bioihbjkbjnl/mcl2 huggingface dataset:
A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Intervention: Gefapixant; Placebo (for gefapixant)
Intervention description: Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate the efficacy of three dose regimens of gefapixant
      ([MK-7264] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough
      frequency. The primary hypothesis for this trial is that at least one dose regimen of
      gefapixant is superior to placebo with respect to the mean change from baseline in awake
      cough frequency (on the log scale).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women and Men between 18 and 80 years of age inclusive

          -  Have refractory chronic cough

          -  Women of child-bearing potential must use 2 forms of acceptable birth control - Have
             provided written informed consent.

          -  Are willing and able to comply with all aspects of the protocol

        Exclusion Criteria:

          -  Current smoker

          -  Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio <60%

          -  History of upper or lower respiratory tract infection or recent significant change in
             pulmonary status within 4 weeks of the Baseline Visit

          -  History of opioid use within 1 week of the Baseline Visit

          -  Body mass index (BMI) <18 kg/m^2 or ≥ 40 kg/m^2

          -  History of concurrent malignancy or recurrence of malignancy within 2 years prior to
             Screening (not including subjects with <3 excised basal cell carcinomas)

          -  Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP)
             >90 mm Hg

          -  Clinically significant abnormal electrocardiogram (ECG) at Screening

          -  Significantly abnormal laboratory tests at Screening

          -  Pregnant or Breastfeeding

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results and, in the judgment of the Investigator or Sponsor, would make the
             participant inappropriate for entry into this trial
Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to comply with the Pediatric Investigation Plan requirements of
      Ipilimumab
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  12 < 18 years of age

          -  Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma

          -  Karnofsky Performance Status (KPS) or Lansky Score ≥ 50

        Exclusion Criteria:

          -  Primary Ocular Melanoma

          -  Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1
             (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists

          -  Symptomatic brain metastases

          -  History of autoimmune diseases
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: conivaptan; Placebo
Intervention description: IV; IV
Intervention MeSH terms: Conivaptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: conivaptan; Liver Cirrhosis; Hypertension, Portal

Summary:

      To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic
      patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic
      response in patients with cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written
             Informed Consent and appropriate privacy language as per national regulations must be
             obtained from the subject or legally authorized representative prior to any
             study-related procedures (including withdrawal of prohibited medication, if
             applicable)

          -  Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis

          -  Subject has clinical evidence of portal hypertension by the presence of esophageal
             varices, ascites or both

        Exclusion Criteria:

          -  Clinical evidence of volume depletion or dehydration

          -  Subject has a history of bleeding from esophageal varices within three months before
             the start of the study
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
Condition: Acromegaly; Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors; Acromegaly
Intervention: octreotide FluidCrystal® injection depot
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acromegaly; neuroendocrine tumour (NET); carcinoid syndrome; octreotide; Sandostatin LAR

Summary:

      This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy,
      and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a
      functional, well-differentiated NET, with carcinoid symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

        Acromegaly:

          -  Male or female patients ≥18 years of age

          -  Acromegaly currently treated with Sandostatin LAR

        NET:

          -  Male or female patients ≥18 years of age

          -  Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid
             syndrome (number of bowel movements and/or flushing)

          -  Currently treated with Sandostatin LAR for symptom control

        Exclusion Criteria:

        Acromegaly:

          -  Inadequate bone marrow function

          -  Abnormal coagulation or chronic treatment with warfarin or coumarin derivates

          -  Impaired liver, cardiac and/or renal function

          -  Known gallbladder, bile duct disease or pancreatitis

          -  Diabetes with poorly controlled blood glucose levels despite adequate therapy

          -  Hypothyroidisms not adequately treated

        NET:

          -  Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
             adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma,
             goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine
             carcinoma and small cell carcinoma

          -  Carcinoid syndrome refractory to treatment with conventional doses of somatostatin
             analogues (SSAs)

          -  Inadequate bone marrow function

          -  Abnormal coagulation or chronic treatment with warfarin or coumarin derivates

          -  Impaired liver, cardiac and/or renal function

          -  Known gallbladder, bile duct disease or pancreatitis

          -  Short-bowel syndrome

          -  Diabetics with poorly controlled blood glucose levels despite adequate therapy

          -  Hypothyroidism, not adequately treated
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenABCWY; Placebo; MenACWY
Intervention description: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.; 0.5 mL saline solution (IM); Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 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: 305.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis ABCWY; Adolescents; Vaccination; Meningococcal disease

Summary:

      Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single
      dose of MenACWY vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescents from 10-18 years of age, generally in good health, and available for all
             study visits, who/whose legally acceptable representative has given written informed
             consent at the time of enrollment.

          -  Female subjects of childbearing potential must have a negative urine pregnancy test.

        Exclusion Criteria:

          -  Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
             meningitidis. Previous immunization with any meningococcal vaccine.

          -  Exposure to individuals with clinically proven meningococcal disease or clinical
             bacterial meningitis without further microbiologic characterization.
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: ACP-196; Nab-paclitaxel; Gemcitabine
Intervention description: ACP-196 capsule; Nab-paclitaxel infusion; Gemcitabine infusion
Intervention MeSH terms: Paclitaxel; Gemcitabine; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acalabrutinib

Summary:

      To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects
      with previously untreated metastatic pancreatic cancer using standard response criteria
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  ECOG performance status of 0 or 1.

          -  Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.

          -  No previous radiotherapy, chemotherapy or investigational therapy for the treatment of
             metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a
             radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months
             have elapsed since completion of the last dose and no lingering toxicities are
             present.

        Exclusion Criteria:

          -  Prior malignancy (other than pancreatic 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 or which will not limit survival to <
             2 years.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction, or gastric restrictions and bariatric surgery,
             such as gastric bypass.

          -  Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with
             endobiliary stents may participate as long the enrollment criterion relating to serum
             bilirubin concentration is met.

          -  Breastfeeding or pregnant
Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF
Condition: Heart Failure; Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: KNO3; KCl
Intervention description: Active Comparator; Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be performed to determine the safety, tolerability, and dose-response to
      inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:

        1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely
           given to subjects with HFpEF.

        2. Determine if there is a dose-response effect of nitrate supplementation on exercise
           capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations
           to exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. NYHA Class II-III symptoms.

          2. LV EF > 50%.

          3. Stable medical therapy for at least 1 month.

          4. Evidence of significant diastolic dysfunction, meeting the European Society of
             Echocardiography criteria for HFpEF.

        Exclusion Criteria

          1. Any rhythm other than sinus with native conduction.

          2. Inability to exercise.

          3. Moderate or greater valvular disease.

          4. Hypertrophic, infiltrative, or inflammatory cardiomyopathy.

          5. Pericardial disease.

          6. Current angina.

          7. Acute coronary syndrome or coronary intervention within the past 2 months.

          8. Primary pulmonary arteriopathy.

          9. Clinically significant lung disease.

         10. Ischemia on stress testing without subsequent revascularization.

         11. Treatment with phosphodiesterase inhibitors that cannot be withheld.

         12. Treatment with organic nitrates or allopurinol.

         13. Significant liver disease impacting synthetic function or volume control.

         14. Poor echocardiographic windows.

         15. eGFR < 30 mL/min/m2 or Cr >2.5.

         16. Current smoking.

         17. Alcohol dependency.

         18. History of Barret's esophagus.

         19. G6PD deficiency

         20. Methemoglobinemia - baseline methemoglobin level >3% prior to any study medication.
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
Condition: Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps
MeSH terms: Asthma; Respiratory Tract Diseases; Respiration Disorders; Nasal Polyps; Asthma, Aspirin-Induced; Polyps
Intervention: Ifetroban; Placebo
Intervention description: 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD; 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
Intervention MeSH terms: Ifetroban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The overall aim of the study is to determine the efficacy of oral ifetroban, a novel
      antagonist of T prostanoid (TP) receptors, as a treatment for patients with
      aspirin-exacerbated respiratory disease (AERD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of AERD, defined as meeting the diagnostic triad with:

               -  History of physician-diagnosed asthma and

               -  History of physician-diagnosed nasal polyposis and

               -  History of pathognomonic reactions aspirin or other nonselective cyclooxygenase
                  (COX) inhibitors.

          2. Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of
             ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no
             hospitalizations or ER visits for asthma for at least the prior 6 months)

          3. Age between 18 and 70 years

          4. No current smoking (not more than one instance of smoking in the last 3 months)

          5. Non-pregnant

        Exclusion Criteria:

          1. Hypersensitivity to montelukast

          2. Current use of zileuton

          3. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs

          4. Current use of any NSAIDs aside from the aspirin provided during the study

          5. Current use of beta blockers

          6. Use of any biologics within the last 4 months prior to initiating the study
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
Condition: Gram-Positive Bacterial Infections
MeSH terms: Bacterial Infections; Bacteremia; Gram-Positive Bacterial Infections
Intervention: Telavancin; Vancomycin, nafcillin, oxacillin, or cloxacillin
Intervention description: Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days; Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.
Intervention MeSH terms: Vancomycin; Cloxacillin; Oxacillin; Telavancin; Nafcillin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety
      administered to patients with bloodstream infections and whether telavancin is effective in
      treating these infections.
    

Eligibility criteria:

        Inclusion Criteria

        - Documented S. aureus bacteremia

        Exclusion Criteria

        - Patients who had received or would have received more than 72 hours of potentially
        effective systemic antistaphylococcal therapy within 7 days prior to randomization. The
        following agents were considered potentially effective antistaphylococcal therapy:
        antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin),
        cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and
        linezolid
Donepezil HCl & Cognitive Deficits in Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder; Cognition Disorders; Cognitive Dysfunction
Intervention: Donepezil HCl; Placebo
Intervention description: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.; Placebo used in placed of Donepezil HCL
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This 11-week study will examine the safety and effectiveness of the medication donepezil
      (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents
      with Autism Spectrum Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autism Spectrum Disorder (ASD)

          -  Asperger's Disorder

          -  IQ of 75 or above

          -  Baseline assessment tests within the acceptable range

        Exclusion Criteria:

          -  Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder

          -  Seizure disorder requiring the use of anticonvulsant medications

          -  Congenital rubella, cytomegalovirus, or tuberous sclerosis

          -  Certain medications prescribed for management of behavior (please contact the
             investigator for a complete list)

          -  Medications/preparations that are known to interact with donepezil HCl

          -  Significant medical illness, endocrinopathies, cardiovascular disease, or severe
             chronic malnutrition

          -  Pregnancy or sexually active females not using a reliable method of contraception
A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
Condition: Diabetes
Intervention: Phentermine/Topiramate; Placebo
Intervention description: phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks; Oral placebo capsules, once daily, 28 weeks
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes; Type 2 Diabetes; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Glycemic Control

Summary:

      The purpose of the study is to determine the long-term safety and efficacy of VI-0521
      (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2
      diabetic adults. Continuation of initial 6 month trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the qualifying OB-202 trial

          -  If females of child-bearing potential, subjects must be using adequate contraception

          -  Provide written informed consent

          -  Be willing and able to comply with scheduled study visits, treatment plan, lab tests
             and other study procedures

        Exclusion Criteria:

          -  Subjects who have developed one or more morbidities during the OB-202 trial that would
             pose a safety concern