bioihbjkbjnl/mcl2 huggingface dataset:
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Placebo; Brivaracetam
Intervention description: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Intervention MeSH terms: Brivaracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy: partial onset seizures; brivaracetam

Summary:

      This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50
      mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female from 16 to 65 years

          -  Well-characterized focal epilepsy or epileptic syndrome according to the International
             League Against Epilepsy (ILAE) classification

          -  History of partial onset seizures

          -  Subjects having at least 4 partial onset seizures during the 4-week Baseline Period
             and at least 2 partial onset seizures during the 3 months prior to Visit 1

          -  Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a
             stable dose.

        Exclusion Criteria:

          -  Seizure type IA non-motor as only seizure type

          -  Seizures occurring only in clusters

          -  Status epilepticus during the last 2 years before Visit 1

          -  History of cerebrovascular accident (CVA)

          -  Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: SelG1; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: SelG1; P-selectin; monoclonal antibody; sickle cell disease; sickle cell anemia; sickle cell; pain crisis; pain crises; vasoocclusion; vaso-occlusion; priapism; hepatic sequestration; splenic sequestration; chest syndrome; SCD

Summary:

      The purpose of this study was to determine whether the investigational drug SelG1 when given
      to sickle cell disease patients either taking or not taking hydroxyurea was effective in
      preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the
      bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may
      prevent small blood vessels from becoming blocked and therefore reduce the occurrence and
      severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the
      drug and how long it stayed in the blood stream.

      Funding Source - FDA Office of Orphan Products Development (OOPD)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)

          -  If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at
             least 6 months, with the dose stable for at least 3 months

          -  Between 2 and 10 sickle cell-related pain crises in the past 12 months

        Key Exclusion Criteria:

          -  On a chronic transfusion program or planning on exchange transfusion during the study

          -  Hemoglobin <4.0 g/dL

          -  Planned initiation, termination, or dose alteration of hydroxyurea during the study

          -  Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Tenalisib
Intervention description: Tenalisib 800 mg BID, Orally
Intervention MeSH terms: Tenalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
Masking: None (Open Label)
Masking description: None (open label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phosphoinositide 3-kinase; Pi3k Delta and gamma inhibitor; Tenalisib; Leukemia, Lymphocytic, Chronic, B-Cell

Summary:

      The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy
      and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at
      least one prior therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with diagnosis of B-cell CLL

          2. Disease status defined as refractory to or relapsed after at least one prior therapy.

          3. Presence of measurable lymphadenopathy presence of > 1 nodal lesion

          4. ECOG performance status ≤ 2.

          5. Adequate bone marrow, liver, and renal function

        Exclusion Criteria:

          1. Richter's (large cell) transformation, or PLL transformation.

          2. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5
             half-lives (whichever is shorter).

          3. Prior exposure to drug that inhibits PI3K

          4. Patient with ASCT/Allo-SCT receiving treatment for active GVHD.

          5. Ongoing severe systemic bacterial, fungal or viral infection.

          6. Central nervous system (CNS) involvement of leukemia or lymphoma.

          7. Ongoing immunosuppressive therapy including systemic corticosteroids.

          8. Known history of severe liver injury as judge by investigator.

          9. Any severe and/or uncontrolled medical conditions or other conditions that could
             affect patient participation

         10. Women who are pregnant or lactating.

         11. Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus
             (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV)
             infection iv. active CMV infection

             -
Efficacy of Spinal Oxytocin in Healthy Volunteers
Condition: Healthy Volunteer Study
Intervention: Oxytocin 15 mcg; Oxytocin 150 mcg; Placebo
Intervention description: Oxytocin 15 mcg will be administered spinally; Oxytocin 150 mcg will be administered spinally; placebo will be administered spinally
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are randomized into one of 3 groups to receive, in a double-blind manner, intrathecal saline or intrathecal oxytocin, 15 mcg or 150 mcg
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Randomization is prepared by a statistician not otherwise involved in the study or data analysis and is maintained by the Wake Forest University School of Medicine research pharmacy. Study drug is dispensed by the research pharmacy labelled as "Study drug containing normal saline or oxytocin 15 mcg in normal saline or oxytocin 150 mcg in normal saline" to indicate the possible contents of the solution, thereby maintaining blind.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effect of intrathecal oxytocin on areas and
      intensity of hyperalgesia and allodynia induced by topical capsaicin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy

          -  weight < 240 pounds

          -  American Society of Anesthesiology Category 1 or 2

        Exclusion Criteria:

          -  allergy to oxytocin or lidocaine

          -  allergy to chilli peppers

          -  Females: active gynecological disease such as uterine fibroids or ongoing bleeding

          -  Pregnancy or currently breastfeeding

          -  Females that have delivered a baby within 2 years of study

          -  Taking prescription medications (exception: oral birth control medication)
Study of Ataluren in ≥2 to <5 Year-Old Male Participants With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Ataluren
Intervention description: White to off-white powder for oral suspension.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics
      (PK), and pharmacodynamics (PD) of ataluren in participants aged ≥2 to <5 years old with
      Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males ≥2 to <5 years of age

          -  Body weight ≥12 kg

          -  Diagnosis of DMD

          -  Nonsense mutation in at least 1 allele of the dystrophin gene

        Exclusion Criteria:

          -  Participation in any other drug or device clinical investigation

          -  Ongoing use of prohibited concomitant medications
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: ACP-196; ACP-196 in combination with pembrolizumab
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic
      Pancreatic Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  ECOG performance status of 0 or 1

          -  Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma
             that is unresectable or metastatic

          -  Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic
             pancreatic cancer or unwilling/unable to receive systemic chemotherapy

        Exclusion Criteria:

          -  Prior malignancy (other than pancreatic cancer), except for adequately treated basal
             cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which
             the subject has been disease free for ≥ 2 years or which will not limit survival to <
             2 years.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction

          -  Breastfeeding or pregnant
Oral Immunotherapy (OIT) for Peanut Allergy
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: Peanut OIT; Placebo
Intervention description: Peanut flour that is orally ingested in a graded fashion.; Oat flour used as a placebo that is orally ingested a graded fashion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 1 Year
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Peanut Allergy

Summary:

      Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is
      to produce a new treatment that would benefit subjects who have peanut allergy by lowering
      the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune
      response in subjects who have peanut allergy (tolerance).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial
             visit

          -  The presence of IgE specific to peanuts (a positive skin prick test to peanuts
             (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L

          -  A history of significant clinical symptoms occurring within 60 minutes after ingesting
             peanuts

          -  Provide signed informed consent

        Exclusion Criteria:

          -  History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or
             neurological compromise (Cyanosis or oxygen saturation < 92% at any stage,
             hypotension, confusion, collapse, loss of consciousness; or incontinence)

          -  Currently participating in a study using an investigational new drug

          -  Participation in any interventional study for the treatment of food allergy in the
             past 12 months

          -  Subjects with a known wheat food allergy will be excluded because of cross
             contamination of oat with wheat

          -  Poor control or persistent activation of atopic dermatitis

          -  Moderate to severe persistent asthma

          -  Currently being treated with greater than medium daily doses of inhaled
             corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI)
             guidelines

          -  Inability to discontinue antihistamines for skin testing and oral food challenges
             (OFCs)
Low Dose ICG for Biliary Tract and Tumor Imaging
Condition: Cholecystitis; Hepatocellular Carcinoma; Liver Metastases
MeSH terms: Cholecystitis
Intervention: Indocyanine green; PINPOINT Endoscopic Fluorescence
Intervention description: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).; The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
Masking: Double (Participant, Investigator)
Masking description: To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Biliary Tract; Indocyanine Green (ICG); Tumors; Near-infrared Fluorescence

Summary:

      Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green
      (ICG) allows for the intraoperative identification of liver anatomy. The investigators have
      new data that a much lower dose improves this visualization. Confirmation of this hypothesis
      would mean that ICG can be administered on the same day of surgery in order to augment
      real-time intraoperative visualization, thereby providing a safe, feasible, and
      cost-effective strategy for the surgical treatment of liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing standard of care laparoscopic hepatic or biliary operations or
             Patients undergoing standard of care laparoscopic resection for hepatic tumors:
             hepatocellular carcinoma or metastatic tumor

        Exclusion Criteria:

          -  Patients with a history of adverse reactions or known allergy to ICG, iodine, or
             iodine dyes and Pregnant and/or lactating patients.
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 671800; Placebo; Montelukast
Intervention description: Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma; Patients receive placebo capsules and/or encapsulated tablets; Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
Intervention MeSH terms: Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a
      double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main
      objective is to assess the effect on lung function. The study will also provide data on the
      pharmacokinetics of BI 671800.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent consistent with ICH-GCP

          2. Three month history of reversible (12% and 200 mL in forced expiratory volume in one
             second - FEV1) asthma (according to GINA) with following spirometry at randomisation:
             FEV1 60%- 85%.

          3. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.

          4. Diagnosis of asthma prior to 40 years.

          5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.

          6. Male or female 18 to 65 years.

          7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine
             screen.

          8. Able to perform pulmonary function testing.

        Exclusion criteria:

          1. Significant diseases other than asthma or allergic rhinitis.

          2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.

          3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.

          4. Uncontrolled asthma on iCS + other controller.

          5. Respiratory tract infection or exacerbation within 4 weeks.

          6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive
             days, or asthma exacerbation during run-in period.

          7. Participation in another interventional study.

          8. Pregnant or nursing women.

          9. Women of child bearing potential not using appropriate methods of birth control as
             defined by the study protocol.
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; Placebo
Intervention description: Two active tablets, given daily; Two placebo tablets, given daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to
      adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a major depressive episode (MDE)

          -  Body mass index less than or equal to 40 kg/m2

          -  Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at
             least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to
             remain stable throughout the study

          -  History of inadequate response during the entire current MDE to 1 or 2 adequate
             antidepressant treatments, including current treatment

          -  Be otherwise physically healthy

        Exclusion Criteria:

          -  Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder,
             schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder,
             obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic
             stress disorder

          -  Have a clinically significant current axis II diagnosis of borderline, antisocial,
             paranoid, schizoid, schizotypal, or histrionic personality disorder

          -  Are experiencing hallucinations, delusions, or any psychotic symptomatology in the
             current MDE

          -  Receive new onset psychotherapy within 6 weeks of screening

          -  Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before
             screening

          -  Have received electroconvulsive therapy during the current MDE

          -  Have attempted suicide within the past 2 years

          -  Have a thyroid pathology

          -  Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin
             syndrome

          -  Have a positive test for human immunodeficiency virus (HIV)

        Additional inclusion/exclusion criteria may apply