bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Chronic Kidney Disease-Mineral and Bone Disorder; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clinical Trial, Phase 2; Renal Dialysis; Secondary Hyperparathyroidism; Chronic kidney disease-mineral and bone disorder; Parathyroid hormone

Summary:

      The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly
      intravenous (IV) administration of etelcalcetide in the treatment of secondary
      hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of
      treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject provides written informed consent.

          -  Subject completed the 12 week treatment phase in the parent study study 20120331 (
             KAI-4169-005; NCT01414114).

        Exclusion Criteria:

          -  Subject pregnant or nursing
A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: foretinib (formerly GSK1363089 or XL880)
Intervention description: treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: c-Met; Papillary Renal Cell Carcinoma(PRC); Sporadic papillary renal cell carcinoma,; Clear cell renal carcinoma; Hereditary papillary renal cell carcinoma,

Summary:

      This clinical study is being conducted at multiple sites to determine the best confirmed
      response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell
      carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic
      forms; subjects with either classification will be accepted into this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of PRC with metastatic disease or bilateral
             multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance
             status of </= 2.

          -  Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.

        Exclusion Criteria:

          -  Radiation to >/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior
             anti-cancer therapy, received prior treatment with a c-met inhibitor, brain
             metastases,

          -  Any uncontrolled intercurrent illness,

          -  Pregnant or breastfeeding,

          -  HIV positive
LDE225 for Patients With PTCH1 or SMO Mutated Tumors
Condition: PTCH1 or SMO Activated Solid and Hematologic Tumors
MeSH terms: Neoplasms
Intervention: LDE225
Intervention description: LDE225 800 mg (hard gelatin capsules) will be administered orally once daily on a continuous dosing schedule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumor malignancy,; hematologic malignancy,; mutation, translocations,; signature,; PTCH1,; SMO,; LDE225,; endometrial cancer,; colon cancer,; bladder,; NSCLC

Summary:

      The purpose of this signal seeking study is to determine whether treatment with LDE225
      demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic
      malignancies to warrant further study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has confirmed diagnosis of a select solid tumor (except medulloblastoma, basal
             cell carcinoma and pancreatic adenocarcinoma) or hematological malignancy (except CML,
             ALL and AML).

          -  Patient has pre-identified tumor with a PTCH1 or SMO mutation.

          -  Patient has received at least one prior treatment for recurrent, metastatic and /or
             locally advanced disease and for whom no standard therapy options are anticipated to
             result in a durable remission.

          -  Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate
             hematological guidelines.

          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Patients has received prior treatment with LDE225.

          -  Patients has neuromuscular disorders associated with elevated CK (i.e. inflammatory
             myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular
             atrophy) or are on concomitant treatment with drugs that are recognized to cause
             rhabdomyolysis

          -  Patients has primary CNS tumor or CNS tumor involvement

          -  Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting
             study drug
Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Valsartan; Placebo to aliskiren; Placebo to valsartan
Intervention description: Aliskiren was supplied in 150 mg tablets.; Valsartan was supplied in 160 mg capsules.; Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.; Placebo to valsartan was supplied in capsules matching valsartan 160 mg.
Intervention MeSH terms: Valsartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: hypertension; systolic blood pressure; exercise test; cardiovascular disease; aliskiren; valsartan

Summary:

      This study compared the blunting effect of aliskiren and valsartan monotherapies on
      exercise-induced rises in systolic blood pressure in patients with mild to moderate essential
      hypertension.
    

Eligibility criteria:

        Inclusion criteria:

          -  Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg measured at rest

          -  Patients able to exercise and to reach 85% of their predicted heart rate during a
             standard exercise test on a treadmill according to the Bruce Protocol

        Exclusion criteria:

          -  Patients not confident in exercising or not able to exercise

          -  Absolute contraindication to exercise

          -  Mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood
             pressure ≥ 110 mmHg measured at rest

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
Condition: Elevated Body Mass Index
MeSH terms: Body Weight
Intervention: LIK066; Placebo
Intervention description: LIK066 25 mg tablets; Matching placebo tablets
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus

Summary:

      A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and
      normoglycemic patients with elevated body mass index (BMI)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects with stable health condition as determined by past medical history, physical
             examination, electrocardiogram, and laboratory tests at screening.

          -  Patients with dysglycemia are patients with: Fasting plasma glucose >100mg/dL (5.6
             mmol/L), or HbA1c > 5.7% and < 10% at screening.

          -  Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.

          -  If treated with antidiabetic medications (other than prohibited medications), patients
             must be on a stable dose for 12 weeks prior to randomization and maintain the dose
             until the end of the study.

          -  Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at
             screening, with stable body weight (± 5 kg) within 3 months prior to screening

        Key Exclusion Criteria:

          -  Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or
             other chronic medical condition which is considered serious or unstable, other than
             stable cardiovascular disease, treated hypertension, dyslipidemia or other stable
             chronic disorders

          -  Clinically significant GI disorder related to malabsorption or that may affect drug or
             glucose absorption or history of significant gastrointestinal surgery that could
             affect intestinal glucose absorption

          -  Enrollment in a diet, weight loss or exercise programs with the specific intent of
             losing weight, within 3 months prior to randomization, or clinical diagnosis of any
             eating disorder

          -  Pregnant or nursing (lactating) women, and women of child-bearing potential
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Oral tobacco; Nicotine Gum
Intervention description: Snus; 4 mg Nicotine gum
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: This was an open label trial.
Enrollment: 391.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral Tobacco Products; Snus; Smoking Substitution; Harm Reduction; Biomarkers of Tobacco Exposure

Summary:

      For the primary goals, we hypothesize that 1) the oral tobacco product will be more
      efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2)
      among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette
      smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal
      nicotine use will be observed during and beyond the treatment period.

      For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal
      symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced
      dramatically when smokers switch from cigarettes to each of these products; however, this
      reduction will be greater with the use of medicinal nicotine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking at least 10 cigarettes daily for the past year,

          -  in good physical health (no unstable medical condition;

          -  no contraindications for medicinal nicotine, as appropriate for the study, stable,
             good mental health (e.g., no recent unstable or untreated psychiatric diagnosis,
             including substance abuse, as determined by the DSM-IV criteria).

        Exclusion Criteria:

        Subjects must not be currently using other tobacco or nicotine products; Female subjects
        cannot be pregnant or nursing.
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
Condition: Pain; Nausea; Pruritus
MeSH terms: Pruritus
Intervention: naloxone
Intervention description: continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
Intervention MeSH terms: Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: morphine; naloxone; pediatrics; adverse effects; pain

Summary:

      This is an investigator initiated dose finding study designed to determine the optimal dose
      of naloxone to prevent or minimize the most common side effects induced by opioids, namely
      itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the
      Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute,
      moderate to severe pain, and who are to be treated with intravenous Patient controlled
      analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be
      recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of
      patients will be post operative patients, and will start therapy and the investigational drug
      in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan
      on studying between 10 and 99, male and female patients over a 2 year period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients greater than 6 and less than 18 years of age with acute,
             moderate to severe pain who are to start treatment with IVPCA morphine as inpatients
             of the Children's Center of the Johns Hopkins Hospital

        Exclusion Criteria:

          -  patients who require concomitant benzodiazepine administration

          -  allergic to opioids

          -  have been in an investigational drug trial within 1 month

          -  received opioids with in 7 days of the study

          -  parent with psychiatric illness which impairs their ability to provide consent parent
             who does not speak English
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Condition: Sinusitis; Cystic Fibrosis
MeSH terms: Sinusitis; Cystic Fibrosis; Fibrosis
Intervention: Pulmozyme (dornase alfa); Placebo
Intervention description: 2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device; 2.5 mL of placebo delivered via Sinustar nebulizer device
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Cystic fibrosis; chronic sinusitis; mucolytic

Summary:

      Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to
      determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo)
      in patients with cystic fibrosis who have recently undergone sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical and laboratory diagnosis of cystic fibrosis

          -  Age greater than or equal to 5 years

          -  Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted

          -  Sinus surgery within one week of enrollment

        Exclusion Criteria:

          -  Pregnancy

          -  Intolerance of orally inhaled Pulmozyme (dornase alfa)
Trial of L-DOPA as a Treatment to Improve Vision in Albinism
Condition: Albinism
MeSH terms: Albinism
Intervention: Levodopa; Levodopa; Placebo
Intervention description: Solution taken orally three times a day.; Solution taken orally three times a day.; Solution taken orally three times a day.
Intervention MeSH terms: Levodopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 3 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Levodopa; Albinism; Vision

Summary:

      This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized,
      placebo-controlled, double-masked clinical trial to see if vision can be improved in
      individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these
      individuals may increase melanin pigment production. Increased melanin has previously been
      shown to be associated with improved vision.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 to 60 years with albinism

        Exclusion Criteria:

          -  Glaucoma or at increased risk of glaucoma

          -  History of dystonia

          -  History of melanoma

          -  Planning to undergo eye muscle surgery during study time frame

          -  Undergoing vision therapy

          -  Taking iron supplements or vitamins with iron

          -  Taking medication for ADHD

          -  Known liver or gastrointestinal disease

          -  Previous treatment with levodopa

          -  Psychological problems

          -  Ocular abnormalities other than those associated with albinism

          -  Pregnant, nursing or planning to become pregnant during study

          -  Known allergy to levodopa/carbidopa
S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
Condition: Adult Meningioma
MeSH terms: Meningioma
Intervention: hydroxyurea
Intervention description: 20 mg/kg/day PO
Intervention MeSH terms: Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent adult brain tumor; adult grade I meningioma

Summary:

      RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor
      cells from dividing so they stop growing or die.

      PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with
      unresectable benign meningioma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed unresectable primary, recurrent, or residual benign
             meningioma

          -  Measurable disease by CT scan or MRI

          -  Must have disease progression within the past 10 years OR progressive neurologic
             deficit within the past 6 months

          -  Must have undergone prior radiotherapy with subsequent disease progression OR refused
             radiotherapy

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  SWOG 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC at least 4,000/mm^3

          -  Platelet count at least lower limit of normal

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except adequately treated basal or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior cytotoxic chemotherapy for meningioma

          -  Prior mifepristone allowed

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose
             maintained for at least 72 hours prior to CT scan or MRI

          -  No concurrent antitumor hormonal therapy

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 6 months since prior radiotherapy

          -  No concurrent radiotherapy

        Surgery:

          -  Not specified
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Condition: Migraine; Acute Treatment of Migraine
MeSH terms: Migraine Disorders
Intervention: Rimegepant; Placebo; Sumatriptan
Intervention description: Rimegepant capsules; Rimegepant placebo-matching capsules; Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Intervention MeSH terms: Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1026.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711)
      compared with placebo in the acute treatment of migraine as measured by Pain Freedom
      (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point
      numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an
      optimal dose to support the Phase 3 clinical trials.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patient with at least 1-year history of migraines (with or without aura) including the
             following:

               -  Migraine attacks more than 1 year with age of onset prior to 50 years of age

               -  Migraine attacks, on average, last about 4 - 72 hours if untreated

               -  No more than 8 attacks of moderate to severe intensity per month within last 3
                  months

               -  Patient must be able to distinguish migraine attacks from tension/cluster attacks
                  and must have consistent migraine headaches of at least 2 migraine headaches
                  attacks of moderate to severe intensity in each of the last 3 months

               -  Less than 15 days of headache (migraine or non-migraine) per month in each of 3
                  months prior to screening

          -  Male and female ≥ 18 years and ≤ age 65

          -  No clinically significant abnormality identified on the medical or laboratory
             evaluation

        Key Exclusion Criteria:

          -  Patient has a history of basilar migraine or hemiplegic migraine

          -  Patient does not receive migraine relief from triptan migraine treatment

          -  Medications that may alter the pH of the stomach (acid reducing agents), such as H-2
             antagonists, Proton Pump inhibitors (PPI), antacids

          -  History of ergotamine or triptan intake greater than/equal 10 days per month on a
             regular basis for greater than 3 months

          -  History of non-narcotic analgesic intake on greater then/equal 15 days per month for
             greater than/equal 3 months