cyrilzakka/clinical-trials huggingface dataset:
Assessment of Endogenous Oxalate Synthesis

This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.

Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use low-oxalate controlled diet and intravenous infusion of the isotope tracer carbon 13 oxalate, timed with blood and urine collections, to determine the daily rate of endogenous oxalate synthesis in non-stone forming volunteers and in subjects with calcium oxalate kidney stones. A DXA scan will be used to assess body composition.

Eligibility Criteria:
Inclusion Criteria:

* Mentally competent adults, able to read and comprehend the consent form
* Body Mass Index (BMI) between 18.5 and 50 kg/m2
* Acceptable 24 hour urine collections (judged on screening)
* good health as judged from a medical history, reported medications, and a complete blood metabolic profile
* with or without history of calcium oxalate kidney stones

Exclusion Criteria:

* History of any hepatic, bowel, or endocrine disease or other condition that may influence the absorption, transport or urine excretion of ions
* Abnormal urine chemistries or blood metabolic profiles
* Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
* Pregnancy, intention to become pregnant in the near future, or lactation
* Aged lower than 18 or greater than 75 years
* BMI lower than18.5 or greater than 50 kg/m2
Heart at Home- a Self-care Study

In the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of systolic heart failure
* NYHA (New York Heart Association) classification \> 1
* left ventricular ejection fraction ≤ 35%
* need for a regular control visit
* time from the last visit no longer than 6 months

Exclusion Criteria:

* Patients who were known to enter a major medical operation
* severe comorbidity,
* participation in other clinical trial during last three months-
* poor compliance in terms of familiarity with mobile phone
Transcranial Random Noise Stimulation in Food Addiction Treatment

Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.

Transcranial random noise stimulation is a noninvasive brain stimulation technic. The modulation of the electrical activity of the right and left dorsolateral prefrontal cortex (DLPFC) by tRNS is able to act on the phenomenon of craving in other addictions. This allows us to make the assumption that tRNS stimulation could constitute a treatment for food addiction especially in obesity.

Eligibility Criteria:
Inclusion Criteria:

* Female or male between 18 and 65 years old
* Patients suffering from obesity, with a BMI ≥ 30.
* Food dependence score at the Yale Food addiction Scale ≥ 3

Exclusion Criteria:

* Presence of a an other psychiatric diagnosis of Axis I (DSM IV);
* Presence of addictive comorbidity other than food addiction
* Psychotropic treatment;
* Pregnancy or lactation;
* Contraindication to fMRI .
"GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South

The primary objective of this study is to test the feasibility and acceptability of a 12-week behavioral weight management intervention adapted for Black men living in the rural South. The intervention is guided by Self-Determination Theory of Motivation, Social Cognitive Theory, and Ecological Systems Theory. Key aspects of the intervention include a football-themed curriculum, facilitator and peer concordance to the extent possible (ie., similarly aged Black men), an emphasis on male-specific health concerns, group-based competition at multiple levels of the intervention (e.g., during in-person physical activity sessions and for achieving behavioral goals), a limited educational component, and physical activity being a substantial component of meeting sessions.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American or Black American male
* BMI 27kg/m\^2 to 50kg/m\^2 (healthcare provider approval required for those with a BMI \>45)
* Able to speak and understand English

Exclusion Criteria:

* Positive response to any question on the Physical Activity Readiness Questionnaire (PAR-Q) (Participant may be included if approval is provided and documented by a healthcare provider)
* Currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention
* Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm hg), diabetes, or asthma (Participant may be included if approval is provided and documented by a healthcare provider)
* Pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators
* Any musculoskeletal condition that would preclude meeting recommended levels of moderate-to-vigorous physical activity
* Within 30 days prior to participating in the intervention, have taken prescription or nonprescription medications, herbals, or supplements for weight loss
* On special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia)
* Major surgery in the past 6 months
* Have undergone weight loss surgery or considering surgery
* Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
* Weight loss ≥5% during the past 6 months
* Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
* Intending to move within 6 months
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥18 years of age at the time of the screening visit
2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)
3. Willing to consistently maintain usual diet for the duration of the study

Exclusion Criteria:

1. Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit
2. Having undergone lipid apheresis within 4 weeks prior to the screening visit
3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit
4. Previous participation in any clinical trial of REGN1500

Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
Effects of rTMS on Human Brain Activity

The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI).

Participants will undergo a screening that includes a psychiatric and medical history screening, TMS and MRI safety screening, and urine screening. If participants pass the screening procedure, they will be introduced to transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and a task that involves viewing words, sentences, or pictures. There will be up to seven visits and each visit will take less than 3 hours.

MRI can be dangerous for people that have medical devices, metal objects, or metal debris in their bodies. TMS procedures are associated with a very low risk of seizures, "muscle-tension" type headache, ear damage, numbness of the face, fainting, dizziness, memory impairment, trouble concentrating, and acute mood changes. This study will use only levels of TMS that are within safety guidelines. There is also a risk of potential loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* Age restrictions: between 18-35 years old
* Use of effective method of birth control for women of childbearing capacity.
* Willing to provide informed consent.

Exclusion Criteria:

* Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (urine test)
* Current serious medical illness (self-report)
* History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* Subjects are unable or unwilling to give informed consent
* Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)

Subjects with a clinically defined neurological disorder including, but not limited to:

* Any condition likely to be associated with increased intracranial pressure
* Space occupying brain lesion.
* History of stroke.
* Transient ischemic attack within two years.
* Cerebral aneurysm.
* Dementia.
* Parkinson's disease.
* Huntington's disease.
* Multiple sclerosis.
* Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold
* Subjects with cochlear implants
* Subjects not willing to tolerate the confinement associated with being in the MRI scanner
* Women who are pregnant or breast-feeding (urine test)
Effects of Nevirapine on the Steady State Pharmacokinetics of Fluconazole in HIV Positive Patients

The purpose of this study was to determine the effects of nevirapine on the steady state pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine when given in combination with fluconazole.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western Blot
* CD4 + cell count ≥ 100 cells/mm3
* Patients who meet the following laboratory parameters

  * Granulocyte count \> 1000 cells/mm3
  * Hemoglobin \> 9.0 g/dl (men and women)
  * Platelet count \> 75,000 cells/mm3
  * Alkaline phosphatase \< 3.0 times the upper limit of normal
  * Aspartame Transaminase (AST) and Alanine Transaminase (ALT) \< 3.0 times the upper limit of normal
  * Total bilirubin \< 1.5 times the upper limit of normal
* Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved from of barrier contraception
* Patients able to provide written informed consent and comply with study requirements

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Seated systolic blood pressure below 100 mmHg, or greater than 160 mmHg, and/or heart rate less than 50 or greater than 100 beats/min
* History of drug allergy or known drug hypersensitivity
* Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
* Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 28 days of study entry (Study Day 1). Such substances in these categories include: macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (e.g. itraconazole), rifabutin and phenytoin
* Patients requiring systemic treatment with CYP3A4 (cytochrome P450 3A4) substrates such as terfenadine, astemizole, cisapride, triazolam and midazolam during the course of the trial
* Use of protease inhibitors or non-nucleoside reverse transcriptase inhibitors within 28 days of Study Day 1 or during the trial
* Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
* History of any clinically important disease including hepatic, renal, cardiovascular or gastrointestinal disease
* Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention

The objectives of this trial are to assess the effects of interactions between genetic factors and diet with various macronutrient intake on the metabolic disorders, obesity and type 2 diabetes risk, prevention, development and progress.

This is a randomized, crossover study that includes 1 screening visit and four meal challenge test visits, separated by a 1-2-weeks washout period. The screening will include 2000 people, males and females, to evaluate the genotype frequencies in studied population, and to find carriers of the rare genetic single nucleotide polymorphisms (SNPs), who will fulfill all the other inclusion criteria. An oral glucose tolerance test (OGTT) will be completed at screening visit. Moreover, the fasting blood samples will be collected for genetic analysis, and measurements of blood glucose and lipid metabolism profile, high-sensitivity C-reactive protein (hs-CRP), hormones/peptides and other factors involved in energy balance regulation. Subjects will be asked to record their daily food intake for 3 days. Assessments of vital signs and body height and weight, waist and hip circumferences, body fat content and body fat distribution, review of concomitant medication/supplement use and inclusion and exclusion criteria, and evaluation of adverse effects will be performed throughout the study. To meal challenge test only men will be included, since the sex hormones may influence the study endpoints. Subjects will be encouraged to maintain their habitual diet during wash-out periods. During the each meal challenge test subjects will consume one of the study meals in random order. The blood will be collected at fasting state and 30, 60, 120, 180 and 240 minutes after meal intake. The energy expenditure and substrate utilization will be measured by indirect calorimetry method at the fasting and postprandially.

Eligibility Criteria:
Inclusion Criteria:

* healthy men with normal body weight and with overweight/obesity
* men with metabolic syndrome, hypertension, type 2 diabetes newly diagnosed, or not treated with any medicines
* maintaining the usual diet and lifestyle throughout the study

Exclusion Criteria:

* infectious or acute diseases in the last 4 weeks before the study visits
* any medicines/dietary supplements consumption in the last 4 weeks before the study visits
* high level of daily physical activity
* the following any special diet or dietary patterns (vegetarian, high-fat etc.)
* the presence of any other significant disease which may affect the results (hormonal disorders, history of any surgeries on gastrointestinal tract, allergies known or suspected, heart failure, history of cancer, any kidney, pancrea and liver diseases, except non-alcoholic fatty liver)
* abusive alcohol consumption
* abusive coffee or energy drinks consumption
* drug consumption
The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?

This study aimed investigate the chronic effect of orange juice consumption on gut microbiota and in the bioavailability of flavanones and metabolites by feces, blood and urine analysis.

Non-randomized study with interrupted time series and open-label, in which women were enrolled and advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages during 30 days before of intervention (n=10; BMI 23.8 kg/m2; 28 years). After 30 days, the participants will consume during 60 days 300 mL of orange juice daily. After 60 days of orange juice intervention, the participants will be submitted to 30 days of washout. Samples of blood, urine and feces will collect in five different occasions (baseline, 30 day, 60 day, 90 day, and 120 day) in order to evaluate the prebiotic effect of orange juice on gut microbiota and in the bioavailability of its flavanones. The recruitment process began in September 2016 and the intervention was carried out from October 2016 to February 2017, and the data analysis will start in February 2017. The sample number took into account variances on blood hesperitin levels with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Silveira et al., 2015). The minimum sample size should have six individuals into the same group. Considering an approximately 15% dropout rate, the final sample size of study was constituted by 10 women. Primary endpoint is the changes in total bacteria population (Lactobacillus spp., Bifidobacterium spp., and reduction of Clostridium spp.) that can result in increased of butyric, acetic, and propionic acid concentrations, and reduction of ammonium production. Secondary endpoint is enhancement of bioavailability of flavanones (hesperitin, naringenin) and metabolites in the blood, urine and feces. Kolmogorov Smirnov and Levene test will be used to assess the normality and homogeneity of data, respectively. One-way analysis of variance (ANOVA) will be apply to determine the intervention effect over the time 0, 30 day, 60 day, 90 day, and 120 day). P significance was set up ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

Healthy women BMI 18.5 - 29.9 kg/m2.

Exclusion Criteria:

Gastrointestinal diseases Pregnant women Regular use of medications Dietary restrictions, vegetarian diet, macrobiotic, etc. Use of vitamins or dietary supplements Use of probiotics or prebiotics in the last 3 months and antibiotics in the last 6 months.
Evaluation of Perioperative Cystoscopy and Methylene Blue Test in Detecting Complications in TVT and TOT Procedures

Comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in TVT and TOT operations.


Eligibility Criteria:
Inclusion Criteria:

* Providing consent to participate in the study
* Being between the ages of 18 and 85
* Having stress urinary incontinence
* No active cardiac disease
* No connective tissue disorders (e.g., Marfan syndrome)
* No known gynecological malignancy
* BMI under 30
* No chronic constipation
* No inflammatory bowel disease

Exclusion Criteria:

* Not providing consent to participate in the study
* Being under 18 or over 85 years old
* Not having stress urinary incontinence
* Having active cardiac disease
* Having connective tissue disorders (e.g., Marfan syndrome)
* Having a known gynecological malignancy
* Having a BMI over 30
* Having chronic constipation
* Having inflammatory bowel disease
Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke

Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.

Eligibility Criteria:
Inclusion Criteria:

* First-ever ischemic stroke
* Cortical or subcortical stroke
* National Institute of Health Stroke Scale NIHSS\>12 or motor NIHSS\>6 at inclusion
* MRI-proved ischemic stroke

Exclusion Criteria:

* pregnant or breast-feeding women
* alcoholism
* ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption \< 1 month
* allergic reaction after SSRI administration
* MRI contraindication
* NIHSS\>22
* Severe aphasia
* Coma
Structural and Functional Connectivity in Partial Epilepsies Studied with MRI and MEG

Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies.

SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures.

The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process.

The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* intracranial EEG recordings scheduled
* no neurological or psychiatric disease for healthy volunteers

Exclusion Criteria:

* contraindication to MRI
* pregnancy
Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations

The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing a major surgical oncology procedure as defined below:

  * Pancreatectomy
  * Hepatectomy
  * Esophagectomy
  * Gastrectomy
  * Retroperitoneal Sarcoma Resection
* 18 years of age and older
* Hemoglobin level of ≥ 10g/dL to \< 13g/dL, within 10 days of enrollment
* If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
* If subject is a sexually active male or a sexually active female of child- bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
* IRB-approved informed consent, signed by the subject or the subject's legally authorized representative ≥ 18 years of age

Exclusion Criteria:

* Pre-operative hemoglobin level ≥ 13g/dL or \< 10g/dL
* Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110)
* History of allergy to Procrit®
* Known hypersensitivity to mammalian cell-derived products or human albumin
* History of spontaneous venous thrombotic vascular events
* Anemia due to factors other than cancer,(e.g. iron deficiency, B12 deficiency)
* History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events. Prior superficial thrombophlebitis is not an exclusion criterion
* History of (within 6 months) uncontrolled cardiac arrhythmias, cerebrovascular accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or other arterial thrombosis. ACS includes Unstable Angina, Q wave Myocardial Infarction (QwMI), and non-Q wave myocardial infarction (NQMI)
* Currently receiving therapeutic or prophylactic anticoagulants for conditions other than planned surgery. The only exceptions are low dose aspirin (≤ 325 mg/day) or low dose anticoagulant to maintain patency of intravenous (IV) lines
* Patient is a candidate for autologous blood transfusion