bioihbjkbjnl/mcl2 huggingface dataset:
a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This is an open-label, multicenter, non-interventional, prospective observational study. we
      collect the safety information of pramipexole over 12w treatment. Parkinson disease patients
      with different severity who have already used pramipexole could be observed in this study. In
      the whole observation period, treatment decision was determined by physician and patient
      completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient
      withdraw, laboratory test.
    

Detailed description: 
      Purpose:
    

Intervention name(s): pramipexole
Intervention type(s): Drug
Intervention description(s): as prescibed by the investigator
Intervention MeSH terms: Pramipexole
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        3000
Roles of Vitamin D and HDL in Obese Children
Condition: Obese; Vitamin D Deficiency; Low HDL
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This is a pilot study to determine the association between Vitamin D deficiency in obese
      children and low high density lipoprotein (HDL) and dysfunctional HDL.
    

Detailed description: 
      Subjects will be identified through the Department of Pediatric - High Body Mass Index (BMI)
      Clinic by Dr. Aurelia Radulescu during standard of care visit. Dr. Radulescu will determine
      if the subject meets study eligibility requirements.

      Visit 1 (Baseline/Screening): Consent/assent will be obtained, medical history, demographic
      information along with height and weight will be collection. Clinical Laboratory testing,
      although not part of this study, will include the following standard of care tests. The
      results of Vitamin D and Lipid profile testing will be shared with Dr. Li by Dr. Radulescu.

        -  Lipid profile

        -  Vitamin D

        -  AST/ALT

        -  Hb A1C

        -  Glucose

        -  CBS w/diff

        -  TSH

        -  BUN, Creatine

        -  UA

      Subjects will be placed on standard of care Vitamin D supplementation for 12 weeks.

      Visit 2 (3 month visit) End of Study: Subjects will return to the BMI clinic at month 3 for
      follow-up and additional clinical laboratory testing (see visit 1 for a description of
      testing to be performed) in order to assess their response to Vitamin D supplementation.
      Subjects with previously reported abnormal Lipid values will have a Lipid profile repeated at
      this visit. Month 3 visit will be the End of Study visit.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): All subjects enrolled into the study will be prescribed standard of care Vitamin D
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obese; Children; Vitamin D deficiency; Low HDL
Obesity in Children and Adolescents: Associated Risks and Early Intervention
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and
      increases insulin sensitivity; the study team hope to get better effect of weight decrease
      and metabolic processes repair in the intensive treatment group with intervention of physical
      activity, diet correction and Metformin use.
    

Detailed description: 
      During the first visit, study participants would follow the clinical investigation
      (anthropometry, physical examination, blood tests (hormonal and biochemical state),
      bioimpedance, ultrasound evaluation) and be attributed into 4 groups (matched for age,
      gender, pubertal stage and BMI), 100 subjects in each group.

        1. st group - control: during the first visit patients get standardized information on
           healthy lifestyle, diet and exercise. Next visit (control) will be scheduled for the
           clinical and laboratory evaluation after 12 months of intervention.

        2. nd group - intensive diet and physical activity group: Children will be seen

             1. by a dietician once a month for diet re-evaluation;

             2. physical therapist, who will give physical activity course twice a week (1 h each).

             3. pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after
                12 months of intervention.

        3. rd group - intensive diet and physical activity group plus insulin sensitization:
           Metformin will be prescribed for this group of study children in the doses of 1000
           mg/day Children will be seen by

             1. a dietician once a month for diet re-evaluation;

             2. physical therapist, who will give physical activity course twice a week (1 h each);

             3. pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after
                12 months of intervention.

        4. th group- insulin sensitization without intensive diet and physical activity. Metformin
           will be prescribed in the doses of 1000 mg/day after standardized information on healthy
           lifestyle, diet and exercise during the first visit only. This group of children will be
           seen by pediatric endocrinologist every 3 months.

      Intervention duration - 12 months. In the case of Metformin intolerance, children will
      continue the study in 2nd group.

      Clinical and laboratory evaluation after 12 months of intervention.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin 500 mg BID for 12 months
Other intervention name(s): Metforal
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight; body mass index; lipid profile; glucose profile
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
Condition: Dental Caries on Pit and Fissure Surface
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention
      rates of sealants placed under Isolite vs. cotton roll isolation. This study will also
      compare the patient and operator acceptability and satisfaction of the two isolation
      techniques as well as the time consumed for sealant application during the two isolation
      techniques.
    

Detailed description: 
      104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics,
      ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of
      first and second molars and premolars will be randomized to receive sealants with the use of
      the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants
      will be placed by pediatric dentistry residents. Sealants will be placed on first and second
      permanent molars that have a matched contralateral molar requiring a sealant as well.
      Photographs may be taken of the sealants on the day of placement and at a 6-month and 12
      month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric
      dentists.
    

Intervention name(s): Isolite System; Cotton Roll Technique
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pit and Fissure sealants; Isolation; permanent teeth; children; Isolite®; Dental caries
Acupressure in Reducing Post-TBI Fatigue
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior
      works have demonstrated that it may profoundly impact the ability to return to productive
      activity and cognitive functions. However, few interventions have been applied in this
      population.The purpose of the current will be to test the effect of acupressure on fatigue
      reduction after traumatic brain injury.
    

Detailed description: 
      Fatigue is a pervasive and critical long-lasting symptom experienced by patients with
      traumatic brain injury (TBI) and can persist up to months or years after head injury.
      However, thus far, only few non-pharmacological interventions, such as mindfulness, are
      implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure
      can significantly improve fatigue in different populations, such as cancers survivors and
      patients with hemodialysis. Therefore, we would like to test whether acupressure effectively
      improve fatigue after TBI.
    

Intervention name(s): Acupressure
Intervention type(s): Behavioral
Intervention description(s): Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Effects of Nasal Steroids and Montelukast on Olfactory Functions in Patients With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory
      functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty
      patients with seasonal were included in this study. Patients were randomly divided into three
      groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy,
      group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory
      functions were determined using the Sniffin' Sticks olfactory test before and after a month
      treatments.

      Threshold, discrimination, identification, and TDI values were not significantly different
      among the groups before treatment. For Group 1 and Group 3 patients, there were statistically
      significant differences in threshold, discrimination, identification, and TDI values before
      and after treatment (p < 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the
      before and after treatment values of threshold, discrimination, identification, and TDI
      showed no significant differences (p > 0.05). According to the findings of our study, MF is
      superior to montelukast in improving olfactory function. Although montelukast has been shown
      to be effective against AR symptoms, its effect on olfactory function was not demonstrated in
      this study.
    


Intervention name(s): Montelukast,mometazon froat
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Montelukast; Sniffin' Sticks test; allergic rhinitis; mometasone furoate
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
Condition: Hypertriglyceridemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of
      different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG)
      levels in participants with hypertriglyceridemia and established CVD or at a high risk for
      CVD.
    


Intervention name(s): ISIS 678354; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ISIS 678354 solution for SC injection.; Sterile Normal Saline (0.9% NaCl).
Other intervention name(s): AKCEA-APOCIII-LRx, IONIS-APOCIII-LRx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AKCEA-APOCIII-LRx; IONIS-APOCIII-LRx; Dyslipidemia; Metabolic Disease; Hyperlipidemia; Cardiac Disease; Lipid Metabolism Disorders; Triglycerides High; Vascular Diseases
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to understand if saxagliptin is more effective than placebo as a
      treatment for type 2 diabetic subjects who are not controlled with diet and exercise
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects in the short-term period who
      have an elevated blood sugar that requires additional medication for blood sugar control will
      be eligible to enter the long-term treatment extension period where they will receive
      metformin (rescue medication) added onto their blinded study medication
    

Intervention name(s): Saxagliptin; Saxagliptin; Saxagliptin; Saxagliptin; Placebo; metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT); Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT); Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Other intervention name(s): BMS-477118; BMS-477118; BMS-477118; BMS-477118
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP)
Condition: Chronic Non-Specific Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence.
      CNNP is a leading cause of disability which contributes to higher costs due to loss of
      productivity, disability, and increased absenteeism from work. Yoga has been found effective
      managing neck pain but there has been no study at work setting for chronic non-specific neck
      pain.

      To determine the effectiveness of Yoga@work program for chronic non specific neck pain among
      office workers, present randomised controlled trial was undertaken.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Yoga@work program included physical movements, yoga posture, breathing exercise, pranayama and yoga chants. Session with trainer was conducted on worksite once a week for an hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Pelvic organ prolapse is a common disorder that results in significant patient morbidity.
      Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP)
      and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP
      remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani
      (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during
      childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures
      employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse
      surgery, there is a paucity of information regarding the identification of these structures
      outside of surgical dissection. Furthermore, there is no published data describing the
      relative distances between the apex of the vagina and these ligaments in women with prolapse.
      Recent developments in imaging have enabled the identification of the distal subdivisions of
      the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the
      subdivisions of the pubovisceralis. The visualization of these structures is possible using a
      3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and
      in live humans, with excellent interrater reliability. The investigators propose to use this
      technology to explore the anatomy of the sacrospinous ligaments.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with pelvic organ prolapse 21-80 years old
Corever in the Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The study primarily aims to compare the effects of two doses of Corever with placebo in
      patients with hypertension.
    

Detailed description: 
      The study aims to compare the effects of two doses of Corever with placebo in patients with
      essential hypertension. Eligible subjects who belong to one of the following subtypes are
      planned to be enrolled: (1) patients with essential hypertension without drug control, or (2)
      uncontrolled hypertension despite treatment with up to 2 antihypertensive agents. Of note,
      the second category will receive randomized study treatments in addition to continuing their
      previous medication throughout the trial. The study also wants to investigate the safety
      profile of Corever during treatment period.
    

Intervention name(s): Corever
Intervention type(s): Drug
Intervention description(s): Corever
Other intervention name(s): CRTA04
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Corever; hypertension
The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
Condition: Violence
Study type: Interventional

Summary: 
      The American Academy of Pediatrics recommends that parents receive anticipatory guidance
      about violence prevention as part of the routine well child visit. Educational resources are
      needed to help physicians routinely provide these important anticipatory guidance messages.
      In this study, consecutive parents will be exposed to routine anticipatory guidance messages
      before the well child visit with the physician. After the clinic visit, parents will be
      invited to participate in a research study to determine if they plan any changes at home. The
      key research question of this study is:

      Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids
      brochure, entitled, "Pulling the Plug on TV Violence", help parents develop plans to
      decreases their children's exposure to violence in the media (e.g. less media time, no TV in
      the bedroom)?
    


Intervention name(s): AAP Handout entitled, Pulling the Plug on Violence.; Play Nicely Program; Control Group
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): This handout is two pages and is part of the Connected Kids Program, American Academy of Pediatrics; Multimedia program available at www.playnicely.org.; Standard care in primary care clinic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Violence prevention; Media; Primary care; Parenting
Autonomic Assessment in Patients With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by
      urgency to move the legs during inactivity or resting state. Although the exact mechanism is
      not clearly understood, sleep disturbances and dopamine deficiency may regarded as a
      potential contributing factor for autonomic dysfunction. The objective of the study is to
      evaluate autonomic functions and determine possible associations between autonomic
      dysfunction with clinical factors in patients with RLS.
    

Detailed description: 
      Restless legs syndrome (RLS) also known as Willis- Ekbom disease, is a common sensorimotor,
      sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs
      (or less commonly the arms) during inactivity or resting state.

      Although, the clinical importance of autonomic involvement in patients with restless legs
      syndrome (RLS) remains incompletely understood, sleep disturbances and dopamine deficiency
      may regarded as a potential contributing factor for autonomic dysfunction.

      Previous reports have described autonomic impairment including changes in nocturnal blood
      pressure and heart rate variability (HRV), gastrointestinal, urinary and sexual dysfunction
      in patients with RLS. Despite many studies about electrophysiological autonomic changes in
      RLS, number of studies exploring autonomic functions by using Scales for Outcomes in
      Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) are limited.

      In this study, the investigators plan to compare the presence of autonomic symptoms by using
      Scales for Outcomes in Parkinson's disease-Autonomic (SCOPA-AUT) questionnaire in drug- naive
      RLS patients to healthy controls. In addition, the investigators aim to evaluate possible
      associations between autonomic dysfunction with clinical factors in patients with RLS.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were selected from a tertiary care neurology outpatient clinic. Age and gender
        matched control group obtained from the family members of the tertiary care hospital's
        staff.
      
Keywords: restless legs syndrome; autonomic dysfunction; dysautonomia; SCOPA-AUT questionnaire