bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Condition: Benign Paroxysmal Positional Vertigo
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Intervention: Gufoni; Vibration; Sham
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation
      in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal
      semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          1. history of vertigo associated with changes in head position

          2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic
             nystagmus) in both turning positions detected with Frenzel glasses or videoculography
             in the Head turning test

          3. vertigo associated with the elicited nystagmus

          4. symptom within 2 weeks

          5. put one's signature on consent

        Exclusion Criteria:

          1. patients with identifiable central nervous system disorders that could explain the
             positional vertigo and nystagmus

          2. the patients with apogeotropic form which was transited from geotropic after previous
             therapeutic maneuvers

          3. the patients who transited from apogeotropic from vertical canal BPPV during study

          4. patients who had possible cause of secondary BPPV such as Meniere's disease, migraine
             or recent trauma history

          5. patients whose affected ear cannot be identified

          6. patients with multiple canal atypical positional nystagmus or who were treated
             previously with repositioning maneuvers were excluded.

          7. patients with cervical or lumbar spine problem
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: Androgen Deprivation Therapy; bicalutamide; bevacizumab
Intervention description: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months; 50mg orally daily for 6 months; 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
Intervention MeSH terms: Bevacizumab; Bicalutamide; Androgens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Androgen deprivation therapy; ADT; bevacizumab

Summary:

      The purpose of this research study is to assess the efficacy of antiangiogenic therapy
      (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of
      minimal systemic disease (based on rising PSA without metastases).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of biopsy documented prostate cancer (any Gleason score)

          -  Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or
             primary radiation (external beam or brachytherapy)

          -  If past prostatectomy, pathologic stage no greater than T1-3, N1, M0

          -  PSA recurrence with PSAdt < 18 months. There is no minimum PSA for prostatectomy
             patients. For patients treated with primary radiation therapy PSA should be greater
             than 2.0 ng/ml

          -  No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR

          -  Prior ADT allowed if < 6 months and testosterone recovered to within 50 units (ng/dl)
             of normal range

          -  ECOG Performance status of 0-1

          -  Absolute neutrophil count of >1,500

          -  Platelet count > 100,000

          -  Hg > 8g/dl

          -  No history of bleeding or thromboses within the last 12 months that required medical
             intervention

        Exclusion Criteria:

          -  History of cancer within 5 years, other than prostate cancer and non-melanoma skin
             cancer

          -  Medical condition requiring concomitant corticosteroids

          -  Active infection

          -  Prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry

          -  Documented local recurrence or metastatic prostate cancer

          -  Inability to comply with study and/or follow-up procedures

          -  Life expectancy of less than 2 years

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored
             bevacizumab cancer study
Saracatinib and Alcohol Drinking
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: Saracatinib; Placebos
Intervention description: Saracatinib 125 mg once per day for 8 days; Placebo once per day for 8 days
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effects of the study medication,
      saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory
      setting in which participants are given an initial drink of alcohol followed by the choice to
      drink up to 12 more drinks over a three-hour period. The investigators hypothesize that
      saracatinib will reduce craving and number of drinks consumed prior to and after exposure to
      the initial drink of alcohol and during the three hour drinking period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-50

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of saracatinib

          -  Regular use of other substances
Vitamin D in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: cholecalciferol
Intervention description: Given orally
Intervention MeSH terms: Cholecalciferol; Vitamin D
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

      PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D
      works in treating patients with prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  25(OH) D3 level < 80 ng/mL

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status 0-2

          -  Creatinine ≤ 2.0 mg/dL

          -  Corrected serum calcium ≤ 10.5 mg/dL

        Exclusion criteria:

          -  History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or
             tropical sprue)

          -  Hypersensitivity to cholecalciferol or one of its components

        PRIOR CONCURRENT THERAPY:

          -  No other concurrent vitamin D supplementation
Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: pemetrexed; carboplatin; radiotherapy
Intervention description: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles; Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles; 2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed +
      carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell
      lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer

          -  Measurable disease

          -  Good performance status

          -  Adequate bone marrow reserve, hepatic, pulmonary and renal functions

        Exclusion Criteria:

          -  Serious concomitant systemic disorder

          -  Prior chemotherapy for this cancer and/or prior thoracic radiotherapy

          -  Pregnancy/breast-feeding

          -  Significant weight loss over the previous 6 weeks before study entry

          -  Inability or unwillingness to take vitamin supplementation and corticosteroids
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
Condition: Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Gemcitabine; Lurbinectedin (PM01183)
Intervention description: Powder for solution for infusion; Powder for solution for infusion; Powder for concentrate for solution for infusion
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in
      comparison to docetaxel for the treatment of unresectable non-small cell lung cancer
      (NSCLC)patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed unresectable NSCLC

          -  Patients must have failed one prior line of CT-based therapy for unresectable disease

          -  Age between 18 and 75 years

          -  Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1

          -  Adequate hematological, renal, metabolic and hepatic function

          -  At least three weeks since the last prior therapy, at least four weeks since
             completion of any prior radiotherapy

          -  Negative pregnancy test for pre-menopausal women

        Exclusion Criteria:

          -  Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic
             congestive heart failure or asymptomatic with left ventricular ejection fraction
             (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active
             hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled
             infection, pleural or pericardial effusions, myopathy, limitation of the patient's
             ability to comply with the treatment or to follow-up the protocol, any other major
             illness

          -  Histological features of neuroendocrine or bronchioalveolar differentiation.

          -  Unknown epidermal growth factor receptor (EGFR)mutation status or previously known
             EGFR mutated status in patients with adenocarcinoma.

          -  Prior or concurrent invasive malignant disease, unless in complete remission for more
             than three years.

          -  Significant cancer-related weight loss (≥10%)within four weeks prior to treatment
             start

          -  Prior treatment with docetaxel-containing therapy

          -  Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement

          -  Paraneoplastic syndromes
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Cyclophosphamide; Fludarabine; Mitoxantrone; Rituximab
Intervention description: as prescribed, 6 cycles; as prescribed, 6 cycles; as prescribed, 6 cycles; 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label study will assess the efficacy and safety of MabThera
      (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell
      Lymphoma not eligible for autologous stem cell transplantation. Participants will receive
      MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to
      standard chemotherapy for 6 cycles. In participants experiencing complete or partial
      response, MabThera will be continued as consolidation therapy for 2 more cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult participants, >/=18 years of age

          -  untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation

          -  known mantle cell lymphoma international prognostic index (MIPI) at diagnosis

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  adequate hematological, renal and hepatic function

        Exclusion Criteria:

          -  known hypersensitivity to murine proteins or chemotherapy regimen

          -  previous first-line therapy

          -  history of other malignancy within the last 5 years, except for squamous cell
             carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma

          -  active infection

          -  clinically significant cardiac disease

          -  regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06700841; Vehicle (Placebo)
Intervention description: PF-06700841 topical cream; Vehicle topical cream
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: psoriasis; topical

Summary:

      This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter
      study in participants with mild to moderate plaque psoriasis. The duration of study
      participation will be approximately 22 weeks, including up to a 6 week screening period, 12
      week treatment period, and approximately 4 week follow up period. Approximately 280
      participants are planned to be randomized into the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  plaque psoriasis for 6 months

          -  PGA score mild or moderate

          -  body surface area (BSA) 2-15%

        Exclusion Criteria:

          -  other skin conditions that would interfere with the evaluation of psoriasis

          -  history of herpes zoster or simplex

          -  Infected with Mycobacterium tuberculosis
Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma
Condition: Esophageal Neoplasms; Stomach Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Adenocarcinoma; Neoplasm Metastasis; Stomach Neoplasms; Esophageal Neoplasms
Intervention: capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin)
Intervention description: Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic esophagogastric adenocarcinomas; ESOPHAGEAL CANCER; GASTRIC CANCER; ADENOCARCINOMA; TARGTED THERAPY; BEVACIZUMAB; CAPECITBAINE; OXALIPLATIN; METASTATIC

Summary:

      The purpose of this study is to evaluate the progression free survival of capecitabine
      (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic
      esophagogastric adenocarcinomas.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Histologically or cytologically documented and radiographically measurable
             adenocarcinoma of the esophagus or stomach that is metastatic/recurrent and not
             amenable to potentially curative treatment

          -  No prior therapy for metastatic disease

          -  Prior radiation therapy is permitted, provided it is completed > 28 days prior to day
             1 of study drug

          -  Normal organ and marrow function

          -  Karnofsky Performance Status 70-100%

        Primary Exclusion Criteria:

          -  Unstable or poorly controlled hypertension > 150/100 mm Hg

          -  Arterial thromboembolic events within 6 months

          -  Clinically significant uncontrolled cardiac disease

          -  Significant proteinuria at baseline

          -  Grade 2 or greater peripheral neuropathy

          -  History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6
             months
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: EFX; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind,
      placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4
      NASH.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive,
             based on the date of the screening visit.

          -  Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has
             biopsy-proven NASH documented within the last 2 years).

          -  Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic
             resonance imaging- proton density fat fraction (MRI-PDFF) at screening.

          -  Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of
             randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease
             (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the
             following NAS components:

               -  Steatosis (scored 0 to 3),

               -  Ballooning degeneration (scored 0 to 2), and

               -  Lobular inflammation (scored 0 to 3)

          -  Cohort C only: FibroScan® measurement > 13.1 kPa.

          -  Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis
             according to the NAS system, confirmed by the central or local reader.

        Exclusion Criteria:

          -  Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6
             months prior to screening.

          -  Type 1 and insulin-dependent Type 2 diabetes.

          -  Poorly controlled hypertension (blood pressure > 160/100).
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
Condition: Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Zimura; Lucentis
Intervention description: Zimura in combination with Lucentis; Zimura in combination with Lucentis
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Zimura; ARC1905; Lucentis; ranibizumab; Wet AMD; avacincaptad pegol; complement factor C5 inhibitor

Summary:

      To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in
      combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related
      macular degeneration (NVAMD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active subfoveal NVAMD

        Exclusion Criteria:

          -  History or evidence of severe cardiac disease

          -  Any major surgical procedure within one month of trial entry

          -  Subjects with a clinically significant laboratory value

          -  Any treatment with an investigational agent in the past 60 days for any condition

          -  Women who are pregnant or nursing

          -  Known serious allergies to the fluorescein dye used in angiography, povidone iodine,
             to the components of the ranibizumab formulation, or to the components of the Zimura
             formulation

          -  Any prior treatment for AMD other than oral supplements of vitamins and minerals