bioihbjkbjnl/mcl2 huggingface dataset:
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium; placebo; olodaterol; tiotropium; tiotropium; olodaterol
Intervention description: fixed dose combination; fixed dose combination; fixed dose combination; fixed dose combination
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 813.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the efficacy and safety of 12 weeks once daily
      treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)
      compared with tiotropium and placebo in patients with COPD.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis chronic obstructive pulmonary disease

          -  Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal
             and post FEV1/ FVC < 70%

          -  Male or female patients, 40 years of age or more

          -  Smoking history more than 10 pack years

        Exclusion criteria:

          -  Significant diseases other than COPD

          -  History of asthma

          -  COPD exacerbation in previous 3 months

          -  Completion of pulmonary rehabilitation program within previous 6 weeks or current
             participation in pulmonary rehabilitation program.

          -  Pregnant or nursing women

          -  Patients unable to comply with pulmonary medication restrictions
A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Condition: Hereditary Angioedema Types I and II
MeSH terms: Angioedema; Angioedemas, Hereditary; Hereditary Angioedema Types I and II
Intervention: C1-esterase inhibitor
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in
      preventing hereditary angioedema (HAE) attacks when it is administered under the skin of
      subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks.
      The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the
      treatment phase, wherein subjects will be randomized to treatment with either low- or
      medium-volume C1-INH. Subjects who have an insufficient treatment response during the study
      will be given an opportunity to undergo a dose increase. The study aims to enroll eligible
      subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in
      study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the
      United States (US) who complete Treatment Period 2 will be allowed to participate in an
      Extension Period. During the Extension Period participating US subjects will continue to
      receive treatment with open-label CSL830 for up to an additional 88 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 6 years or older.

          -  A confirmed diagnosis of HAE type I or II.

          -  HAE attacks over a consecutive 2-month period that required acute treatment, medical
             attention, or caused significant functional impairment.

          -  For subjects who have used oral therapy for prophylaxis against HAE attacks within 3
             months of first study visit: use of a stable regimen within 3 months of the first
             study visit.

        Exclusion Criteria:

          -  Incurable malignancies.

          -  Any clinical condition that will interfere with the evaluation of C1-INH therapy.

          -  Clinically significant history of poor response to C1-esterase therapy for the
             management of HAE.

          -  Suspected or confirmed diagnosis of acquired HAE or HAE with normal C1-INH.

          -  Inability to have HAE managed pharmacologically with on-demand treatment.
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
Condition: High Risk Stage III Melanoma
MeSH terms: Melanoma
Intervention: ipilimumab; Placebo
Intervention description: IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal; IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
Intervention MeSH terms: Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if ipilimumab is effective in preventing or delaying
      recurrence and prolongs survival after complete resection of high risk stage III melanoma
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Complete and adequate resection of Stage III melanoma with histologically confirmed
             melanoma metastatic to lymph node

          -  Disease-free

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

          -  Randomization within 12 weeks of surgery

        Exclusion Criteria:

          -  Prior therapy for melanoma except surgery

          -  Auto-immune disease
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
Condition: Facial Rhytides; Glabellar Rhytides
MeSH terms: Facies
Intervention: OnabotulinumtoxinA; Normal Saline
Intervention description: OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.; Placebo (normal saline) injected into the protocol-specified areas on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 787.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial
      rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe forehead lines, glabellar lines, and crow's feet lines

          -  Willing to have facial photos taken

        Exclusion Criteria:

          -  Prior exposure to botulinum toxin of any serotype for any indication

          -  Anticipated need for treatment with botulinum toxin of any serotype for any indication
             during the study, other than study treatment

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral
             sclerosis

          -  Any facial resurfacing laser or light treatment, microdermabrasion, or superficial
             peels in the past 3 months

          -  Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or
             permanent facial make-up in the past 6 months

          -  Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past
             year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid
             and/or eyebrow surgery)

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg,
             Gore-Tex®), and/or fat transplantation
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
Condition: Severe Asthma
MeSH terms: Asthma
Intervention: Biological: Experimental: Tezepelumab
Intervention description: Tezepelumab subcutaneous injection every 4 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All subject will be dosed tezepelumab administered subcutaneously
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asthma; Uncontrolled Asthma; Severe Uncontrolled Asthma

Summary:

      This is an open-label, single arm study designed to evaluate the safety of tezepelumab
      administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with
      inadequately controlled severe asthma.
    

Eligibility criteria:

        Inclusion Criteria:

        Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have
        received a physician-prescribed asthma controller medication with medium or high dose ICS
        for at least 12 months.

        Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg
        fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3
        months.

        At least one additional maintenance asthma controller medication is required according to
        standard practice of care and must be documented for at least 3 months.

        Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score
        ≥1.5 at screening or on day of registration.

        Exclusion Criteria:

        Pulmonary disease other than asthma. History of cancer. History of a clinically significant
        infection. Current smokers or subjects with smoking history ≥10 pack-yrs. History of
        chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or
        breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in
        the current study or previous tezepelumab studies
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: No Treatment Added; Milnacipran Added
Intervention description: No added treatment; Milnacipran 100 mg/d added
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: fibromyalgia; milnacipran; pregabalin; treatment; Forest Research Institute

Summary:

      To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another
      drug called pregabalin in people with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR)
             Criteria

          -  tolerate at least 300 mg/day of pregabalin

          -  have an incomplete response to pregabalin treatment

        Exclusion Criteria:

          -  suicidal risk

          -  substance abuse

          -  pulmonary dysfunction

          -  renal impairment

          -  active cardiac disease

          -  liver disease

          -  narrow angle glaucoma

          -  autoimmune disease

          -  cancer

          -  inflammatory bowel disease

          -  unstable endocrine disease

          -  prostatic enlargement
Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: Vacuum Assisted Closure (VAC) and Gauze Suction (GSUC)
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Intervention: GSUC; VAC
Intervention description: Gauze-based wall suction negative pressure wound therapy; Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Wound healing; Negative pressure wound therapy; Skin graft

Summary:

      The purpose of this study is to compare how well two methods (VAC and G-SUC) of securing skin
      grafts using negative pressure wound therapy work. Negative pressure wound therapy is a
      commonly used method of applying suction on wounds to remove fluid from wound and to promote
      healing. The VAC system is widely used and consists of a foam dressing and a portable
      computerized suction pump. The G-SUC method uses commonly available dressing supplies
      attached to vacuum (suction) pump located on the wall above a hospital bed. The investigators
      have frequently used both methods over the past 10 years and have not observed any specific
      negative side effects of either.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients of any sex, hospitalized at the University of Chicago Medical Center,
             requiring split thickness skin autografts with wounds that are amenable to placement
             of an occlusive dressing for negative pressure therapy will be eligible to participate
             in the study

        Exclusion Criteria:

          -  Pregnant women, children under 18 years of age and other patients who are "vulnerable"
             as defined by the Institutional Review Board will not be eligible for the study
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis; Fibrosis
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg tablets administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sofosbuvir; Velpatasvir; SOF/VEL; GS-5816; Hepatitis C; HCV; Cirrhosis; CPT-B

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin
      (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus
      (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA > 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  Confirmed CPT class B (7-9) at screening

        Exclusion Criteria:

          -  Current or prior history of solid organ transplantation, significant pulmonary
             disease, significant cardiac disease, or porphyria

          -  Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of
             baseline/Day 1

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Screening ECG with clinically significant abnormalities

          -  Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B
             (NS5B) inhibitor or any HCV NS5A inhibitor

          -  Laboratory results outside of acceptable ranges at screening
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: desvenlafaxine succinate sustained release tablets
Intervention description: 25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Open-label Long-term extension study

Summary:

      The primary objective of this study is to evaluate the long-term safety of desvenlafaxine
      succinate sustained release tablets during 10-month open-label treatment of Japanese subjects
      with major depressive disorder (MDD).

      The secondary objective is to evaluate the long-term response of subjects receiving
      desvenlafaxine succinate sustained release tablets by clinical global evaluation, general
      well-being and absence of symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who have completed double-blind therapy in short-term study for the
             indication of major depressive disorder (MDD), including scheduled evaluations, with
             no major protocol violations and no study events that, in the opinion of the
             investigator, would preclude the subject's entry into the long-term, open-label study.

        Exclusion Criteria:

          -  Clinically important abnormalities on baseline (day 56 of the short-term study)
             physical examination, or any unresolved clinically significant abnormalities on
             electrocardiogram (ECG), laboratory test results, or vital signs recorded before day
             56 in the previous short-term study for the indication of MDD.
Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine 5 cm^2 transdermal patch; Rivastigmine 10 cm^2 transdermal patch
Intervention description: Rivastigmine 5 cm^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.; Rivastigmine 10 cm^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.
Intervention MeSH terms: Rivastigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 262.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Dementia, Alzheimer's, Rivastigmine, donepezil

Summary:

      This study was designed to evaluate the safety and tolerability of switching from donepezil
      to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable
      Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period
      followed by a 20-week open-label extension period. Patients were randomized to either an
      immediate switch from donepezil to rivastigmine patch formulation or to a switch to
      rivastigmine patch formulation following a 7-day withdrawal period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 50 years of age;

          -  Have a diagnosis of probable Alzheimer's Disease;

          -  Have an MMSE score of > or = 10 and < or = 24;

          -  Must have a caregiver who is able to attend all study visits;

          -  Have received continuous treatment with donepezil for at least 6 months prior to
             screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3
             of these 6 months.

        Exclusion Criteria:

          -  Have an advanced, severe, progressive, or unstable disease of any type that may
             interfere with efficacy and safety assessments or put the patient at special risk;

          -  Have a history of malignancy of any organ system, treated or untreated, within the
             past 5 years;

          -  Have a history within the past year or current diagnosis of cerebrovascular disease;

          -  Have a current diagnosis of severe or unstable cardiovascular disease; Have a history
             of myocardial infarction (MI) in the last six months;

          -  Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary
             (lung) disease);

          -  Digestive problems related to peptic ulcer;

          -  Urinary obstruction or current severe urinary tract infection;

          -  Abnormal thyroid function tests;

          -  Low folate or Vitamin B12;

          -  Have a disability that may prevent the patient from completing all study requirements;

          -  Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion
             of a patch;

        Other protocol-defined inclusion/exclusion criteria may apply
Study Evaluating Pantoprazole in Children With GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: pantoprazole for approximately 9 weeks.
Intervention MeSH terms: Pantoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Gastrointestinal Reflux Disease

Summary:

      The purpose of this study is to characterize the PK profile, safety and tolerability of
      single and multiple doses of pantoprazole in children aged 1 through 11 years with
      endoscopically proven GERD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Endoscopically proven GERD diagnosed within 6 months before study entry.

          -  Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must
             be equal to or under 25 kg

        Exclusion Criteria:

          -  History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption,
             Eosinophilic esophagitis

          -  Subjects 6-11 years old unable to swallow tablets