cyrilzakka/clinical-trials huggingface dataset:
Effect of Dietary Macronutrient Composition

The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.

Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US. However, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. Here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. The investigators hypothesize that Hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to African American subjects.

Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid metabolism will be measured in the liver and periphery. This will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. Subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months.

The specific aims are as follows:

AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and African Americans with metabolic syndrome.

Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to African Americans.

AIM 2: Determine the effects of low-CHO and low-fat diets on liver fat regression.

Hypothesis: Compared to a low-fat diet, a low-CHO diet will markedly decrease markers of inflammation coincident with greater improvements in insulin sensitivity as assessed by an intravenous glucose tolerance test.

Eligibility Criteria:
Inclusion Criteria:

* Elevated serum ALT or metabolic syndrome
* African American or Hispanic
* Nondiabetic
* Men or women
* Smokers and nonsmokers
* Pre- and post-menopausal (+/- HRT)
* Stable body weight
* Age 20-65 years
* BMI between 25-45 kg/m2

Exclusion Criteria:

* Diabetes or Pregnancy
* Ethanol intake: males \> 140 g/week, females \> 70 g/week
* Chronic hepatitis B or chronic hepatitis C
* Hemochromatosis or Wilson's Disease
* Autoimmune hepatitis or primary biliary cirrhosis
Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients

This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension


Eligibility Criteria:
Inclusion Criteria:

* Outpatients 18 years and older.
* Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
* Patients with essential diastolic hypertension measured by calibrated standard aneroid or mercury (preferable) sphygmomanometer. Patients must have a MSDBP \> 90 mmHg and \< 110 mmHg at Visit 1 (week -4 to -2), and a MSDBP \> 95 mmHg and \< 110 mmHg at Visit 2 (week 0).
* Patients must have an absolute difference of \> 10 mmHg in their average sitting diastolic blood pressure between Visits 1 and 2.
* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

* Severe hypertension (MSDBP 110 mmHg and/or MSSBP 180 mmHg) at anytime.
* Inability to discontinue all prior antihypertensive medications safely for a period of 14 weeks.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 0 (week -6 to -4).
* Transient ischemic cerebral attack during the last 12 months prior to Visit 0 (week -6 to -4).
* Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing Disease, pheochromocytoma, polycystic kidney disease etc.
* Type 1 diabetes mellitus.
* Type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) \>8% at Visit 1 (week -4 to -2).
* Administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (Visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 0 (week -6 to -4).
* Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
* Other protocol-defined inclusion/exclusion criteria may apply
Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder

The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.

Individuals with opioid use disorder (OUD) demonstrate reward- and stress-related neurocognitive changes compared to individuals without OUD, including cravings for opioids in response to exposure to triggers, tendency to make impulsive and disadvantageous decisions, and a strong attentional bias towards drug-related cues. Together, these deficits are significant contributors to relapse and discontinuation of treatment. Cannabidiol (CBD) has been shown to impact some of these cognitive deficits but studies of CBD among individuals with OUD are mostly lacking. Therefore, this study aims to answer whether CBD has any impact on reward-related neurocognitive deficits in individuals with OUD. If successful, this line of research will lay the groundwork for future studies to evaluate CBD's impact on OUD treatment outcomes.

Eligibility Criteria:
Inclusion Criteria

* English speaking
* DSM5 diagnosis of opioid use disorder
* Receiving buprenorphine or methadone for treatment of opioid use disorder
* Agreeable to abstaining from using any cannabis or CBD products for the duration of the trial.

Exclusion Criteria:

* Any self-reported use of cannabis or CBD products in the past 30 days
* Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10
* Currently pregnant
* Hepatic liver enzymes greater than 3x upper normal limit
* Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil emulsion)
* Currently taking any medications with known significant pharmacokinetic interactions with CBD
Molecular Analysis of Patients With Neuromuscular Disease

The purpose of this study is to identify new genes responsible for neuromuscular disorders and study muscle tissue of patient with known neuromuscular disease, as well as their family members. We are interested in recruiting many types of neuromuscular disease including; Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), and limb-girdle muscle dystrophy (LGMD). There are still many patients diagnosed with muscular dystrophy with no causative gene implicated in their disease. Using molecular genetics to unravel basis of these neuromuscular disorders will lead to more accurate diagnosis/prognosis of these disorders which will lead to potential therapies.

We are looking to discover new disease genes responsible for the neuromuscular diseases found in our participants and their families. Our research lab has a long history of identifying novel genes responsible for various forms of neuromuscular disease including; DMD gene, the sarcoglycans, obscurin, and filamin. Each discovery has resulted in advances in our ability to develop diagnostic tests which benefit patients and their families by providing accurate diagnosis, presymptomatic and/or prenatal testing. Genotype-phenotype correlation studies have increased our understanding of the natural history of these rare disorders benefiting patients through better prognostic determinations by clinicians. Biochemical and pathological analysis of muscle biopsy samples in patients with known and unknown types of neuromuscular disease has led to new insights into disease pathophysiology, which we hope will aid in finding new treatments.

Eligibility Criteria:
The samples used in this study will be derived from individuals at risk for, or suffering from, neuromuscular disease, generally resulting in clinical weakness of one or more muscle groups and their family members.

Inclusion criteria:

1. having a clinical and/or pathological diagnosis of a muscular dystrophy
2. being the first degree relative of someone with such a diagnosis
3. having had a muscle biopsy if diagnosed with a neuromuscular disease
4. willingness to provide a skin biopsy for research only

Exclusion Criteria:

1. not having a neuromuscular diagnosis in you or a family member
2. not wishing to participate
3. being incapable of giving consent and not having a legal guardian willing or able to do so
The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index

The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was "Calgary Sleep Apnea Quality of Life Index" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Apnea hypopnea index (AHI) of ≥5

Exclusion Criteria:

* Presence of sleep disturbances other than OSAS
* Presence of active alcohol or drug addiction
* Psychiatric impairment
* Cognitive impairment
* Recent acute illness (such as myocardial infarction) that may adversely affect their quality of life
* Difficulty in communicating
Clinical and Laboratory Patterns of Pediatric Gross Hematuria

Study the demographic, clinical, laboratory and etiological profile of children with gross hematuria and trace the outcome of these patients for at least 3 months follow up.

Gross hematuria is a scary but common medical problem in children. This condition is considered one of the most important manifestations of kidney and urinary tract diseases. When colour of urine with blood is reddish, brown or dark or cola coloured, the condition is called as macroscopic (gross) hematuria. However, blood in urine may not always be visible to the naked eye, when it is called as microscopic hematuria.

This condition can be transient, intermittent or persistent and it may be symptomatic or asymptomatic. Hematuria originating from glomerulus is almost never bright red but usually brown, tea coloured or cola coloured. In contrary, hematuria originating from the lower urinary tract is usually pink or red in colour.

Pigments and other compounds in certain foods (including beets, berries, and food colourings) and drugs (sulfonamides, rifampicin, ibuprofen, salicylates, phenothiazines, metronidazole, phenolphthalein, chloroquine, deferoxamine, etc.) can change the colour of urine that is called false hematuria.

The causes of hematuria are very diverse, ranging from simple urinary tract infections with rapid recovery to mechanical trauma and severe glomerulonephritis with rapid decline in kidney function, it is essential to recognize the underlying disease and treat it accordingly.

The causes of gross hematuria may be categorized to whether the hematuria is glomerular or non-glomerular in origin. This distinction can be determined by microscopic examination of the urine to detect dysmorphic or monomorphic red blood cells in glomerular and non-glomerular hematuria, respectively. Although glomerular diseases are nearly always associated with some degree of hematuria, gross hematuria as a presenting manifestation is more commonly encountered with acute poststreptococcal glomerulonephritis, lupus nephritis and IgA nephropathy. Non-glomerular hematuria is most often associated with renal stones, tumours, idiopathic hypercalciuria, bacterial or viral urinary tract infection, urolithiasis and structural anomalies of the urinary tract.

It is essential to establish the cause and origin of hematuria in each case through proper history, clinical features and investigations including laboratory, radiological studies and/or percutaneous renal biopsy in some cases. But at the same time, it is important that the pediatrician is aware what any of such procedures might be helpful in establishing a proper diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* lnvestigators will include all patients complaining of gross hematuria between the ages of 1 month up to 16 years.

Exclusion Criteria:

* Children with external perineal or genital region bleeding which may falsely cause presence of blood in urine samples.
* Patients whose legal guardians will refuse participation in the study.
* Patients with follow up for less than 3 months.
Supporting Responsible Fatherhood Program (Fatherhood FIRE)

Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope program to promote responsible fatherhood in the Bronx among low-income adult (18 years or older) fathers with non-custodial children (under the age of 24). The program, called HERO Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by enhancing relationship and anger-management skills and providing marriage education; providing skills-based parenting education, disseminating information about good parenting practices, and encouraging child support payments (in partnership with our local OCSE); and fostering economic stability by providing employment-related supports inclusive of job search, vocational skills training, job referrals, and job retention.

The program model is based on the premise that relationship and parenting skills can be taught, and will lead to improvements in relationships (knowledge about relationships, communication skills, stress management, reduction in destructive conflict), parenting (knowledge about child development, engagement with non-custodial children, effective parenting, co-parent communication, child well-being), and economic status (vocational skills, new employment or career advancement, financial literacy, child support). The investigator will provide core relationship and relationship education workshops using an empirically supported curriculum (24/7 Dad) plus employment workshops, numerous supplemental activities to promote responsible fatherhood, individualized vocational case management, and job-driven employment services. In total, the investigator expects to enroll 1,475 non-custodial fathers in the program and provide an average of 34 hours of total programming per participant (including 24 hours of core workshops), which the investigator believes is a sufficient dosage to detect impacts.

Eligibility Criteria:
Inclusion Criteria:

* Must be over 18 years of age
* Must have a child under the age of 24
* Must be a non-custodial parent or have shared custody
* Income below 200% poverty line

Exclusion Criteria:

* Active intimate partner violence and increased risk of intimate partner violence.
Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate

The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women.

Once determined eligible and providing consent, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be between the ages of 50-70 years
* Completing at least 30 minutes of physical activity at minimum three days per week

Exclusion Criteria:

* As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index \> 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease
* Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
* Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
* Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
* Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for overnight (8-10 hours)
* Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit
* Women who are pregnant
* Women who are lactose intolerant
Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg

The objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force distribution) movement state in these patients.

Comprehensive motion (kinetics and kinematics) data specific to sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. The Vicon Motion Analysis System will be utilized to track movement using markers on the subject and the Bionic Leg per the UCSF Human Performance Center's routine. Once outfitted with the marker system, patients will be instructed to perform multiple sit-to-stand and stand-to-sit transfers while data is gathered.

The sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12" from the floor. The chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).

Eligibility Criteria:
Inclusion Criteria:

* Single ischemic stroke with residual unilateral lower-extremity weakness
* Chronic post-stroke (\>12 months since event)
* Eligible to participate to lower extremity physical therapy
* Age 30 years or greater
* Able to ambulate at least 10 meters without therapist assistance
* Able to ambulate without a leg brace
* Able to transfer from sitting to standing without physical assistance from a therapist
* Able to transfer from standing to sitting without physical assistance from a therapist
* Subject must understand the nature of the study and provide written informed consent prior to enrollment.
* Subject must be willing and able to attend all study sessions

Exclusion Criteria:

* Medically unstable
* Age younger than 30 years
* Subacute post-stroke (\< 12 months since event)
* Status-post multiple strokes
* Status-post traumatic brain injury
* Not eligible to participate in lower extremity physical therapy
* Concomitant degenerative neurological conditions
* Not able to ambulate at least 10 meters without therapist assistance
* Unable to ambulate without a leg brace
* Unable to transfer from sitting to standing without physical assistance from a therapist
* Unable to transfer from standing to sitting without physical assistance from a therapist
* Unable to follow instructions, complete follow-up, or provide informed consent.
* Currently enrolled in another investigational device or drug trial
Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts

This study aims to test the central hypothesis that adding to the diet daily yogurt provides beneficial effects on digestive health and subjective mood in healthy adults.

This clinical trial will include a 4-week lead-in period and a 2-week treatment period. The lead-in period will be devoid of all supplemental and dietary probiotics, fermented dairy products, and fermented foods. Participants will be asked to refrain from consuming all supplemental and dietary probiotics, fermented dairy products, and fermented foods throughout the entire study. During the treatment period, participants will be given yogurt with sugar. This trial will serve as a continuation of the NECTAR Study (NCT04187950).

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Between the ages of 22-64 years at the time of consent
* Body mass index of 18.5 to 29.9 kg/m\^2.
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
* Ability to drop off fecal sample within 30 minutes of defecation
* Have between 3-6 bowel movements per week
* Have completed the NECTAR Study (NCT04187950)

Exclusion Criteria:

* Current pregnancy, lactation, or post-menopausal
* Tobacco use
* Honey allergy or intolerance
* Dairy allergy, lactose intolerance
* Food dye allergy/intolerance
* Prior physician diagnosed gastrointestinal disease (chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, or gastroesophageal reflux disease (GERD))
* Current use or use of antibiotics in the past 3 months
* Current use of any of the following types of medications: laxatives, anti-diarrhea medications, narcotics, enemas, antispasmodics, anticonvulsants, prescription proton pump inhibitors, prokinetic agents, histamine-2 Rc antagonists (prescription GERD medication)
* Body mass index \> 29.9 kg/m\^2
* Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy)
* Restrictive bariatric surgery (i.e. adjustable gastric band) within the past 5 years
* Concurrent enrollment in another dietary, exercise, or medication study (except for the NECTAR Study (NCT04187950))