cyrilzakka/clinical-trials huggingface dataset:
Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D

To explore triheptanoin (C7 oil) compatibility with the ketogenic diet by evaluating EEG, and seizure rate, glycemia and ketosis in proven G1D patients receiving a ketogenic diet.

This is a single site, open label proof of principle exploratory trial to investigate the compatibility of C7 oil with the ketogenic diet in subjects diagnosed with G1D. The ketogenic diet will have been previously described by the patient's treating physician independently of this study and for clinical reasons. The ketogenic diet supplies over 50% of calories from fat, subjects, who are already tolerating over this much fat as part of their previously prescribed ketogenic diet, will replace 45% of their daily caloric intake with the triheptanoin for 24 hours, during a 48 hour inpatient stay. Subjects will have a continuous EEG to monitor for any potential C7 related changes in seizure before, during, and after triheptanoin oil ingestion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glucose transporter type 1 deficiency (G1D), confirmed by clinical genotyping at a CLIA-certified laboratory.
* Stable on ketogenic diet at 2.5:1 to 4:1 ratio (i.e., no changes in ratio will have taken place for 2 months). The initiation of a ketogenic diet is previous to - and thus is not part of this study.
* Males and females 30 months to 35 years and 11 months old inclusive.

Exclusion Criteria:

* Subjects with evidence of independent, unrelated metabolic and/or genetic disease.
* Subjects with a chronic gastrointestinal disorder, such as irritable bowel syndrome, crohn's disease, or colitis that could increase the subject's risk of developing diarrhea or stomach pain.
* Subjects with a BMI (body mass index) greater than or equal to 30.
* Subjects currently not on ketogenic diet.
* Women who are pregnant or breast feeding may not participate. Women who plan to become pregnant during the course of the study, or who are unwilling to use birth control to prevent pregnancy (including abstinence) may not participate. Females age 10 and over will be asked to provide a urine sample for a pregnancy test via dipstick. Subjects will be asked to agree to abstinence or another form of birth control for the duration of the study.
* Allergy/sensitivity to C7
* Previous use of triheptanoin less than 1 month prior to study initiation.
* Treatment with medium chain triglycerides in the last 24 hours.
* Subjects exhibiting signs of dementia, or diagnosed with any degenerative brain disorder (such as Alzheimer's disease) that would confound assessment of cognitive changes, in the opinion of the investigator.
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent, or assent for children age 10-17,
* Addition of a new antiseizure drug in the previous 3 months.
Diagnosing Adverse Drug Reactions Registry

This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.


Eligibility Criteria:
Inclusion Criteria:

* Subject has care coordinated at the treating physician's outpatient clinic;
* Subject has provided written informed consent;
* Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
* Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.

Exclusion Criteria:

* Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;
* Subject has a history of abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \>1.5x normal, or suspected cirrhosis);
* Subject has a history of malabsorption (short gut syndrome);
* Subject has a history of any gastric or small bowel surgery;
* Subject is currently hospitalized;
* Subject is currently being treated with intravenous medication;
* Subject underwent prior pharmacogenomic testing with results reported within the last 12 months.

Subjects may be eligible within 60 days from the date of pharmacogenomic testing.
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding

To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of dual antiplatelet therapy in patients with high tendency for bleeding during urgent and elective PCI.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria (any of the following):

* ≥75 years
* Creatinin clearance rate \< 60 ml per minute
* Anemia (Hb 9-11 mg%)
* Hypertension: BP \> 180/95 mmHg but less than 210/110 m Hg
* Diabetic Pts
* Steroid treated Pts
* Recent (within 6 weeks) non major surgery
* Pts with hematological disorders associated with tendency for bleeding like Thrombocytopenia (platelets 50000-150000) included TTP;

Exclusion Criteria:

Exclusion criteria:

* Age \< 18 year
* Acute STEMI (Primary PCI)\*
* Rescue angioplasty \<12h after lytic therapy\*
* Active bleeding
* S.C LMWH \< 8 hours or UFH \< 4 hours before PCI
* Using IIb /IIIa as an upstream therapy before PCI
* PCI which will be involved with obligatory IIb /IIIa therapy:

(thrombotic complication, occlusive dissection)

* INR\>1.5 on day of cathetrization
* Bolus of 600mg of Clopidogrel before PCI
* Current pregnancy or women in reproductive age without contraceptives
* Hypersensitivity to heparin or bivalirudin or its components \*(possible using IIB/IIIA)
Study 3: Minocycline Decreases Microglia Activation

This study is a mechanistic study that will enroll 9 subjects who are participating in NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in PET and MRI imaging.

This study will recruit 9 subjects from NCT02133885 who will agree to undergo additional autonomic testing and imaging studies at baseline and after 3-6 months of study treatment. Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in Montreal Canada.

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in IRB approved protocol #102-2013 will be eligible to participate.
* (For Study 3 Participants only) Willing to travel to Montreal, Canada for specialized imaging of the participant's brain using magnetic resonance imaging (MRI), positron emission tomography (PET) scanning, Autonomic Nervous System Testing and blood drawing- if participant qualifies

Exclusion criteria for control and resistant hypertensive subjects include:

* currently pregnant or have been pregnant in the last 6 months;
* antibiotic treatment within 2 months of study enrollment;
* currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
* unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection);
* history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
Weighted Pacifier Vs. Non-Weighted Pacifier

This study will determine if it is beneficial to use a weighted pacifier in neonates.

RCI-Pacifiers have been utilized for decades in the NICU to provide benifical Non-Nutritive Suck. They have been instrumental in transitioning premature infants from gavage to breast feeding Yiallouerou, S, et al, studied the effects of dummy/pacifier on autonomic activity during sleep and found pacifier use to be protective during sleep. Risks and Benefits of Pacifiers have cleary been identified Sexton, S and Natsale, R have identified that nonnutritive suck is a natural reflex for a fetus and newborn. Traditionally, the pacifier has been used as a method for fulfilling an infants innate desire to suckle. Study subjects will be introduced to either a standard/traditional pacifier (without stabilizing/weighted attachment) or a stabilizing/weighted pacifier. Standard/traditional pacifiers will be issued to patients that have been assigned an odd number study identifier and , stabilzing/weighted pacifiers will be issued to patients that have been assigned an even number study identifier. All eligible infants born at 30 weeks to 37.6 weeks who meet study criteria will be included. All staff/caregivers will be trained in proper placement of a stabilizing pacifier prior to use. Stabilizing pacifiers will not be placed on the infants chest. Traditional pacifiers will be used as standard of care at EH. The Neonatal Infant Pain Score (NIPS) scale and a caregiver survey will be used to determine efficacy.

Eligibility Criteria:
Inclusion

* 30 week-37.6 gestational age
* Patient is admitted to the NICU
* The patient has the ability to suck as noted in the patient's infant assessment flow sheet prior to enrollment

Exclusion

* Patient with an oral pharyngeal defect
* Patient with an oral feeding tube
* Patient with any medical reason that deems them unfit for the study as '''''''determined by the neonatologist
* Patient with sustained apnea during sucking
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis

We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.

Subjects were randomized into group A and B: group A (n=30) exercised for the first 6 months while group B (n=31) performed a placebo exercise initially (3 months) and cross-over to aerobic exercised for 3 months more.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* more than three months of hemodialysis vintage
* under the permission of their nephrologist
* agreement to be randomly assigned and undergo study protocols

Exclusion Criteria:

* Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking
* presenting representative blindness
Social Media Intervention for Cannabis Use in Emerging Adults

The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help researchers learn about ways to deliver wellness information in a way that is appealing and helpful to young people who use Facebook.


Eligibility Criteria:
Inclusion Criteria:

* self-report using cannabis at least 3 time per week or more often in the past month
* active Facebook profile
* view and click on a social media ad

Exclusion Criteria:

* fail identity verification based on 1) Internet Protocol (IP) addresses, 2) survey time completion, 3) repeat attempts, 4) survey responses, and 5) photo identification via a timestamped selfie sent to the research staff.
ICATA Asthma Mechanistic Study

The purposes of this study are to determine the effects of omalizumab on cells involved in the allergic response, to evaluate predictors of response to omalizumab, and to determine whether response to omalizumab therapy is influenced by the environment. A subset of inner-city children and adolescents currently enrolled in Inner-City Anti-IgE Therapy for Asthma (a clinical trial of omalizumab) will be enrolled in this study.

Immunoglobulin E (IgE) is important in the development of allergic responses and may determine asthma severity. Omalizumab is a man-made monoclonal antibody that directly blocks the cause of allergic reactions. There are three main objectives to this study. The first is to gain an understanding of how omalizumab affects cells involved in the immune response. The second objective is to determine whether response to omalizumab is influenced by exposure to environmental factors, including allergens and viral infections. The third objective is to determine what clinical markers can be used to determine which patients would most benefit from omalizumab therapy. This study will evaluate the immune and allergic responses of inner-city children with moderate to severe asthma who are receiving omalizumab or placebo as part of a parallel study (Inner-City Anti-IgE Therapy for Asthma, ICAC-08, NCT00377572).

Nasal secretions will be collected from all participants at the beginning of this study, toward the middle of the study, and with each asthma exacerbation requiring a clinical visit. Some participants will participate in either the basophil or T-cell studies and associated procedures. These studies require blood collection at five study visits. Sputum collection will occur at four study visits. Those participants involved in the basophil studies will also undergo skin testing at three study visits.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in ICATA (ICAC-08, NCT00377572) Clinical Study
* Positive skin test to German cockroach required for participation in the basophil and T-cell studies and associated procedures
* Cockroach insensitive participants will serve as control groups
Comfort and Cleaning Evaluation of Multipurpose Solutions in Contact Lens Patients

To compare patient comfort and overall lens cleanliness with consecutive use of two multipurpose lens solutions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 yrs or older
2. Males or females
3. Any race or ethnic background
4. CL patients using Opti-Free Express no-rub MPS currently
5. Patients using Focus night and day Lenses

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Corneal ectasia.
3. Current use of Restasis
Gabapentin for Alcohol Withdrawal Syndrome

The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines. This method of treatment has several drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS, a study to compare gabapentin to symptom-triggered lorazepam will be completed.

The current "gold-standard" for the management of alcohol withdrawal syndrome is symptom-triggered administration of benzodiazepines. Benzodiazepines and use of a symptom-triggered approach has several drawbacks such as over administration of medication due to many subjective patient reported symptoms. Benzodiazepines may contribute to a drug-induced delirium or high dosage may necessitate transfer to an ICU setting. Abrupt withdrawal of benzodiazepines also contribute to cravings, rebound insomnia, and anxiety that have been shown to increase the risk of a return drinking.

Clinical use of gabapentin for alcohol withdrawal has been presented by Maldonado at Stanford University Hospitals. (Academy of Psychosomatic Medicine Annual Meeting, 2013-2015) At Mayo Clinic, the Psychiatry Consultation-Liaison hospital service has been recommending the use of a modified gabapentin protocol since January 2015, which has been clinically accepted on medical, surgical, and psychiatric hospital services. The purpose of this research is to investigate the reactive benzodiazepine versus proactive gabapentin approaches to AWS in a prospective, randomized, open-label study.

Eligibility Criteria:
Inclusion criteria

1. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score \>4.
2. Adults age 18 or older.
3. Sufficient understanding of English.
4. Hospitalized on Hospital Internal Medicine or Generose.

Exclusion criteria

1. Severe renal impairment (estimated CrCl \< 30).
2. Intensive Care Unit (ICU) level of care.
3. Not responsive due to alcohol intoxication or withdrawal.
4. Already taking gabapentin more than 300 mg three times a day.
5. Prescribed pregabalin.
6. Primary seizure disorder.
7. Acute benzodiazepine withdrawal.
8. Concurrent substance use disorders (such as opioid use disorder, stimulant use disorder) if the disorder is assessed to be clinically significant. Cannabis use disorder will be allowed.
9. Concurrent anticonvulsant medications for psychiatric indications (e.g. bipolar disorder) will be allowed.
10. Pregnancy.
11. Involuntary legal status (e.g., on court commitment).
12. Patients admitted greater than 12 hours prior to potential enrollment.
13. Patients receiving therapeutic dose of gabapentin (rather than continuation of home dose) prior to enrollment.
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.


Eligibility Criteria:
Inclusion Criteria:

* Has been diagnosed with type 2 diabetes mellitus
* Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
* Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
* Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:

  1. Hormone replacement therapy (female subjects)
  2. Oral contraceptives (female subjects)
  3. Antihypertensive agents
  4. Lipid-lowering agents
  5. Thyroid replacement therapy
  6. Antidepressant agents
  7. Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over-the-counter antiobesity agents

Exclusion Criteria:

* Has been previously exposed to exenatide once weekly
* Has donated blood within 60 days of study start or is planning to donate blood during the study
* Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:

  1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
  2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
  3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
  4. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
  5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
* Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
* Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
Positioning and Ultrasound Examination of the Gastric Antrum

The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and 2 volunteers

Exclusion Criteria:

* Diabetes mellitus
* previous gastrointestinal surgery
* Medication affecting gastric motility
* digestive diseases, gastroparesis
* Pregnancy
Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

This trial aims to develop and validate the urinary multimarker sensor which can measure trace amounts of biomarkers from naturally voided urine in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that urinary multimarker sensor will help to avoid unnecessary prostate biopsy while detect the clinically significant cancers.

The investigators will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.

1. Urine specimen collection. This study was approved by the Institutional Review Board of the Asan Medical Center (Seoul, Republic of Korea) and informed consent will be obtained from all subjects. Biomarkers diffused passively from prostate tissue to the urethra and will be collected from naturally voided urine. Urine will be collected in a sterilized specimen cup containing 10 vol% RNA stabilizer and 1vol% antibiotics and stored in a refrigerator for less than a week before shipping the sample to the laboratory
2. To measure the electrical signals from the four different biomarkers in the urine, the four sensing channels in the extended gate of an field-effect transistor biosensor will be conjugated to antibodies, thus capturing different biomarkers.
3. Without any pretreatment, urine will be added directly to the four different sensing channels. After 20 min of reaction time in the four channels, the bottom gate voltage shifts will be measured at the reference current (1 nA). Each urine sample will generate four independent sensing signals from the corresponding biomarkers. The set of sensing signals collected for each patient will be then analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Men undergoing a first-time prostate biopsy to rule out cancer
2. Serum PSA ≥3ng/mL, ≤20ng/mL
3. Age≥50 years, ≤80 years
4. Clinical stage ≤T2c
5. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. Patients has any prior needle biopsy of the prostate
2. Patients has a prior history of prostate cancer
3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
4. Patients has a prior history of BPH operation
5. Patient with uncorrectable coagulopathies
6. Unable to tolerate a TRUS guided biopsy.
7. Patients had 5-alpha reductase inhibitor in the past six months.
8. The patient has had a urinary tract infection or acute prostatitis in the last three months.