cyrilzakka/clinical-trials huggingface dataset:
Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans

The purpose of this study is to determine whether lowering of fasting homocysteine concentrations improves vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.

A high plasma homocysteine is a potential risk factor for cardiovascular disease and death. However, it remains uncertain whether homocysteine per se, low status of folate, or other factors related to methionine metabolism are involved in the pathogenesis of cardiovascular disease. Previous studies have shown that a high concentration of homocysteine in blood is related to an impaired vascular function in the arteries, an indicator of cardiovascular disease risk. Virtually all intervention trials used folic acid as a homocysteine-lowering agent, which may however affect vascular function through mechanisms not related to homocysteine. We investigated whether lowering of fasting homocysteine concentrations via supplementation with betaine or folic acid improves vascular function in healthy volunteers, in order to distinguish between effects of folic acid and of homocysteine-lowering per se.

Comparison: We compare the effects of supplementation with folic acid to the effects of betaine, and to the effects of a placebo on plasma homocysteine concentrations and vascular function in healthy humans.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy.
* Women postmenopausal: two or more years after last menstruation. If the uterus was surgically removed, the women must be 55 years or older.
* Normal blood values for: hematology, total homocysteine, blood lipids, vitamin B6, vitamin B12, folate, liver enzymes, creatinine.
* Absence of protein and glucose in urine sample.
* Body mass index (BMI) between 18 and 30 kg/m2.
* Good ultrasound visibility of the brachial artery, judged by the sonographer.
* Willing not to use supplements containing B-vitamins, antioxidant vitamins (A, beta-carotene, C and E) or n-3 fatty acids/fish oil supplements from screening day (\>2 months before start of the study) until end of study.
* Willing not to be blood or plasmapheresis donor from 4 weeks before the screening day, and 4 weeks before the start of the study until the end of study.

Exclusion Criteria:

* Any chronic or acute disease (e.g. diabetes, renal disease, inflammation).
* Current, or history of cardiovascular disease.
* Hypertension.
* Medical history or surgical events known to interfere with the study.
* Fasting plasma total homocysteine \> 26 micromol/L.
* Alcohol consumption: more than 21 consumptions /week for women, and more than 28 consumptions/week for men.
* Weight loss or gain \> 2 kg in the month prior to screening.
* Any special diet (prescribed, slimming, macrobiotic or total vegetarian). Sole exclusion of meat and fish from an otherwise 'normal' western diet is allowed.
* Lactose intolerance.
* Use of supplements containing B-vitamins more than once weekly in the period from 3 months before the screening day.
* Participation in any other trial up to 3 months before this study.
* Use of medication known to interfere with the study outcome.
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.


Eligibility Criteria:
Inclusion Criteria

* Patients undergoing a Whipple procedure for various diagnoses (neuroendocrine tumors, adenocarcinoma, benign cystic neoplasms, duodenal and ampullary malignancies, etc) who are deemed intermediate-high risk as per our institutional protocol as shown above.
* Patients \> 18 years of age

Exclusion Criteria

* Negligible and low risk patients
* All patients undergoing arterial resection.
* Age \<18 years
* Currently pregnant
Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)

The Vendys II, an FDA-approved device, uses finger digital thermal monitoring (DTM) after a period of blood flow restriction to evaluate vascular health. This study will evaluate the feasibility of using this device to measure the Vascular Reactivity Index (VRI) in children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT).

Primary Objective:

-Assess the feasibility of the use of VENDYS-II in children and AYA as a measure of vascular endothelial function, where feasibility is defined as completion of the evaluation by at least 70% of consented participants.

Secondary Objective:

-Summarize the incidence of any adverse events that precludes completion of assessment of endothelium-dependent vasodilation using the Vendys II in children and AYA.

Eligibility Criteria:
Inclusion Criteria for HCT candidates:

* Children, adolescents and young adults (AYA) 6-26 years of age who are HCT candidates
* Recipients within 30 days prior to or within 14 days after autologous and allogeneic HCT.

  -. Any preparative regimen.
* Willing and eligible to enroll on PA19-0756

Inclusion Criteria for Healthy Donors:

- Healthy HCT donors between the ages of 6-26 years of age.

Exclusion Criteria:

* Any subject who does not consent/assent to participation.

  -. Any subject with an injury or deformation to the index finger which prevents proper fit of the device.
* Any subject with skin toxicity or neuropathy which prevents comfortable use of the device.
Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

The purpose of MultiSENSE study is to collect data about patient events during worsening heart failure, determine how sensor measurements vary during patient daily activities and during the development and recovery from events of worsening heart failure, develop algorithms capable of detecting the onset of worsening heart failure prior to the overt presentation of patient symptoms using reference measurements: thoracic impedance, heart sounds, physiologic responses to activities and respiration.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate
* Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center
* Currently implanted with a COGNIS device (Model N119 or N120, P107, P108)
* Classified as NYHA Class II, III or IV within the last six months

Exclusion Criteria:

* Inability or refusal to sign the Subject Informed Consent
* Inability of refusal to comply with the follow-up schedule
* Documented as pacemaker dependent
* Unable to rest comfortably in a semi-recumbent position for up to 20 minutes
* Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949
* Currently implanted with unipolar RA, RV, or LV leads
* LV sensitivity programmed to less than 0.7 mV AGC
* History of appropriate tachycardia therapy (external or implanted) for rates \< 165 bpm within 1 week prior to enrollment
* Device battery status indicates approximate time to explant \< 2 years
* Likely to undergo lead or PG revision during the course of the study as determined by the investigator
* Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen
* Have received heart or lung transplant
* Receiving mechanical circulatory support
* Patients who have been referred or admitted for Hospice care
* A life expectancy of less than 12 months per physician discretion
* Enrolled in any concurrent study without Boston Scientific written approval
* Devices previously converted to the SRD-1 and withdrawn from the study
* Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol
* Known pregnancy or plan to become pregnant within the course of the study
* LV offset is programmed to a value greater than zero
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
* Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control
WildCam: A Privacy Conscious Wearable Eating Detection Camera People Will Actually Wear in the Wild

WildCam is a wearable device that collects video data of the user's face and upper torso to capture eating behaviors. WildCam and its accompanying software is privacy conscious, meaning it utilizes a computer vision algorithm that extracts proximal features (the user's body and objects-in-hand) from the video and digitally obfuscates the distal features (background environment and entities therein) to preserve the privacy of the wearer, as well as any bystanders who may be in the device's visual field. The present study tests the impact of 3 different obfuscation techniques on acceptability, including the willingness of users to wear the device. Participants are randomly assigned to 1 of the 3 obfuscation techniques (blurring, masking, or cartooning). Participants wear the WildCam during waking hours during a 7-day period with the randomly selected obfuscation setting enabled and a 7-day period with the raw images (no obfuscation) setting. The order of these periods is counterbalanced, and the two periods are separated by a 7-day washout period during which WildCam is not worn. Structured feedback, including user burden and acceptability surveys, is collected to determine the efficacy of each obfuscation technique on increasing user acceptability, including willingness to use the WildCam device, as opposed to a video-collecting device without obfuscation.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30 or greater
* Chicago Metro Area resident
* Able to speak, read, and write in English
* Valid phone number
* Smartphone ownership
* Have Wi-Fi at home

Exclusion Criteria:

* 15% or greater weight change in last 3 months
* Medication related weight gain
* Genetic obesity syndrome (e.g., Prader-Willi, Bardet-Biedl, Cohen Syndrome)
* Member of household enrolled in study
Modification of Cognitive Processing Therapy (CPT-C) for PTSD and Alcohol Dependence

Objective: To develop a detailed treatment manual that modifies the existing CPT-C treatment protocol to allow for concurrent treatment of PTSD and AD, and to obtain some pilot data regarding its efficacy.

Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days (measured by the Timeline Follow Back Method \[TLFB\]) and reduce the symptoms of PTSD (measured by the \[CAPS and PCL\] scores).

Design: This is a non-randomized, prospective study in which all participants will receive the modified CPT-C for 12 weeks by trained CPT-C clinicians, with each session lasting approximately 1-1.5 hours). Modifications to CPT-C include psychoeducation about alcohol use as an avoidance of PTSD symptoms integrated throughout treatment, integration of coping skills training for AD, weekly breathalyzer tests to measure blood alcohol level, and use and collection of daily dairies of alcohol use.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 21-65 years old.
2. Current alcohol dependence as determined by the Structured Clinical Interview for DSM-IV Axis I Disorder (SCID; First et al. 1996). Abstinence no more than past 29 days. Primary substance dependence diagnosis of alcohol dependence.
3. Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS; Blake et al. 1995).
4. Participants on psychiatric medication must be on a stable regimen for at least 2 weeks before treatment begins.
5. Ability to participate psychologically and physically, able to give informed consent and complete assessments, and participate in study procedures.

Exclusion Criteria:

1. Current psychotic disorders
2. Current suicidal or homicidal ideations
3. Current substance dependence other than alcohol or nicotine dependence
4. Legal charges pending with potential of incarceration
5. Unstable serious medical conditions or one requiring acute medical treatments or anticipation of hospitalization for extended care
Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.


Eligibility Criteria:
Inclusion Criteria:

* Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
* Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
* Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development.
* Participant is receiving oral or inhaled steroids.
* Participant participates in another study that has not been approved as a concomitant study.
* Participant has an allergy or intolerance to any ingredient in the study product.
* Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.
Subjective Social Status and Energy Balance

Investigators examined the associations between SSS, energy balance, food intake and changes in body composition following a high calorie lunch for 2 weeks.

Subjective social status (SSS) is inversely associated with body fatness. The physiological and psychological effects of low social status may spur increased energy intake as a strategy to buffer against future food scarcity. Investigators' central hypothesis is that females with low SSS will not compensate for excess calorie consumption in a single large meal as well as individuals with high SSS, and will therefore remain in positive energy balance leading to body fat gain in response to daily large meals. Investigators' objective is to understand the influence of SSS on eating behavior, weight gain, and energetic compensation. Investigators conducted a 14-day feeding protocol that consisted of consumption of a lunch-time meal that was 60% of participants' estimated 24-hour energy requirements each day in female participants between 20-50 years, with a body mass index between 25- 30 kg/m2. Free-living food intake was recorded using the Remote Food Photography Method outside of the lab on days 1-2 (early), 7-8 (middle), and 12-13 (late), to measure compensation in response to the large lunch. 24-Hour energy balance, 24 hour intake and post-lunch energy intake were calculated for those days. Investigators measured body composition using Dual energy x ray absorptiometry (DXA), weight and resting energy expenditure at the baseline and at the end of the 14 days of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* between 20-50 years
* body mass index between 25- 30 kg/m2

Exclusion Criteria:

* food allergies or food restrictions
* engaged in any weight reduction program within the past 3 months
* experienced any weight loss or gain of \>5% of body weight in the past 6 months for any reason except post-partum weight loss
* taking any medication that suppresses or stimulates appetite
* undergone prior surgical procedures for weight control or liposuction
* current smoker or has not smoked in less than 6 months
* any major diseases including active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)
* active or chronic infections (e.g., HIV or TB)
* cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months
* gastrointestinal disease
* kidney disease
* chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)
* diabetes (type 1 or 2) and taking any anti-diabetic medications and/or controlling the disease via dietary manipulations
* uncontrolled psychiatric disease
* a recent or ongoing problem with drug abuse or addiction
* consume more than three alcoholic drinks per day and has had 7 or more alcoholic beverages in a 24 hour period in the last 12 months
* pregnant or less than 3 months post-partum
* currently nursing or within 6 weeks of having completed nursing
* anticipating a possible pregnancy during the study
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study

TRIDENT Main Study:

TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and systolic blood pressure (SBP) levels defined as 'high normal to borderline high', and on either minimal or no BP-lowering treatment according to current guidelines.

MRI Sub-Study Centres capable of specific MRI of the brain sequences will be identified. The patients in the TRIDENT main study who are identified to be eligible for the MRI Sub-Study will undergo MRI scans at baseline (6 weeks to 6 months post-randomisation) and at 36-month follow-up time points. All data collected will be analysed centrally at the Brain and Mind Centre (BMC) in Sydney, Australia.

Intracerebral haemorrhage (ICH) is the most serious type of stroke, accounting for 10% of stroke in high-income countries and up to 50% in low-to-middle income countries, especially in Asia where hypertension is common. ICH in the context of hypertension is often a manifestation of underlying cerebral small vessel disease (CSVD).

In summary, there is a considerable body of evidence supporting and association of CSVD with hypertension and poor outcomes, but limited evidence as to whether good BP control can modify the natural history of this condition.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for, randomised and continuing in TRIDENT Main Study
2. No contraindications to MRI scan of the brain
3. Provide informed consent for the MRI Sub-Study

Exclusion Criteria:

1. Any MRI contraindications (e.g. metallic implants, claustrophobia, etc.)
2. Less than 6 weeks or greater than 6 months post-randomisation (however, where possible the baseline MRI Sub-Study scan should be conducted as soon as possible after the qualifying ICH. e.g. if the qualifying ICH was 4 months prior to randomisation, the baseline scan should be done as close to 6 weeks post-randomisation as possible)
Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged more than 12 years.(adolescent or adult)
2. Subject who all three of the following diagnosis criteria for possible autoimmune encephalitis have been met.

   * Subacute onset (rapid progression of less than 3 months) of working memory deficits(short-term memory loss), altered mental status, or psychiatric symptoms.
   * At least one of the following:

     * New focal CNS findings
     * Seizure not explained by a previously known seizure disorder
     * CSF pleocytosis (WBC count ≥ 5/mm2)
     * MRI features suggestive of encephalitis
   * Reasonable exclusion of alternative causes
3. Subjects or parent/legal representative willing to provide written informed consent

Exclusion Criteria:

1. Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
2. Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
3. Subject who has been diagnosed with IgA deficiency
4. Subject who has renal disorder (creatinine clearance \< 10 ml/min) or requires dialysis
5. Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
6. Subject who has been diagnosed with immuonological competence or immunodeficiency
7. Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
8. Subject who has low heart condition (Congestive heart failure \>NYHA functional class Ⅱ: unstable coronary artery disease or myocardiac infarction within 3 months prior to screening)
9. Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
10. Females who are pregnant or breast feeding
11. Subject who is considered by investigator to ineligible for the study.
IRM Cognition in Patients With Head Trauma

Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection :

* Clinical, neuropsychological assessments
* Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways
* Functional imaging data.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, over the age of 18.
* Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
* Severe brain injury (Initial Glasgow score between 3 and 8),
* Diffuse axonal injury and/or focal lesions.

Exclusion Criteria:

* Patients with MRI contraindications,
* Antecedents of brain lesions,
* Important lesions of the lobes and cortex on cerebral CT,
* Anoxic lesions related to cardiorespiratory arrest,
* Must be able to perform neuropsychological tests,
* Visual and auditory impairments.
* Aphasia