bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Methylnaltrexone; Placebo
Intervention description: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.; Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.
Intervention MeSH terms: Methylnaltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 804.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain

Summary:

      MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind,
      placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for
      the treatment of opioid induced constipation in participants with chronic, non-malignant
      pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. History of chronic non-malignant pain (originating from a non-malignant source) with
             condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months'
             duration before the screening visit.

          2. Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic
             non-malignant pain for ≥1 month.

          3. No known history of chronic constipation prior to the initiation of opioid therapy.

          4. Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative
             therapy at the start of screening period and use only study-permitted rescue laxatives
             throughout the screening and double-blind treatment periods..

        Key Exclusion Criteria:

          1. Prior treatment with oral MNTX.

          2. Prior treatment with SC MNTX within 30 days of screening.

          3. Women who are pregnant, breastfeeding, or plan to become pregnant during the study.

          4. Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant
             gastrointestinal disorders such as inflammatory bowel disease or clinically
             significant irritable bowel syndrome that would have made bowel movement assessment
             inaccurate.

          5. Current treatment with partial opioid agonists (for example; buprenorphine) or
             combination agonists/antagonists.
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: otelixizumab infusion plus physician determined standard of care; placebo infusion plus physician determined standard of care
Intervention description: infusion; infusion
Intervention MeSH terms: Muromonab-CD3
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Type 1 diabetes; new onset type 1 diabetes; T1DM; Type l diabetes; juvenile diabetes

Summary:

      The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads
      to greater improvement in insulin secretion as compared with placebo infusion. Insulin
      secretion will be assessed using mixed meal-stimulated C-peptide.

      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
      otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
      insulin, diet, and other physician determined standard of care treatments.

      DEFEND-1 is now closed to enrollment.

      DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require
      subjects with new onset type 1 diabetes. Please check back here for more details.

      In the meantime, established and new onset type 1 diabetes patients in North America are
      welcome to consider the TTEDD study:

      http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD&rank=1
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 12-45

          -  Diagnosis of diabetes mellitus, consistent with ADA criteria

          -  No more than 90 days between diagnosis and administration of study compounds

          -  Requires insulin for type 1 diabetes mellitus, or has required insulin at some time
             between diagnosis and administration of study compounds.

          -  Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50
             nmol/L

          -  Positive for one or more of the autoantibodies typically associated with T1DM:
             antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine
             phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin
             autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and
             negative for the other autoantibodies will only be eligible if the subject has used
             insulin for less than 7 days total.

        Exclusion Criteria:

          -  Other, significant medical conditions based on the study doctor's evaluation
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
Condition: Hypercholesterolemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Ezetimibe; Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and
      Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with
      hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5
      mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese

          -  Outpatient with hypercholesterolemia

          -  Female participant who is of reproductive potential has to agree to remain abstinent
             or use (or partner use) two acceptable methods of birth control from date of signed
             informed consent to the 14 days after the last dose of study drug

          -  Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society
             Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases
             for the duration of the study

        Exclusion Criteria:

          -  Uncontrolled hypertension (treated or untreated)

          -  Uncontrolled type 1 or type 2 diabetes mellitus

          -  Homozygous Familial Hypercholesterolemia or has undergone low-density lipoprotein
             (LDL) apheresis

          -  Uncontrolled endocrine or metabolic disease known to influence serum lipids or
             lipoproteins

          -  Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption

          -  History of cancer within the past 5 years (except for successfully treated
             dermatological basal cell or squamous cell carcinoma or in situ cervical cancer)

          -  Human Immunodeficiency Virus (HIV) positive

          -  History of drug/alcohol abuse within the past 5 years or psychiatric illness not
             adequately controlled and stable on pharmacotherapy

          -  Consumes more than 25 g of alcohol per day

          -  Currently following an excessive weight reduction diet

          -  Currently engages in a vigorous exercise regimen (e.g.; marathon training, body
             building training etc.) or intends to start training during the study

          -  Hypersensitivity or intolerance to Ezetimibe or Rosuvastatin

          -  Myopathy or rhabdomyolysis with Ezetimibe or any statin

          -  Pregnant or lactating

          -  Taking any other investigational drugs and/or has taken any investigational drugs
             within 30 days
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
Condition: Growth Hormone Therapy; Infant, Small for Gestational Age
Intervention: Somatropin; Somatropin
Intervention description: Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.; Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 6 Years
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or
      0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive
      performance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.

          -  Birth length- and/or birth weight-SDS adjusted to gestational age < -2.0 (Voigt et al.
             2002, Voigt et al. 2006 or Lawrence et al. 1989).

          -  Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below
             -1 (Hermanussen and Cole 2003).

          -  Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988).

        Exclusion Criteria:

          -  Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic
             features.

          -  Severe pre-maturity (GA < 32 weeks of gestation).

          -  Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC),
             respiratory distress syndrome, if associated with long-term sequelae (like short bowel
             syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).

          -  Inability to perform one- or two leg jumps from a standing position.

          -  Prior GH treatment.
Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma
Condition: Osteoarthritis
MeSH terms: Hemorrhage
Intervention: Group 1 Tranexamic Acid; Group 2 Platelet rich plasma
Intervention description: 2 gr of tranexamic acid will be applied on the surgical site.; 16ml of platelet rich plasma will be applied of the surgical site
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Blood loss; Tranexamic acid; Platelet rich plasma; Total knee arthroplasty

Summary:

      The investigators will include patients who will be schedule for total knee arthroplasty with
      a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a
      verbal and clear detailed information will be given on the intraoperative approach. The first
      group will receive topical tranexamic acid and the second group topical platelet rich plasma;
      both in the surgical site. Both groups will be assessed before and after the intervention
      with laboratory results (hemoglobin, hematocrit levels) and drainage drain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years

          2. Patient candidates for primary total knee replacement

          3. Patients willing to participate in the study and sign de inform consent

        Exclusion Criteria:

          1. Patients with previous history of thromboembolic event in the last 6 months

          2. Patients candidates for revision total knee replacement

          3. Patients candidates for tumoral total knee replacement

          4. Patients candidates for bilateral total knee replacement

          5. Patient with cognitive deficit

          6. Previous history of coagulopathy
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Intervention description: Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 433.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Etrasimod; APD334

Summary:

      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment for moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening

          2. Active UC confirmed by endoscopy

        Exclusion criteria:

          1. Severe extensive colitis

          2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
             of a fistula consistent with CD

          3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Vitamin D (cholecalciferol); Placebo
Intervention description: 2000 I.U. daily for 6 weeks; Placebo (sugar pill) daily for 6 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease; Vitamin D; Cholecalciferol; Skeletal muscle

Summary:

      The purpose of this study is to determine whether or not vitamin D supplementation can
      improve physical performance in persons with severe chronic obstructive pulmonary disease
      (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  COPD

          -  Forced expiratory volume in one second (FEV1) < or = 50% of predicted

          -  Smoking history of at least 10 pack-years

          -  Able to ambulate independently or with the use of an ambulatory assist device (such as
             a cane or walker)

        Exclusion Criteria:

          -  Currently taking > 500 I.U. per day of vitamin D supplements

          -  Primary diagnosis of asthma

          -  Uncompensated heart failure

          -  Heart attack in the previous 6 months

          -  Kidney disease (glomerular filtration rate < 45 mL/min/1.73m2)
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Nivolumab; Docetaxel/Paclitaxel
Intervention MeSH terms: Paclitaxel; Docetaxel; Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable
      advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men & women ≥20 years of age

          -  Histologically confirmed unresectable advanced or recurrent esophageal cancer

          -  Refractory to or intolerant of standard therapy

          -  ECOG Performance Status score 0 or 1

          -  A life expectancy of at least 3 months

        Exclusion Criteria:

          -  Current or past history of severe hypersensitivity to any other antibody products

          -  Patients with multiple primary cancers

          -  Patients with any metastasis in the brain or meninx that is symptomatic or requires
             treatment

          -  Patients with active, known or suspected autoimmune disease
A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: celecoxib; tramadol HCL
Intervention description: 200 mg capsules BID for 6 weeks; 50 mg capsules QID for 6 weeks
Intervention MeSH terms: Celecoxib; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 802.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic low back pain

Summary:

      To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low
      Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject presents with duration of chronic low back pain of > 3 months requiring
             regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have
             been the sole analgesic used

        Exclusion Criteria:

          -  The subject has chronic low back pain, which is neurologic in etiology (i.e.,
             radiculopathy, neuropathy, myelopathy)
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Condition: Sialorrhea
MeSH terms: Sialorrhea
Intervention: MYOBLOC; PLACEBO
Intervention description: MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Sialorrhea; Parkinson's disease; Amyotrophic lateral sclerosis (ALS); stroke; neuroleptics

Summary:

      This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea
      (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected
      directly into the salivary glands. MYOBLOC has been shown in previous trials to safely
      decrease saliva production, thereby demonstrating its potential as a safe and effective
      treatment for troublesome sialorrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring
             secondary to any disorder or related to any cause

          -  Investigator sites will review entire list of inclusion criteria with potential
             subjects

        Exclusion Criteria:

          -  Any known prior exposure to botulinum toxin type B, or known adverse reaction or
             sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC
             solution components.

          -  Prior botulinum toxin treatment to the salivary glands at any time

          -  Investigator sites will review entire list of exclusion criteria with potential
             subjects
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; secukinumab (AIN457); etanercept
Intervention description: Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept; secukinumab (AIN457) 150mg or 300mg subcutaneous; etanercept 50mg subcutaneous
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis,; inflammatory skin disease,; scaly patches; Psoriasis; inflammatory skin disease

Summary:

      This study will assess the safety and efficacy of secukinumab compared to placebo and
      etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with chronic, plaque-type psoriasis for at least 6 months

          -  Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than
             3, and greater than 10% body surface area

          -  Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or
             systemic therapies)

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic
             and guttate psoriasis)

          -  Drug induced psoriasis

          -  Use of other psoriasis treatments during the study

          -  Prior use of etanercept

          -  Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the
             IL-17 receptor

          -  Pregnant or lactating women; women who do not agree to use contraception during the
             study and for 16 weeks after stopping treatment

          -  Significant medical problems such as uncontrolled high blood pressure, congestive
             heart failure, etc.

          -  History of an ongoing, chronic or recurrent infection or evidence of tuberculosis

          -  Allergy to rubber or latex

        Other protocol-defined inclusion/exclusion criteria may apply