bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Lenabasum 20 mg; Lenabasum 5 mg; Placebo
Intervention description: Subjects will receive lenabasum 20 mg twice daily.; Subjects will receive lenabasum 5 mg twice daily.; Subjects will receive placebo twice daily.
Intervention MeSH terms: Dronabinol; Lenabasum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking: Double (Participant, Investigator)
Enrollment: 447.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Pulmonary exacerbation, lenabasum, JBT-101

Summary:

      This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing
      the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12
      years of age or older. Approximately 415 subjects will be enrolled in this study at about 100
      sites in North America, and Europe. The planned duration of treatment with study drug is 28
      weeks.

      Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.

          2. Weight ≥ 40 kg.

          3. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.

          4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months
             for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the
             last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more
             times in the past 12 months for a new PEX.

        Exclusion Criteria:

          1. Severe or unstable CF at screening or Visit 1.

          2. Any of the following values for laboratory tests at screening:

               1. A positive pregnancy test.

               2. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.

               3. Neutrophils < 1.0 x 10^9 /L.

               4. Platelets < 75 x 10^9/L.

               5. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal
                  Disease (MDRD) Study equation.

               6. Serum transaminases > 2.5 x upper limit of normal.

          3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may
             put the subject at greater safety risk, influence response to study drug or interfere
             with study assessments.
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: RG1507
Intervention description: Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 317.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      The study was primarily designed to determine objective response, progression-free survival
      (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory
      Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas
      including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal
      myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory
             osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following
             sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor,
             extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;

          -  Cohort 3 only: age must be >= 2 and <= 21 years

        Exclusion Criteria:

          -  clinically significant unrelated systemic illness which would compromise the
             participant's ability to tolerate the investigational agent, or interfere with the
             study procedures or results;

          -  known hypersensitivity to any of the components of R1507 or prior hypersensitivity
             reactions to monoclonal antibodies;

          -  treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or
             other immunosuppressive agents;

          -  current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal
             or specific kinase inhibitor);

          -  history of solid organ transplant;

          -  other malignant disease diagnosed within the previous 5 years, excluding
             intra-epithelial cervical neoplasia or non-melanoma skin cancer;

          -  active central nervous system disease
Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions
Condition: Stroke; Brain Ischemia; Vasospasm, Intracranial; Hemorrhage, Intracranial
MeSH terms: Stroke; Brain Ischemia; Vasospasm, Intracranial; Intracranial Hemorrhages; Hemorrhage; Ischemia
Intervention: Dexmedetomidine; Fentanyl; Midazolam
Intervention description: Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.; Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.; Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Endovascular procedure; Stroke; Vasospasm, intracranial; Conscious sedation

Summary:

      Dexmedetomidine is a unique sedative medication able to provide sedation without causing
      respiratory depression and maintaining neurological functions. Patients having an acute
      ischemic stroke and need to undergo endovascular therapy require constant assessment of their
      neurological status prior, during and after the interventional procedure. In this study the
      investigators will compare the efficacy of Dexmedetomidine to other standard sedative
      medications in providing optimal sedative effect while maintaining neurological function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with acute ischemic stroke who require endovascular intervention with whom
             mNIHSS score can be obtained

          -  Patients with cerebral vasospasm suspiciousness with or without subarachnoid
             hemorrhage with whom mNIHSS score can be obtained.

        Exclusion Criteria:

          -  History of severe hepatic disease or severe renal disease (GFR<20).

          -  Hemodynamic instability.

          -  Pregnancy.

          -  Known allergy to study drug.

          -  Evidence or history of cardiac electrophysiology instability including uncontrolled
             hemodynamically unstable complex atrial/ventricular arrhythmia or conduction block at
             the time of evaluation with the exception of atrial fibrillation, and heart rate less
             than 60 or systolic blood pressure less than 90.

          -  Respiratory compromise requiring intubation.

          -  Any medical (including history of cardiac conduction block, major hepatic or renal
             disease) or laboratory abnormality that may increase the risk associated with the
             trial participation or drug administration or may interfere with interpretation of
             trial results.
SYL040012, Treatment for Open Angle Glaucoma
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: 1 drop of 0.375% SYL040012 (bamosiran); 1 drop of 0.750% SYL040012 (bamosiran); 1 drop of 1.125% SYL040012 (bamosiran); 1 drop of 1.5% SYL040012 (bamosiran); 1 drop of 0.5 % timolol maleate
Intervention MeSH terms: Timolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SYL040012; bamosiran; siRNA; RNAi; Glaucoma; Ocular hypertension

Summary:

      The purpose of this double-masked, randomized, controlled study is to assess the safety and
      ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops
      compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated
      intraocular pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years of either sex

          -  Good or fair general health as assessed by the investigator.

          -  Signed informed consent prior to any clinical trial-related procedures

          -  Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)

          -  Post-washout mean IOP above target range

          -  BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)

          -  Stable visual field

          -  Central corneal thickness 480-620 μm

          -  Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes

        Exclusion Criteria:

          -  Pregnant or breastfeeding females

          -  Females of childbearing potential not willing to use a medically acceptable
             contraceptive method

          -  Clinically significant systemic disease

          -  Changes of systemic medication that could have a substantial effect on IOP

          -  Known hypersensitivity to any component of the formulations

          -  Unable to comply with the clinical trial requirements

          -  Clinically significant abnormalities in laboratory tests

          -  Severe visual field defect

          -  Any secondary glaucoma

          -  Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow
             angles.

          -  IOP ≥ 35 mm Hg in any eye

          -  Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser
             trabeculoplasty) and refractive surgery

          -  Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6
             months prior to Baseline

          -  Evidence of ocular infection, inflammation, clinically significant blepharitis or
             conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis

          -  Clinically significant ocular disease
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Condition: Clostridium Difficile Infection Recurrence
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Recurrence
Intervention: Full Spectrum Microbiota; Placebo
Intervention description: Orally administered donor derived microbiota; Placebo for CP101
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium Difficile Infection; CP101; Crestovo; FMT; CDI; C. difficile; C. diff; Recurrent Clostridium Difficile Infection; Recurrent C. diff; Recurrent CDI; Finch; Fecal transplant; Fecal microbiota transplant; rCDI; Finch Therapeutics

Summary:

      Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules
      one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose
      of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence
      of C. difficile.

      Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study
      drug (CP101 or placebo) may be eligible to enroll in the open-label extension study
      (CP101-CDI-E02) and will receive CP101.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent

          -  Men or women 18 years of age or older

          -  Current diagnosis of a recurrence of non-severe, non-complicated CDI

          -  Subject has a clinical response to standard-of-care CDI antibiotics for the most
             recent CDI episode

        Exclusion Criteria:

          -  Pregnant, breast-feeding, or considering becoming pregnant during the study

          -  Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's
             disease and ulcerative colitis)

          -  Any prior diagnosis of diarrhea-predominant irritable bowel syndrome

          -  Systemic chemotherapy or radiation for the treatment of cancer during the 60 days
             prior to consent or planned during the 8 weeks following Randomization

          -  Prior fecal transplant for any condition, regardless of route of administration in the
             last year or plans to undergo during the study

          -  Major intra-abdominal surgery within the past 60 days prior to Screening

          -  History of total colectomy/ileostomy or bariatric surgery

          -  Admitted to, or expected to be admitted to an intensive care unit for any medical
             reason. Note: Residents of long term care facilities are eligible study entry

          -  Planned hospitalization or invasive surgery during the study

          -  Severe acute illness unrelated to CDI
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: H.pylori eradication
Intervention description: The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,

Summary:

      The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)
      index, and anthropometric measurements (body mass index and waist circumference)in diabetic
      subjects with non-alcoholic fatty liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetic dyspeptic patients with positive antibody to H.pylori and persistent elevated
             aminotransferase levels with the evidence of fatty liver in ultrasonography, who were
             referred to a gastroenterology clinic

        Exclusion Criteria:

          -  Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
             heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune
             hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum
             creatinine concentration of > 1.5 mg/dl), any severe systemic co-morbidities,
             neoplasm, using any hepatotoxic medication during the past 3 months, previous history
             of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs
             (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal
             cancers), and pregnant or lactating women.
Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine
Condition: Airway Remodeling
MeSH terms: Airway Remodeling
Intervention: Dexmedetomidine; propofol
Intervention description: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.; Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.
Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: upper; airway; dimensions; propofol; dexmedetomidine

Summary:

      Sedation is required in infants and children to successfully complete MRI while maintaining
      respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk
      during MRI examination. Therefore, appropriate drugs need to be selected, administered, and
      titrated to achieve these objectives. Propofol is commonly used for sedation in children in
      the MRI setting because of its predictability, rapid onset, and offset of action.
      Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and
      respiratory stability. The rationale of this research is to assess the effect of these drugs
      on the upper airway and validate their use in children with upper airway disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children undergoing MRI brain

          -  Age 2 - 5 yrs

          -  ASA I - II

        Exclusion Criteria:

          -  OSA

          -  Pathology of upper airway

          -  Craniofacial anomalies

          -  Gastroesophageal reflux

          -  Increased intracranial pressure

          -  Body weight of 20% more than ideal

          -  Contraindication to the use of either drug

          -  Failure to maintain a patent airway during the study
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Brentuximab vedotin; Placebo
Intervention MeSH terms: Brentuximab Vedotin; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus

Summary:

      The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin
      in adults with active systemic lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years

          -  Diagnosis of SLE for at least 6 months prior to screening

          -  Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening

          -  Must have failed a treatment for SLE after a trial of at least 3 months

        Exclusion Criteria:

          -  The subject has any serious health condition, which, in the opinion of the
             Investigator, would place the subject at undue risk from the study

          -  Subject has had recent serious or ongoing infection, or risk for serious infection

          -  Subject has a history of new or recurrent malignancy within the past 5 years

          -  The subject is pregnant and/or breastfeeding

          -  The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that
             may confound clinical assessments in the study

          -  The subject has urgent, severe SLE disease activity, which, in the opinion of the
             Investigator, warrants immediate immunosuppressive therapy and would not be
             appropriate for the study
Dacarbazine and Carmustine in Metastatic Melanoma
Condition: Melanoma Metastatic
MeSH terms: Melanoma
Intervention: Dacarbazine; Carmustine; Neulasta
Intervention description: Dacarbazine IV - Day 1; Carmustine IV- Day 2; Neulasta SC - Day 3
Intervention MeSH terms: Dacarbazine; Carmustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma Metastatic

Summary:

      The purpose of this study is to determine whether dacarbazine and carmustine at the doses and
      schedule used in this study will help to increase tumor shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma
             which has progressed on at least one prior systemic therapy.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and
             estimated survival of at least 3 months.

          3. Patients must be felt to have recovered from effects of prior cancer therapy, such as
             past expected leukocyte nadir for chemotherapy (> 2 weeks).

          4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl;
             platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and
             AST must be less than 3 times the upper limit of normal; creatinine must be less than
             or equal to 1.8 mg/dl.

          5. Women of childbearing potential must have a negative pregnancy test and adequate
             precautions to prevent pregnancy during treatment must be taken.

          6. Patient consent must be obtained prior to entrance onto study.

          7. Patients must have no evidence of significant cardiovascular disease including history
             of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure,
             uncontrolled angina or cerebrovascular accident.

        Exclusion Criteria:

          1. Evidence of significant cardiovascular disease including history of recent (< 6
             months) myocardial infarction, uncompensated congestive heart failure, uncontrolled
             angina, or cerebrovascular accident.

          2. Prior history of psychiatric disorder that could be exacerbated by or which could
             preclude completion of this therapy.

          3. Pregnancy or lactation.

          4. Prior chemotherapy with carmustine