bioihbjkbjnl/mcl2 huggingface dataset:
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin; Placebo; Metformin; Sulphonylruea
Intervention description: One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.; One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.; The patient's stable dose of background metformin therapy should be continued throughout the study.; The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 469.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Canagliflozin; Placebo; Metformin; Sulphonylurea; Hemoglobin A1c; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are
      receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood
      sugar) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and be currently treated with metformin and
             sulphonylurea

          -  Patients in the study must have a HbA1c between >=7 and <=10.5%

          -  Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a
             severe hypoglycemic episode within 6 months before screening
Leukemia Stem Cell Detection in Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Allogeneic HCT; Consolidation chemotherapy
Intervention description: Allogeneic HCT; Cytarabine-based consolidation chemotherapy
Intervention MeSH terms: Cytarabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following
      induction chemotherapy. However, a large majority subsequently relapse and succumb to the
      disease. Currently, cytogenetics and molecular aberrations are the best prognostic
      indicators; however, these factors cannot prognosticate accurately for individual patients.
      Overall, the majority of patients with favorable or intermediate-risk AML will experience
      relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less
      than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably
      translate into cure. This study is undertaken to determine whether the presence of LSCs has
      prognostic value as well as to determine whether the presence of LSCs has predictive value.
      This study has an observational component, whereby we intent evaluate whether the presence or
      absence of LSCs is prognostic. This study also has an interventional component in which it
      uses LSC status to determine whether favorable and intermediate risk AML patients in CR
      receive consolidation with chemotherapy or allogeneic HCT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have previously signed the specimen procurement protocol consent associated with
             the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML
             therapy.

          2. Age 18 years and older

          3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and
             reviewed by an institutional hematopathologist

          4. Completion of induction therapy, as defined by the Investigator and post-induction
             bone marrow biopsy.

        Exclusion Criteria:

          1. Any debilitating medical or psychiatric illness that would preclude ability to follow
             study procedures.

          2. Indeterminate leukemia stem cell assay results at diagnosis.
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Condition: Bipolar Disorder; Major Depressive Episode
MeSH terms: Depression; Bipolar Disorder
Intervention: 7000lux broad-spectrum light; 50lux dim red light
Intervention description: dosage - 15-60minutes NOON-2PM daily; dosage: 15-60minutes NOON-2PM daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Disorder Depression Midday Light Therapy; Bipolar Disorder Type I or II

Summary:

      The purpose of this study is to understand the efficacy of light therapy for bipolar
      depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-65 years

          -  DSM-IV Criteria BD I or II depressive episode,

          -  SIGH-ADS >20; duration >2 weeks.

          -  Stable dose antidepressant drug >8 weeks with concurrent antimanic drug

          -  Controlled thyroid disease

          -  Subjects with preexisting eye diseases will be included.

          -  Able to provide informed consent

          -  Stable minimum dose antimanic drug >4weeks: lithium 0.5 mEq/L, divalproex Na 50
             mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily,
             risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and
             aripiprazole 5 mg qd.

          -  Stable unchanged psychotherapy for >16weeks

        Exclusion Criteria:

          -  The following eye diseases: retinal disease, cataract surgery and lens removal,
             macular degeneration,

          -  Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial
             drugs, melatonin and hypericum.

          -  Acute psychosis (DSM-IV Criteria)

          -  Rapid cycling in the past 1 year

          -  Obsessive compulsive disorder

          -  Alcohol or substance abuse or dependence in the past 6 months.

          -  MRS>5

          -  Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS
             item H11 >2)

          -  Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Condition: Parkinson's Disease; Helicobacter Infections; Motor Fluctuations
MeSH terms: Helicobacter Infections; Parkinson Disease
Intervention: clartihromycin, amoxicillin, and omeprazole; placebo
Intervention description: clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days; placebo therapy
Intervention MeSH terms: Amoxicillin; Omeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: Male
Healthy volunteers: No
Keywords: Parkinson's disease; levodopa; Helicobacter pylori

Summary:

      The purpose of this study is to determine whether treatment of H. pylori (an infection of the
      stomach) improves treatment effectiveness in patients with Parkinson's disease and motor
      fluctuations.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adults diagnosed with idiopathic Parkinson's disease, Hoehn & Yahr stage 2-4 in the
             "off" state, with no other concomitant neurologic diseases.

          -  Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy,
             but with wearing off phenomenon present between levodopa doses (average off time ≥3
             hours off time/day).

          -  Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is
             acceptable. Parkinson's disease treatment may also include any of the following
             medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B
             inhibitors, amantadine, anticholinergics.

          -  Positive for H. pylori IgG Ab by serum ELISA (before inclusion in randomized treatment
             arms).

        Exclusion criteria:

          -  Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding.

          -  History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal
             lesions.

          -  History of previous gastric surgery.

          -  History of previous brain surgery for Parkinson's disease.

          -  Family history of gastric cancer.

          -  Prior treatment for H. pylori+ status.

          -  Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or
             clarithromycin.

          -  Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole.

          -  Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide).

          -  Inability to tolerate or participate in testing in the morning in an "off" state.

          -  Inability to communicate effectively with study personnel in English.

          -  Pregnancy.
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism; Hemodialysis
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: paricalcitol; maxacalcitol; paricalcitol placebo; maxacalcitol placebo
Intervention MeSH terms: Ergocalciferols; Calcitriol; Maxacalcitol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Secondary hyperparathyroidism; Paricalcitol; Hemodialysis; Maxacalcitol

Summary:

      This study is a comparison of the efficacy and safety of paricalcitol injection with
      maxacalcitol injection in adult Japanese chronic kidney disease patients receiving
      hemodialysis with secondary hyperparathyroidism. The main objective of this study is to
      demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone
      without clinically significant hypercalcemia, compared to maxacalcitol injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable
             dialysate calcium and phosphate binders

          -  On three times weekly hemodialysis for at least 3 months prior with intact parathyroid
             hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total
             calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus
             (P) less than or equal to 6.5 mg/dL.

        Exclusion Criteria:

          -  Patients with a recent history of severe cardiovascular or hepatic disease,
             uncontrolled hypertension or uncontrolled diabetes

          -  Patients who have received a parathyroidectomy or ethanol infusion within the prior
             year

          -  Patients taking drugs that affect iPTH, calcium or bone metabolism

          -  Patients who will need to take chronic doses (greater than or equal to 2 consecutive
             weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or
             inducers (e.g., carbamazepine, rifampicin)

          -  Female patients who are pregnant, possibly pregnant, wish to become pregnant, or
             participate in breastfeeding during the study period.
Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Milnacipran; Placebo; Placebo; Milnacipran
Intervention description: Twice daily oral administration of Milnacipran for 5 weeks.; Twice daily oral administration of placebo for 5 weeks.; Twice daily oral administration of placebo for 5 weeks.; Twice daily oral administration of Milnacipran for 5 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: fibromyalgia; milnacipran; Forest Laboratories

Summary:

      The purpose of this study is to evaluate the effect of milnacipran on how the brain processes
      pain in patients with fibromyalgia and to assess the relationship between this effect and
      brain activation patterns during functional magnetic resonance imaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR)
             criteria

          -  Visual analog pain score between 40 and 90 mm

          -  Right-hand dominance

        Exclusion Criteria:

          -  Suicidal risk

          -  Substance Abuse

          -  Pulmonary dysfunction

          -  Renal impairment

          -  Active cardiac disease

          -  Autoimmune disease

          -  Uncontrolled narrow-angle glaucoma

          -  Active liver disease

          -  Cancer

          -  Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue

          -  Unstable endocrine disease

          -  Prostatic enlargement
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
Condition: Infertility
MeSH terms: Infertility
Intervention: Test culture; Control culture
Intervention description: A standard culture medium with added GM-CSF (ready-to-use); The same standard culture medium, but without any additions (ready-to-use)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1332.0
Sex: Female
Minimum age: 25 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: GM-CSF; infertility

Summary:

      This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium
      will increase the chance of a pregnancy after in vitro fertilisation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The couple or single woman has signed an informed consent form before any
             trial-related activities.

          -  In Vitro Fertilization (IVF) or IntraCytoplasmic Sperm Injection (ICSI) treatment
             indicated

          -  25-39 years of age (both inclusive)

          -  Regular menstrual cycle: 21-35 days (both inclusive)

          -  Women treated with a standard Gonadotropin-Releasing Hormone (GnRH) agonist or
             antagonist protocol and a Follicle Stimulating Hormone (FSH) / human Menopausal
             Gonadotropin (hMG) starting dose between 100 and 300 IU daily.

          -  human Chorionic Gonadotropin (hCG) administration when the leading follicle has a
             calculated diameter of minimum 17 mm, or the day after.

          -  At least 3 follicles with a calculated diameter of ≥ 14 mm at the day of hCG.

        Exclusion Criteria:

          -  The woman has previously participated in the DK001 study.

          -  Use of assisted hatching.

          -  Indication for Testicular Sperm Aspiration (TESA) or Percutaneous Epididymal Sperm
             Aspiration (PESA)

          -  Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with
             the interpretation of results of the study (including pre-implantation genetic
             diagnostics).

          -  Use of any investigational drug within 30 days before oocyte retrieval

          -  Any severe chronic disease of relevance for reproductive function.

          -  Oocyte donation patients (donor or recipient).
Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bortezomib (VELCADE); Bortezomib (VELCADE); Doxorubicin hydrochloride (DOXIL/CAELYX)
Intervention description: 1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.; 1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles..; mg/m^2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 646.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Doxil; Caelyx; Doxorubicin; Velcade; Bortezomib

Summary:

      The purpose of this study is to evaluate time to progression, overall survival, response rate
      and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE
      vs. VELCADE monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with multiple myeloma who have received at least 1 prior therapy and who have
             either responded and later had progressive disease or have progressed during their
             first therapy (primary refractory) are eligible for the study

          -  Patients who may have received prior doxorubicin but not more than a cumulative dose
             of 240 milligram per meter square (mg/m^2) doxorubicin, DOXIL, or the equivalent
             amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg
             epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)

          -  Must have normal cardiac function, as evidenced by a left LVEF within institutional
             normal limits.

        Exclusion Criteria:

          -  History of treatment with VELCADE or progressive disease while receiving an
             anthracycline-containing regimen

          -  No change in disease status during initial therapy

          -  No treatment for malignancy within past 5 yrs (other than multiple myeloma) or
             progressive disease while receiving anthracycline-containing regimen

          -  Non-secretory disease

          -  Myocardial infarct within past 6 months

          -  No major surgery in past 30 days.
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor
Intervention description: 150 mg tablet, oral use, every 12 hours (q12h)
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in
      participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and
      113 (NCT01685801).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants from Study 110 or Study 111 entering the ivacaftor arm must have
             completed the assigned study drug treatment duration in the previous study.

          -  Participants from Study 113 entering the ivacaftor arm must have completed all study
             related treatments through the Follow-up Visit and met the Study 113 responder
             criteria during the previous study.

          -  Participants entering the observational arm must have completed at least 4 weeks of
             study drug treatment in their previous study (Study 110 or Study 111), must have
             completed the previous study but do not wish to enroll in the ivacaftor arm, or must
             have completed the previous study but do not meet the inclusion criteria of the
             ivacaftor arm.

          -  Participants of childbearing potential entering the ivacaftor arm must not be
             pregnant.

          -  Participants entering the ivacaftor arm must be willing to comply with contraception
             requirements.

        Exclusion Criteria (Ivacaftor Arm Only):

          -  History of any illness or condition that might confound the results of the study or
             pose an additional risk in administering ivacaftor to the Participant.

          -  Use of moderate or strong inhibitors or inducers of cytochrome P450 (CYP) 3A.

          -  Evidence of cataract or lens opacity at or before the Day 1 Visit.