bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib
Intervention description: This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic myeloid leukemia,; CML,; nilotinib,; myelogenous,; Philadelphia chromosome

Summary:

      This study will further investigate the safety and efficacy of nilotinib in newly diagnosed
      chronic myeloid leukemia patients in the chronic phase
    

Eligibility criteria:

        Inclusion Criteria:

        -Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of
        study entry

        Exclusion Criteria:

          -  Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments
             (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or
             anagrelide

          -  Uncontrolled congestive heart failure or hypertension

          -  Myocardial infarction or unstable angina pectoris within past 12 months

          -  Known T315I mutations

          -  QTcF >450 msec

          -  Significant arrhythmias

        Other protocol-defined inclusion/exclusion criteria may apply
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Condition: Arthritis, Juvenile Idiopathic
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Etanercept
Intervention description: Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of etanercept on the clinical benefit, safety, and
      physical functioning (ability to function in daily life) in children and adolescent subjects
      with 3 subtypes of childhood arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with a diagnosis per International League of Associations for
             Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis
             (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between
             the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and
             17 years.

          -  >= 2 active joints and the following for the relevant JIA subtype: extended
             oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response
             to a disease modifying antirheumatic drug (DMARD); or ERA with a history of
             intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug
             (NSAID) or a DMARD.

        Exclusion Criteria:

          -  Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated
             arthritis per ILAR criteria.

          -  Other rheumatic diseases.

          -  Active uveitis within 6 months of the baseline visit.

          -  Any other significant health problem.
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
Condition: Chemotherapy-Induced Nausea and Vomiting (CINV)
MeSH terms: Nausea; Vomiting
Intervention: Comparator: fosaprepitant dimeglumine; Comparator: Aprepitant; Dexamethasone; Dexamethasone; Ondansetron
Intervention description: single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.; Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).; Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.; Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.; single IV dose of 32 mg of ondansetron on Day 1.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2322.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to
      prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female and is at least 18 years of age; scheduled to receive his or
             her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted
             life expectancy of 3 months or greater

          -  Patient is post menopausal or, if premenopausal, must use double-barrier contraception

        Exclusion Criteria:

          -  Patient has symptomatic primary or metastatic CNS malignancy

          -  Patient has received or will receive Radiation therapy to the abdomen or pelvis in the
             week prior to Treatment Day 1 though Day 6

          -  Patient has vomited in the 24 hours prior to treatment Day 1

          -  Patient has an active infection; Patient uses illicit drugs or has current evidence of
             alcohol abuse

          -  Patient is pregnant or breast feeding
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Condition: Refractory Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: TAS-102; Placebo
Intervention description: 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.; 35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastric Cancer; Metastatic Gastric Cancer

Summary:

      The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC)
      with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma
             including adenocarcinoma of the gastroesophageal junction.

          2. Has previously received at least 2 prior regimens for advanced disease and were
             refractory to or unable to tolerate their last prior therapy.

          3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in
             Solid Tumors (RECIST) 1.1 criteria.

          4. Is able to take medications orally (ie, no feeding tube).

          5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.

          6. Has adequate organ function as defined by protocol defined labs.

          7. Women of childbearing potential must have a negative pregnancy test and must agree to
             adequate birth control if conception is possible. Males must agree to adequate birth
             control.

        Exclusion Criteria:

          1. Has certain serious illnesses or medical conditions

          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,
             extended field radiation, received investigational agent within the specified time
             frames prior to study drug administration.

          3. Has previously received TAS-102.

          4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for
             Adverse Events Grade 2 attributed to any prior therapies.

          5. Is a pregnant or lactating female.
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: adalimumab
Intervention description: 40 mg every other week or 40 mg every week by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1469.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab
      treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate
      the effectiveness of adalimumab retreatment in participants who had therapeutic response to
      adalimumab and were then withdrawn from adalimumab treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was age 18 or older and in good health (Investigator discretion) with a recent
             stable medical history.

          -  Subjects who met the requirements from previous adalimumab psoriasis study
             participation.

        Exclusion Criteria:

          -  Subject considered by the Investigator, for any reason, to be an unsuitable candidate
             for the study.

          -  Female subject who was pregnant or breast-feeding or considering becoming pregnant.
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Glucosamine sulphate and chondroitin sulphate association; Cosamin DS® (Nutramax)
Intervention description: glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal; oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis (OA); knee

Summary:

      The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin
      sulfate association in the treatment of patients with osteoarthrosis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects have to read and sign the approved the Informed Consent form prior to any
             participation in the study.

          -  Male or female Subjects, aged upper to 40 years.

          -  Osteoarthritis of the knee confirmed by radiological examination.

          -  Visual analogue scale (VAS) > 40 mm.

          -  Kellgren and Lawrence grade 1 to 3.

          -  Clinical diagnosis of pain and functional limitation.

        Exclusion Criteria:

          -  History of significant trauma or surgery in the affected joint.

          -  Pregnant women, lactating or not using appropriate contraceptive method.

          -  History or presence of active rheumatic disease that may be responsible for secondary
             osteoarthritis.

          -  Severe inflammation of the joint confirmed by physical examination (excluding also
             erythrocyte sedimentation <40mm/h and rheumatoid factor <1:40).

          -  Body mass index > 30.

          -  Hematologic abnormalities, liver, renal or metabolic functions which undermine the
             serious participation of the patient (at investigator's criteria).

          -  Systemic administration and/or intra-articular corticosteroids in the last 3 months.

          -  Have made use of glucosamine and/or chondroitin.

          -  Lequesne index of > 12.

          -  Arthroplasty in the affected joint.

          -  Use of narcotic analgesics.

          -  Any condition that, in the opinion of the investigator, renders the patient unable to
             participate in the study.
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Linagliptin + metformin; Linagliptin+metformin; Metformin
Intervention description: Linagliptin tablet low dose + metformin tablet 500 mg bid; Linagliptin low dose tablet + metformin 1000 mg tablet bid; Metformin 1000 mg tablet bid
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A phase III randomised, double-blind parallel group extension study to investigate the
      efficacy and safety of twice daily administration of the free combination of linagliptin 2.5
      mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with
      metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing
      the double-blind part of study 1218.46
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated written informed consent, at the latest by the date of Visit 1

          -  Patients completing the entire treatment period of the double-blind study 1218.46, who
             are not treated with rescue medication (Visit 7)

        Exclusion criteria:

          -  Patients who meet one or more of the withdrawal criteria of the treatment period of
             the previous study 1218.46

          -  Pre-menopausal women (last menstruation equal or less than 1 year prior to signing
             informed consent) who:

          -  are nursing or pregnant,

          -  or are of child-bearing potential and are not practicing an acceptable method of birth
             control, or do not plan to continue using this method throughout the study and do not
             agree to submit to periodic pregnancy testing during participation in the trial.
             Acceptable methods of birth control include transdermal patch, intra uterine
             devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual
             abstinence and vasectomised partner and in addition for male partners a barrier
             method, such as the use of condom with spermicide. No exception will be made.

          -  Alcohol abuse within the 3 months prior to informed consent that would interfere with
             study participation

          -  Drug abuse that in the opinion of the investigator would interfere with trial
             participation

          -  Any other clinical condition which, in the opinion of the investigator, would not
             allow safe completion of the protocol and safe administration of the study medication
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Condition: Menopause; Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Soy isoflavones; Placebo
Intervention description: Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.; Placebo soy isoflavones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 248.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring
      compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women
      who have recently gone through menopause.

      Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally
      occurring spinal bone loss and improve biological and other emotional changes of menopause.
    

Eligibility criteria:

        Inclusion Criteria

          -  Absence of menstrual period for 12 months but not more than 5 years, or absence of
             menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than
             40 IU/L

        Exclusion Criteria

          -  Treatment with estrogens, progesterone, raloxifene, or tamoxifen

          -  Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids

          -  Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry

          -  Use of antibiotics in the month prior to study entry

          -  Use of prescription medication to treat hot flashes

          -  Chemical menopause, including post-chemotherapy

          -  Hyperthyroidism

          -  Hypothyroidism

          -  Uncontrolled diabetes

          -  Malabsorption syndromes or other chronic diseases

          -  Body mass index (BMI) less than 20 or greater than 32

          -  Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Intervention: Indomethacin; Placebo
Intervention description: 100 mg Indomethacin PR x 1
Intervention MeSH terms: Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post ERCP acute pancreatitis; Post Fine Needle Aspiration (FNA) acute pancreatitis; Indomethacin; Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

Summary:

      The purpose of this study is to assess whether peri-procedural administration of rectal
      indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled for an ERCP at Dartmouth-Hitchcock

          2. Age greater than 18 years old

          3. Ability to provide written informed consent

        Exclusion Criteria:

          1. Inability to provide written informed consent

          2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis

          3. Current ongoing acute pancreatitis

          4. Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

          5. Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer
             disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)

          6. Pregnant or nursing mothers
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Daclatasvir; Sofosbuvir
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus
      (HCV) Genotype 3 infection
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Subjects must be able to understand and agree to comply with the prescribed dosing
             regimens and procedures, report for regularly scheduled study visits, and reliably
             communicate with study personnel about adverse events and concomitant medications

          -  Subjects chronically infected with hepatitis C virus (HCV) genotype 3

          -  Subjects who are HCV treatment-naive

          -  Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A
             inhibitors is prohibited)

          -  HCV RNA ≥10,000 IU/mL at screening

        Key Exclusion Criteria:

          -  HCV Genotypes other than genotype-3 infection; mixed genotype infections are not
             permitted

          -  Liver or any other organ transplant (including hematopoietic stem cell transplants)
             other than cornea and hair

          -  Current or known history of cancer (except in situ carcinoma of the cervix or
             adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
             to screening

          -  Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained
             imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this
             was performed)

          -  Evidence of decompensated liver disease including, but not limited to, radiologic
             criteria, a history or presence of ascites, bleeding varices, or hepatic
             encephalopathy
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Condition: Contraception
Intervention: LCS12; LCS16
Intervention description: Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h; Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2885.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; Intrauterine; IUD; IUS

Summary:

      This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS).
      The purpose of the study is to investigate which of the 2 administered doses is the lowest
      effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for
      contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5
      years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 35 years (inclusive), in good general health and requesting
             contraception.

          -  Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity
             without hormonal contraceptive use).

        Exclusion Criteria:

          -  Known or suspected pregnancy or is lactating.

          -  History of ectopic pregnancies.

          -  Any genital infection (until successfully treated).

          -  Abnormal uterine bleeding of unknown origin.