cyrilzakka/clinical-trials huggingface dataset:
The Gut Microbiota in Stress, Mood and Eating Behaviours.

Diet has a considerable influence on microbiota composition and the intake of either prebiotics (microbiota-specific food or probiotics (live microbiota species) has been shown to induce positive effects in both anxiety and depression. At present there are few studies exploring stress-related conditions such as emotional/comfort eating behaviours, particularly in individuals who have experienced early life stress and/or find stress difficult to deal with in regards to gut microbiome composition and subsequent behavioural outcomes. Early life stress has been linked to the development of bulimia nervosa and anorexia nervosa in adolescence and adulthood and since the gut microbiota has been proposed as having a causal role in the aetiology and/or maintenance of disordered eating, an empirical question is whether the microbiota may mediate the relation between stress and disordered eating. This is an investigation into the effects of chronic daily consumption of a prebiotic on stress-related eating and mood.

Following an initial screening session based on inclusion/exclusion criteria, participants will be randomly allocated into either the treatment or placebo group and provided with three weeks worth of Vivinal-GOS or maltodextrin in powder form (sachets). There will be four clinical visits as detailed below:

1. Training on how to complete food diaries and collect saliva samples for cortisol awakening response measurements
2. Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).Provided with supplement and invited to next session in three weeks' time.
3. Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).
4. (one week after last visit) collection of final faecal sample

Eligibility Criteria:
Inclusion Criteria:

* A positive or negative screen for exposure to adverse childhood experiences
* A positive or negative screen for stress/emotional related eating behaviours
* Written informed consent

Exclusion Criteria:

* Antibiotic, prebiotic or probiotic use in past three months
* Pre-existing gastrointestinal disorders
Clinical Evaluation of an Integrated PET/MRI System

The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must have a clinical indication for a PET/CT exam
2. Subject must be at least eighteen (18) years of age; and
3. Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging; and
4. Subject must be able to hear and understand instructions without assistive devices; and
5. Subject must provide written informed consent; and
6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
8. Subject must be able to participate in a PET/MR imaging session within 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.

Exclusion Criteria:

1. Subjects who have any axial diameter larger than 55 cm; or
2. Subjects with a weight greater than 227 kgs; or
3. Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator; or
4. Subjects that have implants with MR Unsafe labeling; or
5. Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol ; or
6. Subjects who have a contraindication to MRI according to the screening policy of the participating site
Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance

The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.


Eligibility Criteria:
Inclusion Criteria:

Men and women will be enrolled in this study who:

* Are willing to give consent and comply with evaluation and treatment schedule;
* At least 18 years of age;
* Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site;
* Have a history of open abdominal surgery or laparoscopic abdominal surgery;
* ASA Classification I, II, or III (Appendix II); and
* Have a negative serum pregnancy test (for women of childbearing potential).

Exclusion Criteria:

Subjects will be excluded from the study for any of the following:

* Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
* Acute cholecystitis or acute pancreatitis;
* Evidence of abdominal abscess or mass;
* Diffuse peritonitis;
* Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
* Clinical diagnosis of sepsis;
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
* Planned concurrent surgical procedure other than RYGB or adhesiolysis;
* Prior or planned major surgical procedure within 30 days before or after study procedure;
* Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
* Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
* Any condition which precludes compliance with the study (Investigator discretion).
Ghrelin Decreases Insulin Sensitivity

Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of this study is to investigate the effect of short term ghrelin administration to humans on metabolism.

The current study is initiated in order to assess the impact of acute ghrelin administration on insulin resistance measured by a hyperinsulinemic euglycemic clamp. Second, as free fatty acid is the predominant substrate during fasting, we aim to asses the effects of ghrelin on local and systemic lipolysis.

Eligibility Criteria:
Inclusion Criteria:

* healthy men, age \>= 18 yr age \< 50 yr, body mass index \< 27.5 kg/m2above or equal to 18 yr

Exclusion Criteria:

* any disease, use of prescribed medication, age \< 18 yr or \>= 50 yr
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.


Eligibility Criteria:
Inclusion criteria:

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Exclusion criteria:

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects
Sub-acute Exercise Following Sport-Related Concussion

Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.

The main objective of the proposed study is to determine is exercise during the first 3-7 days following a sport-related concussion can help improve the systemic neurological dysfunction following a concussion while examining the safety and efficacy of a 20-minute, low- to moderate-intensity (40-60% of HRMAX) controlled treadmill aerobic exercise as a therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic, and cognitive function.

Eligibility Criteria:
Inclusion Criteria (concussed):

* high school student-athlete
* suffered a diagnosed concussion
* evaluated between Day 3 and Day 7 since injury

Inclusion Criteria (healthy):

* high school student-athlete
* no diagnosed concussion within the last year
* matched with concussion participant for age and gender

Exclusion Criteria:

* physical limitation prohibiting treadmill walking
* reports dizziness or lightheadedness
* presents with any contraindication for exercise participation as defined by American College of Cardiology (ACC), American Heart Association (AHA), or American College of Sports Medicine (ACSM) guidelines.
Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility

Men are recruited to collect seminal plasma samples and serum samples from men with azoospermia, men receiving medical treatment of infertility and men attending semen analysis. MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find potential differences. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry.

Azoospermic men attending microdissection testicular sperm extraction (MD-TESE) are group A. Second group (B) is the men with poor semen quality, who are treated with aromatase inhibitor, antiestrogen or human choriogonadotropic hormone (HCG) to improve semen quality. Third group (C) consists of men submitting semen analysis. The intended number of participants is 60, 60 and 100 men, respectively.

Seminal plasma and serum samples are collected and miRNA and piRNA are analyzed. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry. The participants are given a physical examination and testicular ultrasound. The primary aim of this study is to develop a tool to better estimate the sperm recovery rate (SRR) of azoospermic men scheduled for MD-TESE. Since no data have been published presenting miRNA and piRNA levels in men with normal semen, a secondary aim is to describe the levels of miRNA and piRNA in unselected men. Third part of this study aims to find if medical treatment improving semen parameters affects miRNA ja piRNA findings.

Eligibility Criteria:
Inclusion Criteria:

* Ability to produce semen sample

Exclusion Criteria:

* Cognitive impairment
* Inadequate language skills for informed consent
Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease

The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.

Prevalence of type 2 diabetes in Asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. Benefit of lowering low density lipoprotein (LDL) cholesterol down to 70 mg/ml in Caucasian patients with coronary artery disease (CAD) has been well established but not in Asian patients with lower risk of myocardial infarction and higher stroke risk. Intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with CAD has been recommended in several guidelines without firm evidence. Risk and benefit of intensive blood pressure and LDL control should be evaluated in Japanese diabetic CAD patients by pragmatic randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome
* Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline

Exclusion Criteria:

* Patients who have active malignant tumor
* Patients who are on hemodialysis due to end stage kidney disease
* Patients whom statins are contraindicated
* Patients who had acute coronary syndrome or stroke within 3 months
* Patients who are pregnant or on breast feeding
* Patients whose physicians deem that attending this trial is contraindicated or inappropriate
A Clinical Study of MIL62 in Systemic Lupus Erythematosus

This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 ;
2. Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
3. Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
4. Low C3 and/or low C4 complement at screening ;
5. High disease activity at screening ;
6. On a stable SLE treatment regimen for at least 30 days prior to the first administration；
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Unsufficient organ function;
2. Have received treatment with B cell targeted therapy within 9 months prior to the first administration;
3. Subjects with CD4+ T lymphocyte count \< 200 cells/μL;
4. Receipt of any of the following prior to the first administration: Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;
5. Received TNF inhibitor, Beliumumab, and Tetasercept within 3 months prior to the first administration; Interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor within 2 months prior to the first administration;
6. Received live or attenuated vaccination within 28 days prior to the first administration;
7. Participated in other clinical trials within 28 days prior to the first administration;
8. Concomitant with other serious diseases；
9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
10. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62；
11. Breastfeeding or pregnant women;
12. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
13. Other conditions unsuitable for participation in this study determined by the Investigator.
Colorado Oral Strengthening Device

University of Colorado is looking for adults with Parkinson's disease to participate in a research study. The study aims to explore how a novel low technology device can achieve an increase in tongue strength comparable to standard of care exercise using tongue depressors but with the kinematics and simple biofeedback of existing high cost devices. Research has shown that tongue resistance exercises paired with biofeedback have resulted in improved tongue strength to support chewing, control of food and liquid in the mouth, and propulsion of material for a swallow.

When an individual contacts the PI or the department research coordinator, a preliminary screen will be administered for any obvious exclusion. If there are no exclusions, the first visit will be scheduled. At this initial visit, a full description of the study and exercise protocol will be provided. A health history questionnaire and an EAT-10 questionnaire will be administered.

If consent is obtained, baseline tongue strength will be measured using the IOPI device. Individuals with Parkinson's will be randomized to exercise with the COSD or with the tongue depressors. Those who will use the COSD will be start with no less than 60% max strength and receive an exercise log. Those using the tongue depressors will also receive an exercise log.

All participants will receive a full demonstration of the exercise and will be asked to return the demonstration.

The second visit will be scheduled for all participants the following week. At that time, the EAT-10 and tongue strength will be re-assessed. The exercise logs will be reviewed to ensure compliance. Participants using the COSD will be issued a new device that is no less than 80% of their max strength.

The third visit will be scheduled the following week (week 3). The EAT-10 questionnaire and tongue strength will be reassessed. The exercise log will be reviewed for compliance. COSD will be inspected for any signs of wear and a new one will be issued if the device appears worn.

The last 2 visits will be scheduled during weeks 6 and 8 of the exercise protocol. The EAT-10 and tongue strength will be re-assessed, and the exercise log will be reviewed for compliance. The COSD will be inspected for any signs of wear and a new one will be issued if the device appears worn. In addition, during the final visit, all participants will be asked to complete a questionnaire regarding their satisfaction with the exercise device they were assigned. The COSD will be collected at that visit.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 89 years old(inclusive)
2. Diagnosis of Parkinson's Disease
3. Hoen and Yahr stage II-IV
4. Signs or symptoms of dysphagia evidenced by an EAT-10 score of 3 or more

Exclusion Criteria:

1. Unwilling to sign the informed consent
2. Atypical Parkinson's Disease, Parkinson Plus, Lewy Body Dementia, Multiple System Atrophy
3. History of head or neck cancer
4. History of seizures
5. Current or past disorders of the jaw
6. Allergy to device materials
The Effect of Kangaroo Care After Cardiac Surgery

The aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery.

Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care.

Hypothesis 2 (H2): The peak heart rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 3 (H3): The respiratory rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 4 (H4): The arterial blood pressure of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 5 (H5): The pain score of infants who received kangaroo care is lower than infants who did not receive kangaroo care.

Kangaroo care has been found to be a feasible intervention before and after cardiac surgery to support infants with congenital heart disease, but it has been stated that formal standards and procedures need to be developed to transform kangaroo care into practice. Skin-to-skin contact is a low-cost, low-risk intervention that supports comfort and contributes to physiological stability in infants before and after neonatal cardiac surgery. It positively affects the pain level of infants. Clinical studies on the application of kangaroo mother care on infants undergoing cardiac surgery are limited in the literature.

Eligibility Criteria:
Inclusion Criteria:

* The gestational week of the infant is greater than 37 weeks
* Cardiac surgery operation within the first 30 days of life
* The infant's chest incision is closed

Exclusion Criteria:

* The infant has non-cardiac congenital defects or syndrome
* Intubation of the infant
RestoreSensor Study

The purpose of the study is to gather clinical information on subjects' experiences with and without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).

This study is a multi-center, prospective, open-label, randomized, crossover study that is designed to gather clinical information on subjects' experiences with the use of the new feature of the RestoreSensor implantable neurostimulator. Current spinal cord stimulators for chronic intractable pain stimulate targeted nerves along the spine using electrical impulses. The stimulation interferes with the transmission of pain signals to the brain replacing painful sensations with a tingling sensation called paresthesia. Variation in the intensity of neurostimulation with body position is a challenge for some patients implanted with conventional spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. Patients need to manually adjust their stimulation using the patient programmer to maintain their comfort level during position changes. The AdaptiveStim feature of the RestoreSensor neurostimulator was developed to address this challenge by improving pain relief and/or convenience relative to manual programming adjustments.

Eligibility Criteria:
Inclusion Criteria:

* Meets the indications as an appropriate surgical candidate (after successful SCS screening trial) for implant of a neurostimulation system for spinal cord stimulation (SCS) treatment of trunk and/or limb pain, per labeled indications
* 18 years of age or older
* Willing and able to attend visits and comply with the study protocol
* Capable of using the patient programmer and recharging the neurostimulator (INS), able to read and answer questionnaires in English, without assistance of a caregiver
* Males and non-pregnant females

Exclusion Criteria:

* Has had a prior implantable SCS neurostimulation system
* Currently enrolled, or plans to enroll in another investigational device or drug trial during the study
* Has unresolved legal issues related to their pain condition for which they would be receiving neurostimulation
* Requires cervical placement of leads.