bioihbjkbjnl/mcl2 huggingface dataset:
Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This randomized control study is aimed to determine efficacy of umbilical cord blood and
      erythropoietin combination therapy for children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion
      or injury of the immature brain. It is a leading cause of childhood onset disability through
      one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy
      which resulted from animal studies. Stem cells included in UCB is expected to exert
      therapeutic efficacy for functional recovery.

      It is also suggested that erythropoietin is useful to repair neurological injury in brain.
      The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which
      would reinforce the effect of stem cell as well.

      Although autologous umbilical cord would be safe, the children who have problems at birth
      seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful
      for these children if its effect is approved.
    

Intervention name(s): Umbilical Cord Blood Infusion; Erythropoietin Injection; Active Rehabilitation; Placebo Umbilical Cord Blood; Placebo Erythropoietin
Intervention type(s): Biological; Drug; Other; Other; Other
Intervention description(s): The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).; Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.; All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.; Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.; Placebo Erythropoietin containing Normal Saline
Other intervention name(s): Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank; Brand name of Erythropoietin: Espogen (made by LG Life Science); Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed; : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin.
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: umbilical cord blood; stem cell; cerebral palsy
Hyper-Arousal in Chronic Primary Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      The purpose of this study is to determine whether individuals with chronic insomnia disorder
      have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good
      sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic
      hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients
      with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass
      index (BMI) and race/ethnicity.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Insomniacs and good sleepers
      
Keywords: Insomnia
Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR) for
      children with ADHD aimed at assessing whether the observable behavioral changes seen during
      treatment are associated with potentially more stable underlying modifications in brain
      functioning (resting-state functional connectivity). Additionally, we will also be looking at
      treatment effects on neuropsychological processes and reading skills. This information will
      contribute to the first Brazilian study assessing the cost-effectiveness of the treatment of
      ADHD. Children with ADHD will be compared to a sample of sex and age-matched sample of
      typically developing children.
    


Intervention name(s): methylphenidate (Ritalin®)
Intervention type(s): Drug
Intervention description(s): The scheme provides for initial dose of 0.3 mg / kg / day, with an average dose of 1mg/kg/day. The increases will be made considering the presentation of the drug (10mg), which allows increments of 5mg or 10mg, which will be made in clinical review, as the clinical symptoms, including increasing the dose until there is more room for improvement or there is presence of significant adverse effects, all the patients with indication of treatment will be assessed before the use of medication, 15 days, 30 days, 3 and 6 months after the start,
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open label; Ritalin®; ADHD
Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 study will assess the safety and tolerability, and characterize the
      pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects
      following single- and repeated-dose administrations as a first step in clinical development
      prior to administering this new investigational medicinal product (IMP) to patients.
    

Detailed description: 
      The anticipated study duration per participant is up to 10 weeks in Part 1.

        -  Screening: 2 to 28 days prior to dosing (Day -28 to Day -2)

        -  Treatment period: Day -1 to Day 29 post dose including

        -  Institutionalization: Day -1 until Day 8

        -  Ambulant period including repeat PK and PD blood sampling and ambulant visits: Day 9 to
           Day 29

        -  Follow-up period: Day 30 to Day 43

      The anticipated study duration per participant is up to 17 weeks in Part 2.

        -  Screening: 2 to 28 days prior to dosing (Day -28 to Day -2)

        -  Treatment period: Day -1 to Day 57 (Q2W/3 doses or Q4W/2 doses) or Day -1 to Day 85
           (Q4W/3 doses), or Day -1 to Day 50 (Q3W) including

        -  Institutionalization: Day -1 until Day 3

        -  Ambulant period including repeat PK and PD blood sampling, ambulant visits and 24 hours
           institutionalization after 2nd and/or 3rd dose: Day 4 to Day 57 (Q2W/3 doses, Q4W/2
           doses), Day 4 to Day 85 (Q4W/3 doses) or Day 50 (Q3W)

        -  Follow-up period: Day 58 to Day 71 (Q2W/3 doses or Q4W/2 doses), Day 71 to Day 85 (Q4W/3
           doses) or Day 51 to Day 64 (Q3W)
    

Intervention name(s): SAR444336; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single or repeated dose subcutaneous injection; Single or repeated dose subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Desmoteplase in Acute Ischemic Stroke (DIAS)
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment
      in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within
      a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and
      tolerability of 3 doses of desmoteplase compared with placebo with special consideration of
      intracranial hemorrhage and major systemic bleedings.
    

Detailed description: 
      Acute stroke is the third leading cause of mortality in developed countries and the major
      medical cause of disability. The outcome can be improved by early treatment with
      thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of
      acute ischemic stroke. However, the use of alteplase is currently restricted by the need to
      administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct
      into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that
      carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window
      and improve the safety profile.Desmoteplase (DSPA) with its high fibrin specificity, lack of
      neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long
      terminal half-life may account for an improved safety and efficacy profile within the first 9
      hours after onset of symptoms.
    

Intervention name(s): Desmoteplase; Desmoteplase; Desmoteplase; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Desmoteplase 62.5 µg/kg BW; Desmoteplase 90 µg/kg BW; Desmoteplase 125 µg/kg BW; Placebo
Intervention MeSH terms: Salivary plasminogen activator alpha 1, Desmodus rotundus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute ischemic stroke
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
Condition: Essential Hypertension; Hepatic Impairment
MeSH terms: Liver Diseases; Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in
      hepatic impairment patients and healthy volunteers
    


Intervention name(s): fimasartan; fimasartan
Intervention type(s): Drug; Drug
Intervention description(s): single administration of fimasartan 120mg; single administration of fimasartan 120mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: fimasartan; hepatic impairment
Insulin Sensitivity in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis/Eczema; Type 2 Diabetes
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Insulin Resistance
Study type: Observational

Summary: 
      The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many
      years. Novel research shows an association between the two conditions. While this
      relationship at least in theory can be explained by lifestyle factors, there is reason to
      believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that
      patients with atopic dermatitis are insulin resistant due to their chronic inflammatory
      state. Insulin resistance might play an unknown part in the increased frequency of type 2
      diabetes among patients with atopic dermatitis. In the present project, the investigators aim
      to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic
      euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control
      group (matched case-control study). The project is a close collaboration between The
      Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.
    


Intervention name(s): Hyperinsulinemic euglycemic clamp
Intervention type(s): Diagnostic Test
Intervention description(s): Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with atopic dermatitis are recruited from Department of Dermatology and
        Allergology at Gentofte Hospital.

        Control subjects are recruited from the Danish recruitment site "www.forsoegsperson.dk".
      
Biospecimen description: 
      Whole blood.
A Clinical Study Conducted in Multiple Centers Evaluating Escalating Doses of Veliparib in Combination With Capecitabine and Radiation in Patients With Locally Advanced Rectal Cancer
Condition: Locally Advanced Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the
      PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with
      locally advanced rectal cancer (LARC).
    


Intervention name(s): veliparib; capecitabine; radiation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): see arm description; see arm description; see arm description
Other intervention name(s): ABT-888; Xeloda
Intervention MeSH terms: Capecitabine; Veliparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLT; radiation; veliparib; locally advanced rectal cancer; ABT-888; capecitabine; MTD; PARP
Reducing PM-associated CV Health Effects for Seniors
Condition: Cardiovascular Diseases in Old Age
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effectiveness of air filtration at reducing
      personal-level exposures to fine particulate matter (PM2.5) and mitigating related
      cardiovascular (CV) health effects among older adults in a residential facility in a
      representative US urban location.

      We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention
      study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted
      in a low-income senior living apartment building in downtown Detroit, Michigan.

      Participants were exposed to three 3-day scenarios separated by one-week washout periods:
      unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE)
      "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of
      each residence.

      The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive
      aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were
      measured in the participants' residences as well as by personal-level monitoring.
    


Intervention name(s): Low efficiency air filtration systems; High efficiency air filtration systems; Air filtration systems without filters (sham)
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects were exposed to low-efficiency filtered air.; Subjects were exposed to high-efficiency filtered air.; Subjects were exposed to unfiltered air.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of RO7049389 compared to placebo in
      single- and multiple-ascending doses in healthy Chinese participants.
    


Intervention name(s): RO7049389; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).; Placebo will be administered orally at a dose and frequency matched to RO7049389.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Normal Versus Dual Wave Insulin Bolus for High-protein Food
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as
      bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h
      post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG)
      (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking
      part under in-patient clinical conditions.
    

Detailed description: 
      The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by
      square-wave bolus that is evenly delivered over several hours as programmed by the patient.
      The aim of this study is to compare post-prandial glycaemic excursions following a
      high-protein meal after administration of insulin by normal vs dual-wave bolus. During this
      prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes,
      treated with insulin pump therapy will be evaluated using the self-blood glucose measurements
      following standardized high-protein meal and two types of boluses (normal or dual-wave). The
      required insulin dose will be calculated based on patient's insulin-exchange ratio. A
      high-protein meal will be given on two subsequent breakfasts and comparisons will be made
      between normal and dual-wave insulin bolus delivery. Prolonged post-prandial glycaemic
      excursions will be identified using the CGMS.
    

Intervention name(s): insulin aspart; insulin lispro; insulin glulisine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial; A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial
Other intervention name(s): NovoRapid®; Humalog®; Apidra®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: dual-wave bolus; square bolus; normal bolus; standard bolus; high-protein meal; prandial insulin requirement
What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate?
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The disruption of spatial orientation is considered the second most common cognitive symptom
      of dementia, affecting nearly all activities of daily living. Research in the field of
      environmental psychology has helped to highlight the influence of the environment on patients
      with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has
      been shown that an environment can provide support for cognitive failures in subjects if that
      particular space is adapted. While numerous studies have focused on the architectural
      environment (hospital, housing facility), none have explored the ability of patients to
      orient themselves in a natural environment such as a garden. Yet, in recent years, such
      gardens, known as healing gardens, have emerged in housing and care facilities, providing
      genuine support for the care management of patients with Alzheimer-type dementia. Various
      works have been published outlining recommendations for their management. However, with
      regard to spatial orientation, none of the available research has explored the basic
      principles on which to rely on in order to organize the elements of outdoor spaces into
      itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of
      such data, these authors recommend relying on five elements, identified by Lynch in his
      landmark book "Image of the City" (1960), that people use to orient themselves and find their
      way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The
      hypothesis to verify is that patients with Alzheimer's disease do not rely on the same
      elements of the garden as non-Alzheimer's subjects in making orientation decisions and to
      mentally picture this environment.
    


Intervention name(s): neuropsychological assessment
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain
      Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes
      are implanted within specific sub-structures of the brain in order to modulate the activity
      in targeted neural circuits associated with different neurological disorders. The results of
      this novel approach to psychiatric disorders have been optimistic. This study aims to
      investigate wether or not the distance to target location has an influence on the outcome.

      In order to deliver DBS, leads containing four electrodes are implanted into the brain target
      in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter
      a triple blind randomised two fazed crossover design of two periods of three months. In both
      crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the
      stimulation conditions. These conditions are stimulation ON (at optimal parameters) and
      stimulation OFF. Stimulation parameters are constant during the entire period. During the
      second crossover branch, stimulation conditions are reversed for all patients.
    


Intervention name(s): VC/VS stimulation
Intervention type(s): Device
Other intervention name(s): Neurostimulator: Kinetra (Medtronic); Electrode: 3387 (Medtronic)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: obsessive-compulsive disorder; Deep Brain Stimulation; Psychosurgery
BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of this trial is to assess clinical efficacy and safety of different
      subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to
      select doses for further clinical trials.
    


Intervention name(s): BI 655066; BI 655066; Ustekinumab; BI 655066
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Medium dose; High dose; Low dose
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment