bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: Placebo; Iltamiocel
Intervention description: Placebo control is the vehicle solution used for the study product.; AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Incontinence, Stress; Tissue Therapy (Cell Therapy); Transplantation, Autologous

Summary:

      This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will
      evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells
      (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of
      stress urinary incontinence (SUI) in adult female patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patient has primary symptoms of SUI, as confirmed by patient medical history
             and clinical symptoms, including a focused incontinence evaluation.

        Exclusion Criteria:

          -  Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of
             etiology from a patient medical history, including a focused incontinence history.

          -  Patient has symptoms of mixed urinary incontinence where urge incontinence is the
             predominant factor.

          -  Patient has had stress urinary incontinence symptoms less than 6 months prior to
             signing the informed consent.

          -  Patient has not previously attempted conservative treatment prior to signing the
             informed consent. (Examples of conservative treatment include behavior modifications,
             bladder exercises, biofeedback, etc.)

          -  Patient has more than 2 episode of awakening to void during normal sleeping hours.

          -  Patient cannot be maintained on a stable dose and/or frequency of medication
             (including diuretics) known to affect lower urinary tract function, including but not
             limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
             for at least 2 weeks prior to screening or is likely to change during the course of
             the study.

          -  Patient is pregnant, lactating, or plans to become pregnant during the course of the
             study.

          -  Patient refuses to provide written informed consent.

          -  Patient is not at least 18 years of age.

          -  Patient is not available for the follow-up evaluations as required by the protocol.
Tanezumab in Osteoarthritis Of The Hip
Condition: Arthritis; Osteoarthritis; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Intervention: tanezumab; tanezumab; tanezumab; Placebo
Intervention description: Tanezumab 10 mg IV every 8 weeks; Tanezumab 5mg IV every 8 weeks; Tanezumab 2.5 mg IV every 8 weeks.; Placebo to match tanezumab IV every 8 weeks
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 627.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA

Summary:

      The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in
      osteoarthritis of the hip in patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the hip according to ACR criteria with Kellgren-Lawrence x-ray grade
             of 2

          -  Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain
             medications have not provided adequate pain relief or are candidates for Hip
             injections, arthroplasty or replacement surgery

          -  Pain level and function levels as required by the protocol at Screening and Baseline

          -  Willing to discontinue pain medications (acetaminophen will be permitted up to a
             certain level) before and during the study

          -  Must agree to the contraceptive requirements of the protocol if applicable

          -  Must agree to the treatment plan, scheduled visits, and procedures of the protocol

        Exclusion Criteria:

          -  Pregnancy

          -  BMI greater than 39

          -  Other severe pain, significant cardiac, neurological or psychological conditions, or
             above the protocol limits for laboratory and blood pressure results
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Irbesartan; Placebo
Intervention description: Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years; Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Intervention MeSH terms: Irbesartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4128.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if Irbesartan is superior to placebo
      in reducing mortality and cardiovascular morbidity in subjects with heart failure with
      preserved systolic function. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age >= 60 years with current symptoms of heart failure consistent with
             New York Heart Association (NYHA) class II-IV

          -  Left ventricular ejection fraction (LVEF) > = 45%

          -  Willing to provide written informed consent AND hospitalization for heart failure
             within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram
             or chest x-ray indicating heart disease.

        Exclusion Criteria:

          -  Acute myocardial infarction within 3 months;

          -  Heart revascularization procedure within 3 months;

          -  Hospitalization for angina within 3 months;

          -  Other heart surgery

          -  Life-threatening or uncontrolled arrhythmia

          -  Subjects with an implantable cardioverter-defibrillator that has discharged in the
             past 3 months;

          -  Stroke or surgery of the arteries in the brain within 3 months;

          -  Serious lung disease which requires use of home oxygen.

          -  Significantly low blood pressure

          -  Significantly high blood pressure

          -  Other known diseases that may limit life expectancy to <3 years;

          -  Known or suspected bilateral kidney artery narrowing;

          -  Geographic or social factors making study participation and follow-up impractical.
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: Ciprofloxacin DPI (BAYQ3939); Placebo
Intervention description: Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.; Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ciprofloxacin; Dry Powder for Inhalation; Exacerbation; Bronchiectasis

Summary:

      The purpose of this study is to evaluate if the time to first pulmonary exacerbation of
      bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days
      every other 28 days or for 14 days every other 14 days over 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic
             or post infectious bronchiectasis

          -  Stable pulmonary status and stable regimen of standard treatment at least for the past
             4 weeks

        Exclusion Criteria:

          -  Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted

          -  Active allergic bronchopulmonary aspergillosis

          -  Active and actively treated non tuberculosis mycobacterial (NTM) infection or
             tuberculosis

          -  Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
Condition: Early Stage Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Rotigotine trans-dermal patches, once daily:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.
After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.
Intervention MeSH terms: Rotigotine
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: 30 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro®

Summary:

      The objective of this open-label extension is to assess the safety and tolerability of
      long-term treatment of the rotigotine patch in subjects with early-stage idiopathic
      Parkinson's disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed six months of maintenance treatment in the SP513
             double-blind trial

        Exclusion Criteria:

          -  Subjects who had an ongoing serious adverse event from SP513 double-blind trial that
             was assessed as related to study medication
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: catridecacog
Intervention description: Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 1 Year
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This trial will be conducted in Asia, Europe and the United States of America (USA).

      The aim of this clinical trial is to investigate long-term safety of rFXIII when administered
      for prevention of bleeding episodes in children aged between 1 and 6 years with congenital
      FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4,
      NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on
      when recombinant factor XIII will be commercially available in subject's respective country
      for use in children of 1-6 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed participation in trial F13CD-3760 (NCT01230021)

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product or related products

          -  Known history of development of inhibitors against FXIII (factor XIII)

          -  Hereditary or acquired coagulation disorder other than FXIII congenital deficiency

          -  Platelet count (thrombocytes) less than 50X10e9 / L

          -  Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus
             erythematosus

          -  Previous history of arterial or venous thromboembolic events e.g., cerebrovascular
             accident or deep vein thrombosis

          -  Any disease or condition which, judged by the trial physician, could imply a potential
             hazard to the subject, interfere with the trial participation or trial outcome
             including renal and/or liver dysfunction
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Condition: Carcinoma, Pancreatic Ductal
MeSH terms: Pancreatic Neoplasms; Carcinoma, Pancreatic Ductal
Intervention: AG-013736; Gemcitabine; Gemcitabine; placebo
Intervention description: oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.; intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.; intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.; placebo
Intervention MeSH terms: Gemcitabine; Axitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 630.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.

Summary:

      The purpose of this study is to determine whether investigational study drug, AG-013736, and
      gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic
             adenocarcinoma not amenable to curative resection.

          -  Adequate renal, hepatic and bone marrow function.

          -  Performance status 0 or 1.

        Exclusion Criteria:

          -  Prior treatment with any systemic chemotherapy for metastatic disease.

          -  Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth
             factor inhibitors.

          -  Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.

          -  Inability to take oral medication.
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis

Summary:

      The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and
      pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5
      years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at
      least 1 allele.

      Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor
      in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is
      designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through
      5 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF

          -  Must have a CFTR gating mutation in at least 1 allele

          -  Aged 2 through 5 years at screening and Day 1

          -  Weight >= 8 kg at screening and Day 1

          -  Hematology, serum chemistry, coagulation, and vital signs results at screening with no
             clinically significant abnormalities that would interfere with the study assessments,
             as judged by the investigator

        Exclusion Criteria:

          -  History of any illness or condition that, in the opinion of the investigator, might
             confound the results of the study or pose an additional risk in administering study
             drug to the participant

          -  An acute upper or lower respiratory infection, or pulmonary exacerbation, or changes
             in therapy for pulmonary disease within 4 weeks before Day 1

          -  Abnormal liver function, at screening

          -  History of solid organ or hematological transplantation

          -  Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A
             within 2 weeks before Day 1

          -  Participation in a clinical study involving administration of either an
             investigational or a marketed drug within 30 days or 5 terminal half-lives before
             screening
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
Condition: Psoriasis, Arthritic
MeSH terms: Arthritis, Psoriatic; Psoriasis
Intervention: Ixekizumab; Placebo; Adalimumab
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Adalimumab; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo
      in participants with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents with established diagnosis of active psoriatic arthritis for at least 6
             months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

          -  Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at
             least 3 swollen joints

          -  Presence of active psoriatic skin lesion or a personal history of plaque psoriasis
             (Ps)

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Current or prior use of biologic agents for treatment of Ps or PsA

          -  Inadequate response to greater than or equal to 4 conventional disease-modifying
             antirheumatic drugs (DMARDs)

          -  Current use of more than one conventional DMARD

          -  Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other
             than PsA

          -  Have participated in any study with interleukin 17 (IL-17) antagonists, including
             ixekizumab

          -  Serious disorder or illness other than psoriatic arthritis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: TA-650
Intervention description: (1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Infliximab; REMICADE; Crohn's disease

Summary:

      The purpose of this study is to assess the efficacy, safety and pharmacokinetics after
      administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an
      insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Crohn's disease

          -  Patients who have relapsed with symptoms associated with Crohn's disease within 8
             weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who
             are judged to be showing an insufficient response to the previous treatment by their
             physician

        Exclusion Criteria:

          -  Severe intestinal strictures (which may have an effect on the number of loose stools
             or diarrhea or dilation of the colon or small bowel proximal to the stricture on
             barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis
             of short bowel syndrome, or previous stoma surgery

          -  The presence of significant internal fistula (possibility that surgery might be
             needed, etc.) is confirmed

          -  A history of a serious infusion reaction to REMICADE

          -  Pregnant, lactating, and probably pregnant women

          -  Patients who have participated in other trials and have been administered other
             investigational products within 12 weeks before consent

          -  Patients judged to be inadequate to participate in this study by their physician