bioihbjkbjnl/mcl2 huggingface dataset:
Association of Air Quality and Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol
      levels and diabetes there are also acute factors potentially triggering acute coronary
      events. The impact of various substances and air pollution are described.

      Particulate matter, especially with small particle size (<2.5µm) has been shown to have a
      positive correlation with myocardial infarctions. However, other studies failed to show this
      correlation.

      With respect to nitric oxydes the majority of published studies detected a significant
      correlation with myocardial infarction, too, although a highly ranked publication failed to
      show the same result. In addition data on the impact of sulfur dioxide and carbon monoxide
      concentration on cardiac events is very heterogeneous.

      Published data indicates additive effects of age and other epidemiological variables
      suggesting the need of a multivariate analysis.

      The rationale of the study is to test if the above mentioned air pollution factors have a
      significant and independent impact on the incidence of myocardial infarctions
    

Detailed description: 
      The analysis will be performed in a well characterized patient cohort of 12.000 myocardial
      infarctions within 10 years being invasively diagnosed at the catheterisation centers of the
      styrian capital Graz.
    

Intervention name(s): air pollution
Intervention type(s): Other
Intervention description(s): impact of various pollution agents above threshold and their correlation with acute myocardial infarctions are analyzed
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with myocardial infarction being transfered to a cath lab either at the
        medical university of Graz or the department of cardiology at the state hospital Graz West
The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit/Hyperactivity Disorder Combined Type; ADHD Predominantly Inattentive Type; ADHD Predominantly Hyperactivity Type; ADHD-not Other Specified
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the familial response to Methylphenidate
      treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects
      development.
    

Detailed description: 
      Attention Deficit/Hyperactivity Disorder (ADHD) is very prevalent and tends to continue from
      childhood to adult life. It's heritability is 76%. It was found that there is a greater ADHD
      prevalence in first-degree families of ADHD subjects- 4-6 times more than the general
      population.

      Pharmacological treatment is the first line treatment today in ADHD, in children and adults,
      and Methylphenidate (specially Ritalin IR) is the first medication given for the disorder.

      The study includes couples of first-degree family members, both diagnosed with ADHD. Subjects
      will receive Ritalin IR for 4 weeks and undergo several psychiatric and cognitive
      questionnaires at each time of the follow-up meeting (a total of 3).
    

Intervention name(s): Methylphenidate- Ritalin IR (Immediate Release)
Intervention type(s): Drug
Intervention description(s): Duration of treatment- 4 weeks. Dosage- up to 3 times/day.
Ages 6-12, up to 25Kg - 35mg maximum per day.
Ages 6-12, above 25Kg - 50mg maximum per day.
Ages 12-65, above 25Kg - 80mg maximum per day.
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder (ADHD); Methylphenidate- RITALIN IR (Immediate Release)
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a
      standard dose of lurasidone in patients with treatment resistant schizophrenia or
      schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of
      positive symptoms and other components of psychopathology (negative symptoms, general
      psychopathology, anxiety, depression, cognitive function, global function, severity of
      illness and tolerability). Patients must qualify for treatment resistance after two or more
      antipsychotic drug trials to be included in this trial.
    


Intervention name(s): Lurasidone; Lurasidone
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg/day for up to 30 weeks; Up to 240 mg/day for up to 30 weeks
Other intervention name(s): Latuda; Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Refractory; Treatment resistant; Lurasidone
Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
Condition: Brain Injury; Concussion
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      Adolescents with concussion will be randomly assigned to a treatment group where they will
      receive sub-threshold exercise, or assigned to a placebo group where they will receive
      structured stretching exercises. Both groups will receive standard medical coverage with
      regular clinic visits. All participants will record symptoms daily on a dedicated web site.
      All participants will be evaluated at time 1 with (1) structured physical exam, and (2)
      structured exercise stress test which is terminated when there is symptom exacerbation. The
      primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for
      two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of
      symptoms, and (3) confirmed by a physician based on a structured physical exam.
    

Detailed description: 
      Adolescents with concussion will be randomly assigned to a treatment group where they will
      receive sub-threshold exercise, or assigned to a placebo group where they will receive
      structured stretching exercises. Both groups will receive standard medical coverage with
      regular clinic visits. All participants will record symptoms daily on a dedicated web site.
      All participants will be evaluated at time 1 with (1) structured physical exam, and (2)
      structured exercise stress test which is terminated when there is symptom exacerbation. The
      primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for
      two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of
      symptoms, and (3) confirmed by a physician based on a structured physical exam.
    

Intervention name(s): Sub-Threshold exercise prescription; Structured stretching prescription
Intervention type(s): Other; Other
Intervention description(s): Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.; Participants will be given a prescription for daily stretching lasting approximately 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nature as a Buffer Among People With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This randomized controlled trial examines the effect of nature exposure on pain intensity
      levels among older adults who experience chronic pain. Investigators examine the effects of
      nature on: the experience of chronic pain, on pain catastrophizing, and on attention
      restoration.
    

Detailed description: 
      Nature has been used to reduce pain in the context of acute pain (e.g., during painful
      medical procedures) but nature has not been examined as an intervention strategy to address
      chronic pain. Second, the mechanism though which nature might reduce the experience of pain
      is not well understood. Participants are cognitively intact individuals aged 60-90 who
      experience chronic pain and who rate their health as fair, good or excellent. Participants
      are randomly assigned to one of three conditions: virtual reality (VR) nature; VR built
      environment; or control. Researchers examine effects of VR nature exposure on the experience
      of chronic pain, pain catastrophizing, and on attention restoration as well as the relations
      among these variables.
    

Intervention name(s): Natural Environment; Built Environment
Intervention type(s): Other; Other
Intervention description(s): the natural environment will be delivered via Samsung VR gear goggles with Samsung smartphone.; the built environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
Other intervention name(s): VR nature; VR built environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: environment; nature
Mobile Messaging for Improved Nutrition
Condition: Diet, Healthy; Anemia
Study type: Interventional

Summary: 
      This project will examine the impact of an infant and young child feeding (IYCF) voice
      messaging intervention delivered to mothers and fathers in Senegal on the consumption of a
      minimum acceptable diet and anemia prevalence in their children.
    


Intervention name(s): Infant and young child feeding voice messaging intervention
Intervention type(s): Behavioral
Intervention description(s): A mobile voice and text messaging intervention aimed at improving IYCF practices will be delivered to mothers and fathers with young children (6-23 months). A total of 16 voice and text message, with the same content, will be sent over a 16-week period (1 voice + 1 text messages (with same content) per week x 16 weeks). Two types of messages will be included: 1) eight scripted and 2) eight unscripted messages from positive deviants. The content of the messages include: breastfeeding until two years of age, consuming a variety of foods within a given meal, the consistency of porridge (thick rather than thin), limiting sweets and fried foods, the importance of animal source foods, consuming vitamin A rich fruits and vegetables, consuming leafy greens, handwashing and feeding infants and young children fruits and vegetables produced by the household.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-randomized control trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Senegal; Infant and young child feeding
Spinal Cord Injury: Endurance, Strength and Cardiac Function Induced by Efficient Training Protocols
Condition: Cardiovascular Disease
MeSH terms: Spinal Cord Injuries; Cardiovascular Diseases
Study type: Interventional

Summary: 
      1. Measurements of peak oxygen uptake (VO2peak) during passive leg cycling (PLC) combined
           with arm crank ergometry (ACE), leg vascular occlusion (100mmHg above systolic BP)
           combined with ACE, and FES isometric contractions combined with ACE in spinal cord
           injured (SCI). All the above mentioned parameters will be compared to Functional
           Electrical Stimulated (FES) lower extremity cycling combined with ACE (FEShybrid). The
           hypothesis is that VO2peak is significantly higher during FES hybrid cycling when
           compared to peak and submaximal PLC, leg vascular occlusion and ACE. But the values for
           VO2peak during FES isometric contractions combined with ACE is not significantly
           different from FES hybrid cycling.

        2. Comparison of sub-maximal and peak VO2 values during arm crank (ACE) and wheelchair
           ergometry (WCE) in persons with spinal cord injury. The hypothesis is that wheelchair
           propulsion due to higher energy expenditure show higher work output and VO2peak than
           ACE.

        3. Does 6 weeks of maximal strength training improve SCI subjects performance during WCE?
           WCE after 6 weeks maximal strength training is less strenuous owing to better work
           economy/ efficiency.

        4. Effect from aerobic high intensity hybrid training on stroke volume (SV) and VO2peak in
           spinal cord injured men.

      8 weeks of high intensity 4 times 4 interval training at 85-90% of peak heart rate during
      hybrid cycling. Hypothesis; VO2peak and SV will be significantly increased from training.
    


Intervention name(s): Ergometry
Intervention type(s): Device
Intervention description(s): MetamaxII Cortex ergospirometry system (Cortex Biophysik GmbH, Germany). Arm cycling ergometer (Ergomed 840L, Siemens, GermanyMonark, Sweden), Electrically braked wheelchair ergometer (VP 100, Handisoft France)
Other intervention name(s): Sensor Medics Vmax Spectra 229 version 10. 1; ERGYS 2 Rehabilitation system; Lactate Pro LT-1710 Analyzer; Polar® accurex watch; Thigh cuffs Criticares NIBP with Riester Metpak manometer; Motionstim 8, Medel Electronics (isometric FES)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Functional electrical stimulation cycling; arm crank; wheelchair; ergometry; paraplegia; spinal cord injury; exercise testing
Treatment of Children With Peer Related Aggressive Behavior
Condition: Oppositional Defiant Disorder
MeSH terms: Aggression; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of the Treatment Program for Children with Aggressive Behaviour
      (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence
      training delivered in an individual format will be evaluated in a randomized controlled trial
      with children aged 6 to 12 years with peer-related aggressive behaviour.
    

Detailed description: 
      The German Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für
      Kinder mit aggressivem Verhalten, THAV) aims at the therapy of children aged 6 to 12 years
      with peer-related aggressive behaviour, which results in a persistent impairment of the
      relationships to other children. Contrary to other treatment approaches, this intervention
      aims at the individual treatment of problem maintaining and moderating factors of aggressive
      behaviour. Depending on the individual problem maintaining factors the treatment aims to
      modify social cognitive information processing, impulse control, social problem solving,
      social skills and social interactions. Methods: The efficacy will be tested in a partial
      randomized control group design with n=100 children. N=60 children will be treated for about
      half a year with the modules of THAV in weekly sessions. The control group of n=40 children
      will receive alternative interventions with group play and techniques to activate resources
      of the child. These interventions give the children the opportunity to train pro-social
      interactions. Outcome parameters are aggressive behaviour und comorbid symptoms as well as
      problem maintaining factors, psychosocial functioning, family burden and treatment
      satisfaction. Moreover, variables of the treatment process are assessed. Questionnaires,
      tests and individual problem checklist were used to assess these outcome and process
      parameters
    

Intervention name(s): Treatment Program for Children with Aggressive Behavior; Play group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 24 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 10 sessions with relatives of the child in most cases with the parents.; 12 double sessions (totally 24 treatment hours) in groups with up to 5 children. Different play activities were presented including techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Additionally up to 3 parent sessions were also included.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: social skills training,; social competence training,; Oppositional Defiant Disorder; peer related aggressive behavior; randomized controlled trial
Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)
Condition: NVP Plasma Level; NVP Related Mutation; 3TC Related Mutation
Study type: Interventional

Summary: 
      Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected
      pregnant women worldwide, both for the prevention of mother to child transmission of HIV
      (PMTCT) and for women's own health. Use of these drugs in pregnant women solely for PMTCT
      means that these drugs will need to be discontinued in the majority of women after delivery.

      Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the
      body for a longer period of time after discontinuation than other drugs in the same regimen),
      such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the only drug
      left in the body (similar to monotherapy). Given two other drugs for up to 1 week after
      discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can help
      reduce, but not eliminate, the development of resistant virus.

      Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women
      in developing countries due to its low cost and its availability in fixed-dose combinations.
      These study will explore how fast NVP is eliminated from women after delivery and to see if
      given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help
      reduce the development of NVP resistant virus.
    


Intervention name(s): AZT/3TC 2 weeks after delivery
Intervention type(s): Drug
Intervention description(s): AZT/3TC 300/150mg will be given every 12 hours for 1 week after NVP discontinuation in arm 1 and for 2 weeks after NVP discontinuation in arm 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: NVP; PMTCT; pregnancy; resistance
Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to
      evaluate the pharmacokinetics, safety and immunogenicity of BAT2306 Injection vs Cosentyx®
      (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 216 healthy male
      subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single
      150mg BAT2306 Injection or Cosentyx® (EU-licensed and US-licensed).
    

Detailed description: 
      The study has a screening period of 14 days. PK blood samples will be collected from subjects
      to determine the serum concentration of Secukinumab, thus to evaluate the similarity of the
      pharmacokinetics of the three study drugs.

      The investigator will perform safety evaluation for vital signs, physical examinations,
      injection site reaction, ECG, clinical laboratory tests and adverse events throughout the
      study. Immunogenicity evaluation (ADA, ADA titration and NAb) will also be evaluated.
    

Intervention name(s): BAT2306; Cosentyx (US-licensed); Cosentyx (EU-licensed)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150mg/1 ml; single dose；prefilled syringe; subcutaneous injection; 150mg/1 ml; single dose；prefilled syringe; subcutaneous injection; 150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
Other intervention name(s): Secukinumab; Secukinumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Weight Loss Maintenance in Primary Care
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      After a three month weight loss phase involving the use of meal replacements, participants
      are randomized into different weight loss maintenance conditions. Aim 1: To test the
      hypothesis that the meal replacement (MR) and reduced energy density eating (REDE)
      interventions, when added separately to the LEARN program, will produce superior weight loss
      maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the
      weight loss maintenance condition that combines MRs and REDE will produce better maintenance
      of weight losses than either individual component and than the LEARN-only condition. Aim 3:
      To test the hypothesis that the two conditions receiving the REDE intervention will
      experience longer-lasting improvements in the energy density and nutritional composition of
      the diet compared to the two non-REDE conditions.
    


Intervention name(s): Weight Loss Phase; Continued CBT; reduced energy density education; continued use of meal replacements
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Weight loss using CBT and meal replacements; Using CBT during weight loss maintenance; Additional nutritional learning; continued use of meal replacements during weight loss maintenance
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating; Dieting; Meal replacements; Energy Density; Weight Loss Maintenance