bioihbjkbjnl/mcl2 huggingface dataset:
ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Trastuzumab; Fluorouracil; Cisplatin; Capecitabine
Intervention description: Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression; 800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles; 1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles
Intervention MeSH terms: Capecitabine; Fluorouracil; Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 584.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall
      survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the
      chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab
      (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg)
      every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800
      mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion
      every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks)
      and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab
      (Herceptin) will continue until disease progression. The target sample size is 300-600
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >=18 years of age

          -  Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or
             gastro-esophageal junction

          -  Adenocarcinoma

          -  HER2-positive tumors

        Exclusion Criteria:

          -  Previous chemotherapy for advanced/metastatic disease

          -  Lack of physical integrity of the upper gastrointestinal tract, or malabsorption
             syndrome

          -  History of cardiac disease

          -  Dyspnoea at rest, due to complications of advanced malignancy or other disease, or
             patients who require supportive oxygen therapy
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Intervention: QVA149; Tiotropium; Placebo to QVA149; Placebo to tiotropium; Salbutamol/albuterol
Intervention description: QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI; Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device; Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI; Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device; salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.
Intervention MeSH terms: Glycopyrrolate; Albuterol; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 247.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Dyspnea; QVA149; tiotropium

Summary:

      This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe
      Chronic Obstructive Pulmonary Disease (COPD) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe stable chronic obstructive pulmonary disease

          -  Smoking history of 10 pack years

          -  Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%

          -  Patients must be able to use computer mouse and display

          -  mMRC grade>2

        Exclusion Criteria:

          -  Patients with a history of long QT syndrome

          -  Patients with Type I or uncontrolled Type II diabetes

          -  Patients who have had a COPD exacerbation or respiratory tract infection within 6
             weeks prior to screening

          -  Patients with any history of asthma

          -  Patients with pulmonary lobectomy, lung volume reduction surgery, or lung
             transplantation

          -  Patients with concomitant pulmonary disease

          -  Patients requiring long term oxygen therapy (>15 h a day)

        Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Condition: Tuberous Sclerosis; Subependymal Giant Cell Astrocytoma
MeSH terms: Astrocytoma; Tuberous Sclerosis; Sclerosis
Intervention: Everolimus; Placebo
Intervention description: Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets.; Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.
Intervention MeSH terms: Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Healthy volunteers: No
Keywords: SEGA; Tuberous Sclerosis; Subependymal Giant Cell Astrocytoma; mTOR; RAD001; Mamalian Target Rapamycin; Everolimus; TSC

Summary:

      This study evaluated the efficacy and safety of Everolimus in treating patients with
      Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All Ages

          -  Definite diagnosis of Tuberous Sclerosis according to the modified Gomez criteria

          -  At least one Subependymal Giant Cell Astrocytoma of at least 1 cm in diameter

          -  Evidence of SEGA worsening as compared to prior MRI scans

          -  Females of child bearing potential must use birth control

          -  Written informed consent

        Exclusion Criteria:

          -  SEGA related surgery is likely to be required in the opinion of the investigator

          -  Recent heart attack, cardiac related chest pain or stroke

          -  Severely impaired lung function

          -  Severe liver dysfunction

          -  Severe kidney dysfunction

          -  Pregnancy or breast feeding

          -  Current infection

          -  History of organ transplant

          -  Surgery within two months prior to study enrollment

          -  Prior therapy with a medication in the same class as Everolimus

          -  Uncontrolled high cholesterol

          -  Uncontrolled diabetes

          -  HIV

          -  Patients with metal implants thus prohibiting MRI evaluations

        Other protocol-defined inclusion/exclusion criteria may apply
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Intervention: Linaclotide 290 micrograms; Linaclotide 145 micrograms; 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; 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: 633.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Constipation; Chronic Constipation; Linaclotide

Summary:

      The objective of this trial is to determine the efficacy and safety of linaclotide
      administered to patients with chronic constipation (CC). The primary efficacy parameter is
      the percentage of patients in each treatment group that meet the protocol definition for
      Complete Spontaneous Bowel Movement (CSBM) Overall Responder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy according to the AGA criteria, with no clinically
             significant findings

          -  Patient has successfully completed protocol procedures (with no clinically significant
             findings): physical exam, 12-lead ECG, or clinical laboratory tests

          -  Patient meets protocol criteria for CC: reports < 3 bowel movements per week and
             reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation
             during > 25% of BMs

          -  Patient demonstrates continued chronic constipation through Pretreatment Period

          -  Patient is compliant with IVRS

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; tocilizumab [RoActemra/Actemra]
Intervention description: stable dose as prescribed; 8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra
      (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe
      rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic
      drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800
      mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued
      at a stable dose. Anticipated time on study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Active moderate to severe rheumatoid arthritis (RA)

          -  On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose
             of at least 15 mg/week for at least 6 weeks

          -  Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or
             equivalent) for at least 25 out of 28 days prior to first dose of study drug

          -  Body weight </= 150 kg

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months of study entry

          -  Rheumatic autoimmune disease other than RA

          -  Functional class IV according to American College of Rheumatology (ACR) classification

          -  Prior history of or current inflammatory joint disease other then RA

          -  Treatment with traditional DMARDs other than methotrexate within 1 month (for
             leflunomide 3 months) prior to baseline

          -  Treatment with any biologic drug that is used in the treatment or RA

          -  Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

          -  Known active current or history of recurrent infection

          -  History of or currently active primary or secondary immunodeficiency

          -  Positive for HIV
Genotropin Treatment In Very Young Children Born Small For Gestational Age
Condition: Infant, Small for Gestational Age
Intervention: Genotropin (PN-180,307) Somatropin; Control-no treatment
Intervention description: Injectable Genotropin; Control-no treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 19 Months
Maximum age: 29 Months
Healthy volunteers: No

Summary:

      To demonstrate the effect on height and psychomotor development of Growth Hormone treatment
      in very young children starting at an age of 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

        Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.

        Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific
        standards).

        Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length
        between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.

        Exclusion Criteria:

        Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational
        age), if associated with dysmorphic features.

        Severe prematurity (Gestational Age (GA) <32 weeks of gestation). Ongoing catch-up growth
        (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement
        interval).

        Severe familial short stature defined as: Father's height below 155 cm or mother's height
        below 145 cm.

        Defined neurological defects and/or severe neurodevelopmental delay.
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Condition: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Dyslipidemias
Intervention: ABT-335; Simvastatin; Placebo
Intervention description: 135 mg, daily, 12 weeks; daily, 12 weeks, see Arm Description for dosage information; Daily, 12 weeks, see Arm Description for placebo information
Intervention MeSH terms: Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 657.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia

Summary:

      The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)
      + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with
      multiple abnormal lipid levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with mixed dyslipidemia

          -  Subjects agree to utilize adequate birth control methods and to adhere to the American
             Heart Association (AHA) diet.

        Exclusion Criteria:

          -  Subjects with unstable medical conditions or medical conditions considered
             inappropriate in a clinical trial.

          -  Patients who are taking certain medications or unstable dose of specific medications.

          -  Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel (prefilled syringe, weekly intravenous IV administration).; Placebo (prefilled syringe, weekly IV administration).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450
      milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive
      disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Treatment naive in the current episode or have inadequate response to 1-3
             antidepressant therapies given at adequate dose and duration in the current episode

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the investigator
Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Weight Loss
Intervention: Rifaximin
Intervention description: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment will not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment.
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Small Bowel Bacterial Overgrowth; Weight Loss; Gastrointestinal; Rifaximin

Summary:

      The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in
      patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was
      that SBBO is an important contributor to the development of weight loss in individuals with
      PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in
      patients with PD and 2) determine the response to its treatment with a poorly absorbed
      antibiotic. The investigators performed a prospective, observational case-control study (Part
      1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients
      who experienced significant weight loss while Controls were defined as those PD patients who
      did not experience significant weight loss.
    

Eligibility criteria:

        Inclusion criteria: Parkinson's Disease

        Exclusion Criteria:

          1. Wheelchair-bound, akinetic individuals

          2. Tube-fed individuals

          3. Presence of dementia

          4. Unwilling or unable to complete the tests

          5. Allergic or intolerant to rifaximin

          6. Presence of chronic upper or lower gastrointestinal disorders that have symptoms that
             may be confused with SBBO (e.g., irritable bowel syndrome, inflammatory bowel disease,
             celiac disease, functional dyspepsia, gastroparesis, and chronic pancreatitis)

          7. Presence of prior surgery on the gastrointestinal tract except cholecystectomy,
             appendectomy or herniorrhaphy

          8. Presence of severe concomitant acute or chronic medical condition that may interfere
             with the completion or interpretation of the test results

          9. Women of childbearing potential. Given the age of patients with Parkinson's disease,
             we do not anticipate this being a large population.

         10. Use of antibiotics within 1 month of breath testing