bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine transdermal patch; Placebo
Intervention description: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.; Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 529.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic pain; opioid; transdermal; osteoarthritis

Summary:

      The objective of this study is to demonstrate the effectiveness and tolerability of the
      buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal
      system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently
      treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during
      which time supplemental analgesic medication (acetaminophen) will be provided to all subjects
      in addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.

          -  an average pain due to osteoarthritis of moderate, moderately-severe, or severe for
             the 14 days prior to enrollment.

        Exclusion Criteria:

          -  ingest opioid analgesics on a daily basis.

          -  ingest >2500 milligrams (mg) acetaminophen on a daily basis.

          -  require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of
             their osteoarthritis pain.

        Other protocol-specific exclusion/inclusion criteria may apply.
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Ipilimumab; Cetuximab/Erbitux; Cisplatin/Platinol; Carboplatin/Paraplatin; Fluorouracil/Adrucil
Intervention MeSH terms: Cisplatin; Carboplatin; Fluorouracil; Nivolumab; Cetuximab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 947.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare nivolumab and ipilimumab with the extreme
      regimen as first line treatment in patients with recurrent or metastatic squamous cell of the
      head and neck cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head
             and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to
             curative therapy.

          -  No prior systemic cancer therapy for recurrent or metastatic disease (except if
             chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).

          -  Measurable disease detected by imaging exam (CT or MRI).

          -  Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have
             results from testing of HPV p16 status.

        Exclusion Criteria:

          -  Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of
             unknown primary, squamous cell carcinoma originating from skin and salivary glands or
             non squamous histologies (eg. mucosal melanoma).

          -  No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other
             antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab
             or EGFR inhibitors in any treatment setting.

          -  Participants with certain diseases such as active autoimmune disease, type I diabetes,
             hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.

          -  Inadequate hematologic, renal or hepatic function.

        Other protocol defined inclusion/exclusion criteria could apply
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Intervention: Ospemifene 30 mg; Ospemifene 60 mg; Placebo; Nonhormonal vaginal lubricant
Intervention description: 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).; 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).; 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).; Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Intervention MeSH terms: Tamoxifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 826.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Urogenital atrophy; Vaginal atrophy; Vulvar and vaginal atrophy in postmenopausal women; Menopausal symptoms

Summary:

      The purpose of this study is to determine whether ospemifene is more effective than placebo
      in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naturally or surgically postmenopausal

          -  Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or
             itching, difficult or painful urination, pain or bleeding with intercourse)

          -  Vaginal pH greater than 5.0

          -  5% or fewer superficial cells in maturation index of vaginal smear

        Exclusion Criteria:

          -  Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial
             pathology

          -  Abnormal Pap smear

          -  Uterine bleeding of unknown origin or uterine polyps

          -  Current vaginal infection requiring medication
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Condition: Schizophrenia; Bipolar I Disorder
MeSH terms: Schizophrenia
Intervention: quetiapine fumarate
Intervention description: Oral dosing, flexible dosing
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 381.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia; Bipolar I Disorder

Summary:

      The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate
      (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is able to provide written assent and the parents or legal guardian of the
             patient are/is able to provide written informed consent before beginning any study
             related procedures

          -  Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112

          -  Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder

          -  Patient's parent or legal guardian will be able to accompany the patient to each
             scheduled study visit

        Exclusion Criteria:

          -  Patients (female) must not be pregnant or lactating

          -  Patients with a known intolerance or lack of response to previous treatment with
             quetiapine

          -  Patients who have previously participated in this study
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
Condition: Trichomonas Infection
MeSH terms: Trichomonas Infections
Intervention: Secnidazole; Placebo
Intervention description: Oral Granules containing secnidazole; Oral Granules of placebo manufactured to mimic secnidazole
Intervention MeSH terms: Secnidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vaginal Itching; Vaginal Discharge

Summary:

      This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed
      treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral
      dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult female or post-menarche adolescent girl ≥12 years of age in general good health

          -  Have a diagnosis of trichomoniasis at the screening visit as determined by one of the
             following:

               -  positive T. vaginalis NAAT test within 30 days of screening for which treatment
                  has not been initiated.

               -  positive OSOM® rapid test.

               -  positive wet mount assessment.

          -  Agree to abstain from vaginal intercourse until the final study visit

          -  Agree not to have any vaginal penetration or use of any vaginal products for the
             duration of the study

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study.

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea,
             or an active genital herpes outbreak

          -  Are suspected clinically of having an acute urinary tract infection.

          -  Have active genital lesions, including primary syphilitic chancres and herpes simplex
             virus lesions, or other vaginal or vulvar conditions which could confound the
             interpretation of the clinical response, as determined by the Investigator (patients
             with genital warts may be enrolled).

          -  Have received systemic antibacterial therapy or topical antimicrobial/antifungal/
             immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft
             tissue), within 14 days prior to the Baseline Visit (Day 1).
Open Label Extension in Adults With Binge Eating Disorder (BED)
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: Lisdexamfetamine dimesylate
Intervention description: 50 or 70 mg administered orally, once a day for 52 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or
      70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
    

Eligibility criteria:

        Inclusion criteria:

          1. Completion of an antecedent SPD489 BED Double-blind Study

          2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders
             Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED

          3. Subject has a body mass index (BMI) of > or =18 and < or =45

        Exclusion criteria:

          1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.

          2. Subject is considered a suicide risk or risk to harm others
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Condition: Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51 Japanese Encephalitis; Havrix®720; Prevnar
Intervention description: 6 mcg or 3 mcg im. at day 0 and day 28; 0.5 ml im. at day 0 and month 7; 0.5 ml im. at day 0 and day 56 and month 7
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1869.0
Sex: All
Minimum age: 2 Months
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatric; Japanese Encephalitis Vaccine; endemic countries; to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51

Summary:

      The primary objective is to assess the systemic and local safety profile of purified
      inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28
      days interval up to Month 7 after the first IC51 vaccination in a pediatric population from
      endemic regions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female healthy children and adolescents aged > 2 months to < 18 years at the
             time of first vaccination.

          -  Written informed consent by the subject's legal representative(s), according to local
             requirements, and written informed assent of the subject, if applicable.

          -  Female subjects: either no childbearing potential or negative pregnancy test, for
             females after menarche willingness to practice a reliable method of contraception.

        Exclusion Criteria:

          -  Clinical manifestation of Japanese Encephalitis

          -  History of Flavivirus vaccination (including any investigational vaccines)

          -  History of vaccination with HAVRIX®720 and/or Prevnar®

          -  History of immunodeficiency or immunosuppressive therapy

          -  Known HIV, HBV or HCV infection

          -  History of hypersensitivity reactions to other vaccines

          -  Acute febrile infection at each visit during which the subject receives a vaccination

          -  Active or passive immunization within 2 weeks prior to the first IC51 vaccination and
             up to the second IC51 vaccination.
Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
Condition: Colonoscopy
Intervention: PICOPREP; PEG-ELS
Intervention MeSH terms: Picosulfate sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or
      polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its
      effectiveness, tolerability and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have signed the informed consent form and have been verbally explained the details of
             the trial and treatment procedures

          -  Chinese citizen

          -  Males or females aged between 18 and 70 years inclusive

          -  Patients scheduled for colonoscopy

          -  Patients who are able to observe instructions given during the study, and are able to
             complete the entire study procedure

        Exclusion Criteria:

          -  Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile
             women who are not on effective birth control

          -  Taking concomitant lithium

          -  Allergy to any ingredient in the study medication

          -  History of gastrointestinal diseases (active ulcers, gastric outlet obstruction,
             gastric retention, intestinal obstruction)

          -  Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal
             pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at
             screening

          -  Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)

          -  Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation,
             diverticulitis or appendicitis)

          -  Ascites

          -  History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding,
             gastric bypass surgery)

          -  History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic
             surgery)

          -  Uncontrolled angina and/or myocardial infarction, congestive heart failure, or
             uncontrolled hypertension within 3 months prior randomisation

          -  Severe liver damage

          -  Kidney function impairment

          -  Diabetics currently on insulin treatment

          -  Having participated in any other clinical trial during the 3 month prior recruitment

          -  Patients who are unable to act in a legal capacity, unable to meet or perform study
             requirements
Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Brinzolamide ophthalmic suspension, 1%; Brimonidine tartrate ophthalmic solution, 0.2%
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1001.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AOG; OHT; Open-Angle Glaucoma; Ocular Hypertension

Summary:

      The purpose of this study was to evaluate the efficacy and safety of a fixed combination of
      Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its
      individual active components in patients with open-angle glaucoma and/or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign Informed Consent document.

          -  Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular
             pressure within protocol-specified range at eligibility visit/s.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential if pregnant, lactating, or not using highly
             effective birth control measures.

          -  Any form of glaucoma other than open-angle glaucoma.

          -  Severe central vision loss in either eye.

          -  Chronic, recurrent, or severe inflammatory eye disease.

          -  Ocular trauma within the preceding 6 months.

          -  Ocular infection or ocular inflammation within the preceding 3 months.

          -  Clinically significant or progressive retinal disease such as retinal degeneration,
             diabetic retinopathy, or retinal detachment.

          -  Best-corrected visual acuity score worse than 55 letters using the Early Treatment
             Diabetic Retinopathy Study chart.

          -  Other ocular pathology (including severe dry eye) that may, in the opinion of the
             Investigator, preclude the administration of study product.

          -  Ocular surgery within the preceding 6 months.

          -  Ocular laser surgery within the preceding 3 months.

          -  Any abnormality preventing reliable applanation tonometry.

          -  Any other conditions, including severe illness, which could make the patient, in the
             opinion of the Investigator, unsuitable for the study.

          -  Other protocol-specified exclusion criteria may apply.
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237 50µg once daily; Tiotropium 18µg once daily; Flu/Sal; NVA237 placebo + Tiotropium placebo.
Intervention description: NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI); Tiotropium 18 μg o.d. delivered via a proprietary inhalation device; Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device; Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 773.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease,; NVA 237,; glycopyrronium,; COPD

Summary:

      This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium
      when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD
             2010 guideline

          -  Current or ex-smokers who have a smoking history of at least 10 pack years

          -  Qualifying FEV1 at Visit 2 (day -7)

        Exclusion Criteria:

          -  Patients with a history of asthma or a history of high blood eosinophil count
             (>600/mm³)

          -  Patients with concomitant pulmonary disease

          -  Patients with lung lobectomy or lung volume reduction or lung transplantation

          -  Patients with α-1 antitrypsin deficiency

          -  Patients who have had live attenuated vaccinations within 30 days prior to screening
             visit or during run-in period

        Other protocol-defined inclusion/exclusion criteria may apply.