bioihbjkbjnl/mcl2 huggingface dataset:
OPTIMA-TBI Pilot Study
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Intervention: Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.; Placebo - Cap
Intervention description: Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA & 100 mg EPA) or placebo capsules.; Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA & 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty
      acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals presenting to the emergency department (ED) within 24 hours of injury, who
             meet the American Congress of Rehabilitation Medicine (ACRM)'s definition of having
             mild traumatic brain injury (mTBI) will be eligible

          -  The ACRM defines mTBI as a traumatically-induced physiological disruption of brain
             function as a consequence of the head being struck, striking an object, or undergoing
             an acceleration/deceleration movement without direct external head trauma and
             resulting in at least one of the following:

          -  any period of loss of consciousness (LOC)

          -  any loss of memory for events immediately before or after the injury

          -  any alteration in mental state at the time of the injury (eg, feeling dazed,
             disoriented, or confused)

          -  focal neurological deficit(s) that may or may not be transient

        Exclusion Criteria:

          -  GCS<13 at any time during ED stay.

          -  Significant polytrauma including: bony fracture or solid organ injury

          -  Study medication cannot be administered within 24 hours of injury

          -  Patient cannot be relied on to complete follow-up (i.e. no reliable telephone number,
             substance dependence, homeless)

          -  Cannot communicate in English

          -  Take an anticoagulant (coumadin or a novel oral anticoagulant) daily

          -  Age less than 18 years or greater than 65 years

          -  Patients already taking fish oil supplements daily

          -  History of cognitive impairment

          -  Allergic to fish/fish oil

          -  Pregnant women (self-reported)
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06700841; Placebo
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: plaque psoriasis

Summary:

      The purpose of this study is to determine whether PF-06700841 is safe and effective in the
      treatment of chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months
             prior to Baseline/Day 1 (prior to first dose of study drug)

          -  Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe")
             at Baseline/Day 1 (prior to first dose of study drug)

          -  Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at
             Baseline/Day 1 (prior to first dose of study drug)

          -  Considered by dermatologist investigator to be a candidate for systemic therapy or
             phototherapy of psoriasis (either naïve or history of previous treatment)

        Exclusion Criteria:

          -  Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
             psoriasis, with the exception of nail psoriasis which is allowed

          -  Have evidence of skin conditions (eg, eczema) at the time of screening or baseline
             visit that would interfere with the evaluation of psoriasis

          -  Cannot discontinue systemic therapies and/or topical therapies for the treatment of
             psoriasis and cannot discontinue phototherapy (UVB or PUVA)

          -  Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).

          -  Have taken Apremilast (Otezla) within 3 months of first dose of study drug.

          -  Have undergone treatment with tofacitinib within 3 months of first dose.
A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; paclitaxel; bevacizumab
Intervention description: 1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity; 90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity; 10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Intervention MeSH terms: Paclitaxel; Bevacizumab; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Cancer of Breast; Cancer of the breast; Breast Neoplasms

Summary:

      This study will compare the cancer response to both treatments for locally advanced or
      metastatic breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females diagnosed with breast cancer and the cancer has spread to distant areas of the
             breast or organs.

          -  Must be able to measure the disease by specific medical parameters

          -  May have received breast cancer treatment in the early stage of the disease

          -  May be restricted in physically strenuous activity but able to carry out light work.

          -  Must have adequate organ function as seen in blood test results.

        Exclusion

        Criteria:

          -  Cancer that has spread to the brain.

          -  Unstable heart problems

          -  Unstable high blood pressure.

          -  Breast cancer treatment after the disease has considered to spread to other areas or
             organs.

          -  Unable to agree with the requirements of the study
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Condition: Post Partum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Ketamine 0.5 mg/kg; Ketamine 0.2 mg/kg
Intervention description: single intravenous infusion of Ketamine (0.5 mg/kg); single intravenous infusion of Ketamine (0.2 mg/kg)
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Postpartum depression is a non-psychotic major or minor depressive episode that occurs during
      pregnancy or within 12 months of post-partum period. The nature of symptoms is same as
      depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal
      thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal
      depression affects children by increasing the risk of emotional and behavioral and physical
      health problems and cognitive difficulties. Thus early screening and intervention is critical
      in reducing the negative impact of PND in the mother and child, family and the community.

      The purpose of this study is to assess the safety, pharmacokinetics and antidepressant
      efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects, ages 18-45 years

          -  Experienced a major depressive episode in the postpartum period beginning within the
             first 4 weeks following delivery and with moderate or severe symptoms (>12 EPDS or >14
             HAM-D).

          -  No or partial response to adequate doses of SSRI medications to treat PND for longer
             than 6 weeks.

          -  PND patients will be requested to maintain the stable dose of antidepressants while
             enrolled in the study trial.

          -  Patients that can speak and read the English language, are able to understand the
             study procedures and sign the informed consent

        Exclusion Criteria:

          -  No current or past psychosis or severe personality disorder.

          -  No current substance abuse or dependence.

          -  No serious and imminent suicidal or homicidal risk.

          -  No recent or history of major and unstable medical problems that affect brain anatomy,
             neurochemistry, or function.

          -  Not diagnosed with cardiovascular disorders.

          -  No increased risk of laryngospasm or active upper respiratory infections.

          -  Not diagnosed with an intellectual disability or neurodegenerative diseases.

          -  Mothers that are currently breastfeeding.

          -  No current pregnancy.
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
Condition: Hepatitis C Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: Daclatasvir; Daclatasvir; Placebo; Peginterferon alfa-2a; Ribavirin
Intervention description: Tablets, Oral, 10 mg, daily, 24-48 weeks; Tablets, Oral, 60 mg, daily, 24-48 weeks; Tablets, Oral, 0 mg, daily, 48 weeks; Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks; Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined
      with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically
      infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is
      safe, well tolerated, and efficacious
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects chronically infected with hepatitis C virus (HCV) genotype 1

          -  HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening

          -  The current standard of care naïve or non-responder

        Key Exclusion Criteria:

          -  Cirrhosis

          -  HCC

          -  Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Rituximab and ABVD for Hodgkin's Patients
Condition: Lymphoma
MeSH terms: Hodgkin Disease
Intervention: Rituximab; Adriamycin; Bleomycin; Vinblastine; Dacarbazine (DTIC)
Intervention description: 375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.; 25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; 10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; 6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; 375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Intervention MeSH terms: Rituximab; Doxorubicin; Liposomal doxorubicin; Dacarbazine; Bleomycin; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Hodgkin's Disease; Lymphoma; Rituximab; Rituxan; Adriamycin; Doxorubicin; Rubex; Bleomycin; Bleomycin sulfate; Blenoxane; BLM; Dacarbazine; DTIC; DTIC-Dome; Vincristine; Vinblastine; Vinblastine Sulfate; ABVD; ABVD Chemotherapy Treatment

Summary:

      Primary Objective:

      - To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD
      combination chemotherapy.

      ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hodgkin's disease patients who relapse after radiation therapy alone and previously
             untreated patients with stage II bulky, III and IV who are eligible for ABVD.

          2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or
             mixed cellularity).

          3. Must have bidimensionally measurable disease.

          4. Must sign a consent form.

          5. Must be older than 16 years of age.

          6. Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL

          7. Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA)
             scan or echocardiogram.

          8. Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl

        Exclusion Criteria:

          1. HIV positive.

          2. Pregnant women and women of child bearing age who are not practicing adequate
             contraception.

          3. Prior chemotherapy.

          4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and
             asthma.
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Placement of the sponge; Mitomycin-C
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary open angle glaucoma; trabeculectomy; mitomycin-C; express mini-shunt

Summary:

      The primary focus of this study is to assess intraocular pressure and complication rates
      between patients who receive mitomycin-C using a sponge versus no-sponge.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women aged 18 years and older at screening.

          2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or
             pseudophakic, with visual field or optic disc changes characteristic of glaucoma.

          3. Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with
             MMC in the superonasal quadrant in the study eye which the physician deems as
             medically necessary.

          4. Capable and willing to provide consent

        Exclusion Criteria:

          1. Unable or unwilling to provide consent

          2. Any previous ocular surgeries in the study eye preventing placement of the
             trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the
             superonasal quadrant

          3. Any previous glaucoma drainage devices in the study eye

          4. Any abnormality other than glaucoma in the study eye that could affect applanation
             tonometry.

          5. Presence or history of any abnormality or disorder that could interfere with the study
             procedure or prevent the successful completion of the study.

          6. Presence or history of uveitis within 10 years or any other ocular infection or
             inflammation within 14 days before day 1.

          7. Any significant unstable cardiovascular, hepatic, renal, respiratory,
             gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
             psychiatric disease.

          8. Known Pregnancy or Breastfeeding

             Physical and Laboratory Findings

          9. Conjunctival scarring precluding a superonasal implantation location.

         10. Vitreous in the anterior chamber.

         11. Abnormality preventing reliable applanation tonometry in the study eye.
A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: LDE225
Intervention description: LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: locally advanced basal cell carcinoma; metastatic basal cell carcinoma; LDE225; sonidegib; Basel Cell Carcinoma (BCC); skin cancer; Basel Cell Carcinoma; BCC

Summary:

      This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225
      in patients with locally advanced or metastatic BCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with locally advanced BCC and metastatic BCC

          -  Patients with adequate bone marrow, liver, and renal function

        Exclusion Criteria:

          -  Patients who had had major surgery within 4 weeks of initiation of study medication

          -  Patients unable to take oral drugs or with lack of physical integrity of the upper
             gastrointestinal tract, or known malabsorption syndromes.

          -  Patients with concurrent medical conditions that may interfere or potentially affect
             the interpretation of the study.

          -  Patients with neuromuscular disorders or are on concurrent treatment with drugs that
             may cause muscle damage.

          -  Patients who were on concurrent therapy with other anti-neoplastic agents.

          -  Patients who had taken part in an experimental drug within 4 weeks of initiation of
             study medication.

          -  Pregnant or nursing (lactating) women

          -  Women of child bearing potential unwilling to use 2 forms of highly effective
             contraception throughout the study and for 3 months after the last treatment

          -  Fertile males not willing to use condoms throughout the study and for 3 months after
             the last treatment.

          -  Patients who were unwilling or unable to comply with the protocol.
AD109 Dose Finding in Mild to Moderate OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: AD109 dose1- A; AD109 dose2- B; Placebo- C
Intervention description: Oral administration at bedtime; Oral administration at bedtime; Oral administration at bedtime
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to
      examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild
      obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AHI between 5 and 20 events/h

          -  PGI-S equal to or higher than 1, or one or more of the following symptoms:

               -  Snoring or nightime gasping/choking

               -  Daytime sleepiness, fatigue or decreased concentration

               -  Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning
                  headache

               -  Irritability, decreased mood or libido

        Exclusion Criteria:

          -  History of narcolepsy.

          -  Clinically significant craniofacial malformation.

          -  Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery
             disease or heart failure or hypertension requiring more than 2 medications for
             control).

          -  CPAP should not be used for at least 2 weeks prior to the study

          -  History of using oral or nasal devices for the treatment of OSA may enroll as long as
             the devices are not used during participation in the study.