cyrilzakka/clinical-trials huggingface dataset:
Lactobacillus Johnsonii Supplementation in Adults With T1D

While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed T1D by physician diagnosis
* Have normal values at screening for CBC and complete metabolic profiles (with the exception of fasting glucose and HbA1c).
* Are able to swallow a capsule.
* Are willing to complete weekly online questionnaires.\*
* Are willing to consume a probiotic or placebo capsule daily for 24 weeks.
* Are willing to provide stool samples throughout the study.
* Are willing to provide blood samples throughout the study.
* Are willing to take three 2-hour Mixed-Meal Tolerance Tests (MMTTs).
* Are able to access a computer with Internet throughout the study.\*

  * Note: Going into the study, we want the participants to have daily internet access. However, if this changes once they are in the study, we will provide paper copies of the questionnaires.

Exclusion Criteria:

* Have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.).
* Have chronic disease kidney disease.
* Have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, transplant patient, Lupus, DiGeorge syndrome, selective deficiency of IgA, Bruton's disease etc.).
* Have an underlying structural heart disease.
* Currently live with an immunocompromised person.
* Are currently taking medications for constipation and/or diarrhea.
* Have taken antibiotics within the past 2 weeks prior to randomization.
* Are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start.
* Are a current smoker.
* Are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months.
* Have a known allergy to milk or milk protein.
A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects

The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participant know what treatment the participant is receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard \[control\] treatment or procedure) study. The study consists of 5 periods: a Screening period, Double-blind treatment period, Single-arm treatment period, Extension period and a Follow-up period. Participants will receive either darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) fixed dose combination (D/C/F/TAF FDC) or DRV/COBI FDC along with FTC/TDF FDC. Primarily percentage of participants with human immunodeficiency virus (HIV) -1 Ribonucleic acid (RNA) less than (\<) 50 copies per milliliter (copies/ml) defined by snapshot analysis will be evaluated. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time
* Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to \>=1,000 copies per milliliter (copies/mL)
* Cluster of Differentiation 4+ (CD4+) cell count \>50 cells/microliter (cells/mcL)
* Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC
* Screening eGFRcreatinine \>=70 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Exclusion Criteria:

* Subject has been diagnosed with a new acquired immunodeficiency syndrome (AIDS)-defining condition within the 30 days prior to screening
* Subject has proven or suspected acute hepatitis within 30 days prior to screening
* Subject is hepatitis C or hepatitis B positive
* Subject has a history of cirrhosis
The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors

This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.

sirolimus 1mg will be administered orally qd daily.

To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. PIK3CA amplification and/or PIK3CA mutation Refractory Solid Tumors.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults

Background: To date, there are no published studies on the effects of pecans on vascular function following a high-fat meal.

Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults.

This will be a randomized, controlled trial in men and postmenopausal women (50-75y). Subjects will be randomized into one of the two study groups: a control group (CON) following their usual diet, or intervention group (PECAN) following their usual diet but also consuming 68g/day of pecans as a snack.

There will be 3 visits: A Screening visit and a baseline and post-diet intervention visit (4-weeks). Anthropometrics, questionnaires, a fasting blood sample, and fasting vascular measures will be collected at each visit. Subjects will participate in a saturated fatty acid meal challenge in which additional blood, vascular measurements will be collected.

Hypothesis: Daily pecan consumption will result in improved fasting blood lipids, vascular measures, antioxidant status, and appetite compared to the control group. Additionally, also the PECAN group will result in improved postprandial blood lipids and vascular measures compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women (without menses for 1 yr and follicle stimulating hormone \> 30 IU/mL) between the ages of 50-75y
* Body mass indexes (BMI) between 18-34.9kg/m2

Exclusion Criteria:

* Nut consumption \>2 servings/week or tree nut butter consumption \>3 servings/week
* Pre-menopausal and menopausal women, hormone replacement therapy if less than 2 years
* Regularly exercise more than 3 h/week
* Weight gain or loss more than 5% of their body weight in the past 3 months
* Plans to begin a weight loss/exercise regimen during the trial
* Gastrointestinal surgeries, conditions or disorders
* History of medical or surgical events that could affect swallowing
* Chronic or metabolic diseases
* Previous MI, stroke, or cancer
* Fasting blood glucose levels greater than 126 mg/dL
* Blood pressure greater than 180/120 mmHg
* Medication use affecting digestion and absorption, metabolism
* Lipid-lowering medications
* Medications for diabetes, depression, or ADD/ADHD
* Regular use of medications known to affect endothelial function or blood vessel tone
* Blood pressure medication and steroid/hormone therapies
* Individuals on a medically prescribed or special diet
* Individuals with food allergies to foods specifically in the study
* Excessively use alcohol (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
* Tobacco or nicotine use
* Individuals taking fish oil and omega-3 fatty acid supplements
* Significant head trauma or brain surgery
* A score \>26 on the Beck's Depression Inventory II (BDI-II)
* A score \<24 on the Mini-Mental State Examination (MMSE) will be excluded.
My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

The primary purpose of this study is to investigate how personality, motivation \& auditory lifestyle relate to hearing aid satisfaction \& acceptance for first-time hearing aid users. As such, first-time hearing aid users will be followed via an app for a period of six months. They will answer baseline questionnaires about personality, lifestyle and hearing aid expectations before the first fit. After the hearing aid fitting, they will be prompted by the app to answer questionnaires about their hearing aid experience at weeks 2, 4, 8, 12, 16, 20 and 24.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 years of age
* Sensorineural hearing loss within the hearing aid's fitting range
* Fluency in local language
* First-time hearing aid user
* Experienced smartphone and app user
* Must sign the informed consent

Exclusion Criteria:

* Severe cognitive impairment that would preclude the ability to perform the necessary tasks (as judged by the HCP)
* Inability for the TPs to travel to the clinic during the study period
* Complex hearing disorders such as Ménière's
Correlation of Fecal Calprotectin and Fecal Immunochemical Test in Determination of Endoscopic Activity in Inflammatory Bowel Disease Patients

Inflammatory bowel disease (IBD) patients often experience a long disease course with periods of remission and flare-ups. Currently, in addition to assessing disease stages based on symptoms, colonoscopy performed by specialized physicians is considered the standard for accurately monitoring disease activity. This procedure allows direct visualization of intestinal lesions. However, colonoscopy is complex, costly, carries the risk of complications, and is not suitable for frequent monitoring. This study aims to explore whether stool tests such as calprotectin and immunochemical tests, which are now standard for assessing disease activity in IBD, correlate with colonoscopy results. It also aims to assess the efficacy of these stool tests in determining whether the disease is in remission or active.

The objective of the study is to investigate the correlation and efficacy of stool test results, calprotectin and fecal immunochemical test, compared to colonoscopy in patients with IBD.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Diagnosed with inflammatory bowel disease, either ulcerative colitis or Crohn's disease.
* Scheduled for colonoscopy for various indications, including:

  1. Follow-up after treatment to assess disease remission
  2. Clinical symptoms or laboratory results suggesting disease flare, such as increased abdominal pain, more frequent diarrhea, or elevated inflammatory markers in the blood
  3. Screening for colorectal cancer in patients with long-standing inflammatory bowel disease.

Exclusion Criteria:

* Patients who decline participation in the research project. Incomplete or unsuccessful colonoscopy.
* Failure to provide stool samples.
* Patients hospitalized for reasons unrelated to inflammatory bowel disease.
FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)

In the Netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as Dara-Rd. In many patients this treatment results in suppressing the disease for a long time. The treatment is continued until it is not effective anymore and the disease progresses.

But until now it is unknown whether continuous therapy also leads to prolonging life. In addition, there are concerns about side effects, leading to a reduced quality of life, the development of severe toxicity that remains, which hampers subsequent therapy, and high costs due to prolonged treatment.

There are indications that temporarily stopping treatment is safe, leading to fewer side effects and allows recovering from toxicity or damage due to treatment. This may improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A).
* Age ≥ 18 years.
* Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and will continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed.
* Partial response or better after treatment with 12 cycles of Dara-Rd, without signs of biochemical progression.
* ANC ≥ 1.0x109/L and platelets ≥ 75x109/L.
* Patient is capable of giving informed consent.
* Written informed consent.

Exclusion Criteria:

* Patient with non-secretory MM at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.
* Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.
* Patient in whom urine M-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.
* Patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone).
* Patient in whom continuation of treatment with Dara-Rd is deemed not feasible because of medical reasons.
* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting

To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.


Eligibility Criteria:
Inclusion Criteria:

* CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.
* Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)
* Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.

Exclusion Criteria:

* Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;
* Subjects with acute decompensated heart failure currently on nesiritide therapy;
* Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and
* Subjects unable to or refusing to provide written informed consent.
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction

The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Patients with heart attacks are treated with medicines to reduce the clotting action of platelets. This study is trying to determine whether erythropoietin alters the clotting action of platelets in patients receiving anti-platelet medicines. It is important to understand the effects of erythropoietin on platelets since preliminary studies in animals suggest that erythropoietin may protect the heart from damage during a heart attack.

Anti-apoptotic effects of erythropoietin in experimental myocardial infarction (MI) and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of recombinant human erythropoietin (rHuEpo) in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of rHuEpo (at a dose previously shown not to inhibit the anti-platelet effects of aspirin and clopidogrel in healthy subjects) on platelet function and other safety measures and measure of infarct size in patients with acute coronary syndromes receiving clinically-indicated standard anti-platelet therapy with aspirin, clopidogrel and glycoprotein Iib-IIIa inhibitors.

Specific Aim 1: To determine the effects of intravenous rHuEpo 400 U/kg daily for 3 days vs. placebo on in vivo and in vitro platelet function in patients with acute MI undergoing percutaneous revascularization.

Specific Aim 2: To obtain pilot data to estimate the effects of administration of rHuEpo 400 U/kg daily for 3 days vs. placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute MI undergoing percutaneous revascularization

Eligibility Criteria:
Inclusion Criteria:

* Age 21-75 years
* Clinical evidence of acute myocardial infarction (MI) with total or sub-total occlusion on angiogram
* Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow
* Ongoing clinically-indicated treatment with aspirin, thienopyridines

Exclusion Criteria:

* Hemodynamic instability/shock or severe congestive heart failure
* Time from onset of chest pain to revascularization procedure \> 16 hours
* Use of intravenous thrombolytic agents for treatment of MI
* Known need for additional revascularization procedures
Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention

Liquid medication administration errors are common, and place children at risk for adverse events. Caregivers with low socioeconomic status (SES), low education and poor health literacy skills are at increased risk for errors. In this study, we seek to assess whether at-risk parents who received a plain language, pictogram-based intervention would have reduced medication dosing errors and improved medication adherence.

Evidence suggests that errors by parents and caregivers in administering medications to their children are frequent. These errors, which include inaccurate dosing as well as nonadherence to medication regimens, place children at risk for morbidity and mortality. Misdosing is prevalent, with 50% or more of pediatric caregivers either measuring an incorrect dose or reporting a dose of liquid medication given outside the recommended range. Of further concern are reports of an overall poor adherence rate of 50% for pediatric medications, with implications for treatment failure and drug resistance.

Few studies have examined strategies for decreasing medication administration errors in pediatric patients. Pictograms represent a promising approach in which simple diagrams are used to improve understanding of concepts. Pictorial-enhanced written materials have been shown to improve comprehension and adherence with medical directions, particularly for patients with low literacy.

We developed a pictogram-based intervention to decrease dosing errors and improve adherence. In this study, we sought to assess whether this intervention would reduce medication dosing errors and improve adherence in a pediatric emergency room serving at-risk families.

Eligibility Criteria:
Inclusion Criteria:

* child 30 days through 8 years old
* child prescribed a liquid medication (short course (\<14 days) daily dose medication or as needed (prn) medication)

Exclusion Criteria:

* caregiver accompanying child to visit not primarily responsible for administering medication to the child
* caregiver not fluent in English or Spanish
* child requiring immediate medical attention
* child who typically takes medications in tablet form
* child having a visit involving a psychiatric problem or child protection issue