cyrilzakka/clinical-trials huggingface dataset:
A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics

This trial is conducted in Europe. The aim of this trial is to investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously
* BMI between 18.5 and 40 kg/m2
* HbA1c between 6.5 and 10.0% both inclusive

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Previous participation in this trial (randomised). Re-screening of screening failures is allowed only once
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (OC), hormonal intra uterine devices (IUDs), implants and injectables; for Germany, a condom for the male partner must be used in combination with OC, IUD, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal
* The receipt of any investigational drug within 3 months prior to this trial
* Previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening).
* Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes)
* Clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the Investigator.
* History of alcoholism or drug abuse during the last 12 months
* Blood donation within the last 3 months. Plasma donation within the last month.
* Additional exclusion criteria for Germany: Male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication
Bariatric Surgery Observation Study Part 2

The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years

The main question\[s\] it aims to answer are:

* The duration of the surgical method on weight reduction and remission of comorbidities
* Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to

  * fill inn questionnaires,
  * have a clinical examinition
  * have an interview with nurse and doctor
  * have blood samples taken
  * undergo other investigations

The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity.

1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015

Exclusion Criteria:

* Not able to consent for participation
* Includable participants not longer living in Norway
Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake

The overarching goal of this project is to implement Boot Camp Translation (BCT) methodology to translate the guidelines and evidence for human papillomavirus (HPV) vaccine into a practice and provider level intervention designed to improve its acceptability and uptake.

As a community engagement approach, Boot Camp Translation (BCT), is a 6-9-month iterative process that brings together multiple stakeholders, including patients, parents, and community members, to translate evidence-based guidelines and recommendations into locally relevant and meaningful messages, materials, and programs.

Aim 1: Implement BCT in three geographically distinct Colorado communities to translate the current evidence for HPV vaccination into locally relevant interventions designed to increase vaccine uptake.

Aim 2: Evaluate the impact of the BCT- designed intervention on practice-level HPV vaccination initiation rates.

The long-term goal is to develop a replicable approach and low-cost method of increasing HPV vaccine uptake that is easily adaptable to different settings and sociodemographic contexts.

Eligibility Criteria:
Inclusion Criteria:

All child patients who have received health supervision at participating practices during the 12 month prior to intervention and the 12 month following intervention implementation, who are ages 9-26 years, and whose parents have not requested removal from the Colorado Immunization Information System (CIIS) will be eligible for the assessment of practice immunization rates in the pre and post periods.

Exclusion Criteria:

* No subjects will be excluded because of gender, ethnicity, or insurance status.
* Any child whose parents have requested removal from the immunization registry; any child with hypersensitivity to any component of one of the recommended vaccines; any child who has moved to a primary care provider other than one at the study clinics.
Usability Evaluation - Reassure Respiration Rate Device: Home User Study

This is a usability evaluation of the Reassure device. The device is a non-contact device which passively monitors breathing.

The purpose of this usability evaluation is to understand any issues that the intended user population have while using the device unsupervised in the home and to determine if the device can collect data that is of sufficient quality to be successfully analysed for respiration rate.

The aim of the set of Reassure Home User Trials is to understand any usability issues that users have while using the Reassure non contact monitor in their home environment.

Other objectives:

* To gather useful feedback on the user interface and suggestions for its improvement.
* To gather information on the device stability in the more variable conditions of the home user environment.
* To gather data in order to demonstrate compliance with IEC62366, and thus IEC60601-1

The users had the device for a minimum of 10 nights, to confirm if the device could be used for an extended period and the likely compliance rates of users

Eligibility Criteria:
Inclusion Criteria:

* volunteer, no previous exposure to the device

Exclusion Criteria:

* restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep
Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria

Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to provide written informed consent.
* Males and Females 55 years of age and over
* Subjects must have a history of high blood pressure and elevated cardiovascular risk defined as one of the following:

  1. Diabetes
  2. Advanced coronary disease defined as previous myocardial infarction. Active angina, or significant changes in tests indicating ischemia
  3. Artery disease in the legs, limiting walking capacity and/or blood flow in the legs
  4. Stroke occurring more than 3 months prior to the screening visit
* All subjects must also have albuminuria (protein in the urine) that is confirmed by a urine test at the first study visit.
* All subjects must currently be treated with a class of drugs called ACE inhibitors (e.g., benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) for at least 2 months prior to the study.
* Women of childbearing potential (WOCBP) must be using adequate methods of contraception to avoid pregnancy throughout the study and four weeks after the study ends.

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Acute systemic febrile/infectious disease or infectious or inflammatory disease of the kidneys
* Narrowing of the kidney arteries
* Hypotension (low blood pressure) or very high blood pressure
* Moderate or Severe Heart Failure
* Chronic autoimmune disease
* Cancer unless cured or no further treatment needed
* Severe kidney failure
* Allergy to drugs used in the study: ARBs (candesartan, irbesartan, losartan, telmisartan, valsartan, and/or any other ARB currently or previously in development) and ACE-inhibitors (benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril)
* Administration of any other investigational drug within 30 days of planned enrollment into the study.
* Any circumstances that would prevent coming for study visits or taking study drugs
Clinical Utility of MyProstateScore 2.0 P2

This is an extension of an ongoing study. Preliminary results from the ongoing study indicate that the MyProstateScore 2.0 (MPS 2.0) Test is significantly improving early diagnosis of prostate cancer. This extension will allow us to ask the study participants in the ongoing study to share patient-level data for chart abstraction. The specific purpose of this study is to generate high-quality real-world data on the clinical utility of LynxDx's new MPS 2.0 test.

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. They will also be asked to submit de-identified charts for patients who meet eligibility criteria.

Physicians will keep their randomization from the ongoing study, and intervention physicians will have the opportunity to order a diagnostic test for their patients free of charge.

Eligibility Criteria:
Inclusion Criteria:

* Licensed urologist
* Have practiced as a urologist for greater than 2 but less than 40 years
* Commonly treats patients at risk for prostate cancer
* Practicing in the United States
* English-speaking
* Access to the internet
* Informed and voluntarily consented to be in the study

Exclusion Criteria:

* Non-English speaking
* Not a licensed primary care provider
* Unable to access the internet
* Not practicing in the U.S.
* Do not voluntarily consent to be in the study
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
* Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any drug.
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab).
* Prior therapy for the treatment of HCV.
* Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
* Any cause of liver disease other than chronic HCV infection.
Assessing the Effectiveness of a Health Literacy Intervention in the Workplace

The purpose of this study is to evaluate the effectiveness of a health literacy/motivational intervention in a workplace setting. Parents will be taught how to use a child health book to lessen inappropriate use of physician services and improve parent confidence in their ability to identify and obtain necessary assistance when their children are ill.


Eligibility Criteria:
Inclusion Criteria:

* currently employed at the Children's Mercy Hospitals and Clinics, MO or KS, or working under contract
* parent/legally authorized representative/primary care giver taking care of a child birth to 12 years old

Exclusion Criteria:

* non-English speaking and reading
* under 18 years old unless a minor parent
* a medical or nursing degree (MD, DO, Physician's Assistant, Nurse Practitioner, RN or LPN)
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)

This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.


Eligibility Criteria:
Inclusion Criteria:

- Eligible for DMEK surgey

Exclusion Criteria:

Related to ocular health

* Re-DMEK or prior penetrating keratoplasty
* Ocular hypertension resistant to topical medication
* Previous vitrectomy
* Minimally invasive glaucoma devices
* Aphakia
* Anterior chamber or iris claw lens
* Implantable Collamer Lens (ICL)
* Clinically significant corneal scarring
* Central corneal thickness \>750 µm
* BCVA \< 0.1

Related to general health

* Not able to give informed consent
* Inability to position correctly due to organic or psychological condition.

Related to surgical procedure

* Graft diameter \>9 mm or \< 7mm
* Graft central endothelial cell count \< 2000 cells/mm2
* Graft unfolding duration \>1 hour
* Graft morphology grade 4-5
* Significant graft decentration (graft contour not visible in microscope)
* Significant presence of Descemet remnants in the graft-host interface
* Presence of inward folds
* Graft 'stroma-surface' placed facing away from recipient stroma
ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.


Eligibility Criteria:
Inclusion Criteria:

* Subject has chronic intractable pain of the trunk and/or limbs.
* Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

* Subject is unable to operate the system.
* Subject is an unsuitable surgical candidate.
* Subject has a condition currently requiring or likely to require the use of diathermy.
* Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
* Subject is \<18 years old.
* Subject is pregnant or nursing.
* Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
* Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).
Efficacy of Vitamin A in Fortified Extruded Rice in School Children

The project aims to evaluate the potential impact triple fortified rice grains, mixed into natural rice grains, can have on vitamin A status if fed to school children in Southern Thailand. Within a 60 day intervention study, changes in vitamin A status in young children fed the fortified rice compared to children consuming non-fortified rice will be assessed.

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in developing countries of South and Southeast Asia. Rice is a common staple for a large part of these sub-regions of Asia. In spite of a wide range of rice varieties eaten, rice is eaten by all age groups and is one of the first few foods used as complementary food for infants.

Fe fortification of rice using a method of heat extrusion and micronized ferric pyrophosphate (FePP) as iron fortificant has shown to be efficacious in increasing iron stores and reducing the prevalence of iron deficiency in Indian school children. Subsequent extrusion trials have shown promising results with respect to color and vitamin A (VA) stability when rice grains were triple fortified with Fe, Zn and vitamin A.

Preliminary data in the region of Satun, South Thailand, have shown that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. Since rice is the main staple food in this area, rice triple fortified with Fe, VA and Zn is a promising strategy to combat micronutrient deficiencies in children.

The aim of this study is to demonstrate whether triple fortified rice has an impact on vitamin A status of children. The study will be conducted in school children (8 to 12 years old). The children will be randomized to either receive a daily lunch rice meal prepared from fortified rice (the triple fortified rice grains will be mixed into natural rice at a ratio of 1:50) or from non-fortified rice for 60 days. As serum retinol concentration, the most widely used indicator for the assessment of vitamin A status, is not a very reliable indicator due to homeostatic control and the influence of infection, we will in addition use the tracer methodology using dilution of stable isotopes with which total body vitamin A pool size will be estimated prior to the intervention and after 60 days of the intervention..

Eligibility Criteria:
Inclusion Criteria:

* Children, aged 8-12 years, both sexes, attending the local primary schools
* No known or reported history of significant chronic illness
* Free of acute illness and febrile and gastrointestinal problems

Exclusion Criteria:

* Children with severe vitamin A deficiency with a clinical sign of Bioit's spot or ocular signs of xerophthalmia will be excluded
* Children who have serum retinol \< 0.7 umol/L
Fermented Soy and Heartburn Symptom Relief

Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.

There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset.

Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Usually it is caused by the regurgitation of gastric acid into the esophagus. The prevalence of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.

Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro studies, of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve the heartburn symptom severity.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent in English.
* Willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
* Experience heartburn symptoms at least 2 days a week during the past 3 months.
* Use OTC product(s), supplements, or dietary manipulation to relieve heartburn symptoms in the last 3 months.
* Willing to take the study soy supplement before resorting to OTC product(s) to control heartburn symptoms.
* Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits.
* Willing to provide information about dietary intake; 3-day online 24-hr recalls during baseline, intervention, and washout.
* Willing and able to provide a valid social security for study payment purposes.

Exclusion Criteria:

* Do not meet the above criteria.
* Soy allergy
* Severe heartburn problem (cannot be ignored and often limits your concentration on daily activities) during the last week
* Diagnosed or currently being treated for any gastrointestinal diseases including GERD, gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.
* Self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during the study duration.
* Currently participating in another clinical study.