prehabilitation for Patients Awaiting Liver Transplantation

This study will assess the feasibility, safety and effectiveness of a structured prehabilitation program combining exercise training, nutritional optimization and psychological support for patients with cirrhosis awaiting liver transplantation.

Due to their chronic liver disease, patients with cirrhosis awaiting liver transplantation develop low muscle mass, poor nutritional status and decreased reserves putting them at high risk of postoperative complications, prolonged hospital stay, and failed discharge home after liver transplantation. Prehabilitation aims to optimize a patient before they undergo a major surgery. These programs combine exercise training, with nutritional optimization and psychological support. Together, these contribute to improve their muscle mass, tolerance to exercise, and nutritional status. The current study will assess whether an individualized and structured prehabilitation program combining supervised exercise training, nutritional optimization and psychological support will benefit patients with cirrhosis awaiting liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Diagnosis of cirrhosis, based on a combination of clinical, laboratory, imaging, or histology
* Active on the liver transplant waiting list of the MUHC

Exclusion Criteria:

* Biological Model for End Stage Liver Disease \>20
* Hepatic decompensation within the last month
* High risk varices not on primary or secondary prevention
* Recurrent large volume paracentesis
* Persistent hepatic encephalopathy
* Platelets \<20,000/µL, or hemoglobin \<80g/L
* Altered hemodynamics
* Significant heart disease
* Awaiting combined organ transplantation
* Awaiting repeat liver transplantation
* Condition limiting mobilization and/or exercise, or recurrent falls
High Omega-3/Low Omega-6 Treatment Diet for Aspirin-exacerbated Respiratory Disease (AERD)

The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6 fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease (AERD).


Eligibility Criteria:
Inclusion Criteria:

* History of physician-diagnosed asthma
* History of nasal polyposis
* History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or diagnosis of AERD via a physician-conducted challenge to aspirin
* Age between 18 and 70 years

Exclusion Criteria:

* Current smoking, defined as daily tobacco smoking in the last 6 months and at least one instance of tobacco smoking in the last 3 months.
* Current pregnancy or breastfeeding
* BMI \<20
* History of allergy to fish or any unwillingness to eat fish as a regular part of the diet
* Use of Zyflo (zileuton) in the last two weeks
* Presence of an implantable cardioverter-defibrillator
* Use of oral steroids in the last two weeks
* Participation in any other clinical trial in the last month
* Any use of nonsteroidal antiinflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme during the course of the study
Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS patients, however, the relationship between (disturbed) sleep quality and fatigue is still not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo controlled cross-over trial with sodium oxybate is carried out in CFS patients.

The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the effect of sodium oxybate on sleepiness and general health in the same target population.

Zero-hypothesis: there is no effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition;
* Negatively screened for fibromyalgia syndrome(FMS) according to the American College of Rheumatology (ACR) classification criteria;
* 18 years or older;
* 65 years or less;
* Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the trial and has to employ an acceptable method of birth control (double barrier method of contraception);
* Written, signed and dated informed consent must be obtained from each patient;
* Patient able to understand and follow the requirements of the study
* Willing to abstain from taking any medication or treatment prohibited in the protocol

Exclusion Criteria:

* FMS;
* Presence of an inflammatory rheumatic disease or a painful disorder other than FMS;
* Fatigue that is explained by medical or psychiatric causes;
* Older than 65 or younger than 18 years of age;
* Apnea/hypopnea index (AHI) \> or equal to 15 on polysomnography (PSG) (exempted if receiving continuous positive airway pressure CPAP and shown good compliance)
* Deficiency in succinic semialdehyde dehydrogenase;
* Porphyria;
* Breathing or lung problems;
* Unsufficiently controlled hypertension (high blood pressure: \> 140/90 mmHg);
* Heart failure;
* Liver or kidney problems (serum creatinine level \> 2,0 mg/dl);
* Presence of a seizure disorder or epilepsy;
* Sodium oxybate treatment in the past;
* Primary history of substance abuse (including abuse of alcohol);
* Inability to withdraw from psychoactive drugs;
* Current use of sedative (benzodiazepine and non-benzodiazepine GABA-ergic agonists), opioids or antidepressant medication or a drug-free interval of less than 4 weeks;
* Female patient who is pregnant, lactating or has a positive pregnancy test result.
* Occupation that requires night-shift work;
* Willing to abstain from using alcohol
Collection of the Thrombo-VaxCov Cohort

In the context of anti-Covid19 vaccination, atypical thrombosis have occured and potential link with vaccination is under investigation.

This study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after antiCovid vaccination.

In the context of anti-Covid19 vaccination, atypical thrombosis have occurred and potential links with vaccination is under investigation. In France, the study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after anti-Covid vaccination.

Eligibility Criteria:
Inclusion Criteria:

atypical thrombosis symptoms onset within 4 weeks of vaccination

Exclusion Criteria:

children
Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients

The specific research questions addressed in the present study are:

* to investigate the impact of treatment with low-dose aspirin in HIV-1-infected patients treated with ABC and test it would result in decreased in vivo platelet activation and platelet hyperreactivity
* to investigate if aspirin has the same effects in HIV-infected as in HIV-uninfected patients.

Highly active antiretroviral therapy (HAART) may reduce the deleterious effects of HIV on the cardiovascular system by decreasing viral load and chronic inflammation; however some antiretrovirals enhance cardiovascular risk due to direct adverse effects on platelets or the endothelium.

Abacavir/lamivudine (ABC/3TC) and tenofovir/emtricitabine (TDF/FTC) are the most widely used nucleoside reverse transcriptase inhibitor (NRTI) associations in HAART. ABC has been initially considered as one of the most benign antiretroviral drugs due to a better metabolic profile than other nucleoside analogues, but since the D.A.D. study reported an association between the use of ABC and an increase in cardiovascular risk there has been controversy around this drug.

Clinical evidence suggests that in vivo platelet activation and platelet hyperreactivity contribute to adverse cardiovascular events and hyperreactive platelets may transform a normal reparative response to a mild arterial injury into an unwanted thrombotic event.

Aspirin is the cornerstone in the prevention of atherothrombotic events, as it has been shown to be effective both in the primary and secondary prevention of MI (6), and its beneficial effects likely involve the modulation of inflammatory and immune pathways. But despite heightened awareness regarding elevated CVD risk among HIV-infected patients, aspirin or others antiplatelet therapy were markedly underprescribed among HIV-infected patients at risk for CVD events (7).

Based on this, the proposed study will assess whether low-dose aspirin, in well-characterized HIV-1-infected patients treated with ABC, would result in decreased in vivo platelet activation and platelet hyperreactivity. Moreover will be investigate if aspirin will have the same effects in HIV-infected as in HIV-uninfected patients.

Eligibility Criteria:
Inclusion Criteria:

* a viral load \<50 copies per millilitre
* ABC treatment for at least 6 months

Exclusion Criteria:

* age younger than 18
* nonsteroidal anti-inflammatory drug use in the past week (including aspirin), renal failure (creatinine clearance \<30 mL/min), platelet count \<100,000/microL, history of gastrointestinal bleeding within the last 6 months, presence of coexisting inflammatory disease, cancer, active bacterial or fungal infection, bleeding history, oral anticoagulant therapy and allergy to aspirin
Physiologic Effects of Sleep Restriction

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. Voluntary sleep restriction is common, with 28% of the US adult population reports getting 6 or fewer hours of sleep per night, and those who do are 24% more likely to have cardiovascular disease and have twice the risk of hypertension. Insufficient sleep may conceivably be one of the most common, and most preventable, cardiovascular risk factors. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators will combine our cardiovascular studies with state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the physiologic effects of sleep restriction. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* No chronic medical conditions other than seasonal or environmental allergies
* On no prescription medications other than second generation antihistamines (Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices.
* BMI 18.5-35 kg/m2
* Both normotensive and prehypertensive people are eligible and will be studied
* Not a current smoker or tobacco user
* Not pregnant or breast feeding and not intending to become pregnant or breast feed

Exclusion Criteria:

* The investigators will exclude subjects who have any medical or psychiatric disorders
* History of anxiety or depression, and those taking any medications other than non-sedating antihistamines or oral contraceptives.
* Those found to have depression on a depression screening tool (BDI-II) will be excluded. Current smokers will be excluded.
* All female subjects will undergoing a screening pregnancy test and excluded if positive.
* Subjects found to have significant sleep disorders will be excluded.
Equinox Personal Coaching Versus Self-Directed Exercise

The purpose of this study is to compare the Equinox Personal Coaching exercise training method to self-directed exercise training in helping subjects become more fit. Men between 30 and 44 years of age who exercise on a regular basis and are interested in receiving Equinox personal training will be invited to participate. The investigators will enroll 36 subjects at University of California, Los Angeles (UCLA), the only site. The hypothesis of this study is that subjects randomized to the Personal Coaching Method will result in significantly greater lean mass accrual than those randomized to self-directed training over the 12 weeks of the study.

Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either Coached training or self-training, which they will do for 12 weeks, then complete two End of Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean body mass measurements, and strength and aerobic performance tests, and will take place at Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 30-44 years
* Body mass index less than 30 kg/m2.
* Currently exercising with or without coaching more than 4 days but less than 8 days per month for the past three months (Equinox Motivated or Super Motivated categories);
* Willing to commit to 12 weeks of thrice weekly training at the Century City Equinox club with or without an Equinox coach.

Exclusion Criteria:

* Over age 44
* Musculoskeletal conditions limiting participation
* Unstable cardiovascular, pulmonary, metabolic, or other disorders that would preclude high intensity exercise training.
* Abnormal ECG at Screening that indicates the subject is not healthy enough for maximal exercise in the opinion of the principal investigator
* Family history of sudden death associated with exercise, based on self-report
Study to Evaluate the Learning Curve to Anchor GYN-CS® Device

GYN-CS® is a new concept in intrauterine device technology. It is fixed to the uterine fundus, is frameless and entirely flexible. The GYN-CS® 3 has a lifespan of 3 years and GYN-CS® 10 has lifespan of 10 years, both used in this study. The primary objectives are: Analyse the learning curve of the surgeon and the ease of insertion of the device.

This study is a mono-center, open-label, single-arm (non-randomized trial, in which each participant receives GYN-CS® 3 or GYN-CS® 10) prospective study for the insertion evaluation of GYN-CS®. Providing no complications occur, the women will remain in the study for 3 years.

The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.

The learning curve parameters are the time of the procedure (starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted) and a scale for the ease of insertion of the device.

Following insertion of GYN-CS® 3 and 10, women will be reexamined at discharge, at 6-8 weeks, at 1, 2 and 3 years after insertion. At 3 years after insertion of the GYN-CS® 3, it will be removed during the follow-up visit. At 3 years after insertion of the GYN-CS® 10, the device doesn't need to be removed at the follow-up visit. During every visit a vaginal ultrasound and gynecological examination are performed as well as a satisfactory scale of the IUD is questioned at the patient.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, women,
* Pregnant women in the second trimester
* 18-48 years of age
* Birth by Caesarean section planned
* Be willing to stay in the study for 3 years
* Return for follow-up at the designated times
* Signed informed consent

Exclusion Criteria:

* The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out)
* Suspicion of endometrial or uterine pathology such as congenital malformation of the uterus
* Large uterine fibromata (\> 3 cm in diameter)
* Acute leukemia
* Severe blood clotting disorders and undiagnosed genital tract bleeding
* Significant medical disease that in the medical opinion of the investigator is likely to interfere with patient ability to complete the entire trial
* Participants receiving corticosteroid therapy (hydrocortisone\>40mg/d or an equivalent) or immunosuppressive drugs
* Caesarean section \< 36 weeks
Efficacy of a Web-Based Alcohol Intervention for High School Students

This study evaluates the efficacy of the eCHECKUP TO GO as an intervention to reduce underage drinking and the associated negative consequences among high school seniors. The aim of this project is to provide a brief, low cost intervention that can be easily disseminated as a school-based intervention to address this important public health problem.


Eligibility Criteria:
Inclusion Criteria:

* Senior enrolled in high school sites

Exclusion Criteria:

* none
The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study

To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.


Eligibility Criteria:
Inclusion Criteria:

1. greater than 37 gestational weeks
2. single pregnancy
3. vaginal delivery
4. estimated fetal weight 2500-4500 gr.

Exclusion Criteria:

1. PPROM
2. 37 or lower gestational week
3. multiple pregnancy
4. grand multiparıty (greater than 5)
5. coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)
6. a history of any bleeding during pregnancy
7. caesarean delivery or any uterine scar
8. a history of postpartum haemorrhage
9. hydramnios
10. known uterine anomalies
11. suspected abnormal placentation (accreta, increta, or percreta)
12. prepartum hemoglobin concentration less than 8 g/dL
13. history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours
Transcranial Magnetic Stimulation and Cognitive Stimulation in Mild Cognitive Impairment

This study evaluates the effect of 5Hertz (Hz) repetitive Transcranial Magnetic Stimulation (rTMS) on Left Dorsolateral Prefrontal Cortex enhancing Cognitive Stimulation in Mild Cognitive Impairment.

Mild Cognitive Impairment (MCI) is defined as an intermediate state between normal aging and an early stage of neurodegenerative diseases. It is estimated that exist 24.3 million people worldwide with neurocognitive disorders. Cognitive Stimulation (CS) is defined as the set of techniques and strategies that optimize the effectiveness in various functions of different cognitive abilities throughout its use in rehabilitation on MCI. Transcranial Magnetic Stimulation (rTMS) is a safe neuromodulation technique that modifies brain electrical activity through electromagnetic fields. There is evidence of the relationship between CS and rTMS for the improvement in MCI levels and cognitive functions; it´s important to deepen the knowledge of the therapeutic potential of both techniques combined on MCI

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders.
* Subjects from 60 to 85 years old.
* Meet Diagnostic and Statistical Manual, 5th edition (DSM-5) diagnostic criteria for Mild Cognitive Impairment.
* Patients must provide their oral and written informed consent.

Exclusion Criteria:

* Subjects with history of traumatic brain injury with loss of consciousness.
* Subjects with intracranial metallic objects or metal plates in the skull.
* Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
* Comorbidity with other mental illness.
* Presence of psychotic symptoms, Bipolar Disorder and Substance abuse.
* Alterations in the electroencephalogram (epileptiform activity).
Change in Dielectric Constant, Elasticity and Temperature by Acupuncture

Evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals.

Systemic acupuncture is a therapeutic resource in Chinese Medicine that uses needles at specific points in the body, consistent with a system called acupuncture meridians. The aim of the study is to evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals. Will be evaluated 360 volunteers aged between 18 and 38 years and both sexes divided into six homogeneous groups. Pregnant women or those with a delay in the menstrual cycle for more than 28 days will be excluded. The evaluation will consist of measuring the dielectric constant at different depths of the skin, elasticity and infrared thermography of systemic acupuncture points. The procedure will be performed in three moments: pre systemic acupuncture (prior to stimulation), immediate post-systemic acupuncture (20 minutes after the start of stimulation), and post systemic acupuncture (40 minutes after the start of stimulation). Systemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao), lasting 20 minutes. The multiple comparison ANOVA test will be performed, with statistical significance of 5% (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged between 18 and 38 years, both genders and without health complaints.

Exclusion Criteria:

* Pregnant female volunteers or those with a delay in the menstrual cycle for more than 28 days.