bioihbjkbjnl/mcl2 huggingface dataset:
Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period
Condition: Perinatal Depression; Parents; Self Efficacy; Anxiety; Stress; Parenting Satisfaction
MeSH terms: Depression
Study type: Interventional

Summary: 
      The Parentbot - a Digital healthcare Assistant (PDA) is a mobile application-based
      psychosocial parenting intervention with integrated chatbot features, intended for couples to
      use during the perinatal period. It provides parents with multimedia educational materials
      (text files, audio files and videos), discussion forum, guided mindfulness-based meditation
      videos, guided reflection and gratitude journals and a chatbot to answer their queries
      related to perinatal care in real-time.

      This study aims to:

        1. Develop a theory-based perinatal intervention with integrated chatbot features for both
           first-time and experienced parents

        2. Examine the effectiveness of the PDA intervention in improving parenting self-efficacy
           (primary outcome), stress, depression, anxiety, social support, parent-child bonding and
           parenting satisfaction (secondary outcomes) among parents during the perinatal period

        3. Examine the perceptions of parents from both the intervention and control group after
           the intervention

        4. Collate suggestions for further improvement from the participants and members of the
           research team

      The hypotheses of this study are:

      The PDA intervention group will have significantly higher scores for parenting self-efficacy,
      social support, parent-child bonding and parenting satisfaction, as well as lower scores for
      stress, depression and anxiety compared to the control group receiving standard care after
      the intervention at one-month postpartum (post-test 1) and three-months postpartum (post-test
      2).
    


Intervention name(s): PDA mobile application
Intervention type(s): Behavioral
Intervention description(s): Parentbot - a Digital healthcare Assistant (PDA):
A mobile application-based psychosocial parenting intervention with integrated chatbot features. It consists of multimedia educational materials (text files, audio files and videos), discussion forums, guided mindfulness-based meditation videos, guided reflection and gratitude journals and a chatbot.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Masking: None (Open Label)
Primary purpose: Supportive Care
Respiratory Functions, Trunk Control and Mobility Evaluation in Multiple Sclerosis
Condition: Physical Therapy
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Respiratory functions and body control are affected in patients with multiple sclerosis (MS).
      Because of this effect, the dependency of individuals increases in daily living activities
      and their quality of life decreases.

      We think that respiratory functions, respiratory muscle strength and trunk control affect
      vital mobility as well as vital importance for individuals with MS. As a result of the
      investigations, it is concluded that the literature is insufficient in this area.

      The aim of this study is to investigate the effects of pulmonary function, respiratory muscle
      strength and trunk control on functional mobility in individuals with MS and compare with
      healthy individuals.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MS patients who are ambulatory

        Healthy volunteer individuals of similar age and sex to patients
      
Keywords: Multiple Sclerosis; Respiratory function; Respiratory muscle strength; Trunk control; Functional mobility
Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement
Condition: Stroke; Problem of Aging
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to find out if quercetin can increase blood levels of
      hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a
      corresponding increase in blood flow to the brain.
    


Intervention name(s): quercetin/placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Quercetin 500mg once per day versus placebo
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: quercetin; brain blood flow; aging; memory
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of topiramate as compared to
      placebo in preventing migraines in children.
    

Detailed description: 
      Pediatric migraine headache is a common cause of severe recurring headaches in children,
      especially children between the ages of 5 and 15 years. These headaches can be disabling and
      tend to interfere with a child's daily activities, such as going to school or playing with
      friends. Because pediatric migraine children tend to be misdiagnosed, they are often not
      treated effectively. Topiramate, an anti-seizure medication, has been shown to prevent
      migraines in adults, and it has been approved to treat seizures in children as young as 2
      years of age as add-on treatment (used with another drug) and also can be used alone
      (monotherapy) in children as young as 10 years old. Since topiramate has already been studied
      in children, information about its safety in children is available. In this study, children
      with migraine headaches will be identified. It is not necessary for the child to have the
      migraine aura (having blurry vision; seeing flashing lights) to be included in this study.
      This is a randomized, double-blind, placebo-controlled study of Topiramate (or placebo) given
      for 4 to 5 months. An optional 3-month open-label extension (topiramate only; no placebo)
      will follow. The objective of the study is to demonstrate that topiramate is effective and
      safe when used to prevent migraine headaches (with or without aura) in children. Safety will
      be assessed throughout the study.

      Topiramate sprinkle capsules (or placebo), starting at 15 milligrams per day for 1st week;
      increased to 30 milligrams per day for week 2; increased to 50 milligrams (in tablets) per
      day in week 3, then adjusted as needed to 2 to 3 milligrams/kilogram/day for the rest of
      study (140 days total).
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: pediatric migraine; migraine headache; migraine prophylaxis; migraine prevention; migraine
Angiotensin II Blockade and Inflammation in Obesity
Condition: Overweight; Obese; Prehypertension; Hypertension
MeSH terms: Prehypertension; Obesity; Overweight; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Overweight and obesity, which afflicts ~65% of the U.S. population and more than 1 billion
      people worldwide, increases the risk of developing hypertension. Activation of the renin
      angiotensin system (RAS) is an important mechanism by which obesity leads to hypertension. In
      addition to its vasoconstricting and sodium retaining actions, angiotensin II also has potent
      pro-inflammatory actions including macrophage infiltration and expression of proinflammatory
      cytokines in target tissues. Adipose tissue and skeletal muscle appear to be a key sites for
      the generation of proinflammatory cytokines. Although angiotensin II receptor blockade
      reduces inflammation in many tissues, the effects on adipose tissue and skeletal muscle in
      humans are not clear. Importantly, the chronic low grade inflammatory state that accompanies
      obesity complicates hypertension by contributing to insulin resistance and accelerating
      cardiovascular disease. Therefore, the general aim of the present proposal will be to
      determine the influence of angiotensin II receptor blockade on adipose tissue and skeletal
      muscle inflammation and its relation to improvements in insulin sensitivity, if observed, in
      obese hypertensive humans. To address these aims, 44 obese (BMI>30 kg/m2) hypertensive
      (BP>140 systolic and/or 90 diastolic) individuals (age=50-65 years) will be randomized to
      receive 8 weeks of either the angiotensin II receptor antagonist, olmesartan medoxomil, or no
      treatment in a crossover manner. Subcutaneous adipose tissue and skeletal muscle biopsies
      will be obtained and insulin sensitivity (intravenous glucose tolerance tests) will be
      assessed at baseline and following 8 weeks of each intervention. A two week washout period
      will separate the interventions.
    


Intervention name(s): Olmesartan medoxomil
Intervention type(s): Drug
Intervention description(s): Crossover intervention comparing antihypertensive medication to no drug intervention.
Other intervention name(s): Benicar
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: angiotensin II; obesity; diabetes
Study of Blood Lactate Levels in Patients Treated With Antipsychotics
Condition: Movement Disorders; Lactic Acidosis
MeSH terms: Movement Disorders; Acidosis; Acidosis, Lactic
Study type: Observational

Summary: 
      Blood lactate levels in patients receiving typical or atypical antipsychotics have not been
      described in the literature.

      The goal of this study is to assess the dynamics of lactate levels in the blood from typical
      or atypical antipsychotics not confounded by prior antipsychotic treatments, the
      investigators conducted a prospective study of lactate levels in patients receiving
      antipsychotic medication. The investigators hypothesized that 6 months of treatment with
      haloperidol or olanzapine would result in a change in blood lactate levels and extrapyramidal
      side effects.
    

Detailed description: 
      The aim of this study was to compare the blood lactate levels in patients receiving typical
      or atypical antipsychotics.

      Subjects included sixty patients with psychotic disorder were assigned to treatment for 6
      months with haloperidol (typical antipsychotic), N=30 or olanzapine (atypical antipsychotic),
      N=30. Blood lactate levels, other metabolic parameters, and scores on the extrapyramidal
      symptom rating scale (ESRS) were assessed.
    

Intervention name(s): Haloperidol or olanzapine
Intervention type(s): Drug
Intervention description(s): Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth
Other intervention name(s): Haldol; Olzapin
Intervention MeSH terms: Haloperidol; Olanzapine; Haloperidol decanoate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population consists of patients from the psychiatric inpatient and outpatient sections
        of a primary care hospital.
      
Keywords: antipsychotics; lactates; side effects
KT® in Patients With Cervical Spine Surgery
Condition: Pain; Cervical Spinal Stenosis; Disc, Herniated; Cervical Spondylosis
MeSH terms: Spinal Stenosis; Spondylosis; Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      Aim of the study was to investigate the effect of Kinesio taping application on upper
      trapezius muscle after cervical spine surgery.
    

Detailed description: 
      Patients will be randomly divided into three groups. The first group will receive
      conservative treatment and Kinesio Taping application. The second group will receive
      conservative treatment and the third group will receive only Kinesio taping application. The
      treatment procedure will continue for post-operatively three days and assessments will be
      done four times; before the surgery, post-operative 1st day, postoperative 3rd day and two
      weeks after surgery. Data will be recorded on patient assessment file and transferred to the
      computer. Data analysis will be performed with SPSS.22.
    

Intervention name(s): Kinesio Taping; Conventional treatment
Intervention type(s): Other; Other
Intervention description(s): Kinesio Taping relaxation technique (muscle inhibition technique); Therapeutic exercises (active and passive range of motion (ROM) and strengthening exercise ) and TENS (Transcutaneous electrical nerve stimulation) applications
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Kinesio Tape; Pain; Functionality; Cervical Spine Surgery
Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Given the lack of evidence in support of pacing self-management for patients with chronic
      fatigue syndrome (CFS), it is examined whether physical behavior and health status of
      patients with CFS improve in response to a pacing self-management program. The effects of
      pacing will be compared with those observed when applying relaxation therapy to patients with
      CFS.
    

Detailed description: 
      Given the lack of evidence in support of pacing self-management for patients with chronic
      fatigue syndrome (CFS), it is examined whether physical behavior and health status of
      patients with CFS improve in response to a pacing self-management program. The effects of
      pacing will be compared with those observed when applying relaxation therapy to patients with
      CFS.

      According to the power calculation, 36 patients fulfilling the 1994 Centre for Disease
      Control and Prevention criteria for the diagnosis of chronic fatigue syndrome (CFS) will be
      randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both
      treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All
      treatments will be delivered by occupational therapists or physiotherapists. One treatment
      session lasts for about 45 minutes each.

      Outcome measures include the Canadian Occupational Performance Measure (COPM), Medical
      Outcomes Short Form 37 Health Status Survey (SF-36), Checklist Individual Strength (CIS), CFS
      Symptom List and autonomic activity at rest and following 3 activities of daily living
      (writing a standardized test on a laptop computer, ironing, and climbing 26 flights of
      stairs). For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands)
      will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart
      rate variability will be measured continuously in real time during a 2 minutes period, with
      the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be
      placed on the left hand in all patients.
    

Intervention name(s): Pacing; relaxation therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 one-on-one sessions weekly for 3 consecutive weeks; 3 one-on-one sessions weekly for 3 consecutive weeks
Other intervention name(s): activity self-management; activity management; adaptive pacing; stress managament; Jacobson relaxation; visualisation; Schultz relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pacing; activity management; relaxation; physiotherapy; occupational therapy; autonomic nervous system
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain
Condition: Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch
      ZR-02-01 in providing pain relief.
    

Detailed description: 
      This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will
      be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA)
      pain. This patient population was chosen in anticipation that the patients are otherwise
      healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or
      acetaminophen or who have received intermittent opioid analgesic treatment.
    

Intervention name(s): ZR-02-01 Fentanyl Transdermal Matrix Patch; Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.; Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period
Other intervention name(s): ZR-02-01; Placebo Transdermal Matrix Patch
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Chronic Pain; Osteoarthritis Pain; Osteoarthritis
Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, single-center, double-blind, ascending multiple-dose, placebo-controlled study
      to evaluate the tolerability and pharmacokinetics of CSPCHA115 capsules in Chinese healthy
      volunteers.
    


Intervention name(s): CSPCHA115 100 mg; Matching placebo 100 mg; CSPCHA115 200 mg; Matching placebo 200 mg; CSPCHA115 400 mg; Matching placebo 400 mg; CSPCHA115 600 mg; Matching placebo 600 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CSPCHA115 100 mg once daily in the fasted state for 7 days; Matching placebo 100 mg once daily in the fasted state for 7 days.; CSPCHA115 200 mg once daily in the fasted state for 7 days; Matching placebo 200 mg once daily in the fasted state for 7 days.; CSPCHA115 400 mg once daily in the fasted state for 7 days; Matching placebo 400 mg once daily in the fasted state for 7 days.; CSPCHA115 600 mg once daily in the fasted state for 7 days; Matching placebo 600 mg once daily in the fasted state for 7 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CSPCHA115; Asthma; CRTH2
Effect of Flaxseed on Lipid Uptake and Appetite
Condition: Obesity
Study type: Interventional

Summary: 
      Randomized trial to test the effect of flaxseed fractions on appetite regulation and
      intestinal lipid absorption.
    

Detailed description: 
      Randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required
      to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. Test meals
      will be given as breakfast meals, in which different fractions of flaxseeds are incorporated
      into baked products. Appetite will be registered using visual analogue scales during 7 hours
      after the test meal and a total of 10 blood samples will be drawn to evaluate TAG in
      chylomicrons, plasma LDL, HDL and total cholesterol, plasma TAG, insulin, glucose and
      appetite hormone levels. At the end of the test day an ad libitum meal will be served and
      food intake registered.
    

Intervention name(s): Whole flaxseeds, flaxseed mucilage, glucomannan
Intervention type(s): Dietary Supplement
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: fat absorption; fibres
Post - Activation Potentiation After Plyometric and Heavy Resistance Exercise in Soccer Players
Condition: Soccer
Study type: Interventional

Summary: 
      The main purpose of this study will be comparison of acute effects of plyometric and heavy
      resistance exercise on post-activation potentiation
    

Detailed description: 
      This is a single-center, randomized, crossover study. Collegiate soccer players will be
      enrolled in this study. The study will be performed in 3 separate sessions.In the first
      session, participants will be familiarized with the experimental conditions and 1RM will be
      calculated. Participants will then be randomized to receive either heavy resistance or
      plyometric exercise first in the second session and then will be crossed over to receive the
      opposite intervention in the third session. The objective of the study is to compare the
      acute effects of plyometric and heavy resistance exercise on post - activation potentiation
      by measuring physical performance and blood lactate level.
    

Intervention name(s): Plyometric exercise; Heavy resistance exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2 sets of 10 ankle hops, 3 sets of 5 hurdle hops, 5 drop-jumps from a height of 50 cm; 10 single repetitions of back half squats at 90% of 1 repetition maximum
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover design
Masking: Single (Participant)
Primary purpose: Other
Post-Operative Nausea And Vomiting Study In Female Patients
Condition: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic
      medication to prevent nausea and vomiting in females after surgery.
    

Detailed description: 
      A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study
      to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three
      Consecutive Days When Administered with a Single Intravenous Dose of Ondansetron
      Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge
      Nausea and Vomiting in Female Subjects with Known Risk Factors for Post-operative Nausea and
      Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an
      Increased Emetogenic Risk
    

Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Neurokinin-1 Receptor Antagonist; GW679769; Post-operative Nausea; NK-1 Receptor Antagonist; PONV; Post-discharge Nausea and Vomiting; PDNV; Vomiting