bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: pitavastatin; simvastatin
Intervention MeSH terms: Simvastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kowa; KRE; Hypercholesterolemia; combined dyslipidemia; dyslipidemia; pitavastatin; NK-104; simvastatin

Summary:

      The purpose of this study is to compare the efficacy and safety of pitavastatin with that of
      simvastatin in patients with risk factors for heart disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females (18-75 years of age)

          -  At least two cardiovascular disease risk factors

          -  Must have been following a restrictive diet

          -  Diagnosis of primary hypercholesterolemia or combined dyslipidemia

        Exclusion Criteria:

          -  Homozygous familial hypercholesterolemia

          -  Conditions which may cause secondary dyslipidemia

          -  Uncontrolled diabetes mellitus

          -  Abnormal pancreatic, liver or renal function

          -  Abnormal serum creatine kinase (CK) above the pre-specified level
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Azacitidine; Conventional Care Regimen
Intervention description: 75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity; Physician pre-selects prior to randomization from one of the following:
Intensive chemotherapy (cytarabine 100-200 mg/m^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
Best Supportive Care only; until study end
Intervention MeSH terms: Azacitidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 488.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia; Cytarabine; Vidaza; azacitidine; Intensive Chemotherapy; Low Dose Cytarabine; Celgene

Summary:

      The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional
      care regimens on overall survival in elderly AML patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of one of the following

               -  Newly diagnosed de novo acute myeloid leukemia (AML)

               -  AML secondary to myelodysplastic syndromes (MDS)

               -  AML secondary to exposure to leukemogenic therapy or agents with primary
                  malignancy in remission for at least 2 years

          -  Bone marrow blasts >30%

          -  Age ≥ 65 years

          -  Easter Cooperative Oncology Group (ECOG) 0-2

        Exclusion Criteria:

          -  Previous cytotoxic or biologic treatment for AML (except hydroxyurea)

          -  Previous treatment with azacitidine, decitabine or cytarabine

          -  Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)

          -  AML French American British subtype (FAB M3)

          -  AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes

          -  Prior bone marrow or stem cell transplantation

          -  Candidate for allogeneic bone marrow or stem cell transplant

          -  Diagnosis of malignant disease within the previous 12 months (excluding base cell
             carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy
             excised or irradiated with a high probability of cure)

          -  Malignant hepatic tumors

          -  Uncontrolled systemic infection

          -  Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or
             C

          -  Use of any experimental drug or therapy within 28 days prior to Day 1
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: metformin; Comparator: metformin; Comparator: Antidiabetic Standard of Care
Intervention description: sitagliptin 100 mg Once a day (QD) for 24 weeks; metformin 850 mg Twice a day (BID) for 24 weeks; metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks; Patient can take any oral antidiabetic drug (other than metformin)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 30 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once
      daily added to the regimen of patients with inadequate glycemic control on metformin
      monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient Has Type 2 Diabetes Mellitus

          -  Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent

          -  Patient Is Currently On Metformin Therapy (1500 Mg/Day)

          -  Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least
             One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A
             Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age
             With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female
             And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout
             The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study
             Medication

          -  Patient Understands The Study Procedures, The Alternative Treatments Available, The
             Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written
             Informed Consent

          -  Patient Has An A1c of 6.5 % - 11.0%

        Exclusion Criteria:

          -  Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: CS+SG; Placebo
Intervention description: Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.; Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The main objective is to assess the efficacy of a new formulation containing chondroitin
      sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary
      osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient >= 45 years .

          -  Primary OA of the knee according to ACR criteria.

          -  OA radiological grade II-III according to Kellgren and Lawrence.

          -  Patients with moderate-severe pain.

        Exclusion Criteria:

          -  Patients with clinical significant trauma or surgery in the target knee.

          -  Concurrent arthritic disease (antecedents and/or current signs) that could confound or
             interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's
             disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic
             osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis,
             Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed
             connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel
             disease or fibromyalgia.

          -  Pain in other parts of the body greater than the knee pain that could interfere with
             the evaluation.

          -  Subjects with any active acute or chronic infections requiring antimicrobial therapy,
             or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal
             infections.

          -  Clinical diagnosis established of uncontrolled diabetes mellitus.

          -  Patients with asthma.

          -  History of hypersensitivity to the active drugs or any excipients of the formulations.
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
Condition: Chronic Constipation; Constipation
MeSH terms: Constipation
Intervention: Linaclotide 290 micrograms; Linaclotide 145 micrograms; Matching placebo
Intervention description: oral capsule, taken once daily each morning at least 30 minutes before breakfast; oral capsule, taken once daily each morning at least 30 minutes before breakfast; oral capsule, taken once daily each morning at least 30 minutes before breakfast
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: 487.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic Constipation; Abdominal Bloating; Linaclotide

Summary:

      The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with
      placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This
      study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients
      who are eligible will be randomized to one of two doses of linaclotide or placebo for 12
      weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency,
      as well as other abdominal and bowel symptoms of CC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy according to the American Gastroenterological
             Association criteria with no clinically significant findings

          -  Patient has successfully completed protocol procedures (with no clinically significant
             findings)

          -  Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per
             week and reports one or more of the following symptoms for at least 12 weeks:

               1. Straining during more than 25% of BMs

               2. Lumpy or hard stools during more than 25% of BMs

               3. Sensation of incomplete evacuation during more than 25% of BMs

          -  Patient demonstrates continued chronic constipation and bloating through Pretreatment
             Period

          -  Patient is compliant with Interactive voice response System (IVRS)

        Exclusion Criteria:

          -  Patient has a 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 would limit the patient's ability to complete or participate in this
             clinical trial or could confound the study assessments
A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain
Condition: Cancer Pain
MeSH terms: Cancer Pain
Intervention: Hydromprphone Hydrochloride (HCl) OROS; Morphine Sustain Release (SR)
Intervention description: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.; Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Hydromorphone hydrochloride OROS; Morphine

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral
      System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR)
      in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with cancer pain and experiencing inadequate pain control on or
             approaching Step 2 of the World Health Organisation (WHO) analgesic ladder

          -  Participants with pain scores greater than and equal to 4 on the average in the last
             24 hours

          -  Participants requiring or are expected to require not more than 540 milligram of oral
             morphine or morphine equivalent every 24 hours for the management of chronic cancer
             pain

          -  Participants who can reasonably be expected to achieve stable dose of opioid study
             medication for the duration of the trial

          -  Participants who can reasonably be expected to achieve stable dose of opioid study
             medication for the duration of the trial

        Exclusion Criteria:

          -  Participants with pure or predominantly neuropathic pain or pain of unknown origin
             (where a mechanism or physical cause cannot be identified)

          -  Participants with acute pain or who have pain on movement

          -  Participants who have received a fentanyl patch within the last 5 days

          -  Participants intolerant or hypersensitive to hydromorphone or other opioids agonists
             (chemical substance capable of activating a receptor to induce a full or partial
             response)

          -  Participants with recent past history (within the previous 5 years) or current history
             of drug abuse or alcohol abuse
Improving Insulin Therapy With Enhanced Care Management
Condition: Diabetes
Intervention: Reciprocal Diabetes Peer Support Program; Nurse Case management; group outpatient counseling visits
Intervention description: participants are paired with another age-matched participation. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact.; patients are not paired in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be assigned to a nurse care manager with whom they were encouraged to follow-up regularly.; Participants in the peer group were also offered three optional 1.5 hour patient-driven group sessions at month 1, 3, and 6
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: telemedicine; case management; insulin; self-care

Summary:

      VA diabetes patients often have difficulty managing their self-care and accessing
      clinic-based services; many also lack social support to help them meet the demands of their
      illness. Enhanced support is especially important when undertaking and sustaining new
      challenging self-care tasks, such as initiating or intensifying insulin treatment regimens.
      Although some VAs have implemented telephone nurse care management programs supported by
      automated calling services, many are reluctant to adopt these models due to nursing
      shortages.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  HbA1c > 7%

          -  age > 21

        Exclusion Criteria:

          -  substance abuse disorder

          -  serious psychiatric illness

          -  serious hearing loss

          -  life expectancy < 12 months
Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Intervention: Dexamethasone; placebo
Intervention description: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Months
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Asthma; Pediatric; Emergency Department; Dexamethasone; Steroid

Summary:

      Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the
      pediatric emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of asthma defined as at least two (2) prior episodes of respiratory illness
             characterized by wheezing treated with inhaled beta agonists

        Exclusion Criteria:

          -  pregnancy

          -  severe chronic cardiac, respiratory, neurological or neuromuscular disease

          -  complete resolution of symptoms after one treatment of beta agonists

          -  severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; Insulin glargine; Metformin
Intervention description: subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets; subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets; Patients usual dosage
Intervention MeSH terms: Metformin; Insulin Glargine; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; exendin-4; Amylin; Lilly

Summary:

      This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide
      and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2
      diabetes mellitus using metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes, but otherwise healthy

          -  HbA1c between 6.6% and 9.5%, inclusive.

          -  Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.

          -  Treated with a stable dose of metformin for at least 2 months prior to screening.

        Exclusion Criteria:

          -  Patients previously in a study using exenatide.

          -  Treated with oral anti-diabetic medications other than metformin within 2 months of
             screening (thiazolidinediones within 5 months of screening).

          -  Treated with insulin within 3 months of screening.
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Meloxicam Test Capsules
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up
      to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male or female ≥ 40 years of age

          -  If a participant in the previous MEL3-12-02 study, completed the study and did not
             discontinue for lack of efficacy or safety

          -  Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain

          -  Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for
             OA pain

          -  If female and of childbearing potential, is nonlactating and nonpregnant

        Exclusion Criteria:

          -  History of allergic reaction or clinically significant intolerance to acetaminophen,
             aspirin, or any NSAIDs, including meloxicam

          -  Requires continuous use of opioid or opioid combination products to control OA pain of
             the knee or hip

          -  Clinically significant unstable cardiac, respiratory, neurological, immunological,
             hematological, or renal disease

          -  Significant difficulties swallowing capsules or unable to tolerate oral medication

          -  Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device,
             or therapy within 30 days before Screening