bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVES:

      I. Determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and
      total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or
      bone marrow rescue in patients with multiple sclerosis.
    

Detailed description: 
      PROTOCOL OUTLINE: Following an induction course of cyclophosphamide IV, patients receive
      filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem
      cell (PBSC) harvesting. PBSCs are collected over several days. Patients who do not mobilize
      sufficient cells undergo bone marrow harvest. Harvested PBSCs or bone marrow then undergo
      T-lymphocyte depletion.

      Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 and methylprednisolone IV
      daily on days -4 to -1. Patients also undergo total body irradiation twice a day on days -4
      to -1. Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0. Patients receive G-CSF
      SC daily beginning on day 0 and continuing until blood counts have recovered for 3 days.

      Patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.
    

Intervention name(s): cyclophosphamide; filgrastim; methylprednisolone; Autologous Stem Cell Transplantation
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Cyclophosphamide; Prednisolone hemisuccinate; Prednisolone phosphate
Primary purpose: Treatment
Keywords: multiple sclerosis; neurologic and psychiatric disorders; rare disease
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in
      the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that
      has come back after treatment.
    

Detailed description: 
      In the Phase I portion of the study patients with a diagnosis of AML who have relapsed
      disease will be treated with an assigned number of doses of 5 azacitidine followed by
      Mylotarg administered two times over two weeks

      In the Phase II portion of the study patients will be treated with the dose of 5azacitidine
      determined to be safe in the Phase I portion of the study followed by Mylotarg.

      A sample of blood or bone marrow will be obtained prior to initiation of treatment and
      another sample obtained after treatment with 5-azacitidine but before Mylotarg and the
      samples will be tested in the laboratory to determine response to treatment.
    

Intervention name(s): 5-Azacitidine; Gemtuzumab ozogamicin
Intervention type(s): Drug; Drug
Intervention description(s): Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.; Mylotarg given 2 times over 2 weeks
Other intervention name(s): Vidaz; Mylotarg
Intervention MeSH terms: Azacitidine; Gemtuzumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
Condition: Spontaneous Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring
      (NeMo Probe) and the accuracy of measurement values.

      To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and
      oxygenation during cerebrovascular events monitored with established methods including brain
      tissue oxygenation tension and microdialysis
    


Intervention name(s): NeMo Probe
Intervention type(s): Device
Intervention description(s): A new minimal-invasive brain tissue probe applying near infrared spectroscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Vaccine Effectiveness of RV1 in a Naïve Population
Condition: Rotavirus Infections; Gastroenteritis; Diarrhea
MeSH terms: Rotavirus Infections; Gastroenteritis; Diarrhea
Study type: Observational

Summary: 
      Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The
      cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would
      amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is an
      average of 8/10,000 patient-days in children < 5 years. An immunization program with a
      live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented,
      free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait
      of the disease and give critical information to the public health agencies as they struggle
      to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases
      with similar characteristics; estimate selection bias in passive laboratory-based
      surveillance; and estimate the agreement between surveillance time-series created from
      passive and active surveillance data sources.
    

Detailed description: 
      In November 2011, Quebec implemented a publicly-funded RV1 vaccination program with its
      routine administration at 2 and 4 months of age. From February 1, 2012 - May 31, 2014, we
      conducted prospective, active surveillance for acute rotavirus gastroenteritis at The
      Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in
      Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke. Active
      surveillance was approved by Research Ethics Boards at each hospital.
    

Intervention name(s): No intervention done
Intervention type(s): Other
Intervention description(s): Not applicable because no intervention was done.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Montreal Children's Hospital and the CHU Sainte-Justine are the 2 main pediatric
        hospitals in Montreal. With these 3 sites, 30% of the Quebec birth cohort will be captured
        and, given the concentration of children in the Montreal area, the participating hospitals
        will ensure that the study remains efficient in terms of resources. We elected Sherbrooke
        as an intermediate area; Montreal will represent an urban population.
      
Biospecimen description: 
      stool sample
    
Keywords: Rotavirus; Gastroenteritis; Vaccination; Pediatrics
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
Condition: Fever; Respiratory Tract Infections; Urinary Tract Infections; Gastroenteritis; Arthritis, Infectious
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections; Arthritis, Infectious; Gastroenteritis
Study type: Observational

Summary: 
      This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic
      (IVD) assay that will include samples that were previously collected from febrile pediatric
      patients. The investigated assay measures the levels of a few host-related, blood-based,
      bio-markers that will be integrated into a single score. Based on this score, each patient
      will be classified into one of three categories: (i) bacterial immune response, (ii) viral
      immune response, and (iii) marginal immune response. The assay prediction and the patient
      diagnosis will than be unveiled and compared to determine their level of concordance.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population will include patients aged 1 month to 18 years of age that were
        sampled both during emergency department (ED) visit or during hospitalization stay and were
        diagnosed with an acute infectious disease or a non-infectious disease. All samples are
        expected to fall into one of the following categories:

          1. Patients with an acute bacterial infection

          2. Patients with an acute viral infection

          3. Patients with an acute mixed co-infection (bacterial and viral)

          4. Patients with a non-infectious disease (control group)
      
Biospecimen description: 
      Serum samples
Cortisol Levels as a Measure of Accumulated Physiological Stress in ICU Patients Undergoing Mechanical Ventilation
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational [Patient Registry]

Summary: 
      Critical illness is a situation of severe and prolonged stress for patients with mechanical
      ventilation (MV). Between 40-80% of these patients present the Post-ICU syndrome, a set of
      physical, cognitive, psychological alterations at hospital discharge. In more than a third of
      the ICU survivors, these sequelae become chronic being observed months and even years after
      ICU stay.

      The characteristics of the Post-ICU syndrome have been related to different risk factors
      associated with the critical illness and its management. However, the impact of accumulated
      physiological stress is still unknown. The physiological response to prolonged stress
      generates high levels of cortisol that have been related to the loss of muscle tissue,
      cognitive and psychological alterations in both clinical populations and healthy subjects.
      The concentration of cortisol in plasma is not a measure of adequate physiological stress due
      to the dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis during critical
      illness. Therefore, the objective of this study is to assess the levels of accumulated
      cortisol in human hair (CHH) during the different stages of the critical illness and its
      recovery, as well as to explore its relationship with the functional and neuropsychological
      sequelae observed in the ICU survivors.
    

Detailed description: 
      A prospective pilot study has been proposed in 50 critical patients with> 24 hours of
      mechanical ventilation. CHH levels will be recorded at admission, 1 month and 1 year after
      ICU discharge. In all survivors, the presence of delirium will be assessed during the ICU
      stay and the functional, cognitive and psychological status will be assessed at short (1
      month after ICU discharge) and long term (1 year after ICU discharge).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Critically ill patients undergoing mechanical ventilation
      
Keywords: Cortisol; Post-ICU syndrome; Cognitive impairment; Anxiety and depressive symptoms; Mechanical ventilated patients
An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).
Condition: Postherpetic Neuralgia; Neuralgia; Herpes Zoster
MeSH terms: Herpes Zoster; Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200
      mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic
      neuralgia.
    

Detailed description: 
      Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at
      least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to
      years later, and for which therapies are often limited by incomplete pain relief and side
      effects. This is a randomized (study medication is assigned by chance), double-blind (neither
      the Investigator or the patient know the name of the assigned study medication),
      placebo-controlled, crossover, parallel-group, multicenter study to determine the
      effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with
      placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of
      RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain
      due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of
      RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth,
      with or without food, for 4 weeks in each of the 2 treatment periods.
    

Intervention name(s): placebo; carisbamate
Intervention type(s): Drug; Drug
Intervention description(s): twice daily for 4 weeks; 200 mg tablet twice daily for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain following the healing of rashes and blisters; herpes virus; rash; varicella-zoster virus; shingles.
Identifying Risk Factors for Developing AKI in Sepsis
Condition: Sepsis; Acute Kidney Injury; Diabetic Ketoacidosis
MeSH terms: Sepsis; Toxemia; Acute Kidney Injury; Ketosis; Diabetic Ketoacidosis
Study type: Observational [Patient Registry]

Summary: 
      A study to evaluate the prevalence of Acute Kidney Injury (AKI) in patients with Diabetic
      Ketoacidosis (DKA) and sepsis using data collected prospectively to a patient registry. The
      primary objective is to compare the prevalence of AKI in sepsis and DKA in different age
      groups in children and investigate the difference in the prevalence of hyperchloremia in the
      two groups.Secondary objectives are Compare the prevalence of AKI in sepsis and DKA in
      different age groups in children and investigate the difference in the prevalence of
      hyperchloremia in the two groups.
    

Detailed description: 
      It is a descriptive study to report the prevalence ofAcute Kidney Injury ( AKI) in the two
      cohorts of sepsis and Diabetic Ketoacidosis ( DKA). In addition we aim to evaluate the
      relation with hyperchloremia. In both groups, attempts will be made to evaluate the
      association of risk factors such as severity of dehydration/shock and hyperchloremia with AKI
      in the two groups.

      Data will be analysed using SPSS software. Categorical variables will be analysed using
      Chi-square test and if appropriate, multiple logistic regression analysis. Continuous
      variable will be analysed with Student's T test and if possible, by linear regression
      modelling. The differences between the two groups may analysed using Analysis of Variance
      (ANOVA).

      The study will collect anonymous data from 2015 to 2020 from the Paediatric Intensive Care
      Audit Network (PICANet) database for a tertiary PICU servicing the pediatric population of
      Wales.This data is submitted prospectively for audit of clinical outcomes of children
      admitted for paediatric intensive care in the United Kingdom. The study was reviewed by the
      Institutional Research and Development department and was given exemption for ethics
      committee review as it does not involve direct patient contact and the data is anonymous.
      Approval was obtained from the relevant database manager, institutional information
      governance department as well as the Health Care Research Wales.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children admitted to PICU with sepsis as per the sepsis consensus conference (2005)
        definition.

        Children with DKA admitted to PICU and wards. Diabetic Ketoacidosis defined based on the
        British Paediatric Society of Endocrinology and Diabetes.
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Condition: Partial Seizures With or Without Secondary Generalization
MeSH terms: Neoplasm Metastasis; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with
      partial seizures and are taking up to 3 medications for this medical condition will take part
      in this research study at approximately 80 different locations in Australia and Europe.

      The purpose of this study is to evaluate the effectiveness, safety and tolerability of
      consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.

      Each patient who qualifies and chooses to participate in the study will receive placebo
      (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose
      of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks.

      The study clinic visits will include a medical history and physical exam, ECG, blood and
      urine sample collection, and completion of a seizure diary.

      Patients who complete the study may enroll in an extension trial and receive active study
      drug.
    


Intervention name(s): SPM 927
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Transdiagnostic Group Behavioral Activation for Autistic Adults
Condition: Autism Spectrum Disorder; Depression, Anxiety; Anxiety; Anger
MeSH terms: Anxiety Disorders; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of
      a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults.
    

Detailed description: 
      Detailed Description: This study is being done to demonstrate the feasibility, acceptability
      and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic
      adults. GBAT is intended to help adults manage stress, anxiety, down moods, and anger.
      Similar programs have been shown to be effective in other contexts but has not yet been used
      for autistic adults or delivered via telehealth. Because this is a new intervention, the
      investigators are interested in learning 1) whether GBAT can be done with autistic adults
      (feasibility), 2) what autistic adults think about GBAT (acceptability), and 3) whether GBAT
      is effective for helping autistic adults cope with their feelings. Results from this study
      will be used to inform adaptation to the intervention and planning for future studies to
      further explore its effectiveness. For this initial feasibility study, 8 autistic adults
      (18-40 years old) with VIQ and NVIQ>85, reading composite at least 6th grade level and
      elevated symptoms of depression, anxiety or anger will be recruited.
    

Intervention name(s): Group Behavioral Activation Therapy for Autism Spectrum Disorder
Intervention type(s): Behavioral
Intervention description(s): This will be a modification of the Group Behavioral Activation Therapy program (Chu et al., 2009) for treatment of depression, anxiety and/or anger in autistic adults.
Intervention model: Single Group Assignment
Intervention model description: 8 participants with autism and depression, anxiety or anger will participate
Masking: None (Open Label)
Primary purpose: Treatment
An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
Condition: Acute Steroid Responsive Dermatoses; Chronic Steroid Responsive Dermatoses
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available
      in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the
      relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
      Unlike more potent steroid products, T Spray has no time limitations on its use; therefore,
      it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis,
      and contact dermatitis.

      In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas
      of the body. Its optional nozzle directs application of the medication to precise areas
      without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions
      on the scalp, back, intertriginous folds, large areas, or areas that require precise
      application would benefit from the T Spray formulation. In the time since the introduction of
      T Spray to dermatology, other topical corticosteroids have entered the market, but T Spray
      remains the only mid-potency corticosteroid available in a spray formulation.

      In a recently published open-label, non-comparator study involving 42 patients with chronic
      steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days.
      Improvement of lesions after one week of treatment was experienced by 85% of patients, and
      95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of
      patients reported an anti-pruritic cooling effect which was experienced upon application.
    


Intervention name(s): Triamcinolone Acetonide spray; Triamcinolone acetonide cream; Alcohol spray
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science