bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Condition: Chronic Constipation; Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide
Intervention description: Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1559.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Constipation; Chronic Constipation; Irritable Bowel Syndrome With Constipation; Linaclotide

Summary:

      The objective of this study is to assess the long-term safety of linaclotide administered to
      patients with chronic constipation (CC) or irritable bowel syndrome with constipation
      (IBS-C).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have

               -  entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum
                  completed the pre-treatment period or

               -  completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005
                  [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811]

          -  Sexually active patients of childbearing potential agree to use birth control

          -  Females of childbearing potential must have a negative urine pregnancy test prior to
             dosing

          -  Lactating females must agree not to breastfeed

          -  Patient must meet protocol criteria for CC or IBS-C

        Exclusion Criteria:

          -  Patient must not use protocol-defined prohibited medicine

          -  Patient is planning to receive an investigational drug at any time during the study

          -  Patient has an unresolved AE or a clinically significant finding on a physical
             examination, 12-lead ECG, or clinical laboratory test
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Stannous Fluoride; Sodium Monofluorophosphate
Intervention description: dentifrice containing stannous fluoride; dentifrice containing Sodium Monofluorophosphate
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing
      dentinal hypersensitivity over a two week treatment period.
    

Eligibility criteria:

        - Subjects who suffer from tooth sensitivity.
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Mirabegron; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Mirabegron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Frequency; YM178; Overactive bladder (OAB); Micturition; Urgency; Urinary urge incontinence; Urinary incontinence

Summary:

      The study is intended to test the efficacy, safety and tolerability of two doses of
      mirabegron against placebo to treat patients with symptoms of overactive bladder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is willing and able to complete the micturition diary and questionnaires
             correctly

          -  Patient has symptoms of overactive bladder for ≥ 3 months

          -  Patient must experience frequency of micturition on average ≥ 8 times per 24-hour
             period during the 3-day micturition diary period

          -  Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without
             incontinence during the 3-day micturition diary period

        Exclusion Criteria:

          -  Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of
             childbearing potential, sexually active and not practicing a highly reliable method of
             birth control

          -  Patient has significant stress incontinence or mixed stress/urge incontinence where
             stress is the predominant factor

          -  Patient has an indwelling catheter or practices intermittent self-catheterization

          -  Patient has diabetic neuropathy

          -  Patient has evidence of a symptomatic urinary tract infection, chronic inflammation
             such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or
             previous or current malignant disease of the pelvic organs

          -  Patient receives non-drug treatment including electro-stimulation therapy

          -  Patient has severe hypertension

          -  Patient has a known or suspected hypersensitivity to YM178, other beta-adrenoreceptor
             (ß-AR) agonists, or any of the other inactive ingredients

          -  Patient has been treated with any investigational drug or device within 30 days

          -  Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day
             micturition diary period

          -  Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or
             alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or Gamma
             glutamyl transferase (γ-GT) > 3x ULN

          -  Patient has a clinically significant abnormal electrocardiogram (ECG)
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Mapracorat; Vehicle
Intervention description: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.; Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic
      Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following
      cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are candidates for routine, uncomplicated cataract surgery.

          -  Subjects must be willing to wait to undergo cataract surgery on the fellow eye until
             after the study has been completed.

        Exclusion Criteria:

          -  Subjects who are expected to require treatment with any systemic or ocular (either
             eye) drugs specified in the protocol during the 18 days following cataract surgery or
             any systemic or ocular corticosteroids within 14 days prior to cataract surgery.

          -  Subjects who have known hypersensitivity or contraindication to the study drug(s) or
             their components.

          -  Subjects who have a severe/serious ocular condition or history/presence of chronic
             generalized systemic disease that the Investigator feels might increase the risk to
             the subject or confound the result(s) of the study.
Anxiolytic and Analgesic Effects of Melatonin
Condition: Anxiety
Intervention: Melatonin; Placebo
Intervention description: Gelatin capsules; Placebo capsules
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: Female
Healthy volunteers: No
Keywords: Melatonin; Surgery; Pharmacokinetic; Anxiolytic

Summary:

      The study's main objective is to investigate melatonin's anxiolytic and sleep-regulating
      effects in patients undergoing surgery. Moreover, the investigators intend to investigate the
      pharmacokinetic parameters of melatonin in this patient population.
    

Eligibility criteria:

        Inclusion Criteria part one:

          -  Patients who are candidates for breast surgery.

          -  BMI between 18 and 30

          -  Visible veins in the elbow region

          -  Fertile women use anti-contraception and have performed a negative pregnancy test

        Exclusion Criteria part one:

          -  Patients, who use daily opioids, benzodiazepines or melatonin

          -  Patients diagnosed with a psychiatric disorder (defined as in medical treatment)

          -  Patients with severe physical disease (ASA 3-4)

          -  Patients with previous or ongoing alcohol or drug abuse

          -  Patients with liver disease (defined as in medical treatment)

          -  Patients diagnosed sleep disturbances

          -  Patients who are unable to cooperate according to the protocol

          -  Patients with allergy to melatonin

        Inclusion Criteria part two:

        - Male patients who are candidates for inguinal or umbilical hernia reapir

        Exclusion Criteria part two:

          -  Patients, who use daily opioids, benzodiazepines or melatonin

          -  Patients diagnosed with a psychiatric disorder (defined as in medical treatment)

          -  Patients with severe physical disease (ASA 3-4)

          -  Patients with previous or ongoing alcohol or drug abuse

          -  Patients with liver disease (defined as in medical treatment)

          -  Patients diagnosed sleep disturbances

          -  Patients who are unable to cooperate according to the protocol

          -  Patients with allergy to melatonin

        Withdrawal- and drop-out criteria part 2:

          -  Patients can withdraw at any time during trial

          -  Complications during surgery occur that lead to:

               1. Immediate reoperation

               2. Hospitalization to intensive care unit

          -  If it is considered in the best interest of the patients physical- and psychological
             health to withdraw from the trial
12 / 48 Week Pivotal PFT vs PBO in COPD I
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Olodaterol (BI1744); Olodaterol (BI1744); placebo
Intervention description: Comparison of low and high doses on efficacy and safety in COPD patients; Comparison of low and high doses on efficacy and safety in COPD patients; Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler
Intervention MeSH terms: Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 625.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This primary objective of this study is to compare two doses of BI 1744 CL inhalation
      solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic
      obstructive pulmonary disease (COPD).

      The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also
      be compared to placebo.
    

Eligibility criteria:

        Inclusion criteria:

          -  All patients must have a diagnosis of chronic obstructive pulmonary disease

          -  Male or female patients, 40 years of age or older Patients must be current or
             ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1
             <80% predicted and post-bronchodilator FEV1/FVC <70%

        Exclusion criteria:

          -  Patients with a significant disease other than COPD

          -  Patients with a history of asthma

          -  Patients with any of the following conditions:

        a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or
        life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the
        past year. known active tuberculosis a malignancy for which patient has undergone
        resection, radiation therapy or chemotherapy within last five years (patients with treated
        basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a
        history of cystic fibrosis
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: placebo; Denosumab
Intervention description: Placebo administered by subcutaneous injection; Denosumab 60 mg administered by subcutaneous injection
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7808.0
Sex: Female
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Postmenopausal Osteoporosis

Summary:

      This study will evaluate the effectiveness and safety of denosumab in treating women with
      Postmenopausal Osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are 60 to 90 years of age may be eligible to participate

          -  Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

        Exclusion Criteria:

          -  BMD T-Score at the hip or the spine of less than -4.0

          -  Patients with any severe or more than two moderate vertebral fractures on spinal x-ray
             at entry
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: raltegravir potassium; Comparator: Placebo
Intervention description: Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.; Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 352.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      This study will investigate the safety and efficacy of raltegravir as a therapy for
      HIV-infected patients failing current therapy with 3-class antiviral resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be HIV positive with HIV RNA values that are within ranges required by
             the study

          -  Patient must have documented failure of certain antiretroviral therapy

          -  Patient must be on the same antiretroviral therapy for at least the past two months

        Exclusion Criteria:

          -  Patient is less than 16 years old

          -  Additional study criteria will be discussed and identified by the study doctor
Study Assessing Double-masked Uveitis Treatment
Condition: Uveitis; Posterior, Disorder
MeSH terms: Uveitis
Intervention: DE-109 44 ug; DE-109 440 ug; DE-109 880 ug
Intervention description: Low dose; Medium dose; High dose
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 592.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of intravitreal injections
      of DE-109 ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of active uveitis

          -  18 years of age or older

          -  Sign informed consent

          -  Meet best corrected ETDRS visual acuity

        Exclusion Criteria:

          -  Uveitis of infectious etiology

          -  Suspected/confirmed central nervous system or ocular lymphoma

          -  Primary diagnosis of anterior uveitis

          -  Uncontrolled glaucoma

          -  Use of topical oculary medication

          -  Implanted device

          -  Significant ocular disease

          -  Lens/media opacities or obscured ocular media

          -  Intraocular surgery or treatments

          -  Capsulotomy

          -  Ocular or periocular infection

          -  Pupillary dilation

          -  History of herpetic infection

          -  Toxoplasmosis or toxoplasmosis scar

          -  Ocular malignancy

          -  Allergy or hypersensitivity to study drug

          -  Participation in other uveitis trial within 30 days

          -  Monoclonal antibody treatment or biologic therapy

          -  Any systemic condition/infection

          -  Immunosuppressive therapy or immunocompromised

          -  Malignancy remission

          -  Females who are pregnant or lactating and females not using adequate contraceptives
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Bosentan
Intervention description: 32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally
Intervention MeSH terms: Bosentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: bosentan; pulmonary arterial hypertension; children; FUTURE 1

Summary:

      The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability
      of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial
      hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent by the parents or the legal representatives.

          -  Patients who completed the FUTURE 1 study.

          -  Patients who tolerated bosentan pediatric formulation and for whom bosentan is
             considered beneficial at the end of FUTURE 1.

          -  Males or females >= 2 and < 12 years of age at enrollment in FUTURE 2 (this study).
             Females who are menstruating must have a negative pregnancy test. A reliable method of
             contraception must be considered, if appropriate.

        Exclusion Criteria:

          -  Intolerance to bosentan despite dose reductions.

          -  Any clinically significant laboratory abnormality that precludes continuation of
             bosentan therapy.

          -  Pregnancy or breast-feeding.

          -  Known hypersensitivity to bosentan or any of the excipients.

          -  Premature and permanent study drug discontinuation during FUTURE 1.
A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: 8mg/kg iv every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the effectiveness of tocilizumab in combination with
      traditional DMARDs with regard to the clinical improvement in disease activity (achievement
      of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have
      had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients
      will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable
      pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular
      treatment period and a further 6 infusions during an optional extension phase. The
      anticipated time on study treatment is 6 to 12 months, and the target sample size is <500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987
             ACR criteria;

          -  DAS28 of >3.2;

          -  At screening either ESR >=28 mm/h or CRP >=1 mg/dL;

          -  Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a
             stable dose for at least 8 weeks prior to baseline.

        Exclusion Criteria:

          -  major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following screening;

          -  functional class IV as identified by the ACR classification of functional status in
             RA;

          -  rheumatoid autoimmune disease other than RA;

          -  prior history of or current inflammatory joint disease other than RA.