bioihbjkbjnl/mcl2 huggingface dataset:
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
Condition: Supranuclear Palsy, Progressive
MeSH terms: Supranuclear Palsy, Progressive
Intervention: BIIB092; Placebo
Intervention description: BIIB092 intravenous infusion on specified days; Placebo intravenous infusion on specified days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 490.0
Sex: All
Minimum age: 41 Years
Maximum age: 86 Years
Healthy volunteers: No

Summary:

      The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to
      placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and
      to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the
      frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory
      abnormalities.

      The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to
      placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored
      revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to
      evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global
      Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to
      placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of
      Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on
      quality of life, relative to placebo, as measured by change from baseline on the Progressive
      Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants with probable or possible PSP

          -  Able to ambulate independently or with assistance

          -  Able to tolerate MRI

          -  Have reliable caregiver to accompany participant to all study visits

          -  Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening

          -  Participant must reside outside a skilled nursing facility or dementia care facility
             at the time of screening and admission to such a facility must not be planned

        Key Exclusion Criteria:

          -  Presence of other significant neurological or psychiatric disorders

          -  Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease

          -  History of early, prominent rapid eye movement (REM) sleep behavior disorder

          -  History of or screening brain MRI scan indicative of significant abnormality

          -  Known history of serum or plasma progranulin level less than one standard deviation
             below the normal patient mean for the laboratory performing the assay

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
Condition: Melanoma and Brain Metastases
MeSH terms: Melanoma; Neoplasm Metastasis; Brain Neoplasms
Intervention: Dabrafenib; Trametinib
Intervention description: Dabrafenib will be provided as 50 mg and 75 mg capsules; Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Intervention MeSH terms: Trametinib; Dabrafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BRAF V600K mutation; Metastatic Melanoma; BRAF V600R mutation; BRAF V600D mutation; BRAF V600E mutation; Brain metastases BRAF inhibitor; Intracranial

Summary:

      This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and
      Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma
      that has metastasized to the brain. This study will evaluate the safety and efficacy of 4
      cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain,
      symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without
      prior local (brain) therapy, and range of ECOG scores from 0-2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG Performance Status range of 0-2

          -  Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.

          -  May be systemic naïve or received up to two previous systemic treatment regimens for
             metastatic melanoma.

          -  Must be able to undergo MRI and have at least one measurable intracranial lesion for
             which specific criteria have to be met.

        Exclusion Criteria:

          -  Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular
             signal-regulated kinase inhibitor.

          -  Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without
             delayed toxicity within treatment specific timeframe.

          -  Treatment with stereotactic radiosurgery or treatment with whole-brain radiation
             within treatment specific timeframe.

          -  Any presence of leptomeningeal disease or any parenchymal brain metastasis

          -  History of another malignancy, some exceptions may apply.

          -  A history or evidence of cardiovascular risk- specific criteria have to be met

          -  A history or current evidence/risk of retinal vein occlusion or retinal pigment
             epithelial detachment - specific criteria have to be met.
Androgen Effect on Klinefelter Syndrome Motor Outcome
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Intervention: androgen oxandrolone; placebo
Intervention description: Oxandrolone ,06 >mg/kg/day, orally, for 2 years; an inactive substance
Intervention MeSH terms: Androgens; Oxandrolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: Male
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Klinefelter syndrome; androgen; androgen oxandrolone

Summary:

      The purpose of this study is to evaluate the effects of low-dose androgen on the motor and
      cognitive development of boys with Klinefelter syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Karyotype diagnosis of Klinefelter syndrome

          -  Chronological age of 4-12 years

          -  No treatment with androgen in the past year

        Exclusion Criteria:

          -  Major liver, kidney or other systemic disease

          -  Variant karyotypes including 47,XYY males

          -  Evidence of spontaneous onset of puberty, defined as testicular size > 4ml
A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With Glioblastoma
Condition: Glioblastoma; Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: TRC105; Bevacizumab
Intervention description: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle; IV
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A total of 6 initial patients were treated with 10 mg/kg of TRC105 monotherapy. All patients progressed within 2 months of initiating treatment, reflecting the rapid progression. Due to the lack of activity in this disease setting with TRC105 alone, the study was amended to treat patients with 10 mg/kg TRC105 weekly in combination with 10 mg/kg bevacizumab every two weeks.
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with
      recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF
      therapy)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically confirmed glioblastoma, recurrent after prior
             external-beam fractionated radiotherapy and temozolomide chemotherapy.

          2. Patients with documented radiographic progression following bevacizumab therapy for
             treatment of glioblastoma.

          3. Patients with up to 3 prior recurrences are allowed.

          4. Karnofsky performance status ≥ 70%.

          5. Age ≥ 18 years old.

          6. Normal organ function

        Exclusion Criteria:

          -  Patients who have had previous treatment with TRC105.

          -  Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or
             intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting
             study drug, or patients who have had minor procedures, percutaneous biopsies or
             placement of vascular access device ≤ 1 week prior to starting study drug, or who have
             not recovered from side effects of such procedure or injury

          -  Patients with cirrhosis, or active viral or nonviral hepatitis.

          -  Patients with active bleeding or pathologic conditions that carry a high risk of
             bleeding,(i.e. hereditary hemorrhagic telangiectasia).

          -  Patients who are currently receiving anticoagulation treatment

          -  Patients unwilling or unable to comply with the protocol
Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia
Condition: Coronary Artery Bypass Surgery
Intervention: multiport antegrade cardioplegia; Aortic root antegrade cardioplegia
Intervention description: Cold blood cardioplegia was used for myocardial protection and just before the removal of the aortic cross-clamp, warm blood shot (normo-kalemic) was started through multi-perfusion set attached to cardioplegia cannula in the aortic root and vein grafts.As contraction of heart started the multiport limb attached to cardioplegia cannula was off and cross clamp was removed .The warm perfusion through the vein grafts was continued at controlled pressures of about 50-70 mmHg, flow rate of 10-30ml/min/graft and temperature of 35-37 oC; only cold blood cardioplegia was used for myocardial protection without hotshot.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 448.0
Sex: All
Healthy volunteers: No
Keywords: Multiperfusion set; Myocardial protection; Coronary Artery Bypass Grafting

Summary:

      In spite improvements in methods of myocardial protection, peri-operative myocardial damage
      is still the commonest cause of early morbidity and mortality after technically successful
      CABG Surgery. What is the optimum method of myocardial protection is still debatable.

      The investigators conducted this study to see effects of multiport antegrade cold blood
      cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion
      through veins graft during proximal ends anastomosis in conventional CABG surgery in patients
      having multi-vessel disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing isolated conventional CABG were included in the study

        Exclusion Criteria:

        The redo CABG surgery. Those who required 2 or less than 2 grafts. Patients who had major
        postoperative neurological complications like stroke. 2nd arterial graft along with LIMA.
        Patients who need CABG within a week of STEMI or NSTEMI. Patients with calcified or
        diseased aorta in which single cross clamp technique was used for proximal aorto-coronary
        anastomosis
Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS topical product
Intervention description: treatment daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal
      Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to
      SevereScalp Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females 12-17 years of age.

        Exclusion Criteria:

          -  Females who are pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child-bearing potential and sexually active and not prepared to
             use appropriate contraceptive methods to avoid pregnancy.
Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection
Condition: Cryptococcal Infection Disseminated
MeSH terms: Infections
Intervention: Flucytosine and fluconazole; Fluconazole
Intervention description: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily; fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
Intervention MeSH terms: Fluconazole; Flucytosine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cryptococcus; HIV

Summary:

      The purpose of this study is to determine if treatment with two medicines in combination
      (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for
      the treatment of an early infection with a fungus called cryptococcus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to give informed consent

          -  Age > 18 years

          -  HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines

          -  CD4+ T-cell count ≤100 cells/µl

          -  Serum CrAg titer≥1:2

          -  Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for
             regular study visits

        Exclusion Criteria:

          -  clinical meningitis:

          -  clinical sepsis:

          -  hemiparesis, aphasia, visual field deficit or other finding on neurological
             examination localizable to the central nervous system

          -  a history of culture proven or suspected (cryptococcal antigen present) cryptococcal
             meningitis

          -  a history of stroke or other infection of the central nervous system

          -  a seizure within the last 2 months

          -  currently taking or ever taken antiretroviral therapy

          -  currently taking anti-tuberculous therapy

          -  currently or recently (<2 months) prescribed fluconazole, itraconazole, clotrimazole
             troches, amphotericin or other oral anti-fungal medications

          -  pregnant or breast-feeding

          -  alanine aminotransferase concentration more than 3 times the upper limit of normal

          -  neutrophil count <1000x103 cells/mL

          -  hemoglobin <8g/dL

          -  platelet count <100,000x 103 platelets/mL

          -  creatinine clearance ≤50 ml/min

          -  individuals with active heavy alcohol use or active recreational drug use
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Condition: Raised Intraocular Pressure
MeSH terms: Ocular Hypertension
Intervention: AZD4017; Placebo; AZD4017; Placebo
Intervention description: tablet, oral, one tablet once daily, 28 days; matching placebo tablet, oral, one tablet once daily, 28 days; tablet, oral 2 tablets twice daily, 28 days; matching placebo tablets, oral, 2 tablets twice daily, 28 days
Intervention MeSH terms: Niacinamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Raised intraocular pressure

Summary:

      The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,
      compared with placebo, over a 28-day period in patients with raised intra-ocular pressure
      (IOP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle
             glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is currently
             prescribed a stable dose of a single anti-glaucoma medication that began at least 30
             days prior to the screening visit; OR

          -  Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22
             mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication

          -  Male patients must be willing to use barrier contraception with spermicide, ie,
             condoms, from the day of first dosing until 3 months after dosing with IP

          -  Placebo treatment for duration of the study must not be considered detrimental to the
             patient

        Exclusion Criteria:

          -  Have uncontrolled intra-ocular hypertension (>36 mmHg)

          -  Have experienced a significant visual field loss or showed evidence of progressive
             visual field loss within the last year (as defined by >1 dB/yr average loss or vision
             threatening new defect)

          -  Have had severe eye trauma at any time
A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]
Intervention description: 150 mg/day until progressive disease or unacceptable toxicity
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1805.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced
      NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated
      time on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  locally advanced or metastatic NSCLC (Stage IIIB or IV);

          -  not a candidate for curative surgery or radical chemotherapy;

          -  no brain metastases, or clinically stable metastases for >=2 months.

        Exclusion Criteria:

          -  radiotherapy over the previous 2 weeks;

          -  weight loss >10% in the previous 6 weeks.
A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency
Condition: Factor XIII Deficiency
MeSH terms: Factor XIII Deficiency
Intervention: FXIII Concentrate (Human)
Intervention description: Subjects will receive approximately 40 U/kg of FXIII every 28 days for 3 doses administered as a bolus intravenous (IV) injection at approximately 250 U/minute.
Intervention MeSH terms: Fibrinolysin
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Healthy volunteers: No
Keywords: Factor XIII

Summary:

      Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with
      potentially life-threatening bleeding. This study will evaluate the safety and recommended
      (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human)
      is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works
      by assisting your blood in the usual clotting process, thereby preventing bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent for study participation obtained before undergoing any
             study-specific procedures

          -  Documented congenital FXIII deficiency that requires prophylactic treatment with a
             FXIII containing product.

          -  Males and females of any age with congenital FXIII deficiency.

          -  Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive

        Exclusion Criteria:

          -  Diagnosis of acquired FXIII deficiency

          -  Administration of a FXIII-containing product, including blood transfusions or other
             blood products within 4 weeks prior to the planned Day 0

          -  Any known congenital or acquired coagulation disorder other than congenital FXIII
             deficiency

          -  Known or suspected to have antibodies towards FXIII

          -  Use of any other investigational medicinal product within 4 weeks prior to the
             Baseline Visit (Day 0)

          -  Positive result at screening for human immunodeficiency virus (HIV)

          -  Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration
             >2.5 times the upper limit of normal

          -  Fibrinogen < lower limit of normal

          -  Active bleeding

          -  Pregnant or breast-feeding

          -  Intention to become pregnant during the course of the study

          -  Female subjects of childbearing potential not using, or not willing to use, a
             medically reliable method of contraception for the entire duration of the study

          -  Surgical procedure anticipated during the study period

          -  Suspected inability (e.g., language problems) or unwillingness to comply with study
             procedures or history of noncompliance