bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: LCI699; Eplerenone; LCI699-matching Placebo; Eplerenone-matching Placebo
Intervention description: LCI699 oral capsules; Eplerenone oral capsules; LCI699-matching placebo oral capsules; Eplerenone-matching placebo oral capsules
Intervention MeSH terms: Eplerenone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Blood Pressure; Hypertension; Resistant Hypertension

Summary:

      This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to
      placebo and eplerenone in participants with resistant hypertension.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140
             millimeters of mercury (mmHg) and <180 mmHg

          -  Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the
             treatment of resistant hypertension

          -  Male and female participants 18 to 75 years of age

        Exclusion criteria:

          -  Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebrovascular accident, or transient ischemic attack

          -  Clinically significant electrocardiography (ECG) findings related to cardiac
             conduction defects

          -  Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)

          -  Malignancies within the last 5 years (excluding basal cell skin cancer)

        Other protocol-defined inclusion/exclusion criteria may apply.
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Erlotinib
Intervention description: 150 mg per day by mouth for 12 months
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Healthy volunteers: No
Keywords: Resectable, recurrent head and neck cancer

Summary:

      The purpose of this study is to determine whether erlotinib will be effective in controlling
      cancer that has returned after treatment with salvage surgery and radiation. This study will
      also determine what effects, good and/or bad, this drug has on the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell
             carcinoma

          2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx.
             Recurrent neck metastasis with unknown primary is allowed

          3. Prior radiation therapy for head and neck cancer

          4. Disease must be considered surgically resectable or candidate for curative
             reirradiation

          5. Adequate diagnostic workup

          6. Zubrod Performance Status 0-2

          7. Life expectancy 12 weeks

          8. Age 19, 9. Adequate laboratory data.

        Exclusion Criteria:

          1. Prior invasive cancers other than head and neck cancer unless disease free for a
             minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ
             are permissible)

          2. Patients who are pregnant or lactating

          3. Psychological condition that renders the patient unable to understand the informed
             consent

          4. Any situation or condition that will interfere with adherence to study activities.
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GLPG0634; Placebo
Intervention description: GLPG0634 capsules.; Placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      -  Participants suffering from active rheumatoid arthritis who had an inadequate response
           to methotrexate were evaluated for improvement of disease activity (efficacy) when
           taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg
           once daily) or matching placebo for 24 weeks.

        -  During the course of the study, patients were also examined for any side effects that
           could occur (safety and tolerability), and the amount of GLPG0634 present in the blood
           (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
           action-related parameters in the blood (Pharmacodynamics) were determined. Also, the
           effects of different doses of GLPG0634 administration on participants' disability,
           fatigue and quality of life were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects who are ≥18 years of age on the day of signing informed
             consent,

          -  have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria
             of RA and ACR functional class I-III,

          -  have ≥6 swollen joints (from a 66-joint count) and

             ≥8 tender joints (from a 68-joint count) at Screening and at Baseline,

          -  Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range
             (ULN),

          -  have shown an inadequate response in terms of either lack of efficacy or toxicity to
             MTX,

          -  have agreed to be washed out from MTX for a period of at least 4 weeks before or
             during the Screening period.

        Exclusion Criteria:

          -  current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD),
             with the exception of antimalarials, which must be at a stable dose for at least 12
             weeks prior to Screening,

          -  current or previous RA treatment with a biologic DMARD, with the exception of biologic
             DMARDs: administered in a single clinical study setting, and; more than 6 months prior
             to Screening (12 months for rituximab or other B cell depleting agents), and; where
             the biologic DMARD was effective, and if discontinued, this should not be due to lack
             of efficacy,

          -  previous treatment at any time with a cytotoxic agent, other than MTX, before
             Screening.
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Bromocriptine; Placebo
Intervention MeSH terms: Bromocriptine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 12 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance
      (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and
      glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)
      agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its
      recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an
      exciting development, representing a novel mechanism for improving IR. BCQR has not been
      studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data
      support the proposed study of possible benefits of BCQR on insulin action, glycemic control,
      and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR
      in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This
      is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes
      will include fasting and postprandial glucose, glycemic variability, insulin dosing,
      hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 1 Diabetes (T1D) of >1 year duration based on a clinical course consistent with
             T1D and rapid conversion to insulin requirement after diagnosis.

          2. HbA1c 6.5-10% (adults) or any HbA1c up to 12% (pediatrics)

          3. age 12-60 years of age

        Exclusion Criteria:

          1. Any comorbid condition associated with inflammation, insulin resistance, or
             dyslipidemia including cancer, heart failure, active or end stage liver disease,
             kidney disease (except microalbuminuria), inadequately treated thyroid disease, or
             rheumatologic disease;

          2. Tobacco or marijuana use;

          3. Pregnancy;

          4. Regular or frequent oral steroid use;

          5. Current use of insulin sensitizing medications, neuroleptics, ergot-related
             medications, or triptan medications for migraine,

          6. Diagnosis or history of psychosis,

          7. Diabetes of other cause such as Maturity Onset Diabetes of the Young or cystic
             fibrosis-related diabetes.
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
Condition: Heart Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure
Intervention: CLP; Placebo
Intervention description: Oral administration; Oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of CLP on serum potassium and signs and
      symptoms of fluid overload in heart failure patients with chronic kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart failure with New York Heart Association (NYHA) Classification III or IV

          -  Hospitalization for heart failure decompensation associated with fluid overload within
             the last six months

          -  Chronic kidney disease

          -  Must be able to understand study procedures and willing and able to provide written
             informed consent

        Exclusion Criteria:

          -  No hospitalization within 4 weeks of Baseline Visit

          -  In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine,
             gastrointestinal, neurological or other disease or condition that makes the patients
             study participation unsafe

          -  History or presence of gastrointestinal conditions such as severe constipation or
             gastrointestinal tract strictures

          -  Current dialysis patient, or anticipated need for dialysis during study participation
Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Intervention: pemetrexed; gemcitabine; carboplatin; Pemetrexed
Intervention description: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression; 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression; area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression; 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Intervention MeSH terms: Carboplatin; Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to help answer:

        -  Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s)
           disappear in patients with relapsed lung cancer (lung cancer that has come back after
           surgical removal and chemotherapy), and to determine how long this will last

        -  Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung
           cancer live longer
    

Eligibility criteria:

        Inclusion Criteria:

          -  You have non-small cell lung cancer that has come back (relapsed) after initial
             treatment with surgery and chemotherapy.

          -  You have good kidney, liver, and bone marrow organ function.

          -  You are fully active or able to carry out light work such as housework or office work.

        Exclusion Criteria:

          -  You have received pemetrexed or gemcitabine in the past for lung cancer

          -  You are currently receiving another treatment for your relapsed lung cancer, or have
             had chemotherapy or certain other therapies for relapsed lung cancer in the past

          -  You are unable to take corticosteroid drugs like dexamethasone

          -  You are unable or unwilling to take the folic acid pills or Vitamin B12 injections
             that are required for the study

          -  You are unable to stop taking aspirin or other drugs that control inflammation for
             certain periods of time during the study

          -  You have had a heart attack in the last 6 months, or have other heart problems that
             are not controlled with medication
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Condition: Pain; Urinary Stone; Urinary Calculi
MeSH terms: Urinary Calculi; Urolithiasis; Calculi
Intervention: Ketorolac; normal saline
Intervention description: IM injection of either normal saline or Ketorolac; normal saline
Intervention MeSH terms: Ketorolac
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: stent removal, pain, kidney stones

Summary:

      This is a prospective randomized double-blind controlled trial assessing the benefits of
      intramuscular ketorolac before or immediately after office ureteral stent removal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral
             stent placement at Clements University Hospital and are presenting to the office for
             cystoscopy and stent removal.

        Exclusion Criteria:

          -  eGFR <50

          -  any active or history of peptic ulcer disease or GI bleeding

          -  Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic
             diathesis, or incomplete hemostasis

          -  Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or
             heparin

          -  Allergic reaction to NSAIDs

          -  Concurrent use of other NSAIDs within 24 hours

          -  Pregnancy (ketorolac contraindicated in this population)

          -  Recent myocardial infarction (MI)
Women's Isoflavone Soy Health (WISH) Trial
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: 25 gm soy protein supplement; Placebo
Intervention description: 25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm); Milk protein administered twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: Female
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Atherosclerosis; Cardiovascular Diseases; Carotid artery intima-media thickness (CIMT); Cognition; Complementary and alternative medicine; Daidzein; Genistein; Glycitein; Intervention; Isoflavones; Menopause; Prevention; Postmenopausal; Randomized controlled study; Soy; Soy Protein; Subclinical Vascular Disease; Ultrasonography; Women

Summary:

      The purpose of this study is to determine whether soy supplementation can reduce hardening of
      the arteries and cognitive decline in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol
             level lower than 20 pg/ml

        Exclusion Criteria:

          -  Signs, symptoms or personal history of cardiovascular disease

          -  Diabetes mellitus or fasting serum glucose of 126 mg/dL or greater

          -  Fasting plasma triglyceride of 500 mg/dL or greater

          -  Serum creatinine greater than 2.0 mg/dL

          -  Uncontrolled hypertension

          -  Untreated thyroid disease

          -  Life expectancy less than 5 years

          -  Current use of hormone replacement therapy (HRT)

          -  Soy, nut, or related food allergies

          -  More than 5 alcohol drinks per day or substance abuse
An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation
Condition: Functional Gastrointestinal Disorders; Constipation
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Constipation
Intervention: MaZiRenWan (MZRW); Placebo
Intervention description: MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily; Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Functional Constipation; Chinese Herbal Medicine; MaZiRenWan; Hemp Seed Pill; Traditional Chinese Medicine; Herbal Medicine

Summary:

      Functional constipation (FC) is a common complaint in clinical practice, but treatment for
      this condition in conventional medicine is suboptimal. Complementary and alternative
      medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however,
      there is little research evidence about these commonly used CHM. The purpose of the study is
      evaluate the efficacy and safety of an ancient CHM formula, MaZiRenWan (MZRW), by comparing
      with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet of Rome III diagnostic criteria of functional constipation

          -  Meet the diagnosis of Excessive Constipation according to the TCM theory

          -  Age of 18 to 65 years (inclusive)

          -  Complete spontaneous bowel movement (CSBM)≦2times/wk

          -  Severity of constipation≧4pts (7 pts scale from 0 to 6pts) and the overall scoring of
             constipation-related symptoms≧8pts (6items in 7pts scale) for self symptom assessment
             in the run-in period

          -  Normal colonic evaluation (colonoscopy or barium enema) within 5 years

          -  Normal liver and renal function in blood test within 3 months

        Exclusion Criteria:

          -  Drug-induced constipation

          -  Secondary causes of constipation (i.e. medical history of diabetes mellitus and
             thyroid disease)

          -  Abdominal surgery (i.e. Caesarean operation)

          -  Severe disease (i.e. cancer and acute present asthma)

          -  Allergy to CHM (i.e. G6PD deficiency)

          -  Pregnancy or breast-feeding

          -  Psychiatric or addictive disorders
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: Cisplatin; Doxorubicin; Methotrexate
Intervention description: Cisplatin 120 mg/m^2; 75mg/m^2; Methotrexate 12g/m^2
Intervention MeSH terms: Doxorubicin; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Healthy volunteers: No
Keywords: Cisplatin; Doxorubicin; Methotrexate; Osteosarcoma; 03-074

Summary:

      This study is designed to test the safety and feasibility of the simultaneous administration
      of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient
             who have undergone a definitive surgical resection as their primary surgery are still
             eligible for participation in this study.

          -  No prior chemotherapy or radiation therapy

          -  Adequate renal function: creatinine < or = to 1.5 upper limit of normal

          -  Adequate liver function as defined by bilirubin < or = to 1.5 X upper limit of normal
             and AST < or = to 3 X upper limit of normal institutional range Adequate hematopoietic
             function as defined by platelet count > or = to 100,000/ram3 an absolute neutrophil
             count > or = to 1,000/mm3.

          -  Adequate cardiac function as defined by shortening fraction > or = to 28% by
             echocardiogram OR ejection fraction > or = to 50% by radionuclide angiogram

          -  Performance status < or = to 2

        Exclusion Criteria:

          -  Prior history of cancer

          -  Prior treatment for cancer

          -  Prior history of Paget's disease

          -  Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic
             cardiac conduction abnormalities

          -  Pregnancy or breast feeding