bioihbjkbjnl/mcl2 huggingface dataset:
Study of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy
Condition: Non Small Cell Lung Cancer; Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Brain Neoplasms
Intervention: enzastaurin; placebo
Intervention description: 1125 mg loading dose then 500 mg, oral, daily, until disease progression; oral, 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: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a multinational study to compare enzastaurin versus placebo in the treatment of
      patients with brain metastases of lung cancer. Approximately 108 patients will be randomly
      assigned to receive either enzastaurin or placebo after having completed whole brain
      radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having radiologically proven brain metastases of lung cancer

          -  Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays
             in one week. Treatment with enzastaurin must start within 14 days after the last
             fraction of the whole brain radiotherapy

          -  No other previous radiotherapy to the brain except for radiosurgery at one occasion

          -  Adequate organ function as measured by appropriate laboratory tests.

          -  Age 18 years or older.

        Exclusion Criteria:

          -  Inability to swallow tablets or show conditions which could interfere with oral
             medication intake (e.g. vomiting, partial bowel obstruction).

          -  Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine,
             phenobarbital or phenytoin.

          -  Concurrent administration of warfarin

          -  Hemophilia

          -  Having had any systemic anti-cancer treatment within the last 2 weeks prior to
             enrolment.
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
Condition: Multicentric Castleman's Disease
MeSH terms: Castleman Disease
Intervention: Siltuximab
Intervention description: Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.
Intervention MeSH terms: Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multicentric Castleman's Disease; Multicentric; Castleman; Siltuximab; Long term safety

Summary:

      The purpose of this study is to evaluate the long-term safety of siltuximab in patients with
      multicentric Castleman's disease (MCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has multicentric Castleman's disease

          -  Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment
             arm)

          -  Have had their last administration of study treatment (siltuximab or placebo) less
             than 6 weeks (window of plus 2 weeks) prior to first dose

          -  Patients must not have had disease progression while receiving siltuximab. For those
             patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have
             received less than 4 months of siltuximab following crossover will also be eligible

          -  Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of
             siltuximab for this study

        Exclusion Criteria:

          -  Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of
             consent as reason for discontinuing treatment from previous sponsor-initiated
             siltuximab study

          -  Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study

          -  Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies,
             to murine, chimeric, human proteins or their excipients
Kinematic-guided BoNT-A Treatment for ET and PD Tremor
Condition: Tremor
MeSH terms: Tremor
Intervention: BoNT-A
Intervention description: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
Intervention MeSH terms: incobotulinumtoxinA; Botulinum Toxins, Type A; Botulinum Toxins; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Kinematics; Botulinum toxin type A

Summary:

      The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by
      studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential
      tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained
      through sophisticated, yet clinically accessible multi-sensor based kinematic information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consenting male and female participants, aged 18 years to 80 years

          -  PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease or ET
             with hand tremor in their motor dominant hand

          -  Stable IPD/ET medication management for the 6 month duration prior to their enrollment
             in the study

          -  Individuals with IPD will be eligible for the study only if tremor is their primary
             and most bothersome symptom as determined by clinical exam and patient report

          -  Participants who are botulinum toxin naïve for tremor management

        Exclusion Criteria:

          -  History of stroke

          -  Muscle weakness or any related compartmental muscle syndrome

          -  Smoking

          -  Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic
             agonists (e.g. salbutamol))

          -  Contradictions per the Xeomin® drug monograph

          -  Patients prescribed zonisamide
Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Broccoli sprout extract; Mango juice
Intervention description: 100 µmols of sulforaphane (dissolvable); 150 mL of mango juice
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Broccoli Sprout Extract; Breast Cancer

Summary:

      The purpose of this research is to examine the effect of a broccoli sprout preparation on
      specific factors in breast tissue that are related to breast cancer risk and to assess
      whether sulforaphane a key component of broccoli sprouts increases the levels of protective
      enzymes in breast tissue. In addition, the investigators will also examine how acceptable the
      broccoli sprouts preparation is to the study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female 18 + years of age

          -  Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for
             definitive surgery

          -  Pre or Post menopausal women reporting no use of hormone replacement therapy,
             tamoxifen or raloxifene within the prior 6 months to eligibility screening

          -  Agree to avoid cruciferous vegetable/condiment intake for 14 days

          -  Agree to sign an informed consent and allow use of some tissue (slides) from biopsy
             and definitive surgery for research purposes

        Exclusion Criteria:

          -  Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma
             in-situ

          -  Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months
             prior to eligibility screening

          -  Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14
             prior to surgery)

          -  Smoked within the past 12 months prior to eligibility screening;

          -  Active infection or inflammation of the breast at time of eligibility screening

          -  Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum
             total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen
             (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST),
             Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and ,
             complete blood count (CBC) values that are 1.5 times in either direction the reported
             normal range
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Intervention: Sodium nitrite; Saline
Intervention description: 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg; 14 day continuous infusion of a vehicle control infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cerebral aneurysm; Subarachnoid hemorrhage; Nitrite

Summary:

      The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and
      to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured
      cerebral aneurysms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ruptured cerebral aneurysm

        Exclusion Criteria:

          -  Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Condition: Pancreatic Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Intervention: Sunitinib
Intervention description: Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days)
Intervention MeSH terms: Sunitinib
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: 20 Years
Healthy volunteers: No
Keywords: Neuroendocrine tumors

Summary:

      The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit
      response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
             (Neuroendocrine Tumor)

        Exclusion Criteria:

          -  Patients with poorly differentiated neuroendocrine cancer are not eligible
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ruxolitinib cream
Intervention description: ruxolitinib cream 1.5% will be applied twice daily as a thin film
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ruxolitinib; Itch; Chronic Pruritus

Summary:

      The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in
      participants with Atopic Dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has clinically confirmed diagnosis of active AD for at least a 6-months.

          -  Participant has chronic pruritus related to AD for at least 3 months .

          -  Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds)
             affected by AD of 1%-20% on Day 1.

          -  Participant has an IGA score of at least 2 on Day 1.

          -  Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening
             visit.

          -  Willingness to avoid pregnancy or fathering children.

          -  Participant must be willing to comply with all study procedures and restrictions
             including discontinuation of all current therapies for AD and pruritus (unless
             otherwise specified), and must be available for the duration of the study.

        Exclusion Criteria:

          -  Female participnat who is breastfeeding, pregnant, or planning to become pregnant
             during the study.

        Participant had significant flares or unstable course in AD.

          -  Participant has clinically infected AD or has used antibiotics (systemic or topical)
             for their infected AD within 2 weeks prior to the run-in period.

          -  Participant has a history of skin disease or presence of skin condition that, in the
             opinion of the investigator, would interfere with the study assessments.

          -  Participant has any clinically significant medical condition or
             physical/laboratory/vital sign abnormality that would, in the opinion of the
             investigator, put the participant at undue risk or interfere with interpretation of
             study results.

          -  Participant has received treatment with JAK inhibitors (systemic or topical) within 4
             weeks prior to the run-in period.

          -  Participant is unlikely, in the opinion of the investigator, to be compliant with
             study procedures and requirements.
Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis
Condition: Intradialytic Hypotension; End Stage Renal Disease; Low Blood Pressure
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hypotension
Intervention: ITD; Sham
Intervention description: ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions; Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Hypotension during dialysis; End Stage Renal Disease; Decrease complications during dialysis; Low Blood Pressure

Summary:

      The purpose of this study is to evaluate the application of the impedance threshold device
      during hemodialysis in children to optimize fluid removal, reduce the incidence of
      complications (such as cramps,vomiting and hypotension), and device tolerance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 8-18 years of age

          -  Subjects undergoing hemodialysis for ESRD

        Exclusion Criteria:

          -  Subjects less than 8 years old or greater than 18 years old.

          -  Hemodialysis for indications other than ESRD.

          -  Current symptoms of chest pain, shortness of breath, fever, presence of dilated
             cardiomyopathy, unstable congestive heart failure, pulmonary hypertension, atrial
             fibrillation, hyperthyroidism, and aortic stenosis.
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Condition: Herpangina; Gingivostomatitis; Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina; Mouth Diseases; Oral Ulcer
Intervention: Sucralfate; Placebo; Acetaminophen; Ibuprofen
Intervention description: Will receive 20mg/kg/dose up to 1 gram.; Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Sucralfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if sucralfate, a medication commonly used for patients
      with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level
      and improve their ability to drink.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥6 months and ≤5 years old

          -  Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand,
             foot and mouth disease

          -  History of decreased oral fluid intake by parent or guardian

          -  English or Spanish speaking parents or guardians

        Exclusion Criteria:

          -  Severely dehydrated or toxic, requiring immediate resuscitation

          -  Exclusively breastfed

          -  Severe dental disease

          -  Significant mouth trauma

          -  Active Malignancy

          -  Preexisting upper airway obstruction or swallowing difficulties

          -  Received intravenous fluids within 24 hours

          -  Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours
             of enrollment
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Intervention: Ranibizumab; Ranibizumab
Intervention description: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.; Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetic Macular Edema; Diabetic Retinal Swelling; DIabetic Eye Disease

Summary:

      This study is to see whether treating diabetic retinal swelling with ranibizumab injections
      into the eye monthly is better than treating diabetic retinal swelling with ranibizumab
      injections into the eye less frequently.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 18 years

          -  Patient related considerations

          -  Phakic or pseudophakic patients with a known history of diabetes will be eligible.

          -  Women of reproductive age will be required to take a urine pregnancy test prior to
             administration of the study drug.

          -  Disease related considerations:

          -  Patients will have met standard, accepted diagnostic criteria for diabetes and will be
             currently treated with at least one systemic antihyperglycemic or insulin medication.

          -  Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40

          -  Central foveal thickness on SD-OCT of >300um

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) or lactation Premenopausal women not using
             adequate contraception. The following are considered effective means of contraception:
             surgical sterilization or use of oral contraceptives, barrier contraception with
             either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or
             contraceptive hormone implant or patch.

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated

          -  Participation in another simultaneous medical investigation or trial

          -  Foveal ischemia on IVFA

          -  Intraocular surgery less than 6 months ago

          -  Epiretinal membrane of clinical significance

          -  Prior vitrectomy

          -  Uncontrolled glaucoma

          -  Macular or peripheral laser within 90 Days from Day 0 injection

          -  Intravitreal steroid injection within 90 days from Day 0 injection

          -  Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection