bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Vitamin D in Parkinson's Disease (PD)
Condition: Parkinson Disease; Accidental Falls
MeSH terms: Parkinson Disease
Intervention: Vitamin D3; calcium; Placebo
Intervention description: Vitamin D3 at 10,000 IU a day; 1000mg calcium daily; A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 50 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Vitamin D; Parkinson disease; accidental falls

Summary:

      A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls,
      strength, and cognition in persons with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parkinson's disease;

          -  ability to ambulate 50 feet;

          -  ability to cooperate with balance testing;

          -  vitamin D level less than 40ng/ml;

          -  balance problems;

          -  ability to walk 50 feet without the help of another person

        Exclusion Criteria:

          -  MMSE < 25;

          -  another neurological or orthopedic deficit that in the examiner's opinion would affect
             testing;

          -  history of renal stones or hypercalcemia;

          -  unwillingness to not be on other vitamin D supplementation during the study
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Azithromycin plus chloroquine
Intervention description: dose of 2000 mg Azithromycin plus 600 mg chloroquine base
Intervention MeSH terms: Azithromycin; Chloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females greater then or equal to the age of 18 with uncomplicated,
             symptomatic malaria as indicated by the presence of blood smears positive for P.
             falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever
             greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38
             C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

        Exclusion Criteria:

          -  Subjects with severe or complicated malaria. Pregnant or breast feeding women.
Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma; Glioma
Intervention: Bevacizumab; Metronomic Temozolomide
Intervention description: Bevacizumab administered intravenously 10mg/kg every other week.; Temozolomide 50mg/m2 given orally on a daily basis.
Intervention MeSH terms: Bevacizumab; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glioblastoma Multiforme; Brain and Central Nervous System Tumors; Recurrent Malignant Glioma; Recurrent Glioblastoma Multiforme; Avastin; Bevacizumab; Temodar; Temozolomide

Summary:

      This is a phase II study of the combination of Avastin and metronomic temozolomide in
      recurrent malignant glioma patients. The primary objective will be to determine the efficacy
      of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The
      secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in
      combination with metronomic temozolomide in terms of progression-free survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed diagnosis of WHO grade IV primary
             malignant glioma

          -  Karnofsy Performance Status (KPS) >/= 60%

          -  Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI.

          -  An interval of at least 4 weeks between prior surgical resection or 1 week from a
             biopsy and enrollment on this protocol

          -  An interval of at least 4 weeks from the end of prior radiotherapy or one week from
             the end of a cycle of chemotherapy and enrollment on this protocol.

          -  No evidence of CNS hemorrhage on the baseline MRI or CT scans

        Exclusion Criteria:

          -  Life expectancy < 8 weeks

          -  Pregnancy or breast feeding

          -  Progression to metronomic temozolomide, defined as tumor progression while taking
             daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide

          -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
             diastolic blood pressure > 100 mmHg on antihypertensive medications)
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Condition: Dysmenorrhea
MeSH terms: Pelvic Pain; Dysmenorrhea
Intervention: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; Placebo tablet
Intervention description: 1 tablet daily by mouth; 1 tablet daily by mouth
Intervention MeSH terms: Levonorgestrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: Female
Maximum age: 17 Years
Healthy volunteers: No
Keywords: cyclic pelvic pain; dysmenorrhea; oral contraceptives

Summary:

      This study is being conducted to evaluate the effects of treatment with Seasonique an
      extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the
      typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to
      extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9
      months. Patients will be required to record menstrual pain in a daily diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually naïve and agree to abstain from sex during the study

          -  Moderate to severe menstrual-related pelvic pain

          -  Regular spontaneous menstrual cycles

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  Treatment with an oral contraceptive within the previous 3 months

          -  Previous treatment failure with an extended oral contraceptive regimen
Oral Testosterone for the Treatment of Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: TSX-002
Intervention description: TSX-002 are capsules with testosterone as the active ingredient.
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypogonadism; Gonadal Disorders; Endocrine System Diseases; Testosterone; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Therapeutic Uses; Anabolic Agents

Summary:

      Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.

      The purpose of this study is to evaluate the ability of TSX-002, which is testosterone
      provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within
      the normal range in hypogonadal men. This will be determined by blood sampling at specified
      times during the study. The study is also intended to evaluate the tolerability of TSX-002,
      which will be taken orally twice per day for 15 days. In addition, the study is intended to
      determine a dosing regimen(s) that achieves testosterone levels within the normal range.
      Related Outcome Measures will be reported for Parts 1, 2, and 4.

      A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on
      the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported
      for Part 3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum
             testosterone < 300 ng/dL (based on the average of 2 morning samples taken at least 1
             week apart)

          -  Men over the age of 18 years with a body mass index (BMI) < 39.0 kg/m2 and weighing ≥
             55 kg

          -  Hemoglobin levels at screening and baseline > 12.5 g/dL

          -  Testosterone treatment not contraindicated

          -  No evidence of suspected reversible hypogonadism

          -  Willing to abstain from current treatment for hypogonadism in accordance with approved
             labeling to facilitate an appropriate washout period before study participation (for
             nondepot formulations of testosterone only)

          -  Understands the requirements of the study and voluntarily consents to participate in
             the study

        Exclusion Criteria:

        -
A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Enzastaurin; Placebo
Intervention description: 500 mg po QD for 6 months; po QD for 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Healthy; Prevention

Summary:

      To compare the difference of a marker of cellular proliferation in all bronchial biopsy
      specimens of former smokers stratified by lung cancer risk, collected before and after
      treatment per patient between the enzastaurin and placebo groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sputum atypia participants with normal sputum cytology will be removed from the study)

          -  Metaplasia or dysplasia on at least one bronchoscopy specimen

          -  History of cigarette smoking ≥30 Pack Years

          -  Quit smoking ≥1 year prior to study entry

          -  Able to undergo bronchoscopy and helical computed tomography (CT) scanning of the
             chest

          -  Able to swallow tablets

        Exclusion Criteria:

          -  Blood clotting abnormalities

          -  Current smoking within the past 1 year

          -  Unwillingness to abstain from smoking while enrolled in the clinical trial or
             unwillingness to avoid significant second hand smoke exposure

          -  Evidence for lung cancer or carcinoma in situ

          -  Active cardiovascular disease

          -  Current illicit drug or alcohol abuse
Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms
Condition: Breast Neoplasms
MeSH terms: Neoplasms; Breast Neoplasms
Intervention: Letrozole / Temsirolimus (CCI-779); Letrozole / Temsirolimus (CCI-779); Letrozole
Intervention description: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily; Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks; Letrozole 2.5 mg daily
Intervention MeSH terms: Sirolimus; Letrozole; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast; neoplasms

Summary:

      To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules
      of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole,
      compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer
      in postmenopausal women. All patients must be appropriate to receive endocrine therapy as
      treatment for advanced disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with histologically confirmed, measurable locally advanced
             disease or metastatic breast.

          -  Must be appropriate to receive endocrine therapy as treatment for advanced disease
             (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase
             inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or
             trastuzumab, are permitted).

          -  Women may either present with de novo advanced or metastatic cancer, or have had tumor
             progression while receiving adjuvant tamoxifen or at any time after completing
             adjuvant tamoxifen, or have had tumor progression while receiving first-line
             metastatic therapy with tamoxifen.

        Exclusion Criteria:

          -  Patients having known central nervous system (CNS) metastases.

          -  Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.

          -  Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1
             week prior to day 1 of treatment on study.
Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery
Condition: Coronary Disease; Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations
MeSH terms: Neurologic Manifestations; Cardiovascular Diseases; Heart Diseases; Coronary Disease
Intervention: Magnesium; 0.9% saline
Intervention description: 100 mg/kg; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 389.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the effects of supplemental magnesium on the
      neurocognitive function of individuals undergoing coronary artery bypass graft (CABG)
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Coronary heart disease

        Exclusion Criteria:

          -  Early dementia

          -  History of psychiatric illness
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Fludarabine; Campath; Transplant; Campath; Fludarabine; Campath; Campath
Intervention description: Induction therapy; Induction therapy; Post-induction therapy; Post-induction therapy; Induction therapy; Induction therapy; Post-induction therapy
Intervention MeSH terms: Vidarabine; Fludarabine; Fludarabine phosphate; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Maximum age: 60 Years
Healthy volunteers: No
Keywords: stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in
      different ways. Some block the ability of cancer cells to grow and spread. Others find cancer
      cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell
      transplant using stem cells from the patient or a donor may replace the patient's immune
      cells that were destroyed by chemotherapy.

      PURPOSE: This phase II trial is studying how well giving fludarabine together with
      alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or
      alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic
      leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of chronic lymphocytic leukemia (CLL)

               -  Advanced or progressive disease with ≥ 2 active clinical signs

        PATIENT CHARACTERISTICS:

          -  Fertile patients must use adequate contraception

          -  No positive Coomb's test with signs of hemolysis

          -  No active infection

          -  No uncontrolled severe disease

          -  No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

          -  No other malignancies within the past 2 years except for adequately treated
             malignancies

          -  No significant traumatic injury within the past 4 weeks

          -  No coexisting medical or psychological condition that would limit study compliance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior treatment for CLL

          -  No major surgery within the past 4 weeks

          -  No prior chemotherapy
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
Condition: Metastatic Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Intervention: pembrolizumab; ACP-196 in combination with pembrolizumab
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant
      Metastatic Urothelial Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed
             histology bladder cancer

          -  Metastatic bladder cancer with disease progression on or after platinum-based
             chemotherapy

          -  Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder,
             and ureters

          -  Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma

          -  Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion
             that measures ≥ 10 mm [≥ 15 mm for lymph nodes]

          -  ECOG performance status of 0 or 1

        Exclusion Criteria:

          -  Prior malignancy (other than bladder cancer), except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years of which will not limit survival to < 2
             years.

          -  Known central nervous system metastases and/or carcinomatous meningitis

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening
A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)
Condition: Chronic Cough
MeSH terms: Cough
Intervention: Gefapixant; Placebo
Intervention description: Oral tablets, BID; Oral tablets, BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a randomised, double-blind, placebo-controlled, crossover, single centre study of
      gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic
      cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective
      cough frequency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of cough for more than 8 weeks

          -  Normal chest radiograph

          -  Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no
             objective evidence of an underlying trigger can be determined after investigation or a
             cough that is unresponsive to 8 weeks of targeted treatment for identified underlying
             triggers including reflux disease, asthma and post-nasal drip [treatment-resistant]).

        Exclusion Criteria:

          -  Current smoker

          -  Individuals who have given up smoking within the past 6 months, or those with >20
             pack-year smoking history

          -  Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the
             potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor
             during the study or within 4 weeks prior to Day 0

          -  Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <60%