bioihbjkbjnl/mcl2 huggingface dataset:
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Suvorexant; Dose-matched Placebo to Suvorexant
Intervention description: oral tablet taken before bedtime; Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
Intervention MeSH terms: Suvorexant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      A cross-over, polysomnography study to test the safety, tolerability and effectiveness of
      different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of Primary Insomnia based on sleep history and the investigator's
             judgment

          -  Must be willing to stay overnight at a sleep laboratory

          -  Must be willing to stay in bed for at least 8 hours each night while at the sleep
             laboratory

          -  Regular bedtime is between 9 PM and 12 AM (midnight)

        Exclusion Criteria:

          -  Breast feeding, pregnant or planning to become pregnant during the study

          -  Within the past 6 months before starting the study you have a history of significant
             cardiovascular disorder such as unstable angina, congestive heart - failure or acute
             coronary syndrome

          -  Currently participating or have participated in a study with an investigational
             compound or device within the last 30 days

          -  Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling
             across 3 or more time zones at any time during the study

          -  Has done shift work within the past 2 weeks

          -  Has donated blood products within the last 8 weeks

          -  Has difficulty sleeping due to a medical condition
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Condition: Seizures
MeSH terms: Seizures
Intervention: Midazolam; Diazepam
Intervention description: Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.; Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
Intervention MeSH terms: Midazolam; Diazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 358.0
Sex: All
Minimum age: 1 Week
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Seizures

Summary:

      The investigators will conduct a randomized controlled trial comparing the use of nasal
      midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute
      seizure activity in children under the age of 18 years with epilepsy in the community
      setting. The primary hypothesis is that nasal midazolam will be more effective and have
      shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses
      are that patients treated with nasal midazolam will have fewer respiratory complications,
      emergency department visits, and admissions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children seventeen years and under will be identified through a Pediatric Neurology
             clinic at Primary Children's Medical Center,

          -  Known seizure disorder, AND

          -  Either have or will be prescribed a rescue anti-epileptic (rectal diazepam, or
             Diastat) for home use by their neurologist.

        Exclusion Criteria:

          -  The neurologist does not prescribe a rescue medication for home use,

          -  18 years of age or older,

          -  They have absence seizures, OR

          -  They have been prescribed lorazepam for home use for seizure activity.
A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Necrosis
Intervention: Golimumab 50 mg; Mavrilimumab 100 mg
Intervention description: Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.; Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Intervention MeSH terms: Golimumab; Mavrilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Golimumab; Mavrilimumab

Summary:

      The primary objectives of this study is to explore the efficacy of mavrilimumab compared with
      golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe
      active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional
      disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor
      (TNF) agents (excluding golimumab) for efficacy or safety reasons.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 80 years

          -  Written consent

          -  Diagnosis of adult onset Rheumatoid Arthritis (RA) as defined by the 2010 American
             College of Rheumatology European League Against Rheumatism (ACR/EULAR) classification
             criteria

          -  Moderately active disease as defined by disease activity score in 28 joints C-reactive
             protein (DAS28[CRP]) greater than or equal to (>=) 3.2 at screening and DAS28
             erythrocyte sedimentation rate(ESR) ≥ 3.2 at Day 1

          -  Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs
             (DMARDs)

          -  At least 4 swollen joints

          -  Inadequate response to one or two anti-TNF agents other than the study comparator, as
             defined by the protocol

          -  Receiving oral or injectable methotrexate, as defined by the protocol.

        Exclusion Criteria:

          -  A rheumatic autoimmune disease or other inflammatory joint disease other than RA

          -  Previous treatment with biologic therapies other than anti-TNF for RA

          -  Treatment with other DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs), as
             defined by the protocol.

          -  Medical history as defined by the protocol.
Cranial Electrotherapy Stimulation in Burned Patients
Condition: Post Traumatic Stress Disorders; Burns
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Alpha Stim 100 (Cranial Electrotherapy Stimulation)
Intervention description: cranial electrical stimulation 100 microamps
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: anxiety; insomnia; pain; Alpha Stim; Cranial electrotherapy stimulation

Summary:

      To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have
      been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to
      some or all of those symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  burned patients requiring outpatient physical or occupational therapy in the USAISR
             Burn Rehabilitation Gym or Center for the Intrepid

          -  Able to read and speak English

          -  Between ages of 18-65 years

          -  Screen positive (score greater than 44) on the PCL-M/C instruments

        Exclusion Criteria:

          -  pregnant patients

          -  patients with implantable pacemakers or electronic stimulators

          -  patients scoring below 44 on the PCL-M/C instrument

          -  patients who previously used CES therapy
The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Condition: Muscle Damage; Muscle Inflammation
MeSH terms: Myalgia; Myositis; Inflammation
Intervention: Lovaza (omega-3-acid ethyl esters); Wheat Germ Oil
Intervention description: Lovaza, 3 grams per day for 65 days; Wheat germ oil, 3 grams/day for 65 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effects of fish oil supplementation (Lovaza,
      GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, free of disease

          -  Must be able to swallow capsules

          -  Free of orthopedic or muscular injuries

          -  Recreationally active

          -  Prior consumption of fish and corn with no adverse reactions

        Exclusion Criteria:

          -  Use of non-steroidal anti-inflammatory drugs (NSAIDS) or topical analgesics during
             study enrollment

          -  Pregnant or nursing

          -  Food allergy to fish or any components of the pills which includes alpha tocopherol,
             partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol
             or wheat germ oil

          -  Competitive athlete or physically active more than 10 hours per week
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Condition: GERD; Acid Reflux Disease; Heartburn; Regurgitation
MeSH terms: Gastroesophageal Reflux; Heartburn
Intervention: AZD3355; Placebo; Gelusil®
Intervention description: Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks; capsule. administered as a single dose twice daily for 4 weeks; Chewable tablets taken as needed
Intervention MeSH terms: Lesogaberan
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD; Acid Reflux; Heartburn; Regurgitation; non-acid reflux; PRO measures

Summary:

      This research study is being done to gather information about how to do further clinical
      studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject able to read and write US english and able to use electronic devices

          -  Subjects who have experienced GERD symptoms for at least six months

          -  Subjects currently taking a prescription or over-the-counter PPI medications for GERD

          -  Body Mass Index (BMI) 18.5-35.0, inclusive

        Exclusion Criteria:

          -  Subjects that have not experienced any GERD symptoms improvement at all after PPI
             treatment

          -  Subjects who have any of the following conditions or diseases- Heart disease, Angina,
             Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such
             as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer

          -  Prior surgery of the upper Gastrointestinal (GI) tract
Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Intervention: Azacitidine; Sargramostim
Intervention description: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.; Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles.
Intervention MeSH terms: Azacitidine; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: maintenance treatment; stem cell transplant; cytarabine-based chemotherapy

Summary:

      To determine the impact of maintenance therapy in patients with MDS/AML in remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > 6 months

          2. Initial diagnosis of poor -risk AML or MDS (defined in section 3.2), treated with
             either stem cell transplant or cytarabine-based consolidation chemotherapy, within the
             past 60-185 days

          3. ECOG performance status 0-2

          4. No morphologic evidence of leukemia or active MDS as determined by JHH
             Hematopathologist independent review of a bone marrow aspirate and biopsy done
             following the completion of therapy and within 14 days prior to enrollment

          5. Peripheral blood count recovery: Neutrophil count ≥ 1000 /µL, platelet count ≥ 50x 109
             /µL without platelet transfusions, and adequate hematocrit independent of red cell
             transfusions .

          6. No evidence of extramedullary leukemia, such as CNS or soft tissue involvement

          7. Adequate end organ function as measured by the following: AST and ALT < 4 x normal,
             total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert's
             syndrome, or ineffective erythropoiesis), creatinine < 2 x upper limit of normal

          8. Ability to give informed consent

          9. In agreement to use an effective barrier method of birth control to avoid pregnancy
             during the study and for a minimum of 30 days after study treatment, for all male and
             female patients who are fertile

        Exclusion Criteria:

          1. Patients with untreated or uncontrolled infections

          2. Patients with untreated or uncontrolled grade 3 or 4 GVHD

          3. Pregnancy and lactation

          4. Concurrent use of any other investigational agents.

          5. Known HIV-positive patients.

          6. Known hypersensitivity to 5AC or GM-CSF
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Condition: Coronavirus; Convalescence
MeSH terms: Coronavirus Infections; Convalescence
Intervention: Anti- SARS-CoV-2 Plasma; SARS-CoV-2 non-immune Plasma
Intervention description: SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320; Normal human plasma collected prior to December 2019
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19

Summary:

      Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control
      (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day
      28.
    

Eligibility criteria:

        Inclusion Criteria

          1. Subjects must be 18 years of age or older

          2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within
             96 hours of randomization (and 120 hours of receipt of plasma)

        Exclusion Criteria

          1. Receipt of any blood product in past 120 days.

          2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the
             opinion of the principal investigator, would affect subject safety and/or compliance.

          3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of
             breath) at time of screening.

          4. Laboratory evidence of COVID-19 infection at time of screening.

          5. History or known laboratory evidence of previous COVID-19 infection.

          6. History of prior reactions to transfusion blood products.

          7. Inability to complete therapy with the study product within 24 hours after
             randomization.
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Intervention: Placebo for Sitagliptin 25 mg; Placebo for Sitagliptin 50 mg; Sitagliptin 25 mg; Sitagliptin 50 mg
Intervention description: 1 tablet orally once daily before breakfast for 8 weeks; 1 tablet orally once daily before breakfast for 8 weeks; 1 tablet orally once daily before breakfast for 8 weeks; 1 tablet orally once daily before breakfast for 8 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin
      (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose
      tolerance who have inadequate glycemic control using diet and exercise therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Impaired glucose tolerance

          -  On diet/exercise therapy

          -  Unlikely to conceive

          -  Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society
             value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g
             oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

        Exclusion Criteria:

          -  History of diabetes mellitus

          -  Disease or condition of clear or likely glucose tolerance disorder

          -  Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
Condition: Disseminated Intravascular Coagulation
MeSH terms: Sepsis; Disseminated Intravascular Coagulation
Intervention: Antithrombin alfa (INN name); Control (Standard treatment)
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DIC associated with severe sepsis

Summary:

      The primary objective of the study is to explore the efficacy and safety of ATryn®
      (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC)
      associated with severe sepsis, when administered by continuous intravenous (IV) infusion over
      five days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent has been obtained from the patient or his/her legally
             acceptable representative

          -  Severe sepsis

          -  Disseminated intravascular coagulation
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Condition: Pain
MeSH terms: Toothache
Intervention: Ibuprofen/acetaminophen; Ibuprofen/acetaminophen; Ibuprofen/acetaminophen; Ibuprofen; Placebo
Intervention description: Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg; Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg; Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg; Two caplets of ibuprofen 200 mg; Two caplets of placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: ibuprofen; acetaminophen; pain; molar extraction

Summary:

      This study will determine the overall analgesic efficacy of three different fixed dose
      ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 16 to 40 years of age

          -  Moderate to severe post-operative pain following surgical extraction of three or more
             third molar teeth

        Exclusion Criteria:

          -  Presence of history of significant hepatic, renal, endocrine, cardiovascular,
             neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic
             disorder

          -  Pregnant or breastfeeding females