bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide 290 micrograms; Matching placebo
Intervention description: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study; Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
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: 803.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Constipation; Linaclotide

Summary:

      The objective of this trial is to determine the efficacy and safety of linaclotide
      administered to patients with irritable bowel syndrome with constipation (IBS-C).

      The primary efficacy parameter is the percentage of patients in each treatment group that
      meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC)
      Responder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has
             two or more of the following three features:

               1. Relieved with defecation

               2. Onset associated with a change in frequency of stool

               3. Onset associated with a change in form (appearance) of stool

          -  Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative,
             suppository, or enema use during the preceding 24 hours) and reports straining, lumpy
             or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs

          -  Patient has successfully completed protocol procedures (with no clinically significant
             findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may
             require a colonoscopy per American Gastroenterological Association (AGA) guidelines)

          -  Patient is compliant with Interactive Voice Response System (IVRS) for daily diary
             reporting of BM habits and IBS symptoms

        Exclusion Criteria:

          -  Patient has history of loose or watery stools for >25% of BMs

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a history
             of a disease or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history or concomitant medication use that could confound the study assessments
Major Depressive Disorder With Mixed Features - Extension
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Lurasidone
Intervention description: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Intervention MeSH terms: Lurasidone Hydrochloride
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: 75 Years
Healthy volunteers: No
Keywords: Depression; Lurasidone; Latuda

Summary:

      Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with
      mixed features.This clinical study is designed to test how well Lurasidone works to treat
      major depressive disorder with mixed features over time.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject provides written informed consent and is willing and able to comply with the
        protocol in the opinion of the Investigator.

        Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study
        D1050305 (NCT#01423240).

        Subject is judged by the Investigator to be suitable for participation in a 12-week
        clinical trial involving open-label lurasidone treatment and is able to comply with the
        protocol in the opinion of the Investigator.

        Exclusion Criteria:

        Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of
        evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

        Subject is considered by the Investigator to be at imminent risk of suicide or injury to
        self, others, or property.
Pediatric Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Quetiapine XR; Placebo
Intervention description: Oral treatment with 150 up to 300 mg/day once daily in the evening; Oral treatment once daily in the evening
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 193.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar Depression; Depression; Children; Adolescents; Seroquel; Bipolar Depression in Children and Adolescents

Summary:

      The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine
      XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating
      children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with
      placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent by one or both parents or legal guardian and written
             assent by the patients before any study procedures are performed.

          -  The patient must have a documented clinical diagnosis for bipolar I or bipolar II
             disorder, and including current episode depressed.

          -  Patients are required to be in outpatient status at the enrollment and randomization
             visits and believed likely to remain an outpatient for the duration of the study.

          -  Patients must be able to swallow the study medication tablets.

        Exclusion Criteria:

          -  The patient must not have been diagnosed with Tourette's Disorder,
             Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder,
             Autistic Disorder and/or Asperger's Disorder.

          -  Patient can not have a history of non-response to an adequate treatment to more than 2
             antidepressants during the current episode.

          -  The patient must not have received electroconvulsive therapy (ECT) within 30 days
             before participating in the study.

          -  Patients who in your doctors judgement pose a current suicidal or homicidal risk.
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide; Placebo
Intervention description: Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks; Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 804.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Lung function; Exacerbations; Quality of Life

Summary:

      To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with
      moderate to severe COPD during one year of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe
             stable COPD

        Exclusion Criteria:

          -  History or current diagnosis of asthma, recent respiratory tract infection or acute
             COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic
             hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
Condition: Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Adenosquamous Cell
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Large Cell; Carcinoma, Adenosquamous
Intervention: CP 751,871 (Figitumumab); Erlotinib; Erlotinib
Intervention description: CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.; Erlotinib (one tablet of 150 mg/day PO).; Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 583.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IGR-1R; Non small cell lung cancer; CP-751; 871; Figitumumab

Summary:

      The objective of this study is to test a clinical benefit of the addition of CP 751,871 to
      erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The
      primary endpoint is Overall Survival (OS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non small cell lung cancer with a primary histology of squamous cell, large cell or
             adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

        Exclusion Criteria:

          -  Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.

          -  Prior Erlotinib therapy.

          -  Prior anti IGF IR based investigational therapy.
Open-Label Lesinurad Monotherapy Extension Study in Gout
Condition: Gout
MeSH terms: Gout
Intervention: lesinurad
Intervention description: Tablets, 400 mg QD
Intervention MeSH terms: Lesinurad
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will assess the serum uric acid lowering effects and safety of lesinurad over a
      long-term timeframe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand the study procedures and the risks involved and is
             willing to provide written informed consent before the first study related activity.

          -  Subject completed the double-blind treatment period in Study RDEA594-303 and was
             actively receiving and tolerating study medication (lesinurad or placebo) at Month 6
             visit.

          -  Subject is willing to adhere to the visit/protocol schedules.

          -  Subject is male or female; female subjects of childbearing potential must agree to use
             an effective non-hormonal method of birth control during the study and for at least 14
             days after the last dose of study medication.

        Exclusion Criteria:

          -  Subject has any other medical or psychological condition, which in the opinion of the
             Investigator and/or the Medical Monitor, might create undue risk to the subject or
             interfere with the subject's ability to comply with the protocol requirements or to
             complete the study.

          -  Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone
             diathesis.

          -  Subject developed kidney stones during Study RDEA594-303
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Maximum age: 110 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis

Summary:

      This is a multicenter, single-arm, extension study to characterize the long-term safety and
      tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in
      adults with Chronic Kidney Disease (CKD) on hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent prior to initiation of any study-specific
             activities/procedures

          -  Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or
             Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)

          -  Female subjects who are: post-menopausal (post-menopausal is defined as no menses for
             the previous 1 year and over the age of 50 years), surgically sterilized, have a
             medical condition that prevents pregnancy, remain abstinent, or are willing to use an
             acceptable method of effective contraception during the study and for 3 months after
             the last dose. Women of child-bearing potential (WOCBP) must have a negative serum
             pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study

          -  Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

        Exclusion Criteria:

          -  Currently receiving treatment in another investigational device or drug study (other
             than in one of the designated parent studies)

          -  Subject has known sensitivity to any of the products or components to be administered
             during dosing

          -  Subject has been prescribed cinacalcet by the primary nephrologist between the
             conclusion of the parent study and the start of dosing with AMG 416 in the current
             study

          -  Subject is receiving dialysis prescription dialysate calcium concentration < 2.25
             mEq/L

          -  Subject is pregnant or nursing
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: bosentan
Intervention description: Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)
Intervention MeSH terms: Bosentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pulmonary hypertension; bosentan; BENEFIT; CTEPH; inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Summary:

      The present trial investigates the long-term safety, tolerability and efficacy of bosentan in
      patients with inoperable CTEPH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients having completed the 16-week treatment period of protocol AC-052-366
             (NCT00313222)

          -  Signed informed consent

        Exclusion Criteria:

          -  Any major violation of protocol AC-052-366 (NCT00313222)

          -  Pregnancy or breast-feeding
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
Condition: Post-stroke Spasticity of the Upper Limb
MeSH terms: Muscle Spasticity; Stroke
Intervention: IncobotulinumtoxinA (400 Units); Placebo Comparator
Intervention description: Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection; Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the upper limb are effective in treating spasticity in patients after stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Upper limb spasticity

          -  Time since stroke greater than 3 months

          -  Need for 400 U Botulinum toxin type A

        Exclusion Criteria:

          -  Body weight below 50kg

          -  Fixed contractures of the upper limb

          -  Generalized disorders of muscle activity like Myasthenia gravis that preclude use of
             Botulinum toxin Type A

          -  Infection at the injection site
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: High Dose Methotrexate
Intervention description: Methotrexate will be given by IV at a dose of 12 gram/m2/dose.
The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: pediatrics; Osteosarcoma; Methotrexate; Outpatient

Summary:

      The primary purpose of this study is to determine the safety and feasibility of delivering
      HDMTX in an outpatient setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 6 years of age;

          -  Localized or metastatic osteosarcoma;

          -  Adequate renal function (GFR > 70 ml/1.73m2) prior to each cycle;

          -  No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient
             MTX cycle;

          -  Parent and/or patient must be able to provide written consent, and complete Patient
             Flow Sheets in English.

        Exclusion Criteria:

          -  Patients, in the opinion of the primary healthcare team, may not be able to comply
             with the safety monitoring requirements of the study, or in whom compliance is likely
             to be suboptimal.

          -  Pregnant females

          -  Breastfeeding females
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Levomilnacipran ER; Levomilnacipran ER; Placebo
Intervention description: Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.; Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.; Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.; Matching placebo capsules, oral administration, once daily for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 724.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Major Depressive Disorder

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major
      depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 8 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  any manic or hypomanic episode

               -  schizophrenia or any other psychotic disorder

               -  obsessive-compulsive disorder

          -  Patients who are considered a suicide risk
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: pregabalin
Intervention description: pregabalin
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: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: open-label; extension study; pregabalin; partial epilepsy

Summary:

      This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when
      administered by itself (without any other anti-epileptic medication) to epilepsy patients for
      the treatment of partial seizures. This is an extension study to a previous clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the previous protocol and wish to continue to receive pregabalin.

          -  Diagnosis of epilepsy with partial seizures

        Exclusion Criteria:

          -  Early withdrawal from the previous protocol, an episode of status epliepticus, or
             primary generalized epilepsy.