bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
Condition: Fissure in Ano; Pain
MeSH terms: Fissure in Ano
Intervention: Cellegesic; Placebo
Intervention description: Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.; Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pain associated with chronic anal fissure

Summary:

      Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal
      pain especially during defecation and for 1 or 2 hours afterwards. There are no approved
      drugs in the United States (US) for this condition and surgery is often the treatment choice.
      Strakan is conducting this confirmatory study so the product can be submitted for regulatory
      approval in the US. Strakan currently markets this product throughout Europe.

      The objective of this study is to determine the effect of nitroglycerin ointment 0.4%
      (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21
      days of treatment in 250 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consenting patients of either sex.

          -  Between 18 and 75 years of age.

          -  With a single, chronic, posterior midline anal fissure.

          -  Defined as having anal pain for the 6 weeks prior to Screening.

        Exclusion Criteria:

          -  More than one anal fissure.

          -  A fistula-in-ano or anal abscess.

          -  Inflammatory bowel disease.

          -  Fibrotic anal stenosis.

          -  Anal fissure secondary to an underlying condition.

          -  Any anal surgery.

          -  Concomitant medication that may interfere with study evaluation.
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: desvenlafaxine succinate sustained release; fluoxetine; placebo
Intervention description: Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.; Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules; Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Intervention MeSH terms: Fluoxetine; Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 340.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: major depressive disorder; MDD; depression

Summary:

      This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release
      vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive
      Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >=7 and <18 years of age

          -  Primary diagnosis of major depressive disorder (MDD)

          -  CDRS-R score >40

        Exclusion Criteria:

          -  History of suicidal behaviour, or requires precaution against suicide

          -  Not in generally healthy medical condition

          -  History of psychosis or bipolar disorder

          -  Seizure disorder
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Tofacitinib; Placebo; Tofacitinib
Intervention description: tablets, 5 mg BID x 6 months; tablets, to match tofacitinib 5 mg BID x 3 months; tablets, 5 mg BID x 3 months
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriatic arthritis; tofacitinib; China

Summary:

      This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating
      signs and symptoms and improving physical function in Chinese patients with active psoriatic
      arthritis and had inadequate response to a conventional synthetic disease modifying
      anti-rheumatic drug. This is a China alone study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese patients

          -  Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
             swollen joints

          -  Active plaque psoriasis at screening

          -  Inadequate response to at least one conventional synthetic DMARD

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis (with exception of nail psoriasis)

          -  History of autoimmune rheumatic disease other than PsA; also prior history of or
             current, rheumatic inflammatory disease other than PsA
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Condition: Diabetes Mellitus, Non-Insulin-Dependent; High Risk for Cardiovascular Event
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin 10 mg; Placebo tablet
Intervention description: Oral dose (od); Oral dose (od)
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17190.0
Sex: All
Minimum age: 40 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Phase IIIb; T2DM; cardiovascular events

Summary:

      This study is being carried out to determine the effect of dapagliflozin on cardiovacular
      outcomes when added to current background therapy in patients with type 2 diabetes with
      either established cardiovacular disease or cardiovascular risk factors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Female or male aged ≥40 years

          -  Diagnosed with Type 2 Diabetes

          -  High Risk for Cardiovascular events

        Exclusion Criteria:

          -  Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of
             radiation therapy to the lower abdomen or pelvis at any time

          -  Chronic cystitis and/or recurrent urinary tract infections

          -  Pregnant or breast-feeding patients
Use of N-Acetylcysteine (NAC) in Fingernail Biting
Condition: Onychophagia
Intervention: N-Acetylcysteine (NAC); Placebo
Intervention description: This is the medication N-acetylcysteine (NAC); Placebo, designed to match in appearance to NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Anxiety; Impulse control; Depression; ADHD; Fingernail Biting; N-Acetylcysteine; NAC

Summary:

      To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC)
      in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy
      on young adults who bite their fingernails. It is proposed that NAC will help decrease
      fingernail biting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Age 18-30 2. Fingernail biter for ≥5 years

        Exclusion Criteria:

          -  1. Any unstable major DSM-IV Axis I psychiatric disorder in the past month (e.g.,
             psychotic disorders, bipolar disorder, major depressive disorder) 2. Current substance
             dependence in the past month 3. Current unstable major medical disorder or medical
             condition in the past 6 months (e.g., renal impairment) 4. Current pregnancy or
             breastfeeding 5. Current seizure disorder or asthma, due to possible elevated risk for
             adverse effects with NAC in individuals with these conditions 6. Known
             hypersensitivity to NAC 7. Use of carbamazepine or nitroglycerin (or any other
             medication deemed to be hazardous if taken with NAC) within 14 days of study
             participation
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients
Condition: Pain; Cancer
MeSH terms: Breakthrough Pain
Intervention: EN3267
Intervention description: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: EN3267; Breakthrough Pain; Safety Study; Fentanyl Tablets

Summary:

      The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in
      treating breakthrough pain episodes in opioid cancer patients who are using stable doses of
      opioid medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 17 years of age or older.

          -  Stable cancer-related pain.

          -  Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg
             of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h,
             and are on a stable dose of opioid medication for relief of breakthrough pain.

          -  Experiencing 1-4 episodes of breakthrough pain per day.

          -  Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance
             Status for Grade 0, 1, or 2.

        Exclusion Criteria:

          -  Have previously been exposed to EN3267.

          -  Are pregnant or lactating.

          -  Have uncontrolled or rapidly escalating pain.

          -  Have any clinically significant condition that would, in the investigator's opinion,
             preclude participation in the study or compromise data collection. These conditions
             may include cardiopulmonary disease, and/or neurologic/psychologic conditions.

          -  Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.

          -  Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion,
             will influence assessment of breakthrough pain.

          -  Are scheduled to receive an investigational drug other than EN3267 during the course
             of the study.

          -  Have hypersensitivity, allergy or contraindication to fentanyl.

          -  Have significant prior history of substance abuse or alcohol abuse.

          -  Would have difficulty complying with the protocol, as assessed by the investigator.

          -  Are unable to read, write, or comprehend the English language in order to complete
             diaries.
Study of Adalimumab in Patients With Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Adalimumab; Placebo; Open-label Adalimumab
Intervention description: 40 mg every other week up to Week 12; Placebo every other week up to Week 12; 40 mg every other week, Week 12 through Week 156
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate how well adalimumab works in the short and long term in patients
      with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or
      psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs
             (NSAIDs)

          -  Chronic back pain with onset < 45 years of age

          -  Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human
             leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis
             clinical criteria

          -  Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline
             visit must be negative

          -  Ability to administer subcutaneous injections

          -  General good health otherwise

        Exclusion Criteria:

          -  Prior anti-tumor necrosis factor (TNF) therapy

          -  Psoriasis or psoriatic arthritis

          -  Fulfillment of modified New York criteria for ankylosing spondylitis

          -  Recent infection requiring treatment

          -  Significant medical events or conditions that may put patients at risk for
             participation

          -  Females who are pregnant or breast-feeding or considering becoming pregnant during the
             study

          -  History of cancer, except successfully treated skin cancer

          -  Recent history of drug or alcohol abuse
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Mesalamine; Placebo
Intervention description: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo; This is an inactive pill
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Diarrhea; Mesalamine; Gastroenteritis; abdominal pain; hypersensitivity

Summary:

      The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in
      patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will
      evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma
      cytokines before and after treatment with Lialda.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria

          1. Men and women age 18-75 years

          2. Rome III criteria for IBS

          3. Symptom onset after apparent acute gastroenteritis

          4. Symptoms of 6 months or greater duration

          5. Normal gross appearance of the colonic mucosa other than erythema

          6. Negative markers for celiac disease and inflammatory bowel disease

          7. Normal thyroid function and serum calcium

          8. Stable medication regimens for other medical conditions.

        Exclusion Criteria:

          1. Age <18 or >75 years

          2. Previous diagnosis of or history compatible with IBS

          3. Constipation-predominant IBS.

          4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV

          5. History of/or presence of malignancy

          6. Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory
             bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic
             resection, paraplegia or quadriplegia. .

          7. Current evidence of drug or alcohol abuse as judged by the investigator

          8. Allergy to mesalamine or aspirin

          9. Investigator perception of patient's inability to comply with the study protocol

         10. Unstable psychiatric disease

         11. Recent change in gastrointestinal medications
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole sodium; Esomeprazole
Intervention description: Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.; Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Intervention MeSH terms: Esomeprazole; Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1069.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GERD; erosive GERD; erosive esophagitis

Summary:

      The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and
      safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the
      treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
    

Eligibility criteria:

        KEY INCLUSION CRITERIA:

          1. Male or female, ages 18 to 75 years.

          2. History of GERD symptoms for at least 3 months immediately before screening.

          3. Heartburn for at least 2 days a week for at least 1 month before screening.

          4. Esophageal erosions of LA Grades C or D based on EGD taken within 14 days prior to
             enrollment.

          5. Subjects who are H. pylori negative based on a screening test.

          6. Females should be either of non-childbearing potential or of childbearing potential.
             Females of childbearing potential must have negative pregnancy tests prior to
             randomization. Female subjects of childbearing potential must agree to use medically
             acceptable methods of contraception.

          7. Subjects must be able to read, write, and understand the language of the symptom
             diary.

        KEY EXCLUSION CRITERIA:

          1. Current or a history of esophageal motility disorders.

          2. Current or a history of Barrett's esophagus.

          3. Current esophageal strictures or esophagitis (known or suspected to be due to etiology
             other than GERD such as infection or medications).

          4. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory
             conditions, or current gastric or duodenal ulcer.

          5. Current or a history of cancer, with the exception of fully excised skin basal cell
             carcinoma.

          6. Inflammatory bowel disease.

          7. Unstable diabetes mellitus.

          8. History of esophageal, gastric and duodenal surgery except simple suturing of an
             ulcer.

          9. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral
             steroids (>= 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Condition: Diabetes, Type I
MeSH terms: Diabetes Mellitus
Intervention: Technosphere Insulin; Active comparator
Intervention description: Inhalation, 15U/30U; sc injectable insulin
Intervention MeSH terms: Insulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 589.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 1 diabetes for at least 1 year

          -  Nonsmokers for prior 6 months

          -  BMI less than or equal to 35kg/m2

          -  HbA1c > or = 7% and < or = 11%

          -  Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male
             subjects

          -  FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted

          -  Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day

          -  Urine cotinine < or = 100 ng/mL

        Exclusion Criteria:

          -  History of chronic obstructive pulmonary disease, asthma, any other clinically
             significant pulmonary disease confirmed by documented history, pulmonary function
             testing or radiologic findings

          -  Evidence of severe complications of diabetes

          -  Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of
             normal