bioihbjkbjnl/mcl2 huggingface dataset:
Topical Rapamycin to Erase Angiofibromas in TSC
Condition: Angiofibromas; Tuberous Sclerosis
MeSH terms: Tuberous Sclerosis; Angiofibroma; Sclerosis
Intervention: Placebo; Rapamycin; Rapamycin
Intervention description: Study cream is applied nightly to the affected areas on the face.; Study cream is applied nightly to the affected areas on the face. Low Dose; Study cream is applied nightly to the affected areas on the face. High Dose
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Healthy volunteers: No
Keywords: Angiofibroma; Tuberous Sclerosis; Rapamycin; Sirolimus; mTOR

Summary:

      The study is a multi-center prospective, randomized, double-blind, placebo-controlled
      evaluation of the safety and efficacy of a topically applied formulation of rapamycin to
      cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will
      apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to
      their angiofibromas for six months.

      The primary goal of this study is to evaluate the efficacy of the topical medication for
      reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study
      is to confirm the safety of the topical medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be willing and able to comply with all trial requirements.

          -  Subject has a diagnosis of TSC and has visible facial angiofibromas.

          -  Female subjects of child bearing potential must not be pregnant and must agree to use
             appropriate contraceptive methods .

        Exclusion Criteria:

          -  Subject is currently receiving therapy with Rapamycin.

          -  Subject is receiving any form of immunosuppression or has previously experienced
             immune dysfunction.

          -  Subject is currently participating in or has participated within the last 30 days in a
             clinical trial involving an investigational drug.

          -  Subject has a known hypersensitivity to either the vehicle or Rapamycin.

          -  Subject is a pregnant or nursing female.

          -  Subject has other dermatologic conditions that would preclude or prevent adequate
             assessment of changes to their facial angiofibromas.

          -  Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their
             facial angiofibromas within the previous 6 months.
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Novartis Meningococcal (MenACWY-CRM) vaccine
Intervention description: All subjects will have blood draws at Day 1, Day 8, and Day 29.
Intervention MeSH terms: Lactitol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Adolescents; Persistence

Summary:

      The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent
      subjects who completed study V59P6 in which they received either Novartis Meningococcal
      (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The
      study will also enroll age-matched subjects who have never received any other meningococcal
      vaccine (naïve subjects) to serve as an additional control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled
             in the parent study or naïve to meningococcal vaccination.

          -  Female subjects were to be negative for pregnancy

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Receipt of any meningococcal vaccine outside of parent study (V59P6)

          -  Serious, acute, or chronic illnesses including HIV infection/disease and any
             malignancy

          -  receipt of any vaccine 14 days prior to the study, or expected through the duration of
             the study

          -  any condition which in the eyes of the investigator would pose a health risk to the
             subject or render them inappropriate for a research study
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
Condition: End Stage Renal Disease; Chronic Kidney Disease Stage 5; ESRD
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: AZD1722 (in-patient); Placebo (in-patient); AZD1722 (out-patient); Placebo
Intervention description: doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting; Placebo, size and color matched to experimental drug administered in a CPU; doses between 5 and 45 mg BID; Placebo, size and color matched to experimental drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hemodialysis

Summary:

      The purpose of this study is to determine if the study drug is safe, tolerable and active in
      reducing fluid overload/weight gain between dialysis sessions for patients with End Stage
      Renal Disease on Hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 80 years, inclusive;

          -  Body mass index between 18 and 45 kg/m2, inclusive;

          -  Ambulatory (≥ 6 months) maintenance hemodialysis;

          -  Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.

        Exclusion Criteria:

          -  Currently taking diuretic medication;

          -  Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day
             -1 and completed prior to randomization);

          -  Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive
             occasions during the 2-week run-in period;

          -  Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: plain yogurt drink; vitamin D fortified yogurt drink; vitamin D-calcium yogurt drink
Intervention description: daily intake of two bottle of plain yogurt drink; daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL; daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 90.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: vitamin D fortification; yogurt drink; type 2 diabetes; efficacy

Summary:

      The aim of this study is to evaluate the possible effects of daily intake of yogurt drink
      fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic,
      metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:Age:

          -  30 to 50 years,

          -  Fasting blood glucose ≥ 126 mg/dl

        Exclusion Criteria:

          -  Receiving vitamin D or calcium or omega-3 supplements within the last three months,

          -  On any medication which could potentially influence vitamin D metabolism (notably
             estrogens, and calcitonin) within the last three months,

          -  Any other concomitant disease such as renal, hepatic, and other endocrinological
             disorders, and malignancies, which could influence vitamin D metabolism.

          -  Receiving insulin or any change in the type and/or dose of the current hypoglycemic
             medications
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Intervention: Gymnema Sylvestre; Placebo
Intervention description: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner; Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 30 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: Gymnema Sylvestre; Glycemic control

Summary:

      Prediabetes (PD) was defined as an state in which glucose levels are above normal but not
      enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as
      impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c
      (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the
      prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with
      IGT, it is expected that by 2035 this number will increase to 417 million people affected.
      Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:
      increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose
      utilization in various ways and inhibition of glucose uptake in the intestine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI: 25.0-34.99 kg / m2.

          -  Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)

          -  Written informed consent.

          -  body weight stable over the last 3 months.

          -  Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the
             time of laboratory tests.

          -  Women who are not contemplated get pregnant within the next 6 months.

        Exclusion Criteria:

          -  Women pregnant or breastfeeding.

          -  Physical or mental disability that makes it impossible to perform the intervention.

          -  Diagnosis of hypertension or heart failure.

          -  Smokers.

          -  Untreated thyroid disease.

          -  Consumption of oral agents or other medications or supplements with proven properties
             that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin,
             lipid-lowering).

          -  Diagnosis of liver disease or elevation twice of the upper normal value of liver
             enzymes.

          -  Diagnosis of renal disease or creatinine > 1.5 mg / dl.

          -  Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or
             2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.

          -  Total Cholesterol ≥ 280 mg/dL.

          -  Triglycerides ≥ 300 mg/dL.

          -  Known allergy to calcined magnesia or Gymnema sylvestre.
The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study
Condition: Cardiomyopathy; Heart Failure
MeSH terms: Renal Insufficiency; Heart Failure; Cardiomyopathies
Intervention: POMx, pomegranate polyphenol extract; Sugar Pill
Intervention description: 1000 mg orally once daily.; Matching sugar pill
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: The participant will either receive POMx or matching placebo (sugar pill)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Cardiomyopathy; Heart Failure

Summary:

      This blinded, controlled study will examine the impact of pomegranate polyphenol extract
      (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal
      insufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (≥21 years of age) with cardiomyopathy (ejection fraction ≤40%) of at
             least 1 year duration and CRI (GFR <60 cc/hr for at least 3 months) will be eligible
             for enrollment.

          -  Subjects must have New York Heart Association (NYHA) functional class I-III symptoms
             and be on stable doses of HF evidence-based therapies (β-blocker, ACE inhibitor or
             ARBs, aldosterone inhibitor [if appropriate]) for at least 3 months or have a
             documented contraindication or intolerance to such therapy

        Exclusion Criteria:

          -  Subjects admitted to a hospital for acute myocardial infarction (defined as positive
             troponins) or HF exacerbation within the last 6 months will not be eligible for
             enrollment.

          -  Subjects on warfarin or rosuvastatin will also be excluded.

          -  Other exclusion criteria are as follows:

               -  HF that is deemed to be congenital or infiltrative in etiology

               -  the presence of a life-threatening illness with a projected survival ≤6 months;
                  ongoing infection

               -  pregnancy

               -  inability to follow-up

               -  end-stage renal disease requiring dialysis

               -  renal transplant listing

               -  recent (within last 6 months) POMx use or intake >8 ounces daily of pomegranate
                  juice

               -  known hypersensitivity to any fruit in the Punicaceae family

               -  connective tissue or collagen vascular disease
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABI-H2158; Placebo; Entecavir (ETV)
Intervention description: 3 X 100 mg tablets for oral administration; Sugar pill manufactured to mimic the ABI-H2158 tablets; 0.5 mg tablet for oral administration
Intervention MeSH terms: Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HBV; hepatitis B

Summary:

      This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of
      ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in
      participants with chronic hepatitis B virus (HBV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg

          -  HBeAg ≥500 IU/mL at Screening

          -  In good general health except for chronic HBV infection for ≥6 months documented, for
             example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6
             months apart

          -  Lack of cirrhosis or advanced liver disease

        Exclusion Criteria:

          -  Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir,
             standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an
             investigational agent for HBV infection

          -  History or evidence of advanced liver disease or hepatic decompensation (including
             jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices,
             hepatic encephalopathy)

          -  History or presence of clinically significant medical conditions requiring frequent
             medical management or pharmacologic or surgical treatment
Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment
Condition: Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: sirolimus
Intervention description: Given PO
Intervention MeSH terms: Sirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well sirolimus works as secondary
      therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not
      respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response
             to previous treatment and where secondary systemic therapy is indicated because of

               -  Clinical progression of signs and symptoms of chronic GVHD in a previously
                  involved organ, or

               -  Development of signs and symptoms of chronic GVHD in a previously uninvolved
                  organ, or

               -  Absence of improvement after 3 months of primary treatment, or

               -  Continued need for treatment with prednisone at doses >= 1.0 mg/kg/day for more
                  than 2 months, without qualification for type of donor, graft or conditioning
                  regimen

          -  Patient or guardian able and willing to provide informed consent

          -  Stated willingness to use contraception in women of child-bearing potential (Food and
             Drug Administration [FDA] requirement)

          -  Stated willingness of the patient to comply with study procedures and reporting
             requirements

          -  Stated willingness of the physician most involved in management of chronic GVHD (the
             "managing physician,") to comply with study procedures and reporting requirements

        Exclusion Criteria:

          -  Fungal or viral infection with no radiographic evidence of improvement during
             continued appropriate antimicrobial therapy

          -  Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy

          -  Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted
             lesions

          -  Inability to tolerate oral medications

          -  Absolute neutrophil count (ANC) < 1500/uL

          -  Platelet count < 50,000/uL

          -  Persistent or recurrent malignancy, including histopathologic evidence of myeloma or
             lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by
             polymerase chain reaction (PCR) assay as the only evidence of persistent chronic
             myeloid leukemia may be enrolled

          -  Pregnancy

          -  Known history of hypersensitivity to sirolimus
ACTIMMUNE in Intermediate Osteopetrosis
Condition: Osteopetrosis
MeSH terms: Osteopetrosis
Intervention: Interferon gamma-1b
Intervention description: gamma interferon-1b dose escalation over first 4 weeks of study to 100 mcg SC 3 times weekly
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This study evaluates the effects of ACTIMMUNE (IFN-γ1b) in children and adults with
      intermediate osteoporosis. All participants will receive treatment with ACTIMMUNE for 12
      months. The investigators hypothesize that ACTIMMUNE will be tolerated by participants for
      the full 12 months and result in decreased disease severity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of osteopetrosis; and

          -  Anemia (Hemoglobin <12 g/dL) not related to iron deficiency, or

          -  Neutropenia (Neutrophil count <1000 neutrophils/ul unsupported with cytokines), or

          -  Thrombocytopenia (Platelet count <50,000 cells x 109/L), or

          -  History of impaired bone healing, or

          -  ≥ 1 serious infection over prior year defined as requiring hospitalization and/or IV
             antibiotics, and

          -  Age > 1 year; and

          -  Ability to travel to a study center for every 3-6 month study visits; and

          -  Patient or parent/legal guardian is able and willing to provide informed consent. For
             patients 7 to 17 years of age, assent must also be provided.

        Exclusion Criteria:

          -  12 months or fewer following HCT;

          -  Pregnancy or breastfeeding;

          -  Known or suspected allergy to interferon gamma-1b or related products;

          -  Participation in simultaneous therapeutic study that involves an investigational study
             drug or agent within 4 weeks of study enrollment;

          -  ALT greater than 3 fold higher than normal; or

          -  Any other social or medical condition that the Investigator believes would pose a
             significant hazard to the subject if the investigational therapy were initiated or be
             detrimental to the study.
Protocol for Women at Increased Risk of Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: celecoxib; placebo
Intervention description: Celecoxib 400 mg BID; placebo
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breast atypia; double-blind randomized clinical trial; RCT; celecoxib; COX-2 inhibitor; placebo; high risk for breast cancer; breast epithelial hyperplasia; ki-67; chemoprevention

Summary:

      To assess the effects of twelve months of celecoxib administration by evaluating breast
      tissue needle aspirations, to determine if cell growth can be slowed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women who have a high risk of breast cancer

          -  older than 18 years

        Exclusion Criteria:

          -  anticoagulants

          -  marked breast tenderness

          -  pregnant or within twelve months of breast feeding/childbirth