bioihbjkbjnl/mcl2 huggingface dataset:
PreHospital Air Medical Plasma Trial
Condition: Hemmorhagic Shock During Air Medical Transport
MeSH terms: Shock
Intervention: infusion of 2 units of plasma
Intervention description: infusion of 2 units of plasma
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 523.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: hemmorhagic shock, plasma, air medical transport, randomized, multicenter

Summary:

      To determine the effect of the prehospital infusion during air transport of 2 units of AB
      plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional
      care.
    

Eligibility criteria:

        Inclusion Criteria: Hemorrhagic shock not responsive to crystalloid infusion -

        Exclusion Criteria: Isolated Fall, Cervical cord injury, prisoner, pregnant patient,
        traumatic arrest

        -
Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Condition: Age-related Macular Degeneration; Depression
MeSH terms: Vision, Low; Macular Degeneration; Depression; Depressive Disorder
Intervention: BA-LVR; ST-LVR
Intervention description: Low vision clinic-based optometry plus 6 in-home occupational therapy visits; Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: age-related macular degeneration; depression; vision loss

Summary:

      This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL
      (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent
      depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative
      intervention, a low vision occupational therapist collaborates with a low vision optometrist
      to develop and implement a care plan based on a subject's vision status, rehabilitation
      potential, and personal rehabilitation goals. An independent rater masked to treatment
      assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and
      targeted vision function and vision-related quality of life (secondary outcomes) at baseline
      and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months
      to evaluate long-term effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at least 65 years old

          -  Bilateral AMD

          -  Subthreshold depressive symptoms

          -  At least 1 vision goal that is important yet difficult to carry out

        Exclusion Criteria:

          -  Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for which
             surgery within 6 months is likely will be exclusionary conditions

          -  Current diagnosis of depression

          -  Cognitive impairment

          -  Life-threatening illness or any other health conditions that interferes with study
             activities.

          -  Patients who have received low vision rehabilitation or home-based OT in the preceding
             12 months will be excluded.
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; Linagliptin
Intervention description: Placebo, identical to Linagliptin tablet; intended final marketed dose
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and
      longer) in combination with basal insulin in patients with type 2 diabetes mellitus with
      insufficient glycaemic control.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%

          2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18
             years, BMI <= 45 kg/m2

        Exclusion criteria:

          1. Uncontrolled hyperglycemia during Run-in

          2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

          3. Liver impairment; gastric surgery; medical history of cancer in last 5 years

          4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational
             drug before randomisation

          5. Unsufficient birth control, pregnancy and nursing
Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Entecavir; Tenofovir
Intervention description: Tablets, Oral, 1 mg, once daily, 96 weeks; Tablets, Oral, 300 mg, once daily, 96 weeks
Intervention MeSH terms: Tenofovir; Entecavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to show that the combination of entecavir and tenofovir, is
      effective and well tolerated in chronic hepatitis B patients who have failed previous
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e
             antigen(HBeAg)-negative or HBeAg-positive

          -  Subjects must have a treatment failure to their current nucleoside/ nucleotide
             treatment regimen

          -  Prior entecavir and/or tenofovir monotherapy is allowed

          -  Subjects must have compensated liver function

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Evidence of decompensated cirrhosis

          -  Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

          -  Moderate or severe renal impairment

          -  Recent history of pancreatitis

          -  Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of
             being assigned to study drug into this study

          -  Prior entecavir/tenofovir combination therapy
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: TP-03; TP-03 Vehicle
Intervention description: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day; Vehicle of TP-03 ophthalmic solution, administered twice a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
Enrollment: 412.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Demodex

Summary:

      The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its
      vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite
      frequently found in human hair follicles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be willing to sign the informed consent and deemed capable of complying with the
             requirements of the study protocol

          -  Meet all of the following criteria in at least one eye: Have more than 10 lashes with
             collarettes present on the upper lid; have at least mild erythema of the upper eyelid
             margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or
             more mites per lash

        Exclusion Criteria:

          -  Have used lid hygiene products within 14 days of Screening or unwilling to forego the
             use of lid hygiene products during the study

          -  Have used a prostaglandin analogue to promote eyelash growth within 30 days of
             Screening or any plans to initiate treatment during the study

          -  Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be
             unwilling to forego their use during the study

          -  Be pregnant or lactating at the time of Screening
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Methotrexate; Abatacept Placebo; Methotrexate Placebo
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 994.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if abatacept is effective in the treatment of early
      rheumatoid arthritis.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Rheumatoid arthritis (RA) diagnosis less than 6 months

          -  CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h

          -  At least 3 swollen and 3 tender joints

          -  Anti-citrullinated protein antibodies (ACPA) positive

        Exclusion Criteria:

          -  At risk for tuberculosis

          -  Have acute infection

          -  Have chronic or recurrent bacterial or serious latent viral infection

          -  History of malignancies in the last 5 years except squamous skin, basal skin or
             cervical carcinoma

          -  Previous treatment with any conventional or biologic Disease-modifying anti rheumatic
             drugs (DMARD)
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
Condition: Elevated High-sensitivity C-Reactive Protein (hsCRP)
MeSH terms: Hypersensitivity
Intervention: Rosuvastatin; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17802.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Primary prevention; Cardiovascular disease; Statin therapy; C-reactive protein

Summary:

      The purpose of this study is to determine the safety and effectiveness of long-term therapy
      with rosuvastatin compared with a placebo, and to evaluate whether treatment with
      rosuvastatin might be effective in reducing the risk of major cardiovascular events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 50 years or older, women 60 years or older

          -  Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL)

          -  Elevated levels of C-Reactive Protein (CRP) > 2.0 mg/L

        Exclusion Criteria:

          -  History of cardiovascular or cerebrovascular events

          -  Active liver disease

          -  Diabetes mellitus

          -  Uncontrolled hypertension or hypothyroidism

          -  History of certain malignancies

          -  Chronic inflammatory conditions

          -  History of alcohol or drug abuse
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Placebo; Aliskiren 150 mg tablet; Aliskiren 300 mg tablet; Amlodipine 5 mg capsule; Amlodipine 10 mg capsule; Aliskiren/amlodipine 150/5 mg tablet; Aliskiren/amlodipine 150/10 mg tablet; Aliskiren/amlodipine 300/5 mg tablet; Aliskiren/amlodipine 300/10 mg tablet
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2694.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, Aliskiren, Amlodipine

Summary:

      Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in
      combination with amlodipine in patients with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  msDBP ≥ 90 mmHg and < 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional
             Visit 201)

          -  msDBP ≥ 95 mmHg and < 110 mmHg at Visit 3 (Day 1 / randomization).

          -  All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the
             last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).

        Exclusion Criteria:

          -  Severe hypertension

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential

          -  Previous or current diagnosis of heart failure (NYHA Class II-IV).

          -  Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.

          -  Uncontrolled Type 1 or Type 2 diabetes mellitus

          -  Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with
             Similar chemical structures

          -  History of malignancy within 5 years

          -  History of hypertensive encephalopathy or cerebrovascular accident, or history of
             transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or
             any percutaneous coronary intervention
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
Condition: Bone Metastases
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
Intervention: Denosumab; Zoledronic Acid
Intervention description: 120 milligrams by subcutaneous injection every 4 weeks; 4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
Intervention MeSH terms: Zoledronic Acid; Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1779.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone metastases; lytic bone lesions; advanced cancer; multiple myeloma; lymphoma; solid tumors; skeletal related events; skeletal fractures; spinal cord compressions, radiation to bone; surgery to bone, bisphosphonates; denosumab

Summary:

      The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid
      (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in
      subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with histologically/cystologically confirmed advanced cancers including solid
             tumors, multiple myeloma, and lymphoma

          -  Radiographic evidence of at least one bone metastasis (or lytic bone lesion from
             multiple myeloma); ECOG performance status 0, 1, or 2

          -  Adequate organ function

        Exclusion Criteria:

          -  Diagnosis of breast or prostate cancer

          -  Current or prior intravenous bisphosphonate administration

          -  Current or prior oral bisphosphonates for bone metastases, life expectancy of less
             than 6 months

          -  Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Cocaine/Crack and Reduction of Compulsion With Biperiden
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Biperiden; Placebo
Intervention description: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.; Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Intervention MeSH terms: Biperiden
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 111.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cocaine; crack; treatment; dependence; biperiden

Summary:

      Considering the effects of the cholinergic system on the drug reward and self-administration
      mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process.
      Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in
      attenuate compulsion, one o the main symptoms of the drug dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

        Exclusion Criteria:

          -  Being under treatment with psychoactive drugs

          -  Have been diagnosed for other Psychiatric Disorders

          -  Have dependence diagnosis for other drugs, except for tabacco
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: Gabapentin Extended Release; Placebo
Intervention description: Gabapentin ER 1800mg daily; Sugar pill
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hot Flushes; Vasomotor Symptoms; Menopausal Hot Flashes

Summary:

      Depomed's Gabapentin Extended Release is an investigational, extended release formulation of
      Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in
      postmenopausal women
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, postmenopausal women who seek treatment for hot flashes

          -  Patients using hormone replacement therapy(HRT) must be willing to discontinue
             treatment

          -  Patients must be experiencing moderate to severe hot flashes

          -  Patients must be able to sign the informed consent

          -  Patients must be able to enter simple commands and complete questionnaires on the
             frequency and severity of their hot flashes using an electronic diary

        Other inclusions apply.

        Exclusion Criteria:

          -  Patients with hypersensitivity to Gabapentin

          -  Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable
             bowel syndrome (IBS) or unexplained weight loss

          -  Patients treated with estrogen pellets or injectable progestin drug therapy within 6
             months.

          -  Patients currently treated with Gabapentin or Pregabalin for any indication, including
             vasomotor symptoms

        Other exclusions apply.
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
Condition: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago
MeSH terms: Stomach Ulcer; Duodenal Ulcer; Ulcer
Intervention: Esomeprazole; Placebo
Intervention description: 20mg once daily oral; once daily oral
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 343.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: gastrointestinal; GI; NSAID; Japan; Japanese; Gastric ulcer; duodenal ulcer

Summary:

      The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus
      placebo once daily for up to 24 weeks of treatment involving patients with a history of
      gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID)
      therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the
      treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal
      ulcers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history of gastric and/or duodenal ulcer

          -  A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc)
             that requires daily NSAID use,at least 20 years of age

        Exclusion Criteria:

          -  Having gastric or duodenal ulcer in active or healing stage according to the
             Sakita/Miwa classification

          -  History of esophageal, gastric or duodenal surgery

          -  Having severe liver disease or chronic renal disease