bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia
Condition: Aplastic Anemia
MeSH terms: Anemia; Anemia, Aplastic
Intervention: AMG531
Intervention description: Subcutaneous, weekly injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Anemia, Aplastic; Thrombopoietin; Thrombocytopenia

Summary:

      The present study will be conducted to evaluate the efficacy and safety of AMG531 and to
      determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when
      it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with
      immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics
      of this product. Its efficacy and safety during the extension period beyond one year will
      also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who is diagnosed as AA and refractory to immunosuppressive therapy

          -  Platelet ≤ 30,000/μL

        Exclusion Criteria:

          -  Concurrent active infection not adequately responding to appropriate therapy

          -  HIV positivity

          -  Bone marrow reticulin grade of > 1

          -  Clinically significant cardiac disease

          -  Arterial or venous thrombosis within the last 1 year before enrollment

          -  Other cause of thrombocytopenia

          -  AA with hemolytic predominant paroxysmal nocturnal hemoglobinuria (PNH)

          -  Uncontrolled diabetes

          -  Receiving any agent used to treat AA, including antithymocyte globulin (ATG) or ATG +
             cyclosporine within 6 months before starting study treatment and/or cyclosporine or
             anabolic hormone within 6 weeks before starting the study treatment

          -  History of PEG-rHuMGDF, recombinant human thrombopoietin, AMG531, and other
             thrombopoietin (TPO)-receptor agonist

          -  Who plans to conduct hematopoietic stem cell transplantation within 1 year
Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)
Condition: Leukemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: Azacytidine; GM-CSF
Intervention description: Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.; 250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Myelodysplastic Syndrome; MDS; Azacytidine; 5-Azacytidine; 5-AZA; Vidaza; 5-AZC; Aza-CR; Ladakamycin; NSC-102816; GM-CSF; Sargramostim; Leukine

Summary:

      The goal of this clinical research study is to learn if the combination of azacitidine and
      GM-CSF can help to control MDS. The safety of these drugs will also be studied.

      Azacitidine is designed to block certain proteins that stop the function of tumor-fighting
      genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.

      Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white
      blood cells. This may help to fight infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with low- or intermediate-1-risk MDS according to the International
             Prognostic Scoring System (IPSS) classification

          2. Signed informed consent indicating that patients are aware of the investigational
             nature of this study in keeping with the policies of UT MD Anderson Cancer Center.

          3. Age >/= 18 years old.

          4. Prior therapy with growth factor support, lenalidomide, or other investigational
             agents is allowed.

          5. Previously untreated patients are eligible for this study.

        Exclusion Criteria:

          1. Any previous adverse reaction (>/= Common Terminology Criteria for Adverse Events
             (CTCAE) grade 2) to GM-CSF.

          2. Prior treatment with azacytidine or decitabine.

          3. Unresolved diarrhea >/= CTCAE grade 2.
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Condition: Central Nervous System Tumors; Brain Tumors
MeSH terms: Neoplasms; Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: Radiation Therapy; Radiation Therapy
Intervention description: External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.; External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 8 Months
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Brain neoplasm; Brain cancer; Neoplasm intracranial

Summary:

      The purpose of the study was to determine if treating a limited volume of normal tissue
      surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar
      rates of disease control compared to standard radiation therapy. The study was also conducted
      to examine the effect of irradiation on neurological, endocrine and cognitive function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at time of irradiation is greater than or equal to 8 months and less than or equal
             to 25 years

          -  Histologically diagnosed craniopharyngioma, ependymoma, low-grade astrocytoma or
             high-grade glioma and radiographically diagnosed selected patients with
             craniopharyngioma and low-grade glioma.

          -  Adequate performance status, participant has an ECOG (Performance Status Score) of
             0-2(0=Normal Activity; 1=Symptoms but Ambulatory; 2=Bedridden <50% of time)

          -  Histologic type that requires only focal irradiation.

          -  No prior fractionated external beam irradiation

          -  Informed consent signed by patient, parent, or guardian.
Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Condition: Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Intervention: Prednisolone (Corticosteroid); Propranolol; Placebo
Intervention description: Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.; Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.; Liquid placebo will be given during the two month treatment trial.
Intervention MeSH terms: Prednisolone; Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Maximum age: 9 Months
Healthy volunteers: No

Summary:

      This is a prospective randomized, double-blind study to compare the clinical efficacy of
      infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy
      with corticosteroids and placebo. We hypothesize that a two-month treatment period with
      propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and
      vascularity when compared to corticosteroids used without propranolol for the same time
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0 to < 9months

          -  Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma
             (IH) requiring medical treatment

          -  IH patients whose parents desire medical treatment for the IH

          -  Stable cardiac function

        Exclusion Criteria:

          -  IH patients over 9 months of age.

          -  Hypersensitivity to propranolol

          -  Untreated heart failure: If the patient has heart failure associated with the
             hemangioma, propranolol would be initiated after anti-congestive therapy and under
             observation as an in-patient.

          -  Atrioventricular (AV) block

          -  Resting heart < 2 SD of normal*(below)

          -  Resting blood pressure < 2 SD of normal**(below)

          -  Wolff-Parkinson-White syndrome (WPW)

          -  History of unexplained syncope

          -  Bronchial asthma

          -  History of impaired renal or liver function

          -  Diabetes mellitus
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease

Summary:

      This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses
      of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque
      psoriasis will be randomized to receive either AIN457 at one of the three doses studied or
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients
             must meet all of the following criterion:

               1. Coverage of the body surface area (BSA) of 10% or more with plaques

               2. A score of 3 or more on the IGA (Investigator Global Assessment) scale

               3. A PASI score of at least 12 at baseline;

                  Exclusion Criteria:

          -  Have forms of psoriasis other than the required "plaque psoriasis"

          -  Women of childbearing potential

          -  Recent use of investigational drugs or treatment with other biological therapies
             (wash-out periods required)

          -  Previous treatment with this investigational drug

          -  Subjects with active or history of clinically significant cardiac, kidney or liver
             abnormalities

        Other protocol-defined inclusion/exclusion criteria may have applied.
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Drotrecogin alfa activated (Xigris)
Intervention description: We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.
Intervention MeSH terms: Drotrecogin alfa activated; Protein C
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: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis; Anticoagulation; Xigris; PTT

Summary:

      The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an
      anticoagulant at different dose levels during dialysis treatment in patients with End Stage
      Renal Disease (ESRD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. >18

          2. Usually used heparin with HD

        Exclusion Criteria:

          1. Plt <100

          2. Pregnancy

          3. H/o bleeding diathesis

          4. H/o CVA

          5. Pt on Ticlid/plavix/warfarin

          6. SBP >200

          7. BASELINE PTT>50

          8. INR>1.6
Memantine and Naltrexone Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Memantine; Naltrexone
Intervention description: One arm receives 30 mg bid and the other arm receives receives 15mg bid; Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Intervention MeSH terms: Naltrexone; Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Heroin; Opiates; naltrexone; memantine

Summary:

      The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor
      antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified
      heroin-dependent individuals.
    

Eligibility criteria:

        Inclusion:

          -  Adult, aged 18-60.

          -  Meets DSM-IV criteria for current opiate dependence disorder of at least six months
             duration, supported by a positive urine for opiates and a positive naloxone challenge
             test if the diagnosis is unclear.

          -  Able to give informed consent.

        Exclusion:

          -  Pregnancy or breastfeeding

          -  Failure in a sexually active woman to use adequate contraceptive methods

          -  Active medical illness that might make participation hazardous, such as untreated
             hypertension, acute hepatitis with SGOT or SGPT levels > 2 times normal, unstable
             diabetes, or chronic organic mental disorder (e.g., AIDS dementia)

          -  Active psychiatric disorder that might interfere with participation or make
             participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania
             or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts
             within the past year.

          -  History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone,
             clonidine, or clonazepam

          -  Currently prescribed or regularly taking opiates for chronic pain or medical illness

          -  Current participation in another intensive psychotherapy or substance abuse treatment
             program or currently prescribed psychotropic medications

          -  Current participation in a methadone maintenance treatment program and/or regular use
             of illicit methadone ( > 30 mg per week)

          -  History of accidental drug overdose in the last 3 years or any other significant
             history of overdose following detoxification, defined as an episode of opioid-induced
             unconsciousness or incapacitation, whether or not medical treatment was sought or
             received
A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
Condition: Kidney Disease, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Methoxy polyethylene glycol-epoetin beta; Placebo
Intervention description: Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).; Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, single-blind, proof-of-concept study will investigate the protective effects
      of early treatment with Mircera in participants with chronic kidney disease on renal disease
      progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as
      subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin
      values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated
      time on study treatment is 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For diabetic participants: Type 2 diabetes mellitus with glycated hemoglobin (HbA1c)
             greater than (>) 7% or anti-diabetic treatment

          -  For renal allograft recipients: Status at least 6 months post transplantation

          -  Chronic kidney disease stage III

          -  Urinary albumin-to-creatinine ratio less than (<) 3000 milligram (mg)/gram (g) or
             total protein <3000 mg/ 24 hour urine sample where applicable

        Exclusion Criteria:

          -  Hemoglobin-level < 11 or > 14 g/deciliter (dL)

          -  Average systolic blood pressure (SBP) > 140 millimeter of mercury (mm Hg) or average
             diastolic blood pressure (DBP) > 90 mm Hg

          -  Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker
             or aliskiren treatment less than 3 months before enrolment

          -  Present and known iron deficiency

          -  HbA1c >9%
Etanercept and Vascular Function in Psoriasis
Condition: PSORIASIS
MeSH terms: Psoriasis
Intervention: Etanercept; Placebo
Intervention description: Etanercept 50mg twice weekly
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PSORIASIS

Summary:

      The investigators plan to measure the health of the vascular system of subjects taking
      Etanercept for the treatment of plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregant females aged 21-70 years.

          -  Diagnosis of moderate to severe plaque psoriasis

          -  Concomitant therapy: Patients will be allowed to be on concomitant therapy with
             aspirin, statins, thiazide diuretics, calcium antagonists (for treatment - of
             hypertension), clonidine, or vasodilators. Patients will be on stable medical therapy
             for at least 3 months before recruitment.

        Exclusion Criteria:

          -  Uncontrolled cardiac risk factors (hypertension, hypercholesterolemia, smoking,
             diabetes)

          -  Symptomatic coronary or peripheral atherosclerotic vascular disease

          -  Current anti-TNF therapy with etanercept or infliximab or therapy in the previous 3
             months

          -  Presence of psoriatic plaque or other skin condition on the volar surface of the
             forearms which may interfere with vascular ultrasonography

          -  Pregnancy, Breast feeding

          -  Active substance abuse

          -  Other inflammatory condition or malignancy

          -  Renal failure [creatinine > 2.5mg/dL] or liver failure (Liver enzymes > 2x normal)

          -  Current use of COX-2 inhibitors

          -  Inability to give informed consent

          -  Prednisone dosage > 7.5mg/day

          -  Statins, anti diabetes medications, and aspirin will be continued if the patient is on
             stable therapy for at least 3 months, and all medications will be continued without
             alteration of doses during the study period.

          -  Antibiotic administration within 1 week of study drug initiation or active severe
             infection within 4 weeks of study screening

          -  Active guttate, erythrodermic or pustular psoriasis

          -  Systemic psoriasis therapy or psoralen plus ultraviolet (UV) A phototherapy for 4
             weeks before initiation of study
The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders
Condition: Procedural Sedation; Behavior Disorders
MeSH terms: Mental Disorders
Intervention: dexmedetomidine
Intervention description: To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Drug administration by a loading dose followed by continuous infusion during a procedure
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 1 Month
Maximum age: 18 Years
Healthy volunteers: No
Keywords: dexmedetomidine; sedation

Summary:

      Children's compliance during diagnostic or therapeutic procedures is a challenge, often
      requiring the use of sedative and/or analgesic drugs.

      Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time,
      the use of any drug for sedation may affect the exam through an interference with EEG waves.
      Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties,
      with a long effect and which does not alter EEG pattern.

      The aim of this interventional study is to evaluate the effectiveness, safety and feasibility
      of dexmedetomidine for sedation during EEG in children who are not cooperative.

      Children affected by behavioral disorders and requiring sedation to perform EEG were
      considered. The protocol establishes to administer IV dexmedetomidine (loading dose and
      continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale =
      2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during
      and after procedure until the offset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children affected by behavior disorders who underwent EEG procedure with sedation

          -  written informed consent

        Exclusion Criteria:

          -  ASA > 2

          -  hypersensitivity of active substance

          -  therapy with beta blockers or digoxin, arrhythmia