bioihbjkbjnl/mcl2 huggingface dataset:
Emotional and Change-related Attention in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      Several studies seem to indicate that emotional attention and change-related attention are
      impaired in ASD. The goal of this study is to identify the relationships between those two
      types of automatic attention in visual and auditory modalities in subjects with ASD compared
      to healthy controls and also, over the course of development (children, adults). In order to
      achieve this goal, the investigators will use complementary techniques (EEG and MRI-based
      techniques (fMRI, DTI)).
    

Detailed description: 
      Autism Spectrum Disorders (ASD) are characterized by major handicap in social interaction and
      in daily life adaptation. The orienting response towards potentially relevant events involves
      automatic attentional mechanisms that would be elicited mainly by two classes of biologically
      important stimulations: novel stimuli and emotional stimuli. The neural basis of emotional
      and change-related attention in ASD will be explored by investigating brain reactivity in
      both visual and auditory modalities, during tasks mixing emotional and non emotional stimuli.
    

Intervention name(s): MRI-based techniques; EEG
Intervention type(s): Other; Other
Intervention description(s): fMRI, DTI; ERP
Other intervention name(s): Functional magnetic resonance imaging; Diffusion Tensor Imaging; Electroencephaolgraphy; Event-related potential (ERP)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children/ adults with ASD and healthy children/ adults
      
Keywords: Autism Spectrum Disorders; Emotion; Attention; Event-related potential; Functional neuroimaging; Diffusion Tensor Imaging; Development
rTMS for Cognitive Rehabilitation After TBI
Condition: Cognitive Impairment; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      A novel and promising therapy for cognitive dysfunction is non-invasive brain stimulation, of
      which transcranial magnetic stimulation (TMS) is a form. TMS is currently FDA-approved for
      use in depression and migraine. It is under investigation for use in a number of other
      neurologic and psychiatric disorders. In addition to its potential to improve affective
      symptoms, recent research has suggested that TMS targeted to select cortical regions can also
      improve cognition. In trials of TMS therapy for psychiatric disorders, several studies have
      shown benefits for cognitive function alongside symptom amelioration. In healthy persons, a
      course of stimulation of the parietal area improved objective measures of learning and
      memory. Among persons with TBI, there have been case reports supporting improvement in
      cognitive function and postconcussive symptoms; however, there have not yet been any
      controlled studies of TMS for TBI-related cognitive dysfunction.
    

Detailed description: 
      Subjects with a history of TBI will be recruited into this double-blind, sham controlled,
      crossover with washout study design. Study will involve one week (5 consecutive days) of
      treatment, a 7 day off period, followed by a second week of rTMS treatment. Motor threshold
      will determine level of stimulation, and active rTMS stimulation will occur of the right
      DLPFC. Subjects will be paid for their time.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): repetitive Transcranial Magnetic Stimulation (rTMS) utilizes a magnetic coil of wire to non-invasively and painlessly activate small sections of the brain through the skull.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a multi-center, prospective, randomized, open-label, parallel design, two arm
      comparator trial. In the proposed study, the investigators will compare low-dose combination
      therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with
      respect to their blood pressure-decreasing effects in patients with essential
      hypertension.The study consists of a screening visit, followed by randomization and
      administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or
      Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP
      and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.
    


Intervention name(s): Adalat (Nifedipine, BAYA1040); Diovan (Valsartan)
Intervention type(s): Drug; Drug
Intervention description(s): Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM; Valsartan 160 mg OM (Two Valsartan 80mg tablets)
Intervention MeSH terms: Valsartan; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nifedipine GITS/OROS (Adalat®); Valsartan (Diovan®); Hypertension
A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
Condition: High Grade Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety,
      tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy
      with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant
      and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically
      confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or
      infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be
      randomly assigned to one of two treatment arms.

      Upon approval by the Health Authorities/Ethics Committees in the participating countries, an
      additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with
      progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO
      Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab
      and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.
    


Intervention name(s): Bevacizumab; Radiotherapy; Temozolomide (TMZ)
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): 10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days; Total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation phase.; 75 milligrams per square meter (mg/m^2) daily continuous starting concomitantly with the first radiation fraction and ending with the last radiation fraction for a maximum number of treatment days = 49 days. During the TMZ adjuvant treatment phase and for participants from YPC: TMZ (150 to 200 mg/m^2/day) x 12 cycles, 1st cycle 150 mg/m^2/days 1-5, escalated to 200 mg/m^2 on Days 1-5 from Cycle 2 onwards depending on the tolerance during the 1st cycle. Cycle length = 28 days.
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab; Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Agility Training in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      To determine the effects of an unusually highly intensity and individualized sensorimotor and
      visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility,
      and postural stability.
    

Detailed description: 
      Design: Intervention study

      Setting: Outpatient rehabilitation center

      Participants: 55 Parkinson's disease (PD) patients completed the trial and 42 serves as
      comparison healthy controls

      Intervention: An initial screening established specific dysfunctions of PD patients with
      Hoehn-Yahr stage 2-3 who were then randomly assigned to standard care (n = 20) or standard
      care plus at-limit intensity, individualized agility program (15 sessions, 3 weeks, n = 35).

      Main outcome measures: Movement Disorder Society Unified Parkinson Disease Rating Scale,
      Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD
      symptoms

      In group time, repeated measurements of variance analysis were compared to the picture
      parkinson's disease based on MDS-UPDRS M-EDL, Beck depression score, PDQ-39, EQ5D VAS, Schwab
      & England scale. The TUG test and 12 static posturographic measurements are compared and
      compared to the healthy group as a standard.

      An at-limit and individualized sensorimotor and visuomotor agility exercise program vs.
      standard care, will improve non-demented, stage 2-3 PD patients' clinical symptoms, mobility,
      and postural stability by functionally meaningful margins.
    

Intervention name(s): Exercise therapy
Intervention type(s): Other
Intervention description(s): 3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training
Other intervention name(s): Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The single-arm, 3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training (n = 35, 17 males) conceptualized but seldom implemented previously. Each of the 15 training sessions lasted 60 minutes. Patients performed each exercise under increasingly difficult conditions and speed according to principles of periodization. All patients kept an exercise log detailing the positive and negative effects of the intervention on clinical and motor symptoms. The logs and attendance were checked daily. The no-intervention control, consisting of PD patients (n = 20, 12 males) received unsupervised standard care, consisting of the prescribed medications and daily, unsupervised 30 minutes of exercises at home.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: sensorimotor training; exergaming; posture; quality of life
Metro Atlanta Heart Disease Study - II (MAHDS II)
Condition: African Americans With Hypertension.
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A 12-week treatment/control trial was implemented to assess the effects of a multi component
      lifestyle program on improvements in body mass index, weight, perceived stress and blood
      pressure in African American men and women who were at increased risk for cardiovascular
      disease. It was hypothesized that treatment group would experience significant improvements
      when compared to the control group.
    


Intervention name(s): 12-week lifestyle modification
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: high blood pressure, hypertension, African Americans, perceived stress
The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
Condition: Ectopic Pregnancy; Infertility
MeSH terms: Infertility; Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Interventional

Summary: 
      The investigators aimed to investigate the effects of salpingectomy and Methotrexate
      administration on ovarian reserve in ectopic pregnancy.
    

Detailed description: 
      In this study, the effects of unilateral laparoscopic salpingectomy and single dose of
      systemic Methotrexate administration on ovarian reserve in patients diagnosed with ectopic
      pregnancy were investigated.
    

Intervention name(s): Methotrexate; salpingectomy
Intervention type(s): Drug; Procedure
Intervention description(s): single dose systemic methotrexate administration (50 mg/m2); Laparoscopic unilateral salpingectomy
Other intervention name(s): Mtx
Intervention MeSH terms: Methotrexate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ectopic pregnancy; ovarian reserve; salpingectomy; methotrexate
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
Condition: Respiratory Infections; Bronchiolitis; Pneumonia; Apnea
MeSH terms: Infections; Communicable Diseases; Pneumonia; Bronchiolitis; Respiratory Tract Infections
Study type: Observational

Summary: 
      The primary objective of this study is to describe the incidence of RSV-associated LRI among
      infants <1 year of age presenting to the ED during selected shoulder months.
    

Detailed description: 
      -  The primary objective of this study is to describe the incidence of RSV-associated LRI
           or apnea (% RSV positive) among infants <1 year of age presenting to the ED during
           selected shoulder months. The total number of events will also be described.

        -  To characterize the clinical outcomes and demographic data of infants presenting to the
           ED with RSV-associated LRI or apnea

        -  To characterize the social burden (in the form of number of days lost from work by
           parent/ guardian) for these infants through 14 days after the index ED visit and through
           hospital discharge will also be described.

        -  Based on a sample of cases collected in a cohort of patients enrolled at or near the
           peak of RSV disease during the traditional season, a comparison of the rate of RSV
           between shoulder and peak periods will be described.

        -  To describe the overall rates of RSV-associated LRI or apnea based on the general ED
           statistics collected during the entire study period.
    

Intervention name(s): Emergency Dept. Subjects with LRI or Apnea
Intervention type(s): Other
Intervention description(s): No intervention; Epidemiological Study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible subjects with RSV results.
      
Biospecimen description: 
      Nasal wash specimen (RSV)
    
Keywords: Acute Lower Respiratory Infection; Retractions; Bronchiolitis or pneumonia; Wheezing; Rales; Crackles
A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of single and multiple once daily doses of
      50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug enters
      and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide in
      healthy male participants.
    

Detailed description: 
      This is a single-center, open-label (participants and researchers are aware about the
      treatment, participants are receiving), fixed-sequence study in healthy male participants.
      The study consists of 3 phases: Screening Phase (within 21 to 2 days prior to the first dose
      administration on Day 1), Open Label Treatment Phase (Day 1 up to Day 9), and Follow-up Phase
      (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal). The
      maximum duration of study will be 7 weeks per participant. During the Open-Label Treatment
      Phase, participants will receive JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from
      Day 2 to Day 9 along with caffeine 100 mg (2*50 mg tablets), midazolam 2 mg (1 milliliter
      [mL], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9. Blood
      samples will be collected pre-dose (Day 1) up to Day 10 to understand the PK characteristics
      of midazolam, 1-hydroxy midazolam (midazolam metabolite), caffeine, paraxanthine (caffeine
      metabolite), tolbutamide, 4-hydroxytolbutamide and carboxytolbutamide (tolbutamide
      metabolites). In addition, a blood sample will be collected on Day -1 from all enrolled
      participants to study genetic factors that may influence the PK, safety, and/or tolerability
      of JNJ-54861911 and co-medications. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): JNJ-54861911; Caffeine; Midazolam; Tolbutamide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from Day 2 to Day 9.; Single oral dose of caffeine 100 mg (2*50 mg tablets), on Day 1, 2, and 9.; Single oral dose of midazolam 2 mg (1 mL, 2 mg/mL solution), on Day 1, 2, and 9.; Single oral dose of Tolbutamide 500 mg tablet, on Day 1, 2, and 9.
Intervention MeSH terms: Tolbutamide; Midazolam; Caffeine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-54861911; Caffeine; Midazolam; Tolbutamide; Cytochrome P450 3A4; Cytochrome P450 2C9; Cytochrome P450 1A2; Alzheimer's disease
Involvement of Nervous System in Muscle Weakness in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to determine whether nervous system alterations and motor drive
      failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we
      will look after the role of nocturnal hypoxia in these alterations.
    

Detailed description: 
      COPD is a common disease that induces many systemic repercussions. Among these, peripheral
      muscle dysfunction is particularly deleterious because it leads to the decreases of the level
      of activity and the quality of life for patients. Movement involves activation of many
      structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle.
      Netherless, the studies which have described peripheral muscle dysfunction have been focused
      on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have
      reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal
      conduction time, and decrease of the white matter density, and were associated with chronic
      hypoxemia. Such alterations are consistent with the existence of a decrease of the central
      motor drive during voluntary movement in COPD patients. Therefore the study will aim to
      determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Two groups of COPD patients and one group with healthy sedentary subjects
      
Biospecimen description: 
      whole blood
    
Keywords: COPD, nervous system, peripheral muscle dysfunction
A Study to Establish Safety and Maximum Tolerated Dose of IV Trehalose in Healthy Subjects
Condition: Healthy Volunteer Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a double-blind, randomized, placebo-controlled, single ascending dose study
      performed in healthy subjects.

      The study will include up to four escalating dose cohorts with eight (8) subjects in each
      cohort.

      In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV
      administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).

      All subjects, regardless of their treatment arm assignment, will undergo the same evaluations
      and will receive the study drug at the clinic. Each subject will continue to be followed for
      one week post dosing.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, single ascending dose study performed
      in healthy subjects.

      The study will include up to four escalating dose cohorts with eight (8) subjects in each
      cohort.

      In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV
      administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).

      All subjects, regardless of their treatment arm assignment, will undergo the same evaluations
      and will receive the study drug at the clinic. Each subject will continue to be followed for
      one week post dosing.

      Cohorts 1 to 3 After all subjects in a given cohort complete their 1-week follow-up visit
      (Visit 4), a Safety Review Committee (SRC) will review the safety and PK data of that cohort.
      If no safety concerns are identified, and the exposure data supports a higher dose is
      acceptable, the SRC will approve continuation into the next cohort (dose level).

      Cohort 4 Cohort 4 will be initiated based on review of the safety and exposure data from the
      first 3 cohorts by the SRC. This cohort will only be performed if there is a suggestion that
      exposure can be safely increased.
    

Intervention name(s): Trehalose for IV Infusion; Saline 0.9% IV
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Bioblast
Phase 1 Clinical Trial of DA-5207 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of
      DA-5207 transdermal delivery system in healthy adults
    


Intervention name(s): Aricept 5mg Tablet; Aricept 10mg Tablet; DA-5207 A; DA-5207 B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet once daily; 1 tablet once daily; 1 patch once weekly; 1 patch once weekly
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Novel Methods to Reduce Children's Secondhand Smoke Exposure II
Condition: Secondhand Smoke
Study type: Interventional

Summary: 
      The overall aim of the current study is to determine if the use of nicotine containing
      products by caregivers who smoke and who are not interested in quitting, is effective in
      reducing children's secondhand smoke exposure.
    


Intervention name(s): Nicotine polacrilex; Tobacco lozenge
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: second hand smoke exposure; children