bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Technosphere Insulin; Metformin & Secretagogues; Technosphere Insulin & Metformin
Intervention description: Inhalation, 15U/30U, prandial; Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.; Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Secretagogues
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 547.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin
      versus combination metformin and a secretagogue
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months

          -  Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a
             secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any
             dose adjustments within the preceding 6 wks.

          -  Fixed dose combination products of metformin and sulfonylurea are acceptable as long
             as each individual dose meets inclusion criteria

          -  HbA1c >or= to 7.5% and < or= to 11.0%

          -  BMI < or = to 40kg/m2.

          -  FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

        Exclusion Criteria:

          -  Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues
             within the preceding 12 weeks

          -  Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects

          -  History of chronic obstructive pulmonary disease, clinically proven asthma and/or any
             other clinically important pulmonary function testing and/or radiologic findings

          -  Evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
Condition: Cryptococcal Meningitis; Fungal Meningitis
MeSH terms: Meningitis, Cryptococcal; Meningitis, Fungal; Meningitis
Intervention: Sertraline
Intervention description: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks.
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cryptococcal meningitis; cryptococcus; meningitis; yeast; fungus

Summary:

      This is a phase III trial to determine whether adjunctive sertraline will lead to improved
      survival 18-week survival.

      There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF
      concentrations in 172 persons conducted from August 2013 to August 2014. See NCT03002012.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)

          -  HIV-1 infection

          -  Ability and willingness of the participant or legal guardian/representative to provide
             informed consent

          -  Willing to receive protocol-specified lumbar punctures

        Exclusion Criteria:

          -  Age < 18 years

          -  Receipt of >=3 doses of amphotericin therapy

          -  Cannot or unlikely to attend regular clinic visits

          -  History of known liver cirrhosis

          -  Presence of jaundice

          -  Pregnancy

          -  Current breastfeeding
Metoclopramide for Migraine: A Dose Finding Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: metoclopramide; metoclopramide; metoclopramide; Diphenhydramine 25mg
Intervention description: metoclopramide 20 mg; metoclopramide 40 mg; metoclopramide 10 mg; Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do
      not know the best dose to administer. This study compares three different doses of
      metoclorpamide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  acute migraine

        Exclusion Criteria:

          -  secondary cause of headache

          -  lumbar puncture

          -  allergy or intolerance to study medication
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; BI 10773; Placebo; BI 10773; Placebo; Placebo
Intervention description: Placebo matching BI 10773 low dose; BI 10773 high dose once daily; Placebo matching BI 10773 low dose; BI 10773 low dose once daily; Placebo matching BI 10773 high dose; Placebo matching BI 10773 high dose
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 825.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2
      diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and
      macrovascular complications, assessment of both glucose and blood pressure lowering effects
      of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly
      relevant, new information for the use of BI 10773
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients >=18 years with type 2 diabetes

          2. HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol)

          3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99
             mmHg

        Exclusion criteria:

          1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
             overnight fast before randomization

          2. Known or suspected secondary hypertension

          3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or
             transient ischemic attack within 3 months prior to informed consent
Lasix for the Prevention of De Novo Postpartum Hypertension
Condition: Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Hypertension, Pregnancy-Induced; Hypertension
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Intervention: Furosemide; Placebo
Intervention description: Furosemide 20 mg pill taken daily for 5 days; Identical-appearing placebo pill taken daily for 5 days
Intervention MeSH terms: Furosemide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized controlled clinical trial of 82 women with one or more high-risk factors for de novo postpartum hypertension, randomized to one of two arms: 20 mg PO Lasix (furosemide) daily for 5 days or identical-appearing daily placebo for 5 days.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Consenting women will be assigned to Lasix (furosemide) or placebo in a 1:1 ratio according to a randomization scheme achieved using a computer generated algorithm. Neither the participant nor the clinical care team will be aware of the allocation arm.
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: De novo postpartum hypertension; New-onset postpartum hypertension; Lasix; Furosemide

Summary:

      Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum
      hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after
      delivery in high-risk women.

      Secondary objectives: To evaluate whether oral furosemide administered to high-risk women
      after delivery can reduce the frequency of postpartum hypertensive episodes, the need for
      antihypertensive therapy, the risk of postpartum preeclampsia, and the incidence of severe
      maternal morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women

          -  No antenatal diagnosis of hypertensive disorder of pregnancy at the time of admission
             for delivery, defined as existing chronic hypertension diagnosis or documented blood
             pressure of ≥140 systolic OR ≥90 diastolic on at least 2 occasions at least 4 hours
             apart prior to delivery admission who do not go on to get magnesium for seizure
             prophylaxis by the time of delivery

          -  At least 18 years of age

          -  English or Spanish speakers

          -  One or more high risk factors for development of de novo postpartum hypertension

        Exclusion Criteria:

          -  Non-English or Spanish speakers

          -  Women with a contraindication to diuretic therapy

          -  Women who have used diuretics in the two weeks prior to delivery
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
Condition: Dyslipidemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias
Intervention: Evolocumab
Intervention description: Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 1600.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label extension (OLE) study designed to assess the extended
      long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study
      20110118). Approximately 1600 subjects will be enrolled in this study. This study will
      continue for 260 weeks (approximately 5 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent prior to initiation of any study-specific
             activities/procedures.

          -  Subject had completed FOURIER (Study 20110118) while still receiving assigned
             Investigational Product.

        Exclusion Criteria:

          -  Permanent discontinuation of Investigational Product during FOURIER for any reason
             including an adverse event or serious adverse event.

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 4 weeks since ending treatment on another investigational device or drug
             study(ies). Other investigational procedures while participating in this study are
             excluded.

          -  Subject likely to not be available to complete all protocol-required study visits or
             procedures, and/or to comply with all required study procedures to the best of the
             subject and investigator's knowledge.

          -  History or evidence of any other clinically significant disorder, condition or disease
             that, in the opinion of the investigator or Amgen physician, if consulted, would pose
             a risk to subject safety or interfere with the study evaluation, procedures or
             completion.

          -  Subject has known sensitivity to any of the active substances or excipients (eg,
             sodium acetate) to be administered during dosing.

          -  Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed
             during treatment with evolocumab and for an additional 15 weeks after treatment with
             evolocumab discontinues.

          -  Female subjects of childbearing potential unwilling to use an acceptable method of
             effective contraception during treatment and for an additional 15 weeks after the last
             dose of protocol-required therapies.
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Disease Progression
Intervention: Laquinimod
Intervention description: One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1047.0
Sex: All
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis

Summary:

      To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled
      MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability
      and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing
      multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all
             Termination visit activities) according to the MS-LAQ-302 protocol.

          2. Women of child-bearing potential must practice an acceptable method of birth control
             [acceptable methods of birth control in this open label extension phase include:
             surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch
             (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's
             vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the
             study and up to 30 days after the last dose of the study drug..

          3. Subjects must be willing and able to comply with the protocol requirements for the
             duration of the study.

          4. Subjects must be able to comprehend, sign and date a written informed consent prior to
             entering the MS-LAQ-302E study.

        Exclusion Criteria:

          1. Premature discontinuation from the MS-LAQ-302 study, for any reason.

          2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E)
             visit] or breastfeeding.

          3. Subjects with clinically significant or unstable medical or surgical condition
             detected or worsened during the MS-LAQ-302 study, which preclude safe participation
             and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude
             participation in the MS-LAQ-302E study.

          4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: BreathID (Methacetin breath test)
Intervention description: 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The methacetin breath test (MBT) is a non-invasive liver function test which measures the
      ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is
      exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of
      a decline in liver function in patients with cirrhosis who are awaiting liver
      transplantation.
    

Eligibility criteria:

        Inclusion criteria:

          1. Being considered for placement or already on the liver transplantation waiting list

          2. Cirrhosis caused by any cause of chronic liver disease.

          3. Age > 18 years

        Exclusion criteria:

          1. Known or suspected hepatocellular carcinoma

          2. Prior TIPS placement

          3. Severe congestive heart failure

          4. Severe pulmonary hypertension

          5. Uncontrolled diabetes mellitus (HBA1C >9.5%)

          6. Any autoimmune disorder, which is currently being treated with prednisone or any other
             immune suppressive medication.

          7. Previous surgical bypass surgery for morbid obesity (BMI >45)

          8. Extensive small bowel resection

          9. Patients currently receiving total parenteral nutrition if they have contraindications
             to oral drugs

         10. Women who are pregnant

         11. Patients who are allergic to acetaminophen/ paracetamol or any other related
             medications

         12. Patients with an acute current exacerbation of chronic obstructive pulmonary disease
             or bronchial asthma.

         13. Patients that are taking hepatotoxin drugs

         14. Patient, based on the opinion of the investigator, should not be enrolled into this
             study

         15. Patient is unable or unwilling to sign informed consent.

         16. Patients that are participating in other clinical trials evaluating experimental
             treatments or procedures
Genotropin Study Assessing Use of Injection Pen
Condition: Growth Hormone Deficiency; Idiopathic Short Stature
MeSH terms: Dwarfism
Intervention: New Genotropin Pen
Intervention description: Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Genotropin Medical device Patient reported outcome

Summary:

      Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and
      preference of Genotropin injection pen. Patients already on genotropin will be asked to use a
      genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire
      at baseline and 2 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 8-18 years

          -  Using genotropin pen for at least 3 months prior to study enrollment

          -  Compliance with genotropin treatment

        Exclusion Criteria:

          -  Medical conditions that can affect participation in study

          -  Insufficient command of English language to understand questionnaire

          -  Using other growth hormone device and not Genotropin pen
Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Placebo; Placebo; Placebo; BI 10773; BI 10773
Intervention description: Placebo matching BI 10773 low dose; Placebo matching BI 10773 low dose; Placebo matching BI 10773 high dose; Placebo matching BI 10773 high dose; BI 10773 low dose once daily; BI 10773 high dose once daily
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 566.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin
      in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of
      insulin in this population would provide significant new information for the BI 10773 use and
      would offer a potential new therapeutic option in this population.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of T2DM prior to informed consent

          2. Male and female patients on diet and exercise regimen who are pre-treated with
             multiple daily injections (MDI) of insulin alone or in combination with immediate or
             extended release metformin

          3. Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose

          4. HbA1c >=7.5% and <=10% at screening

        Exclusion criteria:

          1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
             overnight fast during placebo run-in

          2. Any contraindications to metformin according to the local label

          3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent