bioihbjkbjnl/mcl2 huggingface dataset:
Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: oophorectomy; Tamoxifen
Intervention description: Excision of an ovary; 20 mg orally every day
Intervention MeSH terms: Tamoxifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; secondary; Hormone Receptor-Positive Breast Cancer

Summary:

      This study will determine if hormone receptor positive premenopausal metastatic breast cancer
      patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a
      longer survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Estrogen receptor or progesterone receptor positive breast cancer

          -  Premenopausal with regular menstrual cycles

        Exclusion Criteria:

          -  Current oral contraceptives
A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
Condition: Thromboembolism
MeSH terms: Sinus Thrombosis, Intracranial; Thrombosis; Thromboembolism
Intervention: Dabigatran etexilate; Warfarin
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      This is a multi-center, prospective, international, randomized (1:1), open-label study with
      two parallel groups. This phase III study is planned to investigate the efficacy and safety
      of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of
      major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with
      blinded endpoint adjudication.
    

Eligibility criteria:

        Inclusion criteria:

          -  Written informed consent in accordance with International Conference on Harmonization
             (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

          -  Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or
             without intracranial haemorrhage

          -  Completion of anticoagulation therapy for 5-15 days which has been administered until
             randomisation; anticoagulation must include full-dose low molecular weight heparin or
             unfractionated heparin

          -  Eligibility for treatment with an oral anticoagulant

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system
             infection or due to head trauma

          -  Planned surgical treatment for CVT

          -  Conditions associated with increased risk of bleeding

          -  History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence
             according to Investigator judgment

          -  Treatment with an antithrombotic regimen for an indication other than CVT and
             requiring continuation of that treatment for the original diagnosis without change in
             the regimen

          -  Severe renal impairment

          -  Active liver disease

          -  Pregnancy, nursing or planning to become pregnant while in the trial

          -  Further exclusion criteria apply
Safety and Efficacy of Emixustat in Stargardt Disease
Condition: Stargardt Disease
MeSH terms: Stargardt Disease; Macular Degeneration
Intervention: Emixustat; Placebo
Intervention description: Once daily oral tablet taken for 24 months; Once daily oral tablet taken for 24 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, double-masked, placebo-controlled study to evaluate the efficacy and safety of emixustat compared to placebo in subjects who have Macular Atrophy secondary to Stargardt disease.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-Masked
Enrollment: 194.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Stargardt Disease; STGD; ABCA4

Summary:

      The purpose of this study is to determine if emixustat hydrochloride reduces the rate of
      progression of macular atrophy compared to placebo in subjects with Stargardt disease.

      Funding Source -- FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of macular atrophy secondary to Stargardt disease (STGD)

          -  Macular atrophy measured to fall within a defined size range

          -  Two mutations of the ABCA4 gene. If only one mutation, a typical STGD appearance of
             the retina.

          -  Visual acuity in the study eye of at least 20/320

        Exclusion Criteria:

          -  Macular atrophy secondary to a disease other than STGD

          -  Mutations of genes, other than ABCA4, that are associated with retinal degeneration

          -  Surgery in the study eye in the past 3 months

          -  Prior participation in a gene therapy or stem cell clinical trial for STGD

          -  Recent participation in a clinical trial for STGD evaluating a complement inhibitor or
             vitamin A derivative

          -  Use of certain medications in the past 4 weeks that might interfere with emixustat

          -  An abnormal electrocardiogram (ECG)

          -  Certain abnormalities on laboratory blood testing

          -  Female subjects who are pregnant or nursing
Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM
Condition: Overweight and Obesity; Eating Behavior
MeSH terms: Overweight
Intervention: Placebo; Bromocriptine-QR
Intervention description: 2 capsules, orally administered once; 1.6mg (2 0.8mg capsules), orally administered once
Intervention MeSH terms: Bromocriptine
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomly assigned to one of two possible intervention arms (active drug vs. placebo) at baseline. Following a 2-week washout period, participants receive the other intervention.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bromocriptine; dopamine agonist; TaqIA polymorphism; eating behavior; food intake; overweight; obesity

Summary:

      The current project applies an integrative three-prong approach to investigate the potential
      of the dopamine D2 receptor (DRD2) agonist bromocriptine to: 1) increase homeostatic
      satiation signaling, 2) alter neural circuitry to reduce hedonically motivated food intake,
      and 3) examines a genetic predisposition that may markedly impact the effectiveness of this
      medication in those at high risk for T2DM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Baseline BMI between 25 and 35

        Exclusion Criteria:

          -  Individuals with current fMRI contraindications (e.g., metal implants, braces)

          -  Probable current Axis I psychopathology (e.g., major depression disorder, panic
             disorder, generalized anxiety disorder, bipolar disorder)

          -  Habitual use of cigarettes or illicit drugs

          -  Pregnancy or breastfeeding

          -  Diagnosis of serious medical problems (e.g., diabetes, cardiovascular disease, stroke)

          -  Current weight loss dieting and/or weight fluctuations great than 10 lbs in the
             previous 6 weeks

          -  Do not consume dairy

          -  Allergy to bromocriptine, dairy, and nuts
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Condition: Breast Cancer; Low Bone Mineral Density; Osteopenia
MeSH terms: Breast Neoplasms; Bone Diseases, Metabolic
Intervention: Placebo; AMG 162 / Denosumab
Intervention description: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months; 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 252.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC; osteopenia; Low bone density

Summary:

      The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects
      undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
    

Eligibility criteria:

        -  Histologically or cytologically confirmed adenocarcinoma of the breast

          -  Subjects with early stage disease who are estrogen receptor positive and who have
             completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone
             therapy) and are currently on or will initiate aromatase inhibitor therapy, and are
             expected to stay on aromatase inhibitor therapy for the duration of the 24-month study

          -  All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute
             toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer
             Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

          -  Female > 18 years of age

          -  ECOG Performance status 0 and 1

          -  Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of
             -1.0 to -2.5

          -  Subject is willing and able to provide signed consent before any study-specific
             procedure

        Other criteria also apply.
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin plus metformin IR; Placebo plus metformin IR
Intervention description: Tablets, Oral, 2.5 mg, Twice daily, 12 weeks; Tablets, Oral, Placebo, Twice daily, 12 weeks
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for
      participants taking saxagliptin in combination with metformin immediate release (IR) versus
      metformin IR alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  18-78 years of age

          -  Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least
             8 weeks

          -  A1C: 7-10%

          -  C-peptide: ≥ 0.8 ng/mL

          -  Body mass index (BMI): ≤45 kg/m^2

        Exclusion Criteria:

          -  Women of childbearing potential unable or unwilling to use acceptable birth control

          -  Women who are pregnant or breastfeeding

          -  Fasting plasma glucose (FPG) >270 mg/dL

          -  Significant cardiovascular history

          -  Symptoms of poorly controlled diabetes

          -  History of diabetic ketoacidosis or hyperosmolar nonketotic coma

          -  Insulin therapy within one year of screening

          -  Cardiovascular even within the prior 6 months

          -  New York Heart Association Stage III/IV congestive heart failure and/or known left
             ventricular ejection fraction <=40%

          -  Significant history of renal or hepatic disease

          -  History of a psychiatric disorder, alcohol or drug abuse within the previous year

          -  Treatment with potent CYP3A4 inhibitors or inducers

          -  Immunocompromised participants

          -  Active liver disease or clinically significant abnormal hepatic, renal , endocrine,
             metabolic, or hematological screening tests
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin
Condition: Intraoperative Complications; Thermal Injury; Electrocoagulation
MeSH terms: Intraoperative Complications; Wounds and Injuries; Burns
Intervention: Covidien Triad monopolar generator
Intervention description: Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Electrosurgery; Radiofrequency energy; Monopolar instruments; Capacitive coupling; Thermal injury; Surgical complications

Summary:

      Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy
      operation. The appearance of burns are common following laparoscopic cholecystectomy;
      particularly at the port site of the active electrode. Willson et al found that 9 out of 19
      skin biopsies from the skin adjacent to the port site of the monopolar instrument's active
      electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997)
      11:653] Authors have speculated that using different generator modes may lead to less
      capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support
      these speculations.

      The investigators hypothesize that capacitive coupling electrosurgical injuries from
      monopolar instruments are occurring during laparoscopic cholecystectomy operations. The
      investigators hypothesize that use of blend modes will reduce the incidence of capacitive
      coupling thermal injuries during laparoscopic operations in comparison to coag modes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older planned to undergo elective laparoscopic cholecystectomy

        Exclusion Criteria:

          -  Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: pemetrexed; etoposide; carboplatin
Intervention description: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles; 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles; Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Intervention MeSH terms: Carboplatin; Etoposide; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 908.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a Phase 3, global, multi-center, open-label study of patients with
      extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to
      receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated
      that pemetrexed plus carboplatin will offer similar survival benefits as compared to
      etoposide plus carboplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of extensive stage small cell lung cancer (SCLC)

          -  Capable of self-care but may be unable to carry out any work activities.

          -  No prior anticancer therapy for SCLC

        Exclusion Criteria:

          -  have previously participated in a study involving pemetrexed

          -  have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication
Seroquel XR in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Quetiapine fumarate (Seroquel)
Intervention description: 600mg Extended release tablet, oral, once daily
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Quetiapine efficacy in schizophrenia

Summary:

      The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia
      patients with acute worsening symptoms. Consequently, to assess whether the study drug is
      safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42
      days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets the DSM-IV criteria for schizophrenia

          -  Patient has a PANSS total score ≥ 70 at baseline

          -  Patient has a CGI-S score of ≥ 4(moderately ill) at baseline

          -  Patient is healthy on the basis of physical examination and vital signs at baseline

        Exclusion Criteria:

          -  Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis,
             or ecstasy abuse

          -  Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B
             or C virus antigen

          -  Patient with unstable or inadequately treated Diabetes Mellitus

          -  Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline
Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: tension-free vaginal tape; TVT-SECUR device
Intervention description: Retropubic mid-urethral sling; Mid-urethral mini-sling
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 281.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: stress urinary incontinence; sling procedures; tension-free vaginal tape

Summary:

      The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal
      tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary
      incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence symptoms

          -  Urodynamic stress incontinence confirmed with multichannel urodynamic testing

          -  Age of at least 21 years

          -  Desires surgical correction of stress urinary incontinence

        Exclusion Criteria:

          -  Post-void residual volume >100cc

          -  Detrusor overactivity on preoperative multichannel urodynamic testing

          -  History of previous synthetic, biologic or fascial sub-urethral sling

          -  Desires future childbearing

          -  History of bleeding diathesis or current anti-coagulation therapy

          -  Current genitourinary fistula or urethral diverticulum

          -  Reversible cause of incontinence (i.e. drug effect)

          -  Contraindication to surgery
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD); Anti-Tumor Necrosing Factor (TNF) Therapy
Intervention description: IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.; During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).; Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months
Intervention MeSH terms: Abatacept; Antirheumatic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1286.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to summarize the safety and tolerability of abatacept during 6
      months of combined treatment with one or more of the background non-biologic disease
      modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects
      with active RA. Secondary objectives assessed the clinical efficacy of combination treatment,
      including disease activity, physical function, and quality of life outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed double-blind portion of the IM101064 study.

          -  Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis

          -  American College of Rheumatology (ACR) functional class I, II, III

          -  Subjects currently or previously received an anti-TNF therapy at an approved labeled
             dose for at least 3 months

        Exclusion Criteria:

          -  Subjects with active vasculitis of a major organ system (except subcutaneous
             rheumatoid nodules)

          -  History of cancer within the last 5 years (other than non-melanoma skin cell cancers
             cured by local resection)