bioihbjkbjnl/mcl2 huggingface dataset:
Montelukast in Modulating Exacerbations of Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine if Montelukast added to other therapy, if any, will
      reduce the severity of asthma symptoms in children during the high incidence of respiratory
      viral infections that occur in children in the post Labor Day school return period.
    

Detailed description: 
      Between 1990- and 2003, we identified in Ontario, and subsequently across Canada, a striking
      increase in hospital admissions for asthma in children occurring predictably in the third
      week of September every year.1 In 2000 we undertook a retrospective case-control study
      comparing the clinical characteristics of children using local emergency rooms for asthma in
      September, with those of children presenting during the non-epidemic months of July-August.
      Based on that pilot study of 169 children, we developed a larger prospective case-control
      study of clinical and biological characteristics of children recruited as they presented to
      an emergency room for asthma during September 2001. The control group for this study were
      children recruited from the community who had symptomatic asthma but did not have a September
      exacerbation requiring emergency room utilization. We identified the presence of rhinovirus
      in the majority of children attending an ER with acute asthma, and also found rhinovirus in a
      substantial proportion of the community based controls. We also found a highly significant
      difference in use of medications for asthma, with the ER cases being much less likely to be
      receiving adequate anti-inflammatory medication. In September 2004 we conducted a pilot
      randomized controlled blinded clinical trial of the efficacy of montelukast in reducing
      morbidity caused by asthma exacerbations associated with respiratory viral infections (RVI)
      in children aged 2 to 14. We found a highly significant reduction in reported symptom free
      days in the montelukast group. The current study is a randomized placebo-controlled trial of
      montelukast, during September 2005 to confirm the results of our pilot study and to examine
      the effectiveness of montelukast in reducing asthma morbidity during RVIs in different age
      and sex groups with a range of risk of exacerbations. We also wish to compare the
      effectiveness of montelukast to placebo in reducing asthma morbidity during RVIs between
      groups of children concurrently taking no or other classes of asthma control medications.
    

Intervention name(s): Montelukast (drug)
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Respiratory viral infections; Exacerbations; Pediatric; Leukotriene receptor antagonists; School
Pulmonary and Systemic Hepatocyte Growth Factors in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured
      fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of
      KGF) than controls, and Bonay et al found a direct relationship between the severity of
      airflow obstruction and HGF mRNA content in lung samples of smokers. These two studies
      suggest, therefore, that the pulmonary regulation of HGF may be abnormal in patients with
      COPD. However, both HGF and KGF can also be released by extra-pulmonary organs, thus having
      the potential to act systemically. Given the current clinical relevance attributed to the
      systemic effects of COPD, in this study we compared the levels of HGF and KGF in the
      pulmonary (bronchoalveolar lavage (BAL) fluid) and systemic compartment (circulating blood)
      of smokers with and without COPD and never smokers.
    

Detailed description: 
      Background: The potential role of growth factors in COPD has begun to be addressed only
      recently and is still poorly understood. In this study we investigate potential abnormalities
      of hepatocyte growth factor (HGF) and keratinocyte growth factor (KGF) in patients with COPD.

      Methods: To this end, we compared the levels of HGF and KGF, measured by ELISA, in
      bronchoalveolar lavage (BAL) fluid and in serum in 18 patients with COPD (62 ± 2 yrs, FEV1 57
      ± 4% ref, X ± SEM), 18 smokers with normal lung function (58 ± 2 yrs., FEV1 90 ± 4% ref) and
      8 never smokers (67 ± 7 yrs, 94 ± 4% ref).

      Results: We found that, in BAL, HGF levels were higher in patients with COPD than in the
      other two groups whereas, in serum, HGF concentration was highest in smokers with normal lung
      function (p<0.01). KGF levels were not significantly different between groups, neither in
      blood nor in BAL, (most values were below the detection limit).

      Conclusions: These results highlight a different response of HGF in BAL and serum in smokers
      with and without COPD that may be relevant for tissue repair in COPD.
    

Intervention name(s): bronchoalveolar lavage, blood analysis
Intervention type(s): Procedure
Intervention MeSH terms: Dimercaprol
Observational model: Defined Population
Time perspective: Other
Keywords: chronic obstructive pulmonary disease; emphysema; inflammation; repair
Dietary Calcium Intake in Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      This study was planned and conducted to investigate effect of adequate calcium intake on
      Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.
    

Detailed description: 
      This study was planned and conducted to investigate effect of adequate calcium intake on
      Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.
      Thirty one women, aged between 20-28 years, diagnosed with PMS and suitable for inclusion
      criteria, were participated in study. Participants were allocated to intervention (n=16) and
      control (n=15) groups randomly.
    

Intervention name(s): Sufficient dietary calcium intake in premenstrual syndrome
Intervention type(s): Other
Intervention description(s): Intervention group was ensured to take at least 1000 mg calcium from foods, 700-800 mg of it from dairy and dairy products, according to Recommended Dietary Allowances (RDA), for two months. These foods were;
50 gr kashkaval cheese,
400 ml milk and
150 gr yogurt for each day.
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: premenstrual syndrome; calcium; quality of life
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The objective of this non-interventional, observational study is to assess the effectiveness
      and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in
      real world clinical practice in China.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with moderate to severe plaque psoriasis in China
      
Keywords: psoriasis; effectiveness; safety; adalimumab
Prescription Audit in OPD of NABH & JCI Approved Hospital in Capital Territory of India
Condition: Quality of Life
Study type: Observational

Summary: 
      Aim of the study: The aim of the study is to evaluate the quality of the prescription
      provided to the outpatient.

      Need of study:

      For the promotion of the good clinical practice To improve the efficiency of the
      multidisciplinary team in the healthcare To utilize resources to provide better patient care
      To improve quality standards and quality of care For implication of professional practices To
      identify and eliminate deficient practice

      Objectives:

        1. To study the quality of good prescription

        2. In minimization of prescription errors and medication errors

        3. Also to comply with good clinical practice

        4. Enhancement of patient safety

        5. In the maintenance of rational prescribing

        6. To study the quality of care provided by the hospital to the patient

      Plan of study:

        -  To select the patient based on inclusion and exclusion criteria

        -  To collect the information from OP's prescription

        -  To identify prescribing errors and medication error

        -  To study the management of good prescription

      Study Sites: Max Super Speciality Hospital, Saket, New Delhi (INDIA) Study Design:
      Observational cohort study Study Duration: 1 month (November 2022)
    

Detailed description: 
      Source of the data: Review of out-patient prescription Sample size: 100 prescription

      Possible outcomes:

      Minimization of prescribing errors It improves the quality of care Enhancement of patient
      safety Compliance with good clinical practice In the maintenance of rational prescribing
    

Intervention name(s): Mentioned
Intervention type(s): Other
Intervention description(s): If prescription is properly filled for specific details than it is compliance
Other intervention name(s): Prescription is properly filled
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Any patient prescription which is randomly picked during study period
      
Keywords: Medical Audit; Prescription Audit; Gender difference
Brain Regulation of Appetite in Twins
Condition: Obesity; Appetite
MeSH terms: Obesity
Study type: Observational

Summary: 
      Scientists are examining the genetic and environmental influences on appetite and weight
      gain. The main purpose of this study is to look at how genetic and environmental factors may
      influence how the brain regulates appetite and food intake. Understanding how the brain
      regulates appetite and food intake may eventually lead to new ways to help people avoid
      obesity or lose weight.
    


Intervention name(s): Functional Magnetic Resonance Imaging; Dual Energy X-ray absorptiometry; Questionnaires; Mood and Appetite Ratings; Test Meals; Computer Tests; Intravenous Catheter (IV) placement
Intervention type(s): Device; Radiation; Other; Other; Other; Other; Procedure
Intervention description(s): Measure brain activity.; Body composition measurements.; Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.; Answer questions about how you are feeling at the moment.; Breakfast, a snack, and lunch provided during study visit.; Perform a series of computer tests to determine reaction time.; Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.
Other intervention name(s): fMRI; DXA
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Monozygotic and dizygotic twins recruited from the University of Washington Twin Registry
      
Keywords: Twins; Obesity; Appetite
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Condition: Cervical Spinal Cord Injury; Spine Injury; Spinal Cord Trauma
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Spinal Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of cross sequential escalating doses of
      AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post
      injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
    


Intervention name(s): AST-OPC1
Intervention type(s): Biological
Intervention description(s): One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical spinal cord injury; AST-OPC1; SCiStar; OPC1; Neural cell; Trauma spinal cord; stemcell transplant; Cervical spine injury; Paralysis; Quadriplegia; Tetraplegia; Spine injury; oligodendrocyte progenitor cell; Subacute spinal cord injury
Zimmer POLAR - Total Knee Arthroplasty (TKA)
Condition: Osteoarthritis; RheumatoId Arthritis; Traumatic Arthritis; Polyarthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      The primary objective of this study is to obtain implant survivorship and clinical outcomes
      data for commercially available Persona fixed bearing knee implants used in total knee
      arthroplasty. The assessment will include implant survivorship and clinical performance
      measured by pain and function, quality of life data, radiographic parameters and
      survivorship.
    

Detailed description: 
      The study design is a prospective, multicenter, study of the commercially available Persona
      fixed bearing knee implants. The study will require each site to obtain Institutional Review
      Board (IRB) approval prior to study enrollment. All potential study subjects will be required
      to participate in the Informed Consent Process.

      All study subjects will undergo preoperative clinical evaluations prior to their total knee
      arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6
      weeks, 6 months, 1 year, 2, 3, 4, and 5 years.

      All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D,
      Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of
      Radiographic Outcomes form.
    

Intervention name(s): Zimmer Persona Total Knee System
Intervention type(s): Device
Other intervention name(s): Primary Knee Replacement,; Total Knee Arthroplasty,; Total Knee Replacement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Pilates on Posture and Physical Fitness Parameters in 5-6 Years Old Children
Condition: Posture; Physical Fitness
Study type: Interventional

Summary: 
      The purpose of this non-randomized controlled study was to investigate the effects of Pilates
      on posture and physical fitness parameters in 5-6 years old healthy children.

      As a result of this study, pilates can be applied as an alternative exercise that improves
      posture and physical fitness in children.
    

Detailed description: 
      The purpose of this non-randomized controlled study was to investigate the effects of Pilates
      on posture and physical fitness parameters in 5-6 years old healthy children.

      As a result of this study, pilates can be applied as an alternative exercise that improves
      posture and physical fitness in children.

      This study will answer whether pilates practice has an effect on posture and whether pilates
      has an effect on physical fitness parameters.Demographic information of the participants was
      recorded. Postural assessments were evaluated by the New York Posture Rating (NYPR) chart
      test and fitness was evaluated by the Eurofit test battery.
    

Intervention name(s): Pilates exercises
Intervention type(s): Other
Intervention description(s): The Pilates Group completed a 10-week Pilates program. The intervention was performed in 20 sessions. In the first session, introduction and explanations regarding the principles and benefits of Pilates was made in a language that preschool children can understand. Exercises were supervised, and they were taught via gamification. In addition, the participation of the children was encouraged and stickers were given to increase their motivation at the end of the sessions. No adverse events occurred during intervention. The exercise program was created based on books and from the booklet acquired in the APPI Pilates Method training courses. Since the study was in preschool children, the basic level of Pilates was performed. Each exercise was performed 5 times for 30 minutes each twice a week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Pilates; Posture; Child; Physical Fitness; Preschool
The Effect of Aerobic Exercise on Genetic Molecules
Condition: Diabetes Mellitus, Type 2; Aerobic Exercise; Genetic Response
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of high intensity interval exercise and
      moderate intensity continuous exercise on some genetic molecules in patients with type 2
      diabetes mellitus.
    

Detailed description: 
      Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication
      that will restrain them from making exercise. 90 male or female volunteers who are suitable
      in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be
      randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1.
      group will make aerobic exercise which is in the form of high intensity interval exercise
      2.group will make aerobic exercise which is in the form of moderate intensity continuous
      exercise 3. Control group. Exercise groups will be cycling under observation in the hospital
      setting. Control group will make simple stretching exercises at home. Participants will be
      requested to complete a 3 months of exercise. They will be evaluated before and at the end of
      the 3 months of exercise with blood tests to measure genetic molecules related with
      metabolism.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study has 3 arms
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Type 2 diabetes mellitus; exercise; aerobic
Carbon Dioxide (CO2) and Cognitive Impairment
Condition: Healthy
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of the study is to better understand the biological mechanisms of carbon dioxide
      (CO2)-induced cognitive impairments.
    

Detailed description: 
      Participants will complete 2 study visits. Each study visit will consist of a 2.5-hour
      exposure session. Concentrations of CO2 during the exposure session will be either 600 ppm
      (control) or 2500 ppm (exposure). The order of the exposure sessions will be randomized and
      the exposure sessions will be at least one week apart. Up to two participants will take part
      in each exposure session.

      During each exposure a neurobehavioral assessment (Strategic Management Simulations or SMS)
      will be administered. Venous blood (30 mL) will be collected from subjects immediately before
      entering the chamber and immediately after the exposure. A subset of subjects (n=12) will
      also undergo a 60-minute fMRI scan.
    

Intervention name(s): 2500 ppm Carbon Dioxide; 600 ppm Carbon Dioxide
Intervention type(s): Other; Other
Intervention description(s): 2.5 hour exposure to 2500 ppm carbon dioxide; 2.5 hour exposure to 600 ppm carbon dioxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Carbon Dioxide; Cognitive Impairment
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the
      pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an
      extent that the dose should be adjusted in subjects with impaired liver function compared to
      the dose for subjects with normal liver function.
    


Intervention name(s): insulin degludec
Intervention type(s): Drug
Intervention description(s): The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
Condition: General Anesthesia
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG
      abnormalities during mask induction with sevoflurane. The aim of our study was to test the
      induction target concentration of sevoflurane on the spikes wave occurrence.
    


Intervention name(s): Induction with Sevoflurane
Intervention type(s): Drug
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Général anesthesia; Gynecology
Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy
      Chinese male subjects. Safety and tolerability data will also be obtained.
    


Intervention name(s): Enbrel (etanercept)
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy
Condition: Thyroidectomy; Pain; Esthetic; Dermal Stapler
Study type: Interventional

Summary: 
      In this study, a randomized controlled study was conducted between two groups of 20 classic
      recipients of intradermal sutures and 20 recipients of intradermal staple methods for
      patients undergoing the same cervical incision. This is a study to see if there is any
      difference in pain and esthetics in scar formation of these groups.
    


Intervention name(s): INSORB; classic intradermal suture
Intervention type(s): Device; Procedure
Intervention description(s): dermal stapler for skin closure; intradermal suture for skin closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment