bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis
Condition: Cholangitis, Sclerosing
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: All-trans retinoic acid
Intervention description: Fixed low dose of ATRA 10 mg twice daily for 24 weeks.
Intervention MeSH terms: Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine whether a low dose of ATRA will improve
      laboratory tests of liver and bile duct inflammation in patients with PSC. The investigators
      will also look for changes to other blood tests which are related to inflammation, scarring,
      and the immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 18-80

          -  Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without
             alternative explanation for findings, for at least 6 months.

          -  Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6
             months.

          -  Ursodeoxycholic acid therapy must be discontinued for at least 3 months.

          -  At least 2 forms of barrier protection for males and females of child-bearing age.

        Exclusion Criteria:

          -  Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary
             sclerosing cholangitis.

          -  Any malignancy, presently or within the past 5 years, except adequately treated
             non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.

          -  Viral hepatitis including hepatitis A, B, C, D, E.

          -  Decompensated cirrhosis, or planned liver transplantation.

          -  Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within
             the past 3 months.

          -  Ascending Cholangitis requiring antibiotics within the past 3 months.

          -  Uncontrolled IBD, or IBD requiring the use of steroids.

          -  Acute or Chronic Kidney Disease with serum creatinine > 2 mg/dL.

          -  Allergy to ATRA or vitamin A compounds.
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Condition: Enterocolitis Clostridium Difficile Recurrent
MeSH terms: Clostridium Infections; Enterocolitis; Recurrence
Intervention: RBX2660 (microbiota suspension); Placebo
Intervention description: A suspension of intestinal microbes; A suspension of saline and cryoprotectant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; C diff; CDI; CDAD; Fecal transplant; Fecal Microbiota Transplant; Diarrhea; FMT; Microbiota restoration therapy; Microbiota suspension; Fecal bacteriotherapy; C diff diarrhea

Summary:

      This is the first prospective, multi-center, double-blinded, randomized controlled study of a
      microbiota suspension derived from intestinal microbes. Patients who have had at least two
      recurrences of C. difficile infection (CDI) after a primary episode and have completed at
      least two rounds of standard-of-care oral antibiotic therapy or have had at least two
      episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients
      whose CDI returns in less than 8 weeks after the last assigned study treatment may be
      eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years

          -  Medical record documentation of recurrent CDI either: a) at least two recurrences
             after a primary episode and has completed at least two rounds of standard-of-care oral
             antibiotic therapy or b) has had at least two episodes of severe CDI resulting in
             hospitalization.

          -  Documented history that the subject's recurrent CDI is controlled while on antibiotics
             even if the subject is not currently on antibiotics.

          -  A positive stool test for the presence of C. difficile within 60 days prior to
             enrollment.

        Exclusion Criteria:

          -  A known history of continued C. difficile diarrhea while taking on a course of
             antibiotics prescribed for CDI treatment.

          -  Requires antibiotic therapy for a condition other than recurrent CDI.

          -  Previous fecal transplant prior to study enrollment.

          -  History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's
             disease, or microscopic colitis.

          -  History of irritable bowel syndrome (IBS).

          -  History of chronic diarrhea.

          -  History of celiac disease.

          -  Colostomy.

          -  Planned surgery requiring perioperative antibiotics within 6 months of study
             enrollment.

          -  Life expectancy of < 12 months.

          -  Compromised immune system.
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Otelixizumab
Intervention description: Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: type 1 diabetes mellitus; diabetes mellitus type 1; type 1 diabetes; diabetes mellitus; diabetes

Summary:

      The purpose of this study is to optimize several multi-dose regimens of otelixizumab,
      determine the highest biologically active dose, evaluate biomarkers and surrogates of
      efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against
      standard safety and efficacy parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 12 to 45 years old who are in good general health

          -  Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic
             control

          -  Measurable C-peptide levels

        Exclusion Criteria:

          -  Females must not be pregnant or lactating and willing to practice contraception

          -  No prior malignancy, other than non-melanoma skin cancer

          -  Body Mass Index (BMI) > 32 at screening
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
Condition: Diffuse Cutaneous Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: JBT-101; Placebo; Part B Open-Label Extension
Intervention description: JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.; Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.; JBT-101 20mg bid on Days 1-364
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JBT-101, Lenabasum, Systemic Sclerosis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Part A

          -  Diffuse cutaneous systemic sclerosis

          -  Have skin thickening from SSc in a body area suitable for repeat biopsy

          -  Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or >3 years and ≤ 6
             years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein
             > 3 mg/L, high sensitivity interleukin-6 > 5 pg/mL, or increase in mRSS ≥ 5 points
             over the last 6 months with total RSS ≥ 12.

          -  Stable treatment for SSc for at least 28 days before Visit 1

        Part B

        •Completion of dosing in Part A without permanent discontinuation of study product because
        of safety or tolerability reasons.

        Exclusion Criteria (Part A and B):

          -  Severe or unstable systemic sclerosis

          -  Significant diseases or conditions other than systemic sclerosis that may influence
             response to the study product or safety;

          -  Any one of the following values for laboratory tests at Screening:

               1. A positive pregnancy test (or at Visit 1);

               2. Hemoglobin < 10 g/dL

               3. Neutrophils < 1.0 x 10^9/L

               4. Platelets < 75 x 10^9/L

               5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation

               6. Serum transaminases > 2.0 x upper normal limit

               7. Total bilirubin ≥ 1.5 x upper limit of normal

          -  Any other condition that, in the opinion of the Principal Investigator, is clinically
             significant and may put the subject at greater safety risk, influence response to
             study product, or interfere with study assessments.
Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
Condition: Nausea; Vomiting; Cesarean Section
MeSH terms: Nausea; Vomiting
Intervention: Ephedrine [Synonyms: Ephedra, Ephedrinum]; Saline Placebo
Intervention description: 25 mg, IM (in the muscle), one time; 0.5 mL, IM (in the muscle), one time
Intervention MeSH terms: Ephedrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nausea; Vomiting; Cesarean Section

Summary:

      The purpose of this research study is to investigate if the incidence of nausea and vomiting
      that subjects experience during and after a Cesarean section can be reduced by giving a shot
      of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be pregnant with a single baby

          -  Must be at term in their pregnancy (estimated gestational age of at least 38 weeks)

          -  Must be scheduled for an elective Cesarean section

          -  Must be between 60-70" tall

          -  Must be free of severe systemic disease (ASA class I or II)

        Exclusion Criteria:

          -  Contraindication to spinal anesthesia

          -  Any allergy to any of the medications included in the study

          -  History of pregnancy-induced hypertension or preeclampsia

          -  History of preexisting hypertension

          -  Diabetes mellitus

          -  Hyperemesis gravidum

          -  Previous perioperative nausea and vomiting

          -  History of motion sickness

          -  Women carrying a fetus with a known abnormality will also be excluded from the study
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: OP0201; Placebo; Amoxicillin-clavulanate
Intervention description: OP0201 20mg per day in two divided doses for 10 days; Placebo 0mg per day in two divided doses for 10 days; Oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 6 Months
Maximum age: 24 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to develop a better understanding of the safety, tolerability
      and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the
      treatment of Acute Otitis Media (AOM) in infants and children.
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. Male and female infants and children aged ≥6 months to ≤24 months

          2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild
             bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of
             the TM

          3. Score of 5 or more on the 5 question version of AOM-SOS scale1

          4. Written informed consent by the child's legal guardian and their willingness to ensure
             that study instructions are followed, all study-related visits are attended, that
             treatment administration is given, and Parent/Caregiver assessments are recorded
             according to the study protocol.

          5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

        Exclusion Criteria includes but is not limited to:

          1. Allergy to penicillin or cephalosporin

          2. History or presence of immunodeficiency disorders

          3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1

          4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere
             with Eustachian tube function

          5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous
             (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

          6. Clinically relevant blockage of 1 or both nasal passages, as determined by the
             investigator's medical judgment
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Condition: Influenza A
MeSH terms: Influenza, Human
Intervention: CT-P27; Placebo
Intervention description: Influenza A treatment drug.; Placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: efficacy; safety

Summary:

      This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from
      nasopharyngeal mucosa, compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Male & Female volunteers

        Exclusion Criteria:

          -  Current clinically significant disease

          -  Pregnant or nursing mother

          -  Abnormal pulmonary function, nose or nasopharynx
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Condition: Grade IV Glioma; Grade IV Astrocytoma; Glioblastoma Multiforme
MeSH terms: Glioblastoma; Glioma; Astrocytoma
Intervention: TVI-Brain-1
Intervention description: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Intervention MeSH terms: Adjuvants, Immunologic
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain Neoplasms; Central Nervous System Neoplasms; Brain Diseases; Neoplasms; Nervous System Neoplasms; Glioblastoma; Astrocytoma; Nervous System Diseases; Central Nervous System Diseases; Glioma; Recurrent astrocytoma; Recurrent glioma; Cancer vaccine; Immunotherapy; Killer T cells; Activated T cells; GM-CSF; Activated lymphocytes

Summary:

      TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can
      produce immune cells, called 'killer' white blood cells that have the ability to kill large
      numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to
      generate large numbers of those 'killer' white blood cells and to deliver those cells into
      your body so that they can kill your cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18

          -  Informed consent

          -  Diagnosis of grade IV glioma with progression following standard treatment.

          -  Must be able to tolerate surgery to provide tumor tissue for vaccine.

          -  Must be able to produce viable vaccine from tumor tissue.

          -  Karnofsky Performance Status must be 70 or greater.

          -  Negative HIV test.

          -  Negative for hepatitis B and C virus.

          -  Respiratory reserve must be reasonable.

          -  Sufficient renal function.

          -  Satisfactory blood counts.

          -  Negative pregnancy test for women of childbearing potential.

        Exclusion Criteria:

          -  Surgically removed cancer reveals that it is not grade IV glioma.

          -  Concomitant life-threatening disease.

          -  Active autoimmune disease.

          -  Currently receiving chemotherapy or biological therapy for the treatment of cancer.

          -  Currently receiving immunosuppressive drugs for any reason.

          -  Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.

          -  Prior treatment with Gliadel wafers.

          -  Corticosteroids beyond peri-operative period.

          -  Psychological, familial, sociological or geographical conditions that do not permit
             adequate medical follow-up and compliance with the study protocol.
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: UNR844-Cl; Placebo
Intervention description: 1.5% Ophthalmic solution for topical ocular administration; placebo
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double-mask(Investigator, patient)
Enrollment: 125.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Presbyopia, adults, randomized study, placebo

Summary:

      The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline
      ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Impaired near vision in each eye and when using both eyes, without any near correction

          -  Need a certain level of near correction

        Exclusion Criteria:

          -  Impaired distance vision in either eye, with distance correction (if any)

          -  Severe short- or long-sightedness

          -  Any significant medical or clinical conditions affecting vision, the eyes or general
             health
Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation
Condition: Lung Transplant Rejection
Intervention: Carfilzomib
Intervention description: Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antibody-mediated rejection; lung transplant; Carfilzomib

Summary:

      The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety
      and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous
      immunoglobulins for AMR after lung transplantation and elucidate important clinical and
      immunologic phenotypes and mechanisms associated with these outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult lung transplant recipients ≥ 18 years of age who meet the diagnostic criteria
             for AMR and who have underwent PFT testing unless intubated and transbronchial biopsy
             prior to enrollment.

        Exclusion Criteria:

          -  Direct contraindications or previous intolerances to any component of the standard of
             care regimen including PLEX, 5% human albumin, 5% gammagard S/D or 10% gammagard
             liquid

          -  Leukopenia

          -  Neutropenia

          -  Thrombocytopenia

          -  Known Child-Pugh B/C cirrhosis

          -  Total bilirubin > 4

          -  ALT > 90

          -  Known systolic heart failure with LVEF < 40%

          -  Known pulmonary hypertension

          -  Any uncontrolled comorbid condition

          -  Pregnant women

          -  Breastfeeding women

          -  Ongoing bacterial or fungal or viral infection that is life-threatening

          -  Active cytomegalovirus disease

          -  Active varicella zoster infection

          -  Previous intolerance to carfilzomib

          -  Concurrent use of another proteasome inhibitor (e.g., bortezomib)