bioihbjkbjnl/mcl2 huggingface dataset:
Choroideremia Gene Therapy Clinical Trial
Condition: Choroideremia
MeSH terms: Choroideremia
Intervention: Injection of AAV2-REP1 (10e11 vg)
Intervention description: Single Group: single arm study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: choroideremia, gene therapy

Summary:

      Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The
      study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients
      will be required to attend a total of 11 study visits over a 24 month period with an
      additional 3 year follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 Years and older

          -  Male

          -  Able to give informed consent

          -  Genetically confirmed diagnosis of choroideremia

          -  Active disease visible clinically within the macula region

          -  Best-corrected visual acuity equal to or worse than 20/32 but better than or equal to
             20/200 in the study eye.

        Exclusion Criteria:

          -  Female

          -  Under the age of 18

          -  History of amblyopia in the study eye

          -  Men unwilling to use barrier contraception methods

          -  Relevant grossly asymmetrical disease or other ocular morbidity which might confound
             use of the fellow eye as a long-term control

          -  Any other significant ocular and non-ocular disease/disorder or retinal surgery

          -  Contraindication to use of medications or contrast agents

          -  Participated in research study involving an investigational product in the past 12
             weeks

          -  Having had gene or cellular therapy at any time prior to this study.
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; RBV
Intervention description: LDV/SOF FDC administered orally once daily; Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
Intervention MeSH terms: Ribavirin; Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state
      pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose
      combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in
      Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of
      dosing of LDV/SOF FDC in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
      LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover
      into the Treatment Phase with no interruption of study drug administration. The primary
      objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and
      tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants
      with HCV.

      During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to
      swallow tablets.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Consent of parent or legal guardian required

          -  Chronic HCV infection

          -  Screening laboratory values within defined thresholds

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol.

          -  Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus

          -  Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)

          -  Pregnant or nursing females

          -  Known hypersensitivity to study medication

          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
Condition: Acute Leukemia
MeSH terms: Leukemia; Acute Disease
Intervention: Micafungin
Intervention MeSH terms: Micafungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: leukemia; induction; prophylaxis; antifungal; micafungin; phase II

Summary:

      The purpose of this study is to determine whether prophylaxis with micafungin is effective in
      the induction chemotherapy for newly diagnosed acute leukemia patients.
    

Eligibility criteria:

        Inclusion Criteria:

        A. patients belong to either A-1 or A-2 A-1. patients with newly diagnosed acute myeloid
        leukemia who approve to get induction chemotherapy with (cytarabine plus idarubicin) or
        (modified Fludarabine + cytarabine + idarubicin ) A-2. patients with newly diagnosed acute
        lymphoid leukemia who approve to get induction chemotherapy with VPDL (vincristine +
        prednisolone + daunorubicin + L-asparaginase), C-VPDL (cyclophosphamide + vincristine +
        prednisolone + daunorubicin + L-asparaginase), or (R)-hyperCVAD ((Rituximab) +
        cyclophosphamide + vincristine + Adriamycin + dexamethasone) B. Eastern Cooperative
        Oncology Group performance status score is equal to or more than 2 C. patients who
        voluntarily sign the agreement

        Exclusion Criteria:

        A. evidence of proven/probable/possible fungal infection within 30 days before induction
        chemotherapy B. hypersensitivity to echinocandin C. patients had other malignancy within 5
        years D. previous treatment history with chemotherapy, radiation therapy, or
        immunosuppressive therapy.

        E. pregnant or breast-feeding women F. immunodeficient patients including AIDS G. patients
        with uncontrolled seizure or psychiatric disorder H. clinically significant heart disorder
        (myocardial infarction within 3 months or left ventricular ejection fraction < 40%) I.
        interstitial lung disease J. previous organ transplantation history K. galactose
        intolerance L. patients who participated this study before.
Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma
Condition: Small Cell Lung Cancer
MeSH terms: Small Cell Lung Carcinoma; Lung Neoplasms
Intervention: Rucaparib and Nivolumab
Intervention description: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Intervention MeSH terms: Nivolumab; Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rucaparib; nivolumab; platinum-sensitive; maintenance; SCLC; immune checkpoint; PARP

Summary:

      The purpose of this study is to evaluate survival and response rate of the combination
      rucaparib and nivolumab as maintenance therapy in platinum-sensitive small cell lung
      carcinoma.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with histologically or cytologically confirmed stage IV, extensive stage,
             small cell lung cancer who achieved either partial or complete remission per RECIST
             1.1 post frontline chemotherapy with platinum doublet (Cisplatin or
             Carboplatin/etoposide).

          -  Enrollment is within 6 weeks of last (4th cycle) of chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Adequate Bone Marrow Function

          -  Adequate Hepatic Function

        Exclusion Criteria

          -  Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune
             checkpoints)

          -  Major surgery within 4 weeks of initiation of study medication.

          -  Current use of (some) immunosuppressants

          -  Active infection requiring systemic therapy

          -  HIV/AIDS

          -  Hepatitis B virus or hepatitis C virus infection at screening

          -  Autoimmune disease

          -  Persisting toxicity related to prior therapy

          -  Pregnancy

          -  Vaccination (except inactive) within 4 weeks of the first dose of nivolumab

          -  Hypersensitivity to the study drugs

          -  Cardiovascular disease

          -  Untreated central nervous system (CNS) metastases or leptomeningeal carcinomatosis

          -  (Some) active secondary malignancy

          -  Active pneumonitis or interstitial lung disease
Celecoxib for Thyroid Eye Disease
Condition: Thyroid Eye Disease
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Intervention: Celecoxib; artificial tears
Intervention description: celecoxib 100mg PO twice per day for 3 months; Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.
Intervention MeSH terms: Celecoxib; Lubricant Eye Drops
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks
      orbital tissues, resulting in characteristic changes in eyelid position, globe position in
      the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially
      blinding disease, and current treatments largely consist of nonspecific reduction of
      inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED
      progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital
      changes become fixed and can be modified only by surgery.

      The investigators propose to treat a cohort of patients with active TED using a selective
      COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group.
      The investigators hypothesize that celecoxib will reduce the severity of disease and/or
      prevent progression to proptosis, diplopia, and corneal exposure or compressive optic
      neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent diagnosis of thyroid eye disease (within the past 3 months)

          -  Have ocular symptoms or signs of TED with a clinical activity score (CAS) of at least
             3

        Exclusion Criteria:

          -  Pregnancy

          -  Previous treatment with corticosteroid for TED for >2wks

          -  Previous treatment with orbital radiation for TED

          -  Impaired renal function

          -  Impaired hepatic function

          -  Treatment with antihypertensive medications except beta-blockers

          -  History of congestive heart failure, cardiac valvular disease, or coronary artery
             disease

          -  Allergy to NSAID or previous adverse reaction (ie. GI bleeding)

          -  Vision loss due to compressive optic neuropathy
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Filgotinib; Placebo; Standard of Care
Intervention description: 200 mg tablet administered orally once daily; Placebo to match filgotinib tablet administered orally once daily; Locally approved treatment, accepted by medical experts as a proper treatment for IBD conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 139.0
Sex: Male
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the testicular safety of filgotinib in
      adult males with moderately to severely active inflammatory bowel disease (IBD).

      Results of this study may be pooled with the results of a separate study being conducted in
      participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or
      non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the
      same objective. The total planned number of participants in both studies combined will be up
      to approximately 250 participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4
             months. Endoscopic and histopathologic documentation of UC or CD.

          -  Have moderately to severely active UC or CD

        Key Exclusion Criteria:

          -  Previously or currently documented problems with male reproductive health

          -  Current use of sulfasalazine or its use within the 26 weeks leading up to Screening;
             sulfasalazine is not permitted at any point during the study

          -  Current use of corticosteroids at a dosage of > 20 mg/day of prednisone or equivalent
             at randomization

          -  Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative
             proctitis, or toxic mega colon

          -  Active tuberculosis (TB) or untreated latent tuberculosis

          -  Use of concomitant prohibited medications as outlined by protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Condition: Bone Loss
MeSH terms: Bone Diseases, Metabolic; Spinal Cord Injuries
Intervention: zoledronic acid; placebo
Intervention description: zoledronic acid, 5mg, iv; iv
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spinal cord injury; osteoporosis; bone loss; zoledronic acid; bisphosphonate

Summary:

      This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be
      administered intravenously to people who have suffered an acute spinal cord fracture. The
      goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this
      population. Outcome measures will include bone density determinations over a one year period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women

          2. Age 18 years and older

          3. Spinal cord injury within 8 weeks of study entry

          4. ASIA AIS A or B

          5. Medically stable in the opinion of their physiatrist

          6. Able to have dexa performed

          7. Able to return for follow-up at 6 and 12 months

        Exclusion Criteria:

          1. Vitamin D deficiency

          2. Hypocalcemia

          3. Renal insufficiency (estimated creatinine clearance <30ml/min)

          4. Abnormal thyroid hormone status

          5. Abnormal mental status

          6. Osteoporosis at the hip or spine by dexa
The Relationship Between Neuropsychological Testing and MRI, PET and COBRE - Project 1: AIM 2 (GE-180)
Condition: Alzheimer Disease; Parkinson Disease; Inflammation
MeSH terms: Parkinson Disease; Alzheimer Disease; Inflammation
Intervention: GE180 PET Scan
Intervention description: GE180 PET Scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will receive one Flutriciclamide (18F-GE180) PET scan.
Masking: None (Open Label)
Masking description: No masking
Enrollment: 24.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: neuroinflammation

Summary:

      The complex pathological cascades leading to both Alzheimer's disease (AD) and Parkinson's
      disease (PD) involve, at various points, inflammation. Since inflammation is a treatable
      symptom, understanding how and when it impacts the brain, and where specifically in the
      brain, would offer important guidance in the development of new treatments, sorely needed in
      both diseases.

      Microglia play an important anti-inflammatory role, and produce a substance, mitochondrial
      translocator protein (TSPO), whose presence can be used as a marker of regional inflammation.
      GE180 is a newly developed PET ligand which binds to TSPO and hence can be used in imaging
      studies to analyze regional inflammation in living patients. In prior studies it has shown
      regional specificity in multiple sclerosis and brain injury. In the current study, the
      investigators will be using GE180 to analyze regional and global inflammation in the brains
      of patients with AD and PD at a single time point.

      The results of the current study will provide enriched understanding of inflammation in these
      conditions, and potentially provide preliminary data to inform design of future
      interventional trials.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be enrolled in CNTN

          2. Aged 55 to 90

          3. Available study partners

          4. Willing and able to participate in longitudinal follow-up study

          5. For MCI patients, fit criteria based in Movement Disorders Task Force or NIA

        Exclusion Criteria:

          1. Significant neurological disorders other than AD or PD;

          2. Unstable medical conditions

          3. History of major psychiatric diseases

          4. MRI evidence of infarction or other focal lesion or multiple lacunes

          5. Clinically significant abnormalities in B12 or TSH

          6. Identified as having a common polymorphism (rs6971) in the TSPO gene which has been
             shown to reduce binding affinity of tracers similar to GE180. This testing will be
             done as part of their CNTN participation.
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Pre-Op pregabalin; Pre-Op Placebo 1; Post-Op pregabalin; Post-Op Placebo 1; Post-Op Placebo 2; Post-Op acetaminophen
Intervention description: Pre-op pregabalin will be administered 60 min prior to surgery.; Placebo 1 will be administered 60 min prior to surgery.; Post-op pregabalin will be administered Post-operatively.; Placebo 1 will be administered post-operatively.; Placebo 2 will be administered post-operatively.; Acetaminophen will be administered Post-operatively.
Intervention MeSH terms: Acetaminophen; Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The sponsor, patients, investigators and study staff involved in the protocol procedures or those involved in data collection, data entry, data analysis will be blinded.
Enrollment: 115.0
Sex: All
Minimum age: 17 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  Accessing the efficacy and safety of pregabalin when used alone and in combo with
           acetaminophen in a dental pain model.

        -  To test whether pre-operative dose of pregabalin increases the time to significant
           post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed
           post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are scheduled to undergo the surgical removal of up to 4 third molars of
             which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.

          -  Patient must have a negative urine drug screen for drugs of abuse (including tobacco)
             at screening and at the day of surgery.

          -  No alcohol for a minimum of 1 day prior to the surgery.

        Exclusion Criteria:

          -  Patients should not be experiencing oral infections or symptoms of concomitant illness
             at the time of a scheduled surgery.

          -  Patients with a history of any type of malignancy within the past 5 years other than
             minor skin related cancers.

          -  Patients who currently have or have had a history of uncontrolled hypertension.

          -  Patients with a known allergy or hypersensitivity to any local anesthetic drug,
             NSAIDs, gabapentin or pregabalin;.

          -  Patients with conditions that affect the absorption, metabolism, or passage of drugs
             out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)