bioihbjkbjnl/mcl2 huggingface dataset:
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Condition: Childhood Cancer; Central Venous Catheters; Deep Vein Thrombosis; Catheter-related Infection; Catheter-related Occlusion
MeSH terms: Catheter-Related Infections; Thrombosis; Venous Thrombosis
Intervention: Enoxaparin
Intervention description: Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children >2 months and 1.5 mg/kg every 12 hours for infants <2 months. Duration of treatment is 6 weeks.
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Childhood Cancer; Central Venous Catheter; Deep Vein Thrombosis; Catheter-related Infection; Catheter-related Occlusion

Summary:

      The primary hypothesis of this study is that occult catheter-related DVT in children with
      cancer is common and directly contributes to development of serious catheter complications,
      specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly,
      anticoagulant treatment of clinically silent (occult) DVT will reduce rates of
      catheter-related infection and occlusion, delays in therapy and need for catheter
      replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of cancer

          2. Age ≤ 18 years

          3. First tunneled central venous catheter (implanted port or external) inserted in the
             upper venous system (subclavian, brachiocephalic, or jugular vein) within the previous
             2 weeks

          4. Catheter expected to be in place for duration of chemotherapy (≥ 3 months)

          5. History of no more than one catheter complication (occlusion or infection)

        Exclusion Criteria:

          1. Prior history of DVT

          2. Currently receiving an anticoagulant or anti-platelet agents on a daily basis

          3. Diagnosis of high grade malignant brain tumor or metastasis to the brain

          4. Clinical signs/symptoms of DVT

          5. Clinical signs/symptoms of Pulmonary embolism

          6. Renal failure

          7. Recent major hemorrhage
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Intervention: 18F fluciclovine
Intervention description: 18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Brain Metastases; Diagnostic; Positron Emission Tomography (PET) Scan

Summary:

      An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish
      Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in
      Detecting Recurrent Brain Metastases After Radiation Therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          2. Previous history of solid tumor brain metastasis of any origin

          3. Histopathological confirmation of the primary solid tumor or a metastatic site

          4. Previous radiation therapy of brain metastatic lesion(s)

          5. A reference lesion considered by the site investigator to be equivocal for recurrent
             brain metastasis

          6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI
             findings and is planned for craniotomy

        Exclusion Criteria:

        1. Patients with a history of active hematological malignancy
Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Inflammation
Intervention: Ranibizumab 0.3 mg; Aflibercept 2.0 mg
Intervention description: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg; Patient will receive intravitreal injection of Aflibercept 2.0 mg
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to compare the post injection inflammation and pain seen after
      intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.

      The investigators will be evaluating patients (1-7 days) post injections for:

      1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as
      measured on a standardized pain scale).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be eligible if the following criteria are met:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 21 years

          -  Exam and OCT confirming Diabetic Macular Edema

          -  Visual Acuity of 20/400 or better

          -  No history of post injection pain or inflammation in the past

        Exclusion Criteria:

          -  Subjects who meet any of the following criteria will be excluded from this study

          -  History of Endophthalmitis in either eye

          -  Current inflammation in either eye

          -  Uncontrolled or symptomatic Dry Eye Syndrome

          -  Intravitreal injection less than 3 months ago

          -  History of Anterior or Posterior Uveitis

          -  History of post injection pain with prior treatments

          -  Recent thromboembolic event (<3 months)

          -  Pregnancy (positive pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception.
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Intervention: diazepam nasal spray; diazepam rectal gel
Intervention MeSH terms: Diazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Seizures; Epilepsy

Summary:

      This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study
      involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1
      comprises the subjects used to determine the relative bioavailability of DZNS versus DRG
      (Diastat)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of refractory epilepsy

          -  Body weight 26 to 111 kilogram (kg) inclusive

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Male or female subject who is not surgically sterile or female subject who is less
             than 2 years postmenopausal, and does not agree to use a highly effective birth
             control method during the study and up to 3 months after the last dose of
             investigational product

          -  Female subject who is pregnant, breastfeeding, or planning to become pregnant

          -  Presence or history of any abnormality or illness that may affect the absorption,
             distribution, metabolism or elimination of diazepam

          -  Other exclusion criteria apply
Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
Condition: Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sitravatinib; Nivolumab
Intervention description: Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.; Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ccRCC; MGCD516; Antineoplastic Agents; Immunologic factors; nivolumab; Tyrosine Kinase Inhibitor; VEGFR; TAM RTKs; PD-1; PD-L1

Summary:

      The study will evaluate the clinical activity of sitravatinib in combination with nivolumab
      in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant
      setting prior to nephrectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Imaging results consistent with locally-advanced RCC

          2. Candidate for partial or complete nephrectomy as part of treatment plan.

          3. Measurable disease per RECIST version 1.1.

          4. ECOG performance status 0 or 1.

          5. Adequate bone marrow and organ function.

        Exclusion Criteria:

          1. Prior systemic anti-tumor treatment for RCC.

          2. Patients who are receiving any other investigational agents.

          3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted
             regardless of whether neoadjuvant therapy is to be administered, as assessed by the
             treating surgeon.

          4. Inability to undergo baseline tumor biopsy.

          5. Active or prior documented autoimmune or immunocompromising conditions.

          6. Uncontrolled hypertension.
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
Condition: Hypophosphatasia (HPP)
MeSH terms: Hypophosphatasia
Intervention: Asfotase Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue non-specific alkaline phosphatase; rickets; osteomalacia

Summary:

      This clinical trial studies the long term safety and efficacy of asfotase alfa in children
      with HPP who completed Study ENB-006-09 (NCT00952484).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Compliant and satisfactory completion of Enobia-sponsored clinical trial ENB-006-09

          -  Written informed consent by parent or other legal guardian prior to any study
             procedures being performed

          -  Parent or other legal guardian willing to comply with study requirements

        Exclusion Criteria:

          -  Clinically significant disease that precludes study participation, in the
             Investigator's opinion

          -  Treatment with an investigational drug other than asfotase alfa

          -  Enrollment in any study (other than ENB-006-09) involving an investigational drug,
             device, or treatment for HPP

          -  Prior treatment with bisphosphonates
Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Condition: Graves Disease
MeSH terms: Graves Disease
Intervention: 1α-D3; Placebos
Intervention description: patients were given PTU and 1α-D3; patients were given PTU and placebos
Intervention MeSH terms: Alfacalcidol; Dihydroxycholecalciferols
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vitamin D; graves' disease; dendritic cells

Summary:

      Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating
      autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in
      healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro
      1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral
      1α-D3 on DC maturation in GD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Graves' disease and still have not gone into remission

          -  Willing to participate in the research

        Exclusion Criteria:

          -  Pregnant patient

          -  Suffered from severe liver disease

          -  Suffered from severe kidney disease

          -  Taking vitamin D substitution therapy

          -  Suffered from another autoimmune disease

          -  Suffered from malignancy
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Condition: Epilepsy, Complex Partial
MeSH terms: Epilepsy, Complex Partial
Intervention: ganaxolone
Intervention description: liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Epileptic Seizures; Seizure Disorder; Seizures; Convulsions; Anticonvulsant; Anticonvulsive; Antiepileptic; Ganaxolone

Summary:

      This study is designed to provide ganaxolone to those patients deriving significant benefit
      from current treatment in protocol 1042-0601.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects who have completed all study visits from previous protocol 1042-0601 and have
             been deemed eligible by the Investigator as:

          -  having had no major adverse events thought to be drug related

          -  deriving benefit from ganaxolone treatment

          -  be properly informed of the nature and risks of the study and give written informed
             consent prior to study entry

          -  must be willing to use a medically acceptable method of birth control and if female of
             child-bearing potential, have a negative qualitative serum pregnancy test

        Exclusion Criteria:

          -  significant medical or surgical condition at screening or that develops during
             protocol participation that might compromise hematologic, cardiovascular, pulmonary,
             renal, gastrointestinal, or hepatic systems, or other conditions that would place the
             subject under increased risk

          -  unwilling to use a double-barrier method of birth control or submit to a serum
             pregnancy test

          -  history of chronic non-compliance with drug regimens

          -  females currently breastfeeding

          -  AST or ALT levels greater than 3 times the upper limit of normal at screen

          -  Inability to withhold grapefruit or grapefruit products during the study
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: LYS006; Placebo
Intervention description: capsule for oral use; capsule for oral use
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. This study consists of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each such including the 4 week screening period is 16 weeks.
At the beginning of the treatment period, subjects will be randomized to one of the two following treatment groups in 2:1 ratio:
LYS006
matching placebo
Masking: Double (Participant, Investigator)
Masking description: Subject and investigator blinded via randomization
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ulcerative colitis, efficacy, safety

Summary:

      The purpose of the study was to assess preliminary efficacy, safety, and tolerability of
      LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006
      has an adequate clinical profile for further development in this indication.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female subjects 18-75 years of age with an established diagnosis of
             ulcerative colitis at least 3 months prior to screening are eligible for the study.

          -  Patients must have active disease with a full Mayo Score between 5 and 10 (inclusive)
             with an endoscopy score of 2 or 3; rectal bleeding and stool frequency scores 1 to 3
             and a physician's global assessment of 1 or 2.

          -  Patients must have responded inadequately to conventional therapy with oral 5-ASA
             prior to screening.

        Key Exclusion Criteria:

          -  Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic
             colitis or acute diverticulitis based on medical history.

          -  History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or
             stoma; history or is at risk of colectomy.

          -  Treatment with biologics within 3 months or 5 half-lives (whichever is longer) prior
             to screening endoscopy, non-biologics advanced therapies within 4 weeks prior to
             screening endoscopy, systemic immunosuppressant or immunomodulator within 6 week,
             topical treatment with 5-ASA or steroids within 2 weeks prior to screening endoscopy
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: TAK-831; TAK-831 Placebo
Intervention description: TAK-831 tablets; TAK-831 placebo matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper
      extremity (arm and hands) motor function and manual dexterity. This study will also evaluate
      the efficacy of TAK-831 versus placebo on activities of daily living (ADL) and other
      secondary assessments.
    

Eligibility criteria:

        Key Inclusion Criteria:

        1. Has a genetically-confirmed diagnosis (homozygous for guanine-adenine-adenine [GAA]
        repeat expansions in the frataxin gene [FXN] in the affected range of Friedreich ataxia
        [FRDA] or a compound heterozygous expansion with a point mutation or deletion), with an
        established disease stage of 2 to 5, inclusive, as determined by the Functional Staging for
        Ataxia, at Screening.

        Key Exclusion Criteria:

          1. Received a diagnosis of ataxic syndromes other than FRDA.

          2. Has a history of cancer, except basal cell carcinoma or in situ cervical cancer that
             has been in remission for greater than or equal to (>=5) years prior to first dose of
             study drug.

          3. Known to be currently infected or has been infected with human immunodeficiency virus
             (HIV), hepatitis B virus, or hepatitis C virus.

          4. Has a known hypersensitivity to any component of the formulation of TAK-831.

          5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse.

          6. Has taken any excluded medication, or has had insufficient washout of medications or
             is unable or unwilling to discontinue medications as required by the protocol.

          7. If male, the participant intends to donate sperm during the course of this study or
             for 95 days after the last dose of study drug.

          8. If female, the participant is of childbearing potential and lactating, pregnant
             (positive prerandomization serum pregnancy test), or plans to become pregnant before
             participating in the study, during the study, or within 35 days after last dose of the
             study drug, or intending to donate ova during such time period.

          9. Has a history of neuroleptic malignant syndrome, water intoxication, or paralytic
             ileus or other conditions that may interfere with absorption of study medication.