bioihbjkbjnl/mcl2 huggingface dataset:
Stress Reduction and Hypertension Prevention in African Americans
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      There are major health disparities in Blacks associated with high blood pressure (BP) and
      psychosocial stress. We evaluated the effects of lifestyle modification with meditation in
      Black adults with high normal and normal blood pressure.

      Participants (n=304) were randomized to either the Transcendental Meditation technique or
      Health Education control in addition to usual care for up to 36 months for BP and secondary
      outcomes.
    

Detailed description: 
      Background: Blacks suffer from disparities in hypertension, cardiovascular disease (CVD) and
      currently, coronavirus-19. These conditions are associated with social determinants of health
      and psychosocial stress. While previous trials demonstrated stress reduction lowering blood
      pressure in grade I range in Blacks, there is a paucity of clinical trial data in Blacks with
      high normal and normal BP.

      Objective: This randomized controlled trial was conducted to evaluate the effect of stress
      reduction with the Transcendental Meditation (TM) technique in Black adults with high normal
      BP and normal BP using International Society of Hypertension (ISH) definitions.

      Methods: A total of 304 Black adults with high normal (130-139/85-89 mm Hg) and normal BP
      (120-129/80-84 mm Hg) were randomized to either TM or health education (HE) arms. BP was
      recorded at 3, 6, 9, 12, 24, 30, and 36 months after baseline. Linear mixed model analysis
      was conducted to compare the BP change between TM and HE participants in the high-normal BP
      and normal-BP groups. Survival analysis for hypertensive events was conducted.
    

Intervention name(s): Health Education; Transcendental Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.; TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.
Other intervention name(s): lifestyle modification; TM technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Meditation (Transcendental Meditation, TM) was employed as a lifestyle modification strategy compared to a health education control with exercise and dietary recommendations but with no stress management component
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Blood pressure; Stress reduction; Meditation; lifestyle modification
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not
      completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces
      tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the
      expression of SOCS3 in DCs.
    


Intervention name(s): IFNbeta-1b
Intervention type(s): Other
Intervention description(s): no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to
      evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit
      Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory
      classroom study.
    


Intervention name(s): NT0102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.; Matching ODT placebo was given once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this project is to examine the short and long term effects of an 8 week, twice
      weekly, outpatient exercise training program for people with bronchiectasis. Participants
      will be randomly allocated to undergo a supervised exercise training program at The Alfred,
      Austin Hospital or Sir Charles Gairdner Hospital.

      The hypotheses of this study are:

        1. Patients with bronchiectasis who complete an exercise program will have a higher
           exercise capacity and better quality of life and these improvements will be sustained
           for up to 12 months after completion

        2. Exercise training will significantly reduce the incidence of pulmonary exacerbations,
           use of antibiotics and rate of hospitalisation
    

Detailed description: 
      Bronchiectasis not related to cystic fibrosis (non-CF bronchiectasis) is a chronic
      respiratory condition characterised by permanent dilatation of the airways arising from
      bronchial inflammation and infection. Predominant symptoms include daily productive cough,
      dyspnoea and generalised fatigue. This profile is associated with diminished health-related
      quality of life (HRQOL) and reduced exercise tolerance.

      Available medical treatments for bronchiectasis include antibiotic and inhalation therapy. To
      date, there is no evidence that these treatments can reduce the exacerbation rate or modify
      the rate of disease progression. While international guidelines for pulmonary rehabilitation
      recommend the inclusion of patients with bronchiectasis, there is a deficiency in evidence
      supporting exercise training in this population. It is proposed that a standard exercise
      training program conducted according to Australian guidelines for pulmonary rehabilitation
      will improve both exercise capacity, quality of life and reduce the number of acute
      infections in both the short and long term in people with bronchiectasis.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 8 week, twice weekly exercise program with endurance and upper and lower limb strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Maternal Loss of Control Eating
Condition: Eating Disorder; Obesity
MeSH terms: Feeding and Eating Disorders
Study type: Observational

Summary: 
      This study focused on investigating the effects of maternal disordered eating on maternal and
      child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents
      and Children (ALSPAC).
    

Detailed description: 
      Deidentified and anonymised data already collected as part of the ALSPAC study will be
      analysed to investigate the effects of maternal eating on maternal and child outcomes (diet,
      eating, weight, metabolic). The Avon Longitudinal Study of Parents and Children (ALSPAC) is a
      longitudinal, prospective study designed to examine the effects of environment, genetics and
      other factors on health and development.All pregnant women living in the geographical area of
      Avon, UK, who were expected to deliver their baby between 1st April 1991 and 31st December
      1992, were recruited. 14,541 women were enrolled. Amongst these pregnancies, there were a
      total of 14,676 fetuses, resulting in 14,062 live births and 13,798 children who were alive
      at 1 year of age and were singletons. The ALSPAC study website contains details of all the
      data that is available through a fully searchable data Dictionary
      (http://www.bris.ac.uk/alspac/researchers/data-access/data-dictionary/).

      Missingness will be assessed and standard data analytical techniques such as MI will be
      used.Crude and adjusted logistic, linear, and multinomial regression models will be employed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women living in the geographical area of Avon, UK, who were expected to
        deliver their baby between 1st April 1991 and 31st December 1992, were recruited. 14,541
        women were enrolled. Amongst these pregnancies, there were a total of 14,676 fetuses,
        resulting in 14,062 live births and 13,798 children who were alive at 1 year of age and
        were singletons.
      
Keywords: ALSPAC; longitudinal
Nitroglycerin Infusion During Cardiac Surgery
Condition: Lactic Acidosis; Blood Glucose, High
MeSH terms: Acidosis; Acidosis, Lactic
Study type: Interventional

Summary: 
      Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin
      trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic
      inflammatory response, while insufficient and delayed neutralization of heparin by protamine
      may contribute to more blood loss during rewarming stage.

      Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment
      for unstable angina, myocardial infarction, congestive heart failure, and perioperative
      hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin
      infusion during rewarming corrects systemic ischemic stress and facilitates heparin
      neutralization in cardiac surgery.
    

Detailed description: 
      A randomized clinical trial in a tertiary academic center in patients with cardiac surgery,
      to receive either nitroglycerin infusion dose of 0-0.1 mcg/kg/min, or 1-5 mcg/kg/min during
      rewarming in cardiopulmonary bypass.
    

Intervention name(s): Nitroglycerin infusion
Intervention type(s): Drug
Intervention description(s): Nitroglycerin infusion during rewarming
Other intervention name(s): Millisrol
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nitroglycerin; cardiopulmonary bypass; cardiac surgery
Becoming a Parent During the COVID-19 Pandemic in Austria and Germany
Condition: Parents; COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This is an online survey in Austria and Germany directed at parents with children born since
      the start of the first lockdown of the COVID-19 pandemic (birthdate beginning with
      16.03.2020). The survey includes questions about:

        -  current stress levels and depressive symptoms,

        -  resilience during the pandemic,

        -  social support,

        -  retrospective birth risk factors, pregnancy distress and pregnancy experience,

        -  demographic factors and

        -  other questions related to parenting and the COVID-19 pandemic.
    

Detailed description: 
      The study evaluated data collected in the course of an online survey during the COVID-19
      pandemic in Austria and Germany. The questions were conceived to reflect aspects of
      pregnancy, childbirth and early child rearing that could be affected by the pandemic, and
      included commonly used and previously validated scores for assessing pregnancy distress
      (Pregnancy Distress Questionnaire, PDQ), birth experiences (Childbirth Experience
      Questionnaire 2, CEQ2) postnatal depression (Edinburgh Postnatal Depression Scale, EPDS),
      perceived stress (Perceived Stress Scale, PSS) and pandemic-related experiences (pandemic
      resilience part, adapted to postnatal period, from the Pandemic Related Stress in Pregnancy
      Scale, PREPS). In addition, the investigators composed questions and scales that referred to
      specific pandemic- and parenting-related issues that were not covered otherwise. The
      investigators also tried to question both the fathers and the mothers, and consequently
      mothers received more pregnancy-related questions than fathers. Furthermore, biological
      mothers received childbirth-related questions which were omitted for adoptive mothers.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parents that had a baby born since the 16th of March 2020 (which corresponds to the
        beginning of the first lockdown in Austria and in Bavaria, Germany)
OptiVol for Precision Medical Management of Heart Failure
Condition: Ischemic and Non-ischemic Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies
Study type: Interventional

Summary: 
      This clinical study is designed to show that a multidisciplinary team following a
      pre-specified standard of care medication decision model based on data from an implanted
      cardioverter device will increase the rate of change in Guideline Directed Medical Therapy
      (GDMT) in the intervention group compared to the conventional group in patients with ischemic
      and non-ischemic cardiomyopathies.
    

Detailed description: 
      Subjects in this study will be randomized (2:1) to an intervention group whose medical care
      will be guided by data from a cardiac implantable electronic device (CIED) including
      information on heart rate, activity, and fluid status derived from the OptiVol monitor versus
      a conventional management control group. Subjects will followed for 12 months with follow up
      contact for 6 consecutive months and a chart review at 12 months. The study population will
      include patients with ischemic and non-ischemic cardiomyopathy who have had an ICD implanted
      per standard of care guidelines.
    

Intervention name(s): Medtronic ICD with Opti Vol-Monitor
Intervention type(s): Device
Intervention description(s): Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICD; OptiVol-Monitor; Cardiac Compass; Garmin Vivo Smart; Guideline Directed Medical Therapy
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
Condition: Aspirin Exacerbated Respiratory Disease (AERD)
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to determine the safety of oral ifetroban compared to
      placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of
      Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin
      challenge.
    


Intervention name(s): Ifetroban, Oral Capsule; Placebo, Oral Capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ifetroban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Samster's triad; Acetylsalicylic acid triad; Widal's triad; Francis' triad; Aspirin triad; Aspirin-induced asthma and rhinitis (AIAR)
Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged
      18 to 60 years.
    

Detailed description: 
      This is a randomized, double-blind (DB), placebo-controlled, parallel, study to assess the
      efficacy and safety of AMPH ER TAB compared to placebo for the treatment of ADHD in adults
      aged 18 to 60 years.

      After Screening and Baseline evaluations are complete, eligible subjects will be randomized
      in the study to take DB AMPH ER TAB or matching placebo orally once daily in the morning
      beginning the day after the Baseline visit for 5 weeks. Dose will be titrated on a weekly
      basis to reach 20 mg per day. Subjects who cannot tolerate the study drug will be
      discontinued from the study.

      A Math Test placement test will be done at Screening or at Baseline. At Visit 5, efficacy
      assessments will include the administration of serial Math Tests at pre-dose and at 0.5, 1,
      2, 4, 8, 10, 12, 13, and 14 hours post-dose (Primary Endpoint) Adult Investigator Symptom
      Rating Scale (AISRS) and Clinical Global Impression Scale Severity (CGI-S) will be conducted
      at Baseline and Visits 1 to 5. Digit Symbol Substitution Test (DSST) will be administered at
      Baseline and Visit 5 (Secondary Endpoints).

      Safety assessments will include treatment-emergent adverse events, physical examination,
      vital signs, body weight, Columbia Suicide Severity Rating Scale (C-SSRS), and direct
      questioning to assess for sleep, appetite, mood and psychotic events.
    

Intervention name(s): AMPH ER Tab 5, 10, 15 and 20 mg; AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Amphetamine; Placebo
Other intervention name(s): Amphetamine Extended Release Tablets; Amphetamine Extended Release Tablets Matching Placebo
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind (DB), placebo-controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Detecting Absence Seizures Using Eye Tracking
Condition: Epilepsy, Generalized; Absence Epilepsy; Absence Seizures; Seizures; Seizure Disorder
MeSH terms: Epilepsy; Seizures; Epilepsy, Absence; Epilepsy, Generalized
Study type: Observational

Summary: 
      The goal of this study is to develop a comfortable system that uses a wearable eye-tracker
      similar to eyeglasses to assist people with epilepsy in counting and measuring the severity
      of seizures. Participants will wear an eye-tracker during a routine EEG.
    

Detailed description: 
      Seizures can be difficult to detect outside of the hospital even with careful observation by
      a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable
      for long term use outside of the hospital. The goal of this study is to develop a comfortable
      system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy
      in counting and measuring the severity of seizures. People participating in this study will
      have a routine EEG performed while an eye tracker measures eye movements. After the EEG is
      complete the researchers will compare the eye movements to the EEG to develop a software
      program that can detect seizures from eye movements.
    

Intervention name(s): Eye movement analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Eye movements will be analyzed to identify if seizures are present and compared to the EEG read
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children or adults with absence seizures.
      
Keywords: eye movements; seizure detection
Clonidine and Morphine in Caudal Anesthesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better
      postoperative analgesia than either drug alone after urogenital pediatric surgery.
    

Detailed description: 
      It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years
      old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients
      will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine
      plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of
      analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded.
      Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort
      score scale, as well as the consumption of analgesics.
    

Intervention name(s): Clonidine; Morphine; Bupivacaine plus clonidine and morphine; Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 mcg/kg; 20 mcg/kg; bupivacaine 0,166% 1 ml/kg
clonidine 1 mcg/kg
morphine 20 mcg/kg; Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
Intervention MeSH terms: Clonidine; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: caudal anesthesia, clonidine, morphine, bupivacaine
Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus
      loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial
      includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day)
      or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.
    

Detailed description: 
      This is a 4-week randomized, open-label trial to investigate the efficacy and safety of
      loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients
      with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly
      assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for
      4 weeks.
    

Intervention name(s): Loxoprofen sodium hydrogel patch; Loxoprofen sodium tablet
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg per day; 60 mg t.i.d.
Other intervention name(s): Loxoprofen hydrogel patch; Loxoprofen tablet
Intervention MeSH terms: Loxoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; loxoprofen; patch