bioihbjkbjnl/mcl2 huggingface dataset:
Physical Activity Intervention in Preschool Children
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      In this research project, the investigators addressed if incorporating physical movements
      with preschoolers will help increase their ability to retain concepts learned in preschool
      such as letter, sound and number recognition. Movement plays an important role in the brain.
      Exercise shows many benefits for the brain to help maintain clearer thought, improve memory,
      and increase activity in the brain, especially the areas involved in memory, attention, and
      language. The following research includes an eight week study of the implementation of
      movement breaks with one preschool class, while using another class as a control group.
      During the two weeks of baseline data, data was collected from every student in both groups
      on their letter recognition with both upper and lower case, letter sound identification, and
      number recognition for numbers 0-10. The group that implemented movement breaks had
      three-five minute scheduled times to stop for movement. Data was collected and compared
      between the two groups to find differences in their academic performance.
    


Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Treatment of Formerly Abducted Children (FAC) in Uganda
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      In the aftermath of traumatic experiences like natural disasters or man-caused traumatic
      events, such as war experiences, a substantial part of the affected individuals develop a
      number of psychological symptoms. The characteristic symptom pattern occurring in the
      aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes
      functional impairment of the affected individuals. The investigators want to test whether
      Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in
      formerly abducted children and youths and former child soldiers, when applied by lay
      personnel.
    


Intervention name(s): Narrative Exposure Therapy; Academic Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.
NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.; Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction.
AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.
Other intervention name(s): NET; AC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Treatment; Randomized Controlled Clinical Trial; Combat; Child Soldiers; Dissemination; Narrative Exposure Therapy; Africa
Study of Efficacy and Safety of CVAA489 in Hypertensive Patients
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The population that will be included in this study, will be regular Turkish hypertensive
      patients who are expected to consume sodium in high amounts. It is hypothesized that, in that
      population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP)
      control rate as expected from literature.
    


Intervention name(s): amlodipine/valsartan
Intervention type(s): Drug
Intervention description(s): Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: essential hypertension
Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare progression-free survival (PFS) of patients
      with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab
      Combined With Chemotherapy or Endocrine Therapy.
    

Detailed description: 
      This is a non-inferiority study to examine Trastuzumab combined with chemotherapy or
      endocrine therapy in patients with metastatic Luminal B2 breast cancer subtype. The main
      purposes of this study are to test the safety and clinical benefit of Trastuzumab combined
      with chemotherapy or endocrine therapy in treating Luminal B2 breast cancer (hormone receptor
      positive and human epidermal growth factor receptor (HER2) positive or amplification). This
      multicentre, randomized study is designed to recruit up to 392 subjects to identify 196
      research subjects for each study treatment.
    

Intervention name(s): Endocrine therapy combined with trastuzumab; Chemotherapy combined with trastuzumab
Intervention type(s): Drug; Drug
Intervention description(s): Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab; Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab
Other intervention name(s): Tamoxifen; aromatase inhibitors; trastuzumab; Capecitabine; Vinorelbine; Gemcitabine; trastuzumab
Intervention MeSH terms: Tamoxifen; Gemcitabine; Capecitabine; Trastuzumab; Vinorelbine; Aromatase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Luminal B2 subtype; First line treatment
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
Condition: Malaria; Pregnant; HIV
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized controlled single blind prospective comparative study
    

Detailed description: 
      This study is intended to be a randomized controlled single blind prospective comparative
      study conducted to compare the efficacy of three monthly doses of sulphadoxine-pyrimethamine
      as intermittent preventive therapy for malaria with azithromycin in HIV positive pregnant
      women
    

Intervention name(s): Sulphadoxine-pyrimethamine; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses; Tabs Azithromycin 500mg daily for 3 days
Other intervention name(s): Vitadar; Zithromax
Intervention MeSH terms: Azithromycin; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: IPT; malaria; pregnant; HIV positive
Movement Enhancing Device for Children
Condition: Upper Extremity Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to assess: 1) how infants move their bodies to explore, play,
      and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these
      abilities can be advanced in a high-risk group through the use of a movement assisting
      device.
    

Detailed description: 
      Certain conditions or diagnoses identified soon after birth are known to put infants at risk
      for having problems with their motor (movement) development as they get older. Infants with
      these diagnoses are at risk for additional developmental problems due to their inability to
      move their bodies to explore, learn, and play. This study tests how a device that assists
      movement can help exploration, learning, and play in children. The information gathered in
      this study will help us better understand how early learning happens and how we can help
      individuals become better movers, learners, and problem-solvers so they can increase their
      participation in everyday play activities.
    

Intervention name(s): Movement Enhancing Device
Intervention type(s): Device
Intervention description(s): Naturalistic play activities using the hands while wearing the movement enhancing device.
Other intervention name(s): WREX (Wilmington Robotic Exoskeleton)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wilmington Robotic Exoskeleton; Reaching; Upper extremity function; Preterm Infants; Brain injury; Pediatrics; Early Intervention; Arthrogryposis
Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults
Condition: Sialorrhea
MeSH terms: Sialorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses
      of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.
    

Detailed description: 
      Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses
      of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary
      goal is to determine the long-term safety and tolerability of MYOBLOC (administered
      intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a
      maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The
      secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered
      intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments
      performed at intervals after treatments every 13 weeks over a maximum possible duration of 1
      year.
    

Intervention name(s): MYOBLOC
Intervention type(s): Drug
Intervention description(s): After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47
Other intervention name(s): rimabotulinumtoxinB; botulinum toxin type B
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; ALS; Stroke; Neuroleptics
A Study to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2"
Condition: Gastric or Duodenal Ulcer
MeSH terms: Duodenal Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to evaluate the drug-drug interaction and safety
      between "BR6001-1" and "BR6001-2" in healthy adult volunteers
    


Intervention name(s): BR6001-1; BR6001-2
Intervention type(s): Drug; Drug
Intervention description(s): One tablet administered alone, Once a day; One tablet administered alone, Once a day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Better Arterial Cannulation Technique With Different Hemodynamics
Condition: Acute Respiratory Failure; Shock
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional
      method (CM) were compared to find the better technique in general and in different
      hemodynamic subsets of patients.

      Method This is a prospective randomized, single center study of 100 patients. The details of
      the primary cannulation technique, number of attempts, time taken, failure and cross-over
      technique were recorded for three different hemodynamic subsets with Systolic blood pressure
      <80 mm hg, 80-100 mm hg and > 100 mm hg.
    


Intervention name(s): Radial artery cannulation
Intervention type(s): Procedure
Intervention description(s): Radial artery cannulation done with conventional and ultrasound guidance in two respective groups of patients and their first pass success and ultimate success rates compared in different hemodynamic subsets of the patients.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radial artery cannulation; ultrasound guided; first success rate; systolic blood pressure; shock
A Study of STSA-1002 in Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose
      escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002
      injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage
      groups.
    


Intervention name(s): STSA-1002 Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laser Versus Physiotherapy in Management of Bruxism in Children: RCS
Condition: Bruxism
MeSH terms: Bruxism
Study type: Interventional

Summary: 
      The goal of this randomized controlled study is to compare laser acupuncture versus modified
      physical therapy in controlling bruxism in children. The main questions aim to answer are:

        -  Laser will decrease tempro-mandibular joint pain from bruxism more than modified
           physical therapy?

        -  Laser will decrease muscles activity from bruxism more than modified physical therapy?
           Children took 6 sessions of either laser acupuncture or modified physical therapy
           Researchers compared laser acupuncture versus modified physical therapy to see if any
           decrease in tempro-mandibular joint pain and muscles activity from bruxism
    

Detailed description: 
      The children participated in the study as bruxers according to the American Association of
      Sleep Medicine (AASM) diagnostic criteria [ Sixteen children will be randomly allocated to
      two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography
      biofeedback training.

      Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will
      be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles.
      Measurements will be taken preoperatively and after 8 weeks.
    

Intervention name(s): Laser acupuncture; Modified physical therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Biostimulation of temporalis and masseter muscles; Progressive muscle relaxation of temporalis and masseter muscles
Other intervention name(s): Doctor smile low level laser device; Relaxation and biofeedback of muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double arm controlled study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bruxism; laser; children; Physiotherapy
Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors
Condition: Melanoma, Stage I; Melanoma Stage III; Melanoma, Stage II
MeSH terms: Melanoma
Study type: Observational

Summary: 
      This is a prospective, multi-centred cohort study whereby the EUNASS Study questionnaire will
      be administered electronically to identify needs of melanoma survivors, the extent to which
      these needs are being met, and identify areas which have the greatest need for development.
      It will also evaluate behaviour in relation to sun protection and skin self-examination
      (SSE). It will be a self-completed questionnaire.

      Qualitative work using semi-structured interviews will explore the needs of melanoma
      survivors in greater depth, will present examples of potential interventions to improve SSE
      and explore factors that determine the likelihood of engaging in an intervention which can
      address unmet needs, such as improving SSE. Taken together, the data will provide the
      evidence base to inform the development of an intervention to improve SSE, which can
      subsequently be tested in secondary care services.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaire
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients attending the Dermatology or Medical Oncology departments with a confirmed
        diagnosis of AJCC V8 stage I - III melanoma in the last year
Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of budesonide may be an effective way to prevent
      bronchial dysplasia.

      PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of
      budesonide in treating former or current smokers who have bronchial dysplasia.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of inhaled budesonide on the number and grade of
      bronchial epithelial dysplastic lesions in former and current smokers. II. Compare the effect
      of inhaled budesonide vs placebo in modulating several intermediate biomarkers (i.e.,
      proliferation, apoptosis, morphometric, and methylation markers) in this patient population.
      III. Correlate the regression of bronchial dysplasia (number and grade) and improvement in
      sputum cytology (morphometric grade of atypical cells) with the modulations in molecular
      biomarkers in this patient population. IV. Compare the stability of the chemopreventive
      effect of these treatment regimens at six months after completion of these regimens in these
      patients. V. Compare the safety of these treatment regimens in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      stratified according to gender, smoking status (current vs former), and morphometric index
      (no greater than 3.4 vs greater than 3.4). Patients are randomized into one of two treatment
      arms. Arm I: Patients receive inhaled budesonide twice daily. Arm II: Patients receive an
      inhaled placebo twice daily. Treatment continues for 6 months in the absence of disease
      progression or unacceptable toxicity. Patients are followed at 7 months and 12 months.

      PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this
      study within 15 months.
    

Intervention name(s): budesonide
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer
How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Condition: Hyper-Alimentation; Healthy
MeSH terms: Hyperphagia
Study type: Interventional

Summary: 
      Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and
      hepatic triglyceride content (HTGC)and metabolism.

      Design: Prospective interventional study with parallel control group. Setting University
      Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean
      (SD) age of 26 (6.6) years and a matched control group.

      Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by
      eating at least two fast food-based meals a day with the goal to double the regular caloric
      intake in combination with adoption of a sedentary lifestyle for four weeks.

      Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton
      nuclear magnetic resonance-spectroscopy at baseline and after the intervention.
    


Intervention name(s): Fast food arm
Intervention type(s): Procedure
Intervention description(s): Doubling of regular caloric intake based on fast food, no exercise allowed
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: weight; metabolism; cholesterol; insulin
Uterine Flora During Elective and Urgent Cesarean Sections
Condition: Endometritis
MeSH terms: Endometritis
Study type: Observational

Summary: 
      Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from
      the uterine flora during non-elective Cesarean sections. We want to study whether the uterine
      flora can predict post-cesarean febrile morbidity and endometritis.
    

Detailed description: 
      Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean
      sections and to study the relationship to the development of postpartum fever and/or
      endometritis.

      Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in
      this study. Cultures will be obtained during the surgery from the open uterine cavity after
      removal of the placenta. Data regarding postpartum morbidity would be collected.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing cesarean sections in Western galilee Hospital
      
Biospecimen description: 
      Uterine bacteriological cultures
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80
      mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (oxycodone HCl); Original OxyContin® (OXY) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 80-mg tablet x 1 dose taken without food.; Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid; Healthy volunteers