bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome
Condition: Constipation-Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Mosapride Citrate; Placebo
Intervention description: One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.; One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.
Intervention MeSH terms: Mosapride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mosapride; Irritable Bowel Syndrome; Constipation

Summary:

      The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin
      receptors in the gastrointestinal tract, is effective in the treatment of
      constipation-predominant irritable bowel syndrome (C-IBS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rome III Criteria for IBS:

        Patients must have recurrent abdominal pain or discomfort at least 3 days per month during
        the previous 3 months that is associated with 2 or more of the following:

          -  Relieved by defecation

          -  Onset associated with a change in stool frequency

          -  Onset associated with a change in stool form or appearance

        In addition, patients have to experience at least two of the following symptoms for at
        least 25% of the time [11]:

          -  Altered stool frequency (< 3 bowel movements per week)

          -  Altered stool form (lumpy/hard i.e. Bristol type I-III [see appendix 1])

          -  Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)

          -  Passage of mucus, bloating, or a feeling of abdominal distension

        Exclusion Criteria:

          -  Previous allergy to mosapride

          -  Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which
             suggest an organic disease)

          -  Age < 18 years

          -  History of bloody stools or melena

          -  Diarrhea (>3 bowel movements per day)

          -  Constitutional symptoms (fever, weight loss)

          -  Severe constipation (< 1 bm/week)

          -  Pregnancy or lactation

          -  Patients with history of cardiac arrhythmias

          -  QT prolongation on baseline ECG

          -  Chronic laxative use and dependence

          -  Patients with previous history of congenital heart disease

          -  Patients with previous history of hypokalemia or hyperkalemia

          -  Patients taking the following classes of drugs: HIV antivirals, macrolides,
             anti-arrhythmics, and azole drugs.
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Visudyne
Intervention description: Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.; Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.
Intervention MeSH terms: Aflibercept; Verteporfin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into
      the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual
      function in Chinese subjects with age-related neovascular or "wet" age-related macular
      degeneration.

      Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both
      treatment groups will receive the other treatment as a sham procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent form

          -  Men and women ≥ 50 years of age.

          -  Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions
             secondary to wAMD (wet Age-Related Macular Degeneration)

          -  BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye

        Exclusion Criteria:

          -  Only one functional eye

          -  Presence of CNV with an origin other than wAMD

          -  Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements
             or vitamins
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Condition: Pulmonary Hypertension Associated With HFpEF
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Oral treprostinil
Intervention description: Sustained-release oral tablets for TID administration
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pulmonary Hypertension; HFpEF; 6-Minute Walk Test; Oral Treprostinil

Summary:

      This was an open-label study to evaluate the safety of continued therapy with oral
      treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term,
      open-label data regarding the effect of continued long-term oral treprostinil therapy for the
      treatment of pulmonary hypertension (PH) associated with heart failure with preserved
      ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and
      every 12 weeks thereafter until either oral treprostinil was commercially available to treat
      PH associated with HFpEF or the study was discontinued by the Sponsor.

      The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow
      enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March
      2020. Due to the lower than expected number of subjects enrolled, the planned secondary
      efficacy-related endpoints were not analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

        1. The subject participated in Study TDE-HF-301, remained on study drug, was compliant with
        study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of
        that study.

        Exclusion Criteria:

          1. The subject was pregnant or lactating.

          2. The subject was prematurely discontinued from Study TDE-HF-301 for any reason.

          3. The subject developed a concurrent illness or condition during Study TDE-HF-301,
             which, in the opinion of the Investigator, represented a risk to the subject's overall
             health if they enrolled in this study.
Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction
Condition: ST-Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Prasugrel 60 mg; Ticagrelor 180 mg
Intervention description: Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.; Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 39.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Korea; Platelet inhibition; Prasugrel; Ticagrelor; ST-segment elevation myocardial infarction

Summary:

      To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment
      elevation myocardial infarction undergoing primary percutaneous coronary intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with ST-segment elevation myocardial infarction

          -  Undergoing primary percutaneous coronary intervention

          -  Aged between 20 and 80 years

        Exclusion Criteria:

          -  Previous administration of any antagonist of the platelet adenosine diphosphate (ADP)
             P2Y12 receptor (clopidogrel, prasugrel or ticagrelor)

          -  History of stroke or transient ischemic attack

          -  Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count
             < 100,000/mm3 or hemoglobin < 10 g/dl

          -  Chronic oral anticoagulation treatment

          -  Contraindication to the antiplatelet treatment

          -  Severe renal insufficiency (serum creatine>2.5 mg/dl)

          -  Severe hepatic dysfunction (serum liver enzyme or bilirubin>3 times normal limit)

          -  Sever chronic obstructive pulmonary disease (COPD) or bradycardia

          -  Body weight < 50 kg
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Spondylitis, Ankylosing
Intervention: Golimumab; Placebo
Intervention description: Golimumab 50 mg SC injection every 4 weeks; Placebo SC injection every 4 weeks
Intervention MeSH terms: Golimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in
      participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to
      receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and
      at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity
      of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg
      subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2,
      the participants were to be told they were receiving active study drug. The primary
      hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to
      placebo as measured by the proportion of participants achieving an Assessment in Ankylosing
      Spondylitis (ASAS) 20 response at Week 16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain
             of ≥3 month duration

          -  Have either an inadequate response to 30 days of optimal daily doses of at least one
             non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30
             day maximal NSAID therapy because of intolerance, toxicity or contraindications to
             NSAIDs

          -  Females of child-bearing potential must use contraception

          -  No history of untreated latent or active tuberculosis

        Exclusion Criteria:

          -  Fulfillment of modified New York criteria for ankylosing spondylitis

          -  Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological
             agents

          -  Any systemic inflammatory condition other than spondyloarthritis

          -  Serious infection within 2 months

          -  Any known malignancy or a history of malignancy within the previous 5 years

          -  Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Condition: Foetal Growth Problem; Small for Gestational Age
Intervention: somatropin; somatropin
Intervention description: 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge; 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 3 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety
      of somatropin in children born small for gestational age (SGA) in Japan.

      In the main period, subjects will receive either active treatment for 104 weeks (two dosing
      regimens) or no treatment for 52 weeks followed by an extension period where subjects who
      received active treatment for 104 weeks (two years) will continue with the same treatment for
      further 156 weeks (three years) while those subjects who received no treatment for 52 weeks
      (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In
      total, subjects participate in trial for 260 weeks (five years).

      Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension
      period is registered as GHLIQUID-1517.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For MAIN period (GHLIQUID-1516):

          -  Born small for gestational age (SGA) with birth weight and birth length below the 10th
             percentile for gestational age, and additional either birth length below or equal to
             -2.0 standard deviation score (SDS) or birth weight below or equal to -2.0 SDS for
             gestational age

          -  Growth failure with height at -2.0 SDS or below for chronological age (CA)

          -  Normal growth hormone (GH) production, defined as peak GH level > 10 ng/mL in one GH
             provocation test

          -  For EXTENSION period (GHLIQUID-1517):

          -  Subjects who completed the main period

          -  Chronological age (CA) for boys at least 4 years, but maximum 11 years

          -  Chronological age (CA) for girls at least 4 years, but maximum 10 years

        Exclusion Criteria:

          -  Subjects with diabetes mellitus

          -  Subjects suffering from malignancy

          -  Several medical conditions
ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: ZD6474 (vandetanib); Best Supportive Care
Intervention description: once daily oral tablet; standard of care
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small-Cell Lung Carcinoma; Adenocarcinoma; Squamous Cell Carcinoma; Large Cell Carcinoma

Summary:

      This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is
      more effective than best supportive care alone, for the treatment of patients with non-small
      cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal
      Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug
      in development that works in a different way to standard chemotherapy drugs. It targets the
      growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour
      may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour
      may take to progress to a further stage. Approximately 930 patients will take part in this
      study. It will be conducted in hospitals and clinics in North and South America, Europe and
      Asia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Non-small cell lung cancer for which the standard cancer treatments of
             surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate
             treatments for you.

        Exclusion Criteria:

          -  Patients who have had standard cancer treatments of surgery, chemotherapy or other
             systemic anti-cancer therapy within 4 weeks before start of study therapy.

          -  Three or more prior chemotherapy regimens.

          -  Significant cardiovascular events.
Omega-3 Fatty Acids and Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Intervention: Omega-3; placebo
Intervention description: Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is being done to understand the effects of dietary omega-3 fats on insulin
      sensitivity in adult men and women.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age 18-65 years

          2. Insulin resistant (Homeostasis Model Assessment (HOMA) Insulin Resistance (IR) ≥2.6)

        Exclusion criteria:

          1. Current use of omega-3 nutritional supplements

          2. Fasting plasma glucose ≥126 mg/dL

          3. Active coronary artery disease

          4. Participation in structured exercise (>2 times per week for 30 minutes or longer)

          5. Smoking

          6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids,
             tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)

          7. Renal failure (serum creatinine > 1.5mg/dl)

          8. Chronic active liver disease (AST>144 IU/L and alanine transaminase (ALT)>165 IU/L)

          9. Anti-coagulant therapy (warfarin/heparin)

         10. International normalized ratio (INR) >3

         11. Use of systemic glucocorticoids

         12. Chronic use of NSAIDS or aspirin

         13. Pregnancy or breastfeeding

         14. Alcohol consumption greater than 2 glasses/day

         15. Hypothyroidism

         16. Fish or shellfish allergy
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Linaclotide; Matching Placebo
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug
      administered once daily to patients with chronic idiopathic constipation (CIC). The primary
      efficacy parameter is the percentage of participants in each dosing group that meet the
      protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy if one is needed according to the American
             Gastroenterological Association (AGA) criteria, with no clinically significant
             findings

          -  Patient has no clinically significant findings on a physical examination and clinical
             laboratory tests

          -  Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week
             and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard
             stools, sensation of incomplete evacuation during the 3 months before the diagnosis
             with the onset at least 6 months before the diagnosis

          -  Patient is compliant with daily interactive voice response system (IVRS) calls

          -  Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per
             week by the IVRS over the 14 calendar days before the Randomization Visit and the
             calendar day of Randomization.

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments

          -  Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren/Amlodipine 150/2.5 mg; Aliskiren/amlodipine 150/5 mg; Aliskiren 150 mg; Amlodipine 2.5 mg; Placebo of Aliskiren; Placebo of Amlodipine; Placebo of Aliskiren/amlodipine 150/2.5 mg; Placebo of Aliskiren/amlodipine 150/5 mg
Intervention description: Aliskiren/amlodipine 150/2.5 mg tablet; Aliskiren/amlodipine 150/5 mg tablet; Aliskiren 150 mg tablet; Amlodipine 2.5 mg capsule; Aliskiren placebo tablet; Amlodipine placebo capsule; Aliskiren/amlodipine 150/2.5 mg placebo tablet; Aliskiren/amlodipine 150/5 mg placebo tablet
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1342.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Aliskiren; Amlodipine; Essential hypertension

Summary:

      The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and
      safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with
      essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110
      mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted
      to support registration of the fixed-dose combination of aliskiren and amlodipine for the
      treatment of hypertension in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140
             mmHg )

          -  Outpatients

        Exclusion Criteria:

          -  Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)

          -  History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers

          -  History or evidence of a secondary hypertension

        Other protocol-defined inclusion/exclusion criteria applied