cyrilzakka/clinical-trials huggingface dataset:
Glutathione-rich Foods for Type 2 Diabetes

The purpose of this research study is to find out whether certain plant-based foods may be beneficial for individuals with type 2 diabetes. To meet the goal, study participants will be fed known amounts of foods and nutrients. Before and after participants have eaten the food, they will self-measure height, weight, and waist circumference and study staff will administer questionnaires. Blood samples will be taken at a local lab to measure blood sugar and blood lipids.All study appointments will be conducted online.

This research study is a randomized, controlled trial that will evaluate whether diet and nutrition education on, and short-term partial feeding of, specific plant foods high in the antioxidant glutathione will impact total glutathione status, gamma-glutamyltransferase (GGT) activity, glucose control or insulin sensitivity in people with type 2 diabetes. Dietary education will include information on plant sources of glutathione, as well as, cooking methods to reduce glycation and lipid peroxidation during cooking, which may indirectly alter glutathione status by reduce demand for elimination of these compounds. Participants will be randomized to one of two groups: the educational intervention plus partial feeding of two small meals per day vs. a wait list control group that will receive standard advice on nutrition for diabetes. After 12 weeks, the intervention group will no longer receive foods, but will be followed for 12 additional weeks to determine if lasting effects are achieved. After 12 weeks, the control group will receive access to the educational materials, but will not receive study foods, to see if the educational intervention alone impacts food/nutrition choices. Both groups will have lab measures (as described above) again after this additional 12 weeks, for a total duration of 24 weeks in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Ages 18 to 65
* Type 2 diabetes
* Free of self-reported acute and confounding chronic diseases (e.g., heart failure, kidney disease, liver disease, gastrointestinal disorder) based on a standardized medical history questionnaire
* Free of alcoholism, smoking and major cardiovascular event with the past 6 months
* Not on insulin to help manage diabetes
* Planning on staying in the San Diego area for the next 6 months
* Willing to select plant-based foods from a "menu" and eat the selected foods provided by the study team
* Have access to the internet and a computer
* Willing to view 4 weekly educational classes online, followed by periodic telephone and email contacts
* Agree to schedule and complete periodic questionnaires and measurements during up to four total online appointments

Exclusion Criteria:

* Alcoholism, smoking and recent cardiovascular events
* Individuals will be excluded if they report any dietary restrictions, allergies or preferences
* Unsuitability based on screening visit
Efficacy of Small Subcutaneous Glucagon Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes

In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable side-effects such as nausea, vomiting, bloating and headache.

The overall objective of this research proposal is to assess the efficacy of lower subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).

It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia without the undesirable gastro-intestinal side effects.

In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Current instructions for the treatment of severe hypoglycaemia call for the immediate injection of 1 mg of glucagon subcutaneously or intramuscularly. Large dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable side-effects such as nausea, vomiting, bloating and headache. Moreover, glucagon emergency kits are relatively expensive (around $100 per kit), thus increasing the financial burden of diabetes on patients and the health care system.

The primary objective of this research project is to the study the pharmacological effects of different doses of glucagon injected subcutaneously to correct hypoglycaemia during controlled conditions mimicking a hypoglycaemic event in adults with type 1 diabetes. More specifically, we will be looking at the effects of subcutaneous glucagon injected at 0.1 or 0.2 mg and 1.0 mg to normalized plasma glucose during a hypoglycaemic hyperinsulinemic clamp in subjects with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of old
* Clinical diagnosis of type 1 diabetes for at least two years.

Exclusion Criteria:

* Clinically significant nephropathy (MDRD \< 60 mL/min/1.73 m2).
* Pregnancy
* Severe hypoglycemic episode within two weeks of screening
* Current use of glucocorticoid medication (except low stable dose)
* Pheochromocytoma or primary adrenal insufficiency (e.g. Addison's disease)
* Medical condition likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Prospective Study of an Investigational Toric Soft Contact Lens

The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.

Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
* Normal eyes not using any ocular medications that would contraindicate lens wear.
* Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
* Spectacle cylinder prescription between 0.50 and 2.00 diopters.
* Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality.
* Any active anterior segment or systemic disease that would contraindicate contact lens wear.
* Use of systemic medications that would contraindicate lens wear.
* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
* History of herpetic keratitis.
* History of refractive surgery or irregular cornea.
* History of pathologically dry eye.
* Corneal vascularization greater than 1 mm of penetration.
* Eye injury within twelve weeks immediately prior to enrollment in this trial.
* Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
* Other protocol-defined exclusion criteria may apply.
A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

The acutely suicidal patient presents a complex and dangerous clinical dilemma. Many suicidal patients receive antidepressant medications, but the onset of action of these medications is at least three weeks, and despite their established antidepressant effect, they have not shown a clear anti-suicidal benefit. Psychoanalysts hypothesized that depression (often leading to suicidality) shares important characteristics with the psychological sequellae of object loss and separation distress. Endogenous opioids (endorphines) have been implicated in mediating social bonding and separation distress in mammals. Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist buprenorphine to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that buprenorphine may be a novel and quick-acting treatment for acute suicidality, especially in the context of depression. The proposed double-blind study will examine the effect of buprenorphine on acutely suicidal inpatients. Depression, suicidality, and overall functioning will be assessed before, during and after a two-week buprenorphine/placebo trial. A small subgroup of patients will also be treated with short-term psychoanalytic psychotherapy throughout the study period. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of suicidality and depression.


Eligibility Criteria:
Inclusion Criteria:

* depression

Exclusion Criteria:

* substance or alcohol abuse
* psychosis
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy

Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.

Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.

Eligibility Criteria:
Inclusion Criteria:

* Indications of capsule endoscopy;
* Informed consent form obtained.

Exclusion Criteria:

* Contraindication of capsule endoscopy;
* Domperidone allergy;
* Unwilling to participate.
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA \< 172 IU/mL (approximately \< 1000 copies/mL) prior to liver transplant
* Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening

Exclusion Criteria:

* Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
* Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease

A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.

A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 180, 365 days,2 years,3 years,4 years and 5 years. Target Lesion Failure (TLF) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be ≥18 of age; male or non-pregnant female.
* Diagnosis of coronary artery disease.
* At least one target lesion with a diameter stenosis ≥70% (visual estimate)
* Acceptable candidate for CABG;
* The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, appropriate Ethics Committee(EC); and the patient is willing to comply with specified follow-up evaluations.

Exclusion Criteria:

* Patient has congenital heart disease, severe valve dysfunction, bridge vascular disease, severe heart failure (NYHA ≥ Ⅲ level), or left ventricular ejection fraction ≤ 30%.
* Patient has undergone previous stenting anywhere within the previous 1 year. Patient has a preoperative renal dysfunction: serum creatinine\> 2.0mg/dl (176.82umol / L).
* Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year;
* Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, Prasugrel, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylene-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately premedicated;
* Patient is allergic to contrast agent Sirolimus.
* Patient has a limited life expectancy is less than 12 months.
* Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
* Patient has poor compliance with the judgment of the investigator and can not complete the study as required.
* Patient who had heart transplant.
Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

The aims of this study are to determine, in adult patients on maintenance topiramate therapy, the steady-state pharmacokinetics and safety of orally and intravenously administered topiramate.

The long-term goal of this research project is to develop a more effective, safer therapy for neonatal seizures. Prior to using an investigational intravenous topiramate formulation in children and neonates, the pharmacokinetics and safety of the formulation must be demonstrated in adults. The immediate aims of this study are to determine the pharmacokinetics and safety of a novel intravenous topiramate formulation. An additional aim is to determine if sex, advancing age, or genotype affects topiramate absorption, distribution, or elimination.

Eligibility Criteria:
Inclusion Criteria:

* Persons taking topiramate
* Persons 18 years of age and older

Exclusion Criteria:

* Patients who are pregnant
* Patients who are breast feeding
* Patients with significant medical problems who may not tolerate intravenous administration
* Patients taking medications known to affect topiramate disposition
A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes

The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood concentrations of the administered trial drug) of faster-acting insulin aspart (faster aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the safety and tolerability of faster aspart and NovoRapid® will also be assessed.

The participants will be in the study for approx. 21 days. Each participant will have 5 visits to the clinic, with an overnight stay at both dosing visits. Participants will have a number of tests, and they will have to give blood and urine samples.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 64 years (both inclusive) at the time of signing informed consent.
* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer.
* Body mass index 18.5 - 28.0 kg/sqm (both inclusive).
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer.

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening.
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily).
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period.
Mindfulness Training for Medical Personnel

In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. If successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.


Eligibility Criteria:
Inclusion Criteria:

* Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.

Exclusion Criteria:

* Those not falling into inclusion criteria.
Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate

Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.

Aim was to evaluate the amount of absorbed saline irrigation fluid during transurethral therapy of benign prostatic hyperplasia (BPH). We want to differentiate two different methods of the surgical therapy: the TransUrethral Resection in Saline (TURiS) and the Photoselective Vaporisation of the Prostate (PVP). Both methods using saline irrigation. To measure the amount of absorbed saline irrigation fluid, we added pure Ethanol to the Irrigation fluid resulting in am 0,02% ethanol containing saline irrigation fluid. The conventional TransUrethral Resection of the Prostate (TUR) method is using electrolyte free irrigation. In the literature this method is well known for the occurence of the transurethral resection syndrome ("TUR syndrome"). This is caused by absorption of electrolyte-free irrigating fluid, followed by a hyponatraemic hyperhydration, and consists of symptoms from the circulatory and nervous Systems.

Eligibility Criteria:
Inclusion Criteria:

* Patients in which a TURiS or PVP to be performed

Exclusion Criteria:

* Alcoholics,
* Patients with severe hepatic impairment,
* Epilepsy,
* Existing metabolic acidosis.
Visual Perception Intervention Programmes Impact on Down Syndrome Affiliate Children's Fine Motor and Visual Perception.

A second copy of chromosome 21 results in Trisomy 21, a genetic disorder commonly referred to as Down syndrome. In addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. Even though people with Down syndrome may experience a range of health problems, they can lead happy, fulfilling lives if they receive the right support and care. Individual differences in the illness's severity are significant.

There will be a randomized control trial. People with Down syndrome who are five to nine years old will be screened for this study. Adults with Down syndrome and severe ID will not be eligible to participate in this study. Participants will be selected using

Conventional physical therapy will be administered to the participants in both groups. Visual perception interventions will be administered to the intervention group, and then standard treatment will follow. For six weeks, there will be three 45-minute treatment sessions per week. Using outcome measure instruments, data will be gathered twice: once at the beginning of the study and again at the end of the six-week course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged between 6-9 years.
* IQ level mild to moderate (below 40)

Exclusion Criteria:

* Heart,
* GIT problems,
* respiratory problems
* and hearing loss.