cyrilzakka/clinical-trials huggingface dataset:
Hepaxa Management of Non-alcoholic Fatty Liver Disease

This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use.

Subjects With fatty liver are given Hepaxa for 6 months. Fibroscan CAP measurements are taken at 3 monthly intervals. Subjects consent to Collection of data from approximately 6 months prior to use of Hepaxa. Patients unresponsive to life style recommendations given as standard practice will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women, ≥18 years of age.
2. Suspicion of NAFLD
3. Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
4. CAP score at -6 months and at inclusion of \>268
5. A fibroscan elastography score \<9 Kpa (Advanced Fibrosis)

Exclusion Criteria:

1. Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic.
2. Significant weight loss (\> 5% body weight) or rapid weight loss (\>1.6 kg/week), within six months of screening.
3. Individuals taking prescription or supplemental omega-3 fatty acids.
4. Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.
Swiss Multiple Sclerosis Cohort-Study

The Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are

1. To maintain a long-term cohort for an undefined duration of patients with Multiple Sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in Switzerland. This requires effective measures to limit drop-outs and the continuous recruitment of MS patients and
2. To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids.

The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data.

Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the:

1. Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response.
2. Exploration of the safety and impact on long-term disability of existing and next generation MS treatments
3. Individualized therapy: A number of highly active but potentially also harmful therapies have lately been established for the treatment of MS. To date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it.
4. Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilling the diagnosis of radiologically isolated syndrome (RIS), clinically isolated syndrome (CIS), relapsing-remitting Multiple Sclerosis (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), neuromyelitis optica spectrum disorder (NMOSD) or Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) according to established criteria
* Intending to attend hospital visits every 6 months (+/- 45 days) or 12 months (+/- 45 days) (facultative cranial MRI every 12 months) over a longer period (at least 5 years)
* Intending to give blood for biobanking every 6 or 12 months during hospital visit or as close as possible to the visit (+/- 8 days)

Inclusion criteria are crafted to identify a population of patients with MS, NMOSD or MOGAD particularly suitable for analysing disease evolution and associated factors, treatment dynamics, and the long-term safety and efficacy profile of disease-modifying drugs.

There are no specific Exclusion Criteria.
Sleep Quality and Amyloid-Beta Kinetics

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.

The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).

Eligibility Criteria:
Inclusion Criteria:

* Age 45-65 years
* Any sex
* Any race/ethnicity
* Mini-Mental Status Examination score (MMSE) \>=27
* Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper

Exclusion Criteria:

* Cognitive impairment as determined by history of MMSE \< 27
* Inability to speak or understand English
* BMI \>35
* Any sleep disorders other than insomnia
* history of sleep-disordered breathing
* STOP-Bang score \> 3
* History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
* Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-9AM
* Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
* Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
* Stroke
* Hepatic or renal impairment
* Pulmonary disease (PI discretion)
* Type 1 diabetes
* HIV or AIDS
* Neurologic or psychiatric disorder requiring medication (PI discretion)
* Alcohol or tobacco use (PI discretion)
* Use of sedating medications
* Inability to get out of bed independently
* Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)
* Abnormal physical examination
* Current pregnancy
* History of migraine headaches (PI discretion)
* History of drug abuse in the past 6 months
* Urinary or fecal incontinence
* Difficulty sleeping in an unfamiliar environment (good sleep quality group only)
* History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI is not a good candidate
Spironolactone After Liver Transplant

To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.

The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* liver transplant

Exclusion Criteria:

* dual organ transplant
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Not pregnant
3. Willing and able to comply with two-year follow-up period.
4. Willing and able to give informed consent prior to enrollment
5. No known allergy to stainless steel or polyester
6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
7. Life expectancy greater than two years
8. High risk candidate for open surgical repair

Exclusion Criteria:

see above
Shared Mental Health Care Linking Mental Health Services With Family Medicine Groups

The purpose of this study is to assess how a multidisciplinary team of mental health professionals provides services to patients from two family medicine practices.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred by family physicians
The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration

The goal of this research is understand if obesity is a major factor for neuropathy development in patients with and without Type 2 diabetes. This study will examine the relationship between weight, metabolism, and nerve function and regeneration.

Peripheral neuropathy causes progressive injury to the longest nerves of the body, starting in the toes, then progressing slowly up the leg. Neuropathy often causes pain, numbness, and weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. The most common cause is diabetes, but work at the University of Utah finds that prediabetes and other consequences of obesity, including abnormal cholesterol levels, may be associated with neuropathy. Research has shown that these risk factors may damage nerves and interfere with the ability of nerves to grow back after an injury.

This study aims to

1. characterize peripheral nerve function and cutaneous nerve structure in obese bariatric surgery candidates;
2. evaluate peripheral nerve regeneration capacity (and other nerve function measures) before and after bariatric surgery in obese subjects with no or mild neuropathy;
3. examine the relationship between ectopic lipid accumulation, lipotoxic mediators, neuropathy and regeneration capacity in surgical candidates before and one year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old
* Subjects must fulfill criteria for bariatric surgery.

Exclusion Criteria:

* History of foot ulceration or neurogenic arthropathy
* Family history of non-diabetic neuropathy in a first-degree family member.
* Presence of any disease known to be associated with peripheral neuropathy including but not limited to vitamin deficiency, toxin exposure, paraproteinemia, heavy alcohol use, hepatitis C, HIV.
* Coumadin use.
* Inability to understand or cooperate with the procedures of the trial.
* Known history of sensitivity to capsaicin products.
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
* Stable heterosexual relationship

Exclusion Criteria:

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
* Nitrate use
* Other exclusion criteria apply
Healthy Eating Better Breathing: A Feeding Study in Patients With Asthma

The study is a randomized, crossover meal-replacement pilot intervention to determine feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma were randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week washout period. During the dietary intervention, all meals and snacks were provided by the study.

The objective of the study is to demonstrate feasibility of a randomized, controlled clinical trial of a dietary intervention in a population of adults with asthma and to determine sample size estimates for a larger, more definitive trial aimed at improving asthma clinical outcomes and improving markers of inflammation and oxidative stress. The study uses a feeding trial design comprised of a 4 week dietary intervention in which all meals are provided to study participants and a 4 week control diet comprised of usual dietary intake. Participants are randomized to the intervention or control diet and then cross over to the alternate assignment after a 4 week washout period.

Eligibility Criteria:
Inclusion Criteria:

* ages 18-50, self-reported physician diagnosis and treatment for asthma within the 12 months prior to enrollment, stable asthma defined as no asthma exacerbation (emergency department visit, systemic steroid treatment, or urgent care visit) or respiratory infection in the 4 weeks prior to enrollment.

Exclusion Criteria:

* active smokers,pregnant or breastfeeding, using systemic corticosteroids or warfarin, had another major pulmonary diagnosis or significant systemic illness, reported excessive alcohol consumption (over 14 drinks per week or six or more drinks on one or more occasions per week), reported food allergy, or weighed over 350 pounds or changed weight by over ten pounds in the two months prior to screening
Reaction Time, Cognitive Function and Physical Fitness of Children and Adolescent Soccer Players

Investigation of the effect of an exercise program with visual stimuli on reaction time, cognitive function and physical fitness of children and adolescent soccer players.

38 male soccer players aged 10-15 participate in the research voluntarily. A wireless reflex measurement system (FITLIGHT Trainer) is used to measure the response time, a cognitive function test (Cognitive Function Scanner Mobile) is used to assess cognitive function and an interactive virtual reality application (VR game) is used to estimate the visual field. Physical fitness is assessed using ALPHA-Fitness and the Eurofit test batteries. The screening takes place in the soccer field with portable devices. After the initial check, the participants were randomly divided into two equal groups using the program http://www.randomizer.org/.

18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The special training program includes training using illuminated units / disks. Each unit is activated alternately, and it is deactivated when the trainee passes in front of it or touches it with any part of his body as well as with another object / sports accessory. The remaining players continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.

Eligibility Criteria:
Inclusion Criteria: male sex, age 10-15 years, soccer experience ≥ 1year

Exclusion Criteria: None
Cannabidiol Effects on Fear Extinction in Social Phobia

The investigators will randomly assign participants with social anxiety disorder to receive oral cannabidiol (CBD) or placebo. Participants will undergo a fear conditioning and extinction trial, and the investigators will examine whether CBD increases the degree of fear reduction during extinction.

This will be a double-blind, randomized controlled trial of cannabidiol (CBD) vs. placebo for potentiating fear extinction in adult outpatients with social anxiety disorder (SAD). After providing written informed consent and passing medical screening, participants will be assessed for SAD and other mental health concerns. They will then engage in a fear conditioning paradigm in which an electrical stimulation is applied to the wrist that is aversive but not painful (at a level determined by each participant) paired with pictures of angry faces. Following the fear conditioning paradigm, they will receive orally administered CBD or placebo. They will then undergo a fear extinction phase in which the conditioned angry faces are shown repeatedly with no further electrical stimulus. Fear toward the conditioned faces following extinction will be measured using galvanic skin response (GSR) and a visual analog scale of self-reported fear. The investigators predict that CBD, compared to placebo, will result in lower GSR and self-reported fear ratings.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above
2. Any gender
3. Any race/ethnicity
4. Primary diagnosis of SAD according to the DIAMOND
5. At least moderate severity of SAD as evidenced by a DIAMOND severity rating of 4 (moderate) or higher
6. Able to speak, read and write English (this is necessary because the study measures are only validated in English)
7. Concurrent medications will be allowed so long as there is not a substantial risk of interaction with CBD
8. Able/willing to consent to participate in study

Exclusion Criteria:

1. \<18 years old
2. Active substance use disorder or mania according to the DIAMOND
3. Severe risk of suicide or non-suicidal self-injury in the interviewer's judgment
4. Current or past schizophrenia spectrum disorder according to the DIAMOND
5. Developmental disability, including autism spectrum disorder, according to clinical interview
6. History of organic brain illness or head injury with loss of consciousness \> 5 minutes
7. Liver function abnormalities as detected by liver functioning test
8. History of allergic reaction to CBD according to clinical interview
9. Unable or unwilling to abstain from CBD or tetrahydrocannabinol use for 24 hr prior to study participation
10. Pregnancy or lack of adequate contraception
11. Any clinical factors that would preclude the participant from providing informed consent or otherwise participating in the research, according to the interviewer's judgment
A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

This study seeks to develop, implement, and assess an innovative 15-session couple-based intervention to be delivered in a group format to young parents that aims to strengthen relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD risk (concurrency, number of partners, unprotected sex), strengthen relationships, and improve parenting among young parenting heterosexual couples.

This study develops a couple-based HIV prevention intervention that is innovative and important because it integrates an intervention that improves sexual health, relationship functioning, and parenting skills. Our intervention will be integrated with an existing community based parenting program. By targeting high risk heterosexual couples experiencing an important life transition that increases their stress, conflict, and sexual risk, the investigators can provide maximum benefit to the men, women, and children in our communities. Using the guiding framework of Attachment Theory and the principles of Emotion Focused Therapy, the investigators will directly address issues of emotion, intimacy,and relationship functioning to create an intervention that strengthens romantic relationships and reduces HIV risk behavior. The investigators will conduct a small pilot randomized controlled trial of 50 parenting couples randomized to either the relationship strengthening HIV prevention intervention or an active control. The intervention will last 15 weeks and each session will be approximately 1.5 hours long. The investigators will assess couples at baseline, 4-months, and 8-months.

Eligibility Criteria:
Inclusion Criteria:

* Women's age between 14 and 25
* Men's age 14 or older
* Have a child that is 0-1 year old
* In a romantic relationship with the mother/father of the baby
* Not known to be HIV positive
* English speaking

Exclusion Criteria:

* Child older than 1 year
* HIV positive
Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery

Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent thrombosis, patients have systematic anticoagulation after surgery which are responsible of hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a biological glue administration on the bleeding loss at five days after a total knee prosthesis surgery operation.

The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated with or a beneficiary of a social security category:

  * having more than 18 years old
  * having signed the informed consent form
  * having undergone a total knee prosthesis surgery operation

Exclusion Criteria:

* incapacity to understand the protocol
* patient having taken anti-coagulants or clopidogrel 10 days before excepted aspirin to a dose equal or less than 160 mg/day
* women having period so generally women having less than 50 years old
* PT less than 60% and ACT taller than 10 sec
* contra-indications to the drug
* Erytropoietine treatment required before surgery
A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients

Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20
2. Short term ventilator care after surgery in intensive care unit

Exclusion Criteria:

1. pneumonia
2. chronic obstructive lung disease
3. asthma
4. end stage renal disease
5. risk factors for aspiration
Summary of Infants Weighing 500 Grams or Less

This is a retrospective single-center cohort study. The comparison in short- and long-term outcomes will be made between those with and without primary microcephaly in infants weighing ≤ 500 g.

This is a retrospective single-center cohort study. The study setting is a level IV neonatal intensive care unit (NICU) at Nagano Children's Hospital in Nagano, Japan. We will retrospectively collect the data of those who were admitted to Nagano Children's Hospital NICU between January 1, 2015, and December 31, 2019. Eligible infants will be identified using our neonatal database and clinical records. The extracted data includes maternal background information and clinical course, infant's status at birth, the clinical course in NICU, and the follow-up data at 6 and 18 months of corrected age.

Among the eligible infants, those with a z score of birth head circumference \< -2 will be classified into the Microcephaly group and others into the Control group. The z score is calculated using the Japanese growth standard.

Eligibility Criteria:
Inclusion Criteria:

* Live-born infants weighing ≤ 500 g at birth
* Infants whose clinical course is available in the electronic medical record

Exclusion Criteria:

* Stillbirths
* Infants who received only palliative care at birth
* Outborn infants
* Infants whose assessment at 3 years of age not completed at data analysis