cyrilzakka/clinical-trials huggingface dataset:
OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes and cardiovascular events in prospective observation studies. Our primary objective is to compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention will be used as independent controls. Secondary aims are to identify mechanisms of action with regard to body composition, anti-inflammatory and metabolic effects of fibers. We propose a randomized, prospective intervention study. The results will be of general relevance for guidance of fiber intake in the population and will help the food industry to design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased fiber intake may therefore provide a simple non-cognitive prevention strategy effective at the population level.

The overall objective is to investigate whether insoluble fibers added to standard nutrition can reduce the progression of impairment of glucose metabolism in a high risk population with impaired glucose metabolism. Large prospective cohort studies clearly show that mainly insoluble cereal fiber from whole grains is associated with reduced risk of type 2 diabetes and cardiovascular disease. However, there is a lack of evidence from prospective intervention studies targeted to evaluate the potential of dietary fibers to reduce diabetes and cardiovascular disease as recently stated by the Cochrane Foundation. Dietary fiber intake is generally much lower than currently recommended, which may in part be related to side effects of whole grain nutrients and their gustatory properties. Intestinally uncomfortable effects are at least partly related to fermentation which is much less induced by insoluble non-fermentable fibers than by soluble fermentable fibers. The prospective demonstration of beneficial effects of insoluble fibers in preventing diabetes type 2 will allow detailed nutritional recommendations. This may serve to support the consumption of metabolically beneficial constituents of fiber-rich diets and help to increase fiber intake by high fiber natural nutrients or everyday nutrients enriched in insoluble natural fibers.

Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance
* Age\>18years old
* both gender

Exclusion Criteria:

* Diabetes type 1 and type 2
* chronic or malignant disease
* Intake of metabolic influence drugs
* Food allergies, fiber intolerance
BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy

Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon.

This is a proof-of-concept observational study to pilot the use of an FDA approved swallowable esophageal cell-collection device to screen for esophageal cancer in two rural primary care clinics in Oregon. The principal investigator will work with clinic staff to gauge the current use and understanding of SECDs as screening tools for esophageal cancer and to identify 50 patients at each site to approach about SECDs as an option for screening, for a total of 100 patients. If patients provide their consent and are eligible, they will undergo SECD administration for cancer screening in their primary care clinic. The study will evaluate the feasibility of use of this diagnostic tool in rural primary care settings, patient acceptability of screening for esophageal cancer via SECD in their primary care clinics, and where there are positive cases, the efficacy of diagnostic and treatment pathways to transitioning patients to tertiary centers for full diagnostic workup.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Willing and able to comply with the protocol
* Live in a rural area
* Chronic GERD Dx
* 3 or more of the following risk factors: Male, age \>50 years White race Tobacco smoking Obesity Family history of BE or EAC in a first-degree relative

Exclusion Criteria:

-
BioEnergetics and Metabolomics in Cystic Fibrosis

With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate nutrition-related factors, such as diet and body composition, on outcomes in patients with CF. The data generated from this study will be used to inform future nutrition intervention studies in adults with CF and CFRD.

Research methods include blood draws for plasma markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle), and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be obtained from the electronic medical record and the CF Registry.

Eligibility Criteria:
Cystic Fibrosis

Inclusion Criteria:

* have confirmed CF diagnosis with at least one Class I to III CFTR mutations
* age ≥ 18 yrs
* on a clinically-stable medical regimen for 3 wks
* no intravenous or oral antibiotics for at least 3 wks prior to study visit

Exclusion Criteria:

* current pregnancy
* unwilling or unable to discontinue enteral tube feeds for one night before the study visit, if applicable
* most recent FEV1% \<40%
* drug (recreational or prescription) or alcohol abuse
* pacemaker or any electronic implantable device
* unable to give informed consent

Healthy volunteers

Inclusion criteria:

* 18-50 yrs of age
* ambulatory status
* absence of hospitalization in the previous year except for accidents

Exclusion criteria:

* current pregnancy
* current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
* current respiratory disease including asthma, chronic obstructive pulmonary disorder, or emphysema
* current chronic autoimmune or pro-inflammatory disease
* history of tuberculosis, HIV, or other chronic infection
* previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
* advanced (≥ stage 3) renal disease
* body mass index (BMI) ≥ 30 kg/m2
* acute illness (such as a viral infection) within the past 2 weeks
* current use of any prescription medications that would indicate presence of an acute or chronic medical condition that may influence study results
* drug (recreational or prescription) or alcohol abuse
* weight instability (± 10% body weight within the last 6 months) or current participation in weight loss or weight gain program
* inability to provide informed consent.
Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease

Non-invasive diagnosis and treatment of nonalcoholic fatty liver disease (NAFLD) remain unmet medical needs. Aim of this study is to investigate the blood levels of three hormonal systems related to obesity, insulin resistance and inflammation in patients with different stages of NAFLD, in order to identify potential diagnostic markers.

Study aim: To compare the blood levels of: a) proglucagon-derived hormones (glucagon-like peptide \[GLP\]-1, GLP-2, glicentin, oxyntomodulin, glucagon, major proglucagon fragment \[MPGF\]), b) follistatins-activins (follistatin-like (FSTL)3, activin B), c) IGF axis (insulin-like growth factor (IGF)-1, total and intact IGF binding protein (IGFBP)-3 and IGFBP-4, in 18 individuals with early stage NAFLD vs. 14 controls To explore the levels of GDF-15, total and intact, in NAFLD versus obese controls (OC) at baseline and during oral glucose tolerance tests (OGTTs)


Eligibility Criteria:
Inclusion Criteria:

* Individuals with liver ultrasound imaging
* Adults

Exclusion Criteria:

* The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma

* Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform.
* Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure.
* The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation) are three energy delivery techniques.
* The present study would report on the outcome (efficacy and safety) of the slow-coagulation versus the titration method in treatment of refractory glaucoma with dark iris.
* The results would provide reliable evidences to supplement clinical judgment when making a decision in favor of each treatment method for glaucoma patients.

* Several protocols afford delivery of the "optimum" dose of laser energy per session necessary to achieve a long-term effective ocular hypotensive response balancing risks related to a high energy treatment and risks related to retreatment due to suboptimum dose delivery.
* There are two main approaches to delivering laser energy, the pops-titration method and the fixed energy method that are the fixed-high and low-energy (the Gaasterland's slow-coagulation technique).
* Of particular interest is which laser energy delivery method (slow-coagulation versus pops-titration) affords the optimal dose of photocoagulation necessary to achieve an effective long-term intraocular pressure (IOP) reduction while minimizing the risk of adverse events related to overtreatment and retreatments especially in refractory glaucomatous eyes with dark iris color.

Eligibility Criteria:
Inclusion Criteria:

* Refractory glaucoma (Neovascular glaucoma) with
* Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure will probably cause corneal complications
* Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure cause eye pain and need pain relief
* Eyes with minimal useful vision and intraocular pressure over the target intraocular pressure
* Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have a high probability of failure
* Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have previously failed
* Patient refuses to undergo more aggressive intraocular surgery
* Patients whose general medical condition precludes invasive surgery

Exclusion Criteria:

* The visual acuity in the fellow eye is no light perception
* Have previously been treated by the transcleral cyclophotocoagulation
* Allergy to anesthetic medication
* Can not measure the intraocular pressure by the applanation method
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in 446 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
2. Participants must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study.
3. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria:

1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
2. Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
3. Total bilirubin \> 1.5 ULN unless due to Gilbert's syndrome
4. Estimated GFR \< 30 mL/min/1.73 m\^2
Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People

A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

Disseminated infection with Mycobacterium tuberculosis (dMTB) has been documented in 10% to 25% of patients with HIV infection in Africa. Unlike pulmonary tuberculosis (pMTB), most cases of dMTB are not recognized and death ensues rapidly. Therefore, dMTB may be a more important cause of HIV-associated mortality than pMTB in developing countries. Mycobacterium vaccae (MV) is an investigational vaccine prepared by heat inactivation of a nontuberculous mycobacteria. MV immunization may reduce the risk of HIV-associated dMTB. The purpose of this study is to define risk factors for HIV-associated dMTB and to assess the safety and effectiveness of an MV vaccine for the prevention of HIV-associated pulmonary and disseminated tuberculosis.

HIV positive patients with prior BCG immunization and HIV negative controls will be entered in a 5-year study in Tanzania. Participants will be randomized to receive a 5-dose series of MV or placebo over 12 months, with a repeat skin test at Month 14. Baseline evaluation will include medical history, chest x-ray, skin tests with purified protein derivative (PPD), and blood tests to evaluate interferon-gamma production. Participants with PPD reactions greater than or equal to 5 mm will receive 6 months of prophylaxis with isoniazid. Participants will be followed every 3 months for 3 to 5 years to assess new pMTB (microbiologic or clinical diagnosis) or dMTB (microbiologic diagnosis). Potential risk factors for dMTB will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* CD4 count more than 200 cells/mm3
* BCG scar

Exclusion Criteria:

* Active tuberculosis. Patients will be deferred from study enrollment until they show no signs of active disease.
* Serious underlying disease (e.g., congestive heart failure, advanced cancer)
* Life expectancy of less than 2 years
* Pregnancy. Women who are pregnant may be eligible for the study after they give birth.
Evaluation of the Validity of the Prothrombin Time Internation Normalised Ratio (PT/INR) Measured at the point-of Care on the Arterial Bloodline of Haemodialysis Extracorporeal Blood Flow

The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation state (prothrombin time) measured inside the therapeutical zone and thanks to a portable monitor. The values obtained at the point of care will be compared to the standard biological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Haemodialyzed patient whose INR needs to be monitored
* Patient not objecting to participate in the study
Planned Parenthood Teen Council Program Study

This is a randomized controlled trial (RCT) evaluation of the Teen Council program that was tested with high school students (grades 10-12) to assess whether it results in a reduction of teen pregnancy among other outcomes.

Over the course of five years, we expected to have approximately 800 teens (400 program and 400 control) in the study. Teens were randomly selected for the program (Teen Council) and control (no program) conditions.

Teens in both groups were surveyed in the late summer/early fall of their enrollment year and each spring thereafter. Participation in the evaluation by control teens and unenrolled program teens was recognized with a small stipend.

The pre-survey was administered during the summer retreat for incoming Teen Council members. The same survey was administered by Philliber staff for the control youth via online, telephone, or mailed surveys during the late summer/fall. The post-surveys were administered at the end of the school year. Again, the survey was administered by program facilitators for the Teen Council program group. Philliber administered the post survey for the control group providing the same options for completion (online, telephone, or mail).

To facilitate follow-up, complete contact information was collected at baseline. This included the telephone numbers, physical addresses, and email addresses of the student and telephone numbers of their parents/guardians. Also requested was contact information for two relatives or adult friends who would likely know how to contact the teen. Parents were asked on the consent form to provide permission to receive change of school information in the event that their teen transferred to a new school. Philliber reached out to unenrolled Teen Council members and control group teens by telephone, email, text messaging, and/or U.S. Mail for survey administration (via telephone, online, or hard copy).

Eligibility Criteria:
Inclusion Criteria:

Applicants had to be:

1. entering 10th, 11th, or 12th grades;
2. able to attend an annual mandatory overnight retreat;
3. interested in providing accurate sexual health information to peers;
4. able to commit to weekly meetings;
5. able to miss school occasionally for presentations (one day per month);
6. responsible for budgeting their time and keeping up with their academic work.

Exclusion Criteria:

Any interested participant who did not meet all of the inclusion criteria:

1. was not entering 10th, 11th, or 12th grades;
2. was not able to attend an annual mandatory overnight retreat;
3. was not interested in providing accurate sexual health information to peers;
4. was not able to commit to weekly meetings;
5. was not able to miss school occasionally for presentations (one day per month); (6) was not responsible for budgeting their time and keeping up with their academic work.
A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)

This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.


Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health.
* Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.

Exclusion Criteria:

- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma

High-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity.

Consolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high.

This study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.

A retrospective analysis conducted at the study center demonstrated an objective response rate (ORR) of 64.3% among patients with primary central nervous system lymphoma (PCNSL) receiving chemotherapy. This prospective, single-arm clinical study is designed to evaluate the safety, efficacy, and tolerability of a novel treatment regimen-rituximab, methotrexate, and thiotepa (RMT) for induction, followed by etoposide and cytarabine (EA) for consolidation-in patients with newly diagnosed PCNSL.

The study hypothesizes that the RMT-EA regimen will increase the ORR to 84% while maintaining an acceptable safety profile. The goal is to generate additional evidence to support the optimization of frontline therapy for PCNSL, with a focus on improving remission depth, minimizing relapse rates, and extending progression-free survival, particularly in younger patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 60 years, male or female
* Histologically and immunohistochemically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) without prior treatment
* No evidence of systemic lymphatic or hematopoietic involvement or other systemic disease, based on thorough physical examination and imaging/laboratory tests
* Diagnosis meets criteria for Primary Central Nervous System Lymphoma (PCNSL)
* Written informed consent obtained from the patient or their legal guardian
* Voluntary agreement to participate in the study

Exclusion Criteria:

* Presence of another active malignancy
* Known history of HIV infection or diagnosis of acquired immunodeficiency syndrome (AIDS)
* Known allergy to any of the investigational drugs or their excipients
* Any condition that, in the opinion of the investigator, may lead to early study termination, including but not limited to:
* Severe comorbidities
* Significant laboratory abnormalities
* Serious social or family circumstances affecting safety or compliance