bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Condition: Irritable Bowel Syndrome; Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Lubiprostone; Placebo
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Keywords: Irritable Bowel Syndrome With Constipation

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of administration of
      lubiprostone in patients with irritable bowel syndrome with constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and older

          -  Stable fiber therapy

          -  Normal colonoscopy/sigmoidoscopy

          -  Able to refrain from use of medications known to treat or associated with constipation
             symptoms

          -  Experiences abdominal discomfort/pain associated with bowel movements

          -  Reports decreased bowel movement frequency and/or other symptoms associated with
             constipation

        Exclusion Criteria:

          -  Diarrhea-predominant or alternating (diarrhea & constipation cycling) IBS, or
             constipation other than that associated with IBS

          -  Open gastrointestinal or abdominal surgery prior to IBS onset

          -  Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained
             weight loss or rectal bleeding

          -  Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric
             disorder, other systemic disease, or abnormal laboratory tests per investigator
             discretion

          -  If female, is currently pregnant or nursing, or plans to become pregnant or nurse
             during the clinical study
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Condition: Candidemia
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Anidulafungin; Fluconazole
Intervention description: Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day).
Maximum treatment duration with anidulafungin is 35 days.; Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria. Maximum total treatment duration is 49 days.
Intervention MeSH terms: Fluconazole; Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Anidulafungin; pediatrics; candidemia; invasive candidiasis; safety

Summary:

      Prospective, open label study to assess the pharmacokinetics, safety & efficacy of
      anidulafungin when used to treat children (aged 1 month - <18 years) with invasive
      candidiasis, including candidemia (ICC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or
             (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age
             groups)

          -  Male and female patients from 1 month to less than 18 years of age.

        Exclusion Criteria:

          -  Any patients with allergy to the drug; and any pregnant female or lactating.

          -  Failed previous antifungal therapy or expected to live < 3 days.

          -  Patients with documented or suspected Candida meningitis.
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Condition: Toothache
MeSH terms: Toothache
Intervention: Naproxen Sodium ER (BAYH6689); Placebo
Intervention description: Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery; Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 312.0
Sex: All
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dental Pain; Analgesia

Summary:

      To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium
      extended-release tablet, compared to placebo in postsurgical dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male and female volunteers between 16 to 45

          -  Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which
             must be at least a partial mandibular bony impaction

          -  No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any
             other pain reliever (Over The Counter or prescription), or herbal supplements within 5
             days of surgery

          -  Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a
             score of at least 2 on a 4 point scale) and a score of >/= 50 mm on the 100-mm visual
             analog Pain Severity Rating Scale

        Exclusion Criteria:

          -  History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid
             analgesics, and similar pharmacological agents or components of the investigational
             products, including the placebo

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic
             diseases, or malignancies

          -  Relevant concomitant disease such as asthma (exercise induced asthma is permitted),
             chronic sinusitis or nasal structural abnormalities causing greater than 50 percent
             obstruction (polyposis nasi, marked septal deviation) that can interfere with the
             conduct of the study

          -  Current or past history of bleeding disorder(s)

          -  History of gastrointestinal bleeding or perforation, related to previous NSAID
             therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct
             episodes of proven ulceration or bleeding)
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine 10 mg/day; Vortioxetine 20 mg/day; Fluoxetine 20 mg/day; Placebo
Intervention description: 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed; Encapsulated tablet
Intervention MeSH terms: Vortioxetine; Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 784.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: paediatric patients

Summary:

      Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive
      symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical
      Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who
             turn 18 years during the study will be allowed to continue in the study).

          -  The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.

          -  The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45
             at the Screening Visit and at the Baseline.

          -  The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at
             the Screening Visit and at the Baseline

          -  The patient has provided assent to participation and parent(s)/legal representative
             (s) signed the Informed Consent Form.

        Exclusion Criteria:

          -  The patient has participated in a clinical study <30 days prior to the Screening
             Visit.

        Other protocol defined inclusion and exclusion criteria may apply
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: pregabalin (Lyrica)
Intervention description: Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of the long-term use of pregabalin at doses up
      to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study
      A0081208 (NCT00830167).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol
             A0081208, and must have received pregabalin/placebo under double-blind conditions.

        Exclusion Criteria:

          -  Patients may not participate in the study if they experienced a serious adverse event
             during the previous fibromyalgia Study A0081208; which was determined to be related to
             the study medication by the investigator or the sponsor.
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Oteseconazole (VT-1161); Placebo
Intervention description: Oteseconazole (VT-1161) 150mg capsule; matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 425.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of
      oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for
      RVVC than other oral antifungal medicines.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for
      the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd
      part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg
      or a placebo (according to a random assignment), and then a 36-week follow-up period.

      In addition, at participating sites, an amendment to the study allows US patients who
      complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a
      48-week observational extension period designed to evaluate the continued effectiveness of
      oteseconazole (VT-1161).

      This study is identical to VMT-VT-1161-CL-011.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  3 or more episodes of acute VVC in the past 12 months

          -  Positive KOH or Gram stain test

          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit

          -  Total vulvovaginal signs and symptoms score of <3 at baseline visit

          -  Must be able to swallow pills

        Key Exclusion Criteria:

          -  Presence or a history of another vaginal or vulvar condition(s)

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  Poorly controlled diabetes mellitus

          -  Pregnant

          -  Recent use of topical or systemic antifungal or antibacterial drugs

          -  Recent use of immunosuppressive or systemic corticosteroid therapies
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: sildenafil citrate (UK-92,480)
Intervention description: sildenafil citrate (UK-92,480)
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension, PAH

Summary:

      To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial
      hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of
      sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part
      1)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 16 and over, and classified as having pulmonary arterial hypertension

          -  Subjects who meet the following conditions on right heart catheterization at screening
             or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary
             wedge pressure of ≤ 15mmHg at rest

          -  Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m

        Exclusion Criteria:

          -  Significant Hepatic and/or renal disorder

          -  Subjects with known hereditary degenerative retinal disorders (such as retinitis
             pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)

          -  Subjects who are currently receiving nitrates or nitric oxide donors in any form,
             ritonavir, ketoconazole and itraconazole
Somatropin Treatment to Final Height in Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Intervention: Somatropin; Ethinyl estradiol; Medroxyprogesterone acetate
Intervention description: 0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).; escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.; 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.
Intervention MeSH terms: Medroxyprogesterone Acetate; Ethinyl Estradiol; Medroxyprogesterone; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: Female
Minimum age: 7 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: syndrome; Turner; Turner's; height; growth; growth hormone; somatropin; short stature; short; hearing; glucose metabolism

Summary:

      A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger
      than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin)
      treatment in promoting linear growth to final height.
    

Eligibility criteria:

        Inclusion Criteria:

          -  girl with Turner syndrome

          -  prepubertal, Tanner stage I breast

          -  height velocity less than 6 cm/year and height less than or equal to the tenth
             percentile for sex and age in general population

          -  at least 6 months (preferably 12 months) of accurate height measurements available for
             calculation of pre-study height velocity

          -  if thyroxine deficient, to have received replacement therapy, and for six months prior
             to enrollment have had normal thyroid function tests

        Exclusion Criteria:

          -  prior treatment with growth hormone

          -  presence of a Y component in karyotype with gonads in situ

          -  diabetes mellitus
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Placebo; TMC435; Peginterferon alfa-2a (pegIFN alfa-2a); Ribavirin (RBV)
Intervention description: Placebo capsule taken by mouth once daily for 12 weeks; 100-mg capsule taken by mouth once daily for 12 weeks; PegIFN alfa-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks for patients randomized to TMC435 and for up to 48 weeks for patients randomized to placebo.; RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Hepatitis C; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with
      placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in
      treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10
             IU/mL

          -  Patient has never received treatment for HCV

          -  Patient must be willing to use contraceptive measures from the time of informed
             consent to 6 months after last dose of study medication

        Exclusion Criteria:

          -  Co-infection with any other HCV genotype or co-infection with the human
             immunodeficiency virus (HIV)

          -  Diagnosed with hepatic cirrhosis or hepatic failure

          -  A medical condition which is a contraindication to pegIFN or ribavirin therapy

          -  History of, or any current medical condition which could impact the safety of the
             patient in the study
Secondary Prevention of Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: alendronate with cholecalciferol; calcium carbonate with cholecalciferol; Falls prevention measures
Intervention description: alendronate 70mg /cholecalciferol 2800IU orally once weekly; calcium carbonate 500mg /cholecalciferol 200IU orally twice daily; personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: disease/disorder proneness/risk; osteoporotic fractures; accidental falls; aging

Summary:

      The purpose of this study is to develop and implement an evidence based protocol for the
      secondary prevention of osteoporotic fractures and falls, and to determine how compliance
      with this intervention improves muscle strength and functional status following a fracture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to rehab unit with the primary or secondary diagnosis of fracture

          -  English speaking

          -  Cognitively able to provide consent or health care proxy available and willing to
             provide consent

          -  Willing to cooperate

        Exclusion Criteria:

          -  Pathologic or periprosthetic fractures

          -  Creatinine clearance less than 15ml/minute

          -  Severe hypocalcemia

          -  Esophageal stricture or achalasia

          -  Taking other treatment for osteoporosis besides calcium or vitamin D in the past
             6-months

          -  History of kidney stones in the past 6-months