bioihbjkbjnl/mcl2 huggingface dataset:
Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptin low dose; placebo; linagliptin medium dose
Intervention description: patient to receive tablets containing low dose linagliptin twice daily; patient to receive placebo tablet(s) matching linagliptin; patient to receive a tablet containing medium dose linagliptin once daily
Intervention MeSH terms: Linagliptin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg
      twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as
      add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient
      glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily
      compared to 5 mg once daily and each treatment's superiority over placebo.
    

Eligibility criteria:

        Inclusion criteria

          1. Diagnosis of type 2 diabetes mellitus.

          2. Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or
             metformin plus 1 other antidiabetic drug. Metformin must be administered in twice
             daily dosing regimen. Patients taking metformin three times daily can be included if
             posology is switched to twice daily and total daily dose is maintained.

          3. Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.

          4. Body Mass Index (BMI) </=45 kg/m2.

        Exclusion criteria

          1. Treatment with extended release metformin.

          2. Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).

          3. Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months
             prior to informed consent.

          4. Impaired hepatic or renal function, or gastric bypass surgery.

          5. Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics,
             antiobesity agents, or insulin within 3 months of informed consent.

          6. Current treatment with systemic steroids or change in dosage of thyroid hormones.

          7. Alcohol or drug abuse within 3 months of informed consent.

          8. Participation in another trial with investigational drug within 2 months prior to
             informed consent.

          9. Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method
             of birth control.
Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: L-arginine; Placebo
Intervention description: subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months.; Placebo tablets that match the L-arginine intervention tablets will be given for three months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Airway Inflammation; Moderate persistent asthma; Severe Persistent Asthma

Summary:

      Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a
      protective role in patients with moderate to severe asthma. The investigators believe that a
      natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma
      exacerbations and improve the asthma care of moderate to severe asthma patients.

      This study is a randomized, placebo controlled trial in which subjects will receive either 3
      months of L-arginine supplementation or a placebo. The investigators will monitor subjects'
      symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw
      blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each
      monthly visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe persistent asthma

          -  Subject is stable on same asthma medications for at least one month

          -  If the subject is a woman of child-bearing age, a negative pregnancy test

        Exclusion Criteria:

          -  Less than 18 yrs/ age

          -  Baseline Forced Expiratory Volume in 1 second (FEV1) <40% predicted

          -  Known or suspected allergy to L-arginine

          -  Pregnant women, nursing women, or women actively trying to achieve pregnancy

          -  Current smokers

          -  Subjects with more than a 15 pack-year history of smoking
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
Condition: Chronic Kidney Disease; Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Cinacalcet hydrochloride; Standard of Care
Intervention description: Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.; Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.
Intervention MeSH terms: Cinacalcet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 28 Days
Maximum age: 2189 Days
Healthy volunteers: No
Keywords: Dialysis; Sensipar; Mimpara; Hemodialysis; Peritoneal Dialysis; Renal; Parathyroid hormone; Pediatric

Summary:

      The primary objective was to characterize corrected serum calcium levels on treatment with
      cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic
             minimum age is ≥ 2 years of age at enrollment)

          -  Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and
             not have received any cinacalcet therapy for at least 30 days prior to start of dosing

          -  Screening corrected calcium from the central laboratory:

          -  ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years

          -  ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years

          -  Serum phosphorus from the central laboratory:

          -  ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year

          -  ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years

          -  SHPT not due to vitamin D deficiency, per investigator assessment

          -  Dry weight ≥ 7 kg at the time of screening

        Exclusion criterion:

          -  History of congenital long QT syndrome, second or third degree heart block,
             ventricular tachyarrhythmias or other conditions associated with prolonged QT interval

          -  Corrected QT interval (QTc) > 500 ms, using Bazett's formula

          -  QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is
             provided by the investigator after consultation with a pediatric cardiologist

          -  Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g.,
             erythromycin, clarithromycin, ketoconazole, itraconazole)

          -  Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron,
             albuterol)
D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents
Condition: Posttraumatic Stress Disorder; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: D-cycloserine; Placebo pill; CBT
Intervention description: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.; Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.; 12-session CBT protocol, called Youth PTSD Treatment.
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Cognitive Behavior Therapy; Children; Adolescents; Pharmacotherapy

Summary:

      The purpose of this study is to show whether D-cycloserine in combination with cognitive
      behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of
      posttraumatic stress disorder (PTSD) in 13-18 year-old children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Certain number of PTSD symptoms plus functional impairment

          -  Must be able to swallow pills

        Exclusion Criteria:

          -  Serious kidney or liver disease

          -  Epilepsy

          -  Bipolar disorder

          -  Psychosis
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Condition: Fistulizing Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Filgotinib; Placebo to match filgotinib
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib as compared to
      placebo in establishing combined fistula response at Week 24. Participants will have the
      option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if
      they meet eligibility requirements.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
             the date of screening visit

          -  Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months

          -  Has draining perianal fistulae as a complication of CD, confirmed by magnetic
             resonance imaging (MRI) at screening

          -  Previously demonstrated an inadequate clinical response, loss of response to, or
             intolerance of at least 1 of the following agents (depending on current country
             treatment recommendations/guidelines):

               -  Antibiotics AND/OR

               -  Immunomodulators AND/OR

               -  Tumor necrosis factor α (TNFα) Antagonist

          -  Is willing and able to undergo MRI per protocol requirements

          -  Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

        Key Exclusion Criteria:

          -  Presence of current rectovaginal anovaginal or enterovesicular fistulae

          -  Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
             fulminant colitis, or toxic mega-colon

          -  History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy,
             or likely requirement for surgery during the study

          -  Use of any prohibited concomitant medications as described in the study protocol

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: LY2951742; Placebo- oral; Placebo - SC; Celecoxib
Intervention description: Administered subcutaneously (SC); Administered orally; Administered SC; Administered orally
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 268.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain.
      The study drugs will be given as an injection under the skin and as an oral capsule. The
      study will last about 28 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology
             (ACR) criteria and confirmed with X-rays and ACR functional class of I to III

          -  Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs
             (NSAIDS), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at
             least 20 days in the past month

          -  Willing to stop all analgesics for OA pain during the study

          -  Experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100
             Visual Analog Scale (VAS) with an increase in pain while walking of at least 10 mm
             following washout of current Osteoarthritis pain medications at screening

        Exclusion Criteria:

          -  Allergic to LY2951742, celecoxib, other NSAIDS, including aspirin, and similar drugs

          -  Arthritis of the knee from other causes

          -  Uncontrolled hypertension

          -  Have OA pain that requires treatment with potent opioids, systemic corticosteroids,
             intra-articular injections, duloxetine, or venlafaxine

          -  Moderate to severe renal impairment

          -  Pregnant or lactating
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Ustekinumab 90 mg; Ustekinumab 4.5 mg/kg; Placebo SC; Placebo IV
Intervention description: one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2); one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2; one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2); one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn Disease; Biologic; Infusion; Injection; CNTO 1275; Ustekinumab; C01275; IL-12p40

Summary:

      The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants
      with active Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for
             at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of >=220
             and <=450

          -  In Population 1, participants must have had active disease despite treatment with
             5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including
             anti-TNF agents. In Population 2, participants must have had active disease and have
             failed to respond to infliximab at the maximum approved dose and treatment regimen for
             Crohn's disease as defined in the US package insert.

        Exclusion Criteria:

          -  Have local manifestations of Crohn's disease such as strictures, abscesses, or other
             disease complications for which surgery might be indicated

          -  Had intra-abdominal surgery within 6 months prior to entering the study

          -  Have received treatment with parenteral nutrition (ie, introduction of nutrition into
             the body via a route other than the mouth) (total parenteral nutrition [TPN]) within 6
             weeks of baseline
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Dociparstat sodium; Idarubicin; Cytarabine
Intervention description: Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy.; Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy.; Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5.
Intervention MeSH terms: Cytarabine; Idarubicin; Heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to
      determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different
      does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation
      therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid
      leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects had to meet all the following criteria to be eligible for enrollment in this
        study:

          1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia
             (AML).

          2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

        Exclusion Criteria:

        Subjects who met any of the following criteria were not eligible for enrollment in this
        study:

          1. Had acute promyelocytic leukemia

          2. Had prior chemotherapy for AML.

          3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of
             myelodysplastic syndrome.

          4. Had central nervous system (CNS) leukemia.
An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
Condition: Cystitis, Interstitial
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: PF-04383119; Placebo
Intervention description: PF-04383119 200 mcg/kg IV, single dose; placebo IV, single dose
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Painful Bladder Syndrome; monoclonal antibody

Summary:

      The purpose of this study is to determine whether PF-04383119 is effective in the treatment
      of pain associated with interstitial cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults at least 18 years of age;

          -  Moderate to severe interstitial cystitis, with a mean pain intensity score above a
             pre-defined level.

        Exclusion Criteria:

          -  Less than 6 months since onset of interstitial cystitis symptoms;

          -  History of recurrent urinary tract infections, or genitourinary cancer;

          -  History of hepatitis B, C or human immunodeficiency virus (HIV);

          -  Use of certain drugs given into the bladder up to 1 month prior to study entry.
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Intervention: Momordica charantia; Placebo
Intervention description: Momordica Charantia: 2000 mg per day for three months; Placebo: 2000 mg per day for three months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 35 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Momordica Charantia; Insulin secretion; Insulin sensitivity

Summary:

      The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in
      patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose,
      glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this
      improvement is due to an improvement in insulin sensitivity and insulin secretion. The
      purpose of this study is to evaluate the effect of the administration of Momordica Charantia
      on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetes mellitus type 2 according to the criteria of the American
             Diabetes Association (<5 years), without pharmacological treatment (oral antidiabetic
             drugs or insulin) at least for three months before entering the study

          -  Fasting glucose: <210 mg/dl

          -  A1C: 7-9%

          -  Body mass index: 25-34.9 kg/m2

          -  Body weight without variations above or under 5% in the last three months before
             entering the study

          -  Women in childbearing years must have a contraceptive method

          -  Letter of consent and release signed by each patient

        Exclusion Criteria:

          -  Pregnant or suspected pregnant women

          -  Woman breastfeeding

          -  Medications known to affect metabolism of glucose and insulin

          -  Personal history of liver or renal disease

          -  Hypertension, thyroid or cardiovascular disease decompensated

          -  Total cholesterol >= 240mg/dl, triglycerides >=400mg/dl, glomerular filtration rate
             <=60ml/min or liver transaminases >=2.5 the upper normal limit