bioihbjkbjnl/mcl2 huggingface dataset:
Effect of an Exercise Program Designed for Orchestral Musicians
Condition: Musculoskeletal Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This study is a randomized clinical trial evaluating the effect of an exercise program
      designed specifically for orchestral musicians on performance-related musculoskeletal
      problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited.
      Half of the subjects will participate in an 11-week home exercise program and attend three
      group exercise sessions and an educational presentation on injury prevention, while the other
      half of the subjects will receive no intervention, and continue their usual activities.
    


Intervention name(s): Exercise program and education
Intervention type(s): Other
Intervention description(s): The exercise program comprises warm-ups, exercises and cool-downs and aims to improve recruitment, strength and endurance of postural muscle groups that are key to the work of a musician. Basic activation exercises progress to dynamic and resisted exercises as well as functional musical movements. There is a series of six exercises of increasing difficulty for each of the following bodily regions: hips, back, neck, shoulders and abdominals.
Topics to be discussed in the educational presentation and e-mails include healthy practice habits, activity dosage, the importance of physical activity, how the body adapts to workload and physical stressors, and instructions pertaining to the exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes
      mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.
    

Detailed description: 
      Sulphonylurea (SU) is a glucose-lowering agent used widely to treat type 2 diabetes mellitus
      (T2DM). SU promotes insulin secretion from the pancreatic islet beta cell via binding and
      inhibition of the ATP-sensitive potassium (KATP) channel. The KATP channel is made up of two
      subcomponents, an inner Kir6.2 K+ channel (coded by the KCNJ11 gene) and an outer SU receptor
      1 (SUR1) (coded by the ABCC8 gene). Although all SUs are mechanistically similar in terms of
      increasing insulin secretion, they bind to distinct regions of Kir 6.2 and SUR1 to exert
      their function. Different types of SU (e.g. tolbutamide, glibenclamide, glipizide,
      glimepiride and gliclazide) can therefore be grouped by their binding sites (A/B/A+B site) on
      the KATP channel [3]. Interestingly, the KCNJ11 E23K (rs5219) variant was shown to confer
      susceptibility to T2DM and the ABCC8 S1369A (rs757110) variant was found to be in complete
      linkage disequilibrium with it i.e. inherited together as a genetic block (haplotype). A
      recent in vitro molecular study suggested that the minor haplotype (K23/A1369) of KATP
      channel is sensitive to inhibition by gliclazide (binds to A-site) but not glibenclamide
      (binds to A+B site), and that the increased responsiveness to gliclazide was largely due to
      the A1369 allele. Understanding how the response to these two SUs may vary with the presence
      of the minor haplotype (K23/A1369) would therefore be beneficial for customization of patient
      treatment to achieve better clinical outcomes.
    

Intervention name(s): Gliclazide; Glibenclamide
Intervention type(s): Drug; Drug
Other intervention name(s): Sun-Glizide; SIN09350P; Benil; SIN07284P
Intervention MeSH terms: Gliclazide; Glyburide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sulphonylureas; gliclazide; glibenclamide
Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions
Condition: Abortion,Induced
Study type: Interventional

Summary: 
      Patients undergoing second trimester abortions will recieve either patient controlled
      analgesia with either remifentanyl or tramadol for pain alleviation.

      We beleive both to be equally effective for pain alleviation.
    

Detailed description: 
      Women undergoing second trimester abortions will recieve patient controlled analgesia eith
      either tramadol or remifentanyl.

      Patients will not know what they are recieving.

      Patients in the tramadol goup will get a loading dose of tramadol and metocloparamide while
      the women in the remifentanyl group will be given a loading placebo.

      Women will then be attached to one of the two patinet controlled analgesia protocols.

      Throughout their laboring process they will be monitored for blood pressure, pulse, breathing
      rate, sedation score and nausea.

      Additional medicatyion will be given for nausea.

      If woman are still in pain the patient controlled analgesia settings will be set to deliver a
      higher dose. If the woman remains in pain, she will be given an additional per os
      medication.If this still does not alleviate pain, the option of epidural analgesia will be
      offered.
    

Intervention name(s): tramadol; remifentanyl; patient contolled analgesia
Intervention type(s): Drug; Drug; Device
Intervention MeSH terms: Tramadol; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tramadol; remifentanyl; patient controlled analgesia; abortion
Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional

Summary: 
      The primary objective of this study was to evaluate the safety and performance of a cold sore
      patch for the treatment of herpes labialis.
    

Detailed description: 
      This was an open, single-center multi-site, non-comparative study to evaluate the safety and
      performance of CSP-Night under actual-use conditions in subjects with herpes labialis of the
      lips and/or perioral skin. A sufficient number of subjects were screened to ensure that 45
      subjects experienced and treated a cold sore outbreak in the course of 14 weeks. Subjects
      were instructed to initiate therapy within approximately 1 hour of onset of their first sign
      or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All
      subjects were expected to return to the study center for clinical assessments within 24 hours
      and 48 hours after initiating treatment, and every other day thereafter, with a final visit
      at Day 10 or at the time of completion/discontinuation if before Day 10. Diaries were
      completed each day, beginning upon initiation of therapy and continuing until study
      completion/ discontinuation, and included information on study product applications and
      compliance.
    

Intervention name(s): Cold Sore Patch
Intervention type(s): Device
Intervention description(s): All eligible subjects received CSP-Night at Screening Visit 1. Subjects were instructed to initiate therapy within approximately 1 hour of onset of their first sign or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All subjects were expected to return to the study center for clinical assessments within 24 hours and 48 hours after initiating treatment, and every other day thereafter, with a final visit at Day 10 or at the time of completion/ discontinuation if before Day 10.
Other intervention name(s): Compeed® Cold Sore Patch Night
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cold Sore Patch
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. Growth Hormone in young adults with growth hormone
      deficiency in childhood. This trial compares a treated group of patients with an untreated
      group of patients.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the safety and efficacy of BLI4700 bowel
      preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations
      prior to colonoscopy in adult patients.
    


Intervention name(s): BLI4700; Polyethylene glycol bowel preparation
Intervention type(s): Drug; Drug
Intervention description(s): Oral bowel preparation; Oral bowel preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis
Condition: Thrombophlebitis; Phlebitis
MeSH terms: Phlebitis; Thrombophlebitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid
      cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment
      is continued after the end of infusion for at least 7 days.

      Number of patients developing superficial phlebitis and duration of phlebitis will be
      recorded.
    


Intervention name(s): Hirudoid cream 0.3 % Mucopolysaccharide polysulfate; Placebo cream without active substance
Intervention type(s): Drug; Drug
Intervention description(s): Hirudoid cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Mucopolysaccaride polysulfate (MPS); MPS; Heparinoide; Infusionphlebitis; Prevention; Superficial thrombophlebitis; Treatment
Medical Abortion for Emergency Contraception Failure
Condition: Emergency Contraception; Abortion, Induced
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy, safety and acceptability of
      pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical
      termination of pregnancy by mifepristone EC failure.
    

Detailed description: 
      Women usually request an abortion when they have experienced an emergency contraception (EC)
      failure; this population represents 13% of all early pregnancy terminations in China. Many
      women would prefer to choose a medical abortion in order to avoid anesthesia, over a surgical
      operation. However, medical termination of a pregnancy after mifepristone EC failure has not
      been studied although it has already been extensively practiced by empirical means in China.
      There is no clarification in literature as to whether mifepristone is still effective in
      medical abortion with its previous failure experience in EC. This randomized study was aimed
      to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and
      misoprostol compared to misoprostol alone in the medical termination of pregnancy by
      mifepristone EC failure.
    

Intervention name(s): mifepristone combined misoprostol; misoprostol alone protocol
Intervention type(s): Drug; Drug
Intervention description(s): women received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally; patients were only administered 0.8 mg of misoprostol orally on day 3.
Intervention MeSH terms: Misoprostol; Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medical abortion; emergency contraception; mifepristone
Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention for High-risk Drinking University Students
Condition: Alcohol Drinking in College
MeSH terms: Alcohol Drinking; Alcohol Drinking in College
Study type: Interventional

Summary: 
      The aims of this pilot study are:

        1. To examine the factors associated with alcohol drinking and alcohol use disorder

        2. To examine the effect of face-to-face alcohol brief intervention on drinking reduction

        3. To examine the effect of a continuous interactive chat-based intervention via "WhatsApp"
           on drinking reduction

        4. To explore the perception of face-to-face alcohol brief intervention

        5. To explore the perception of continuous interactive chat-based intervention via instant
           messaging mobile application "WhatsApp"
    

Detailed description: 
      According to the Department of Health, majority of people in Hong Kong started to develop
      drinking habit at 18-21 years of age in 2014/2015. Amongst them, 16.8% had scored higher than
      3 in the Alcohol Use Disorders Identification Test for Consumption (AUDIT-C) (an abbreviated
      version of the Alcohol Use Disorders Identification Test, or AUDIT, designed by the World
      Health Organization(WHO)), while 3.5% had even scored 8 or above in the test. With higher
      prevalence to begin drinking within 18 and 23 years old, university students could have
      established higher tendency of harmful drinking and alcohol dependence as compared with other
      age groups. Therefore, early interventions such as the evidence-based Alcohol Brief
      Intervention (ABI) suggested by the WHO are particularly needed to target university drinkers
      who are 5% more likely to develop higher frequency of drinking in later of their lives
      compared with other age groups.
    

Intervention name(s): Mobile chat-based instant messages; Alcohol brief intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the active arm study will receive continuous interactive chat-based intervention as an extension of alcohol brief intervention at baseline. The interactive mobile chat will be carried out on Friday night and Saturday before and during the period of "happy hour" and ask for drinking and giving personalized advises on drinking reduction using behavioral change techniques.; Those in the control arm will be assigned to only receive the face-to-face ABI. The ABI consists of: (1) giving feedback and information about the screening result in phase I and hazard of drinking; (2) emphasizing the benefits of reduce drinking and informing about alcohol problems; (3) setting goal on reducing alcohol consumption; (4) reviewing advice and ;(5) giving encouragement.
Other intervention name(s): ABI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chat-based intervention; alcohol brief intervention; high-risk drinking; university students; AUDIT; instant messaging; WhatsApp
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
Condition: Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Vaccination is currently the most effective means of controlling influenza and preventing its
      complications and mortality in persons at risk.

      Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a
      recommendation on the influenza A and B strains that should be used for the production of
      vaccine for the coming influenza season. For the strains which do not change from the
      previous year, the vaccine can be formulated from the old mono bulk from the previous year.

      Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under
      the current Canadian and US licenses. This study is conducted to evaluate safety and
      immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new
      bulk material. This protocol posting has been updated in order to comply with the FDA
      Amendment Act, Sept 2007.
    


Intervention name(s): Fluviral
Intervention type(s): Biological
Intervention description(s): One dose, Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza
Connective Tissue Massage With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of the study was to examine the effectiveness of clinical pilates exercises and
      connective tissue massage in individuals with Fibromyalgia (FM). 32 women were randomly
      divided into two groups as intervention (n=15, mean age=48.80±7.48) and control (n=17, mean
      age=55.64±7.87). While connective tissue massage and clinical pilates exercises were applied
      to the intervention group, control group were applied only clinical pilates
      exercises.According to our results, connective tissue massage increased the effectiveness of
      clinical pilates exercises in individuals with FM.
    


Intervention name(s): Connective Tissue Massage; clinical pilates exercises
Intervention type(s): Other; Other
Intervention description(s): Connective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively.; Exercises were applied 3 times for 6 weeks, a total of 18 sessions. One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Foot Neuromodulation for Nocturnal Enuresis
Condition: Bedwetting
MeSH terms: Enuresis; Nocturnal Enuresis
Study type: Interventional

Summary: 
      To determine the effects of electrical stimulation of the nerves in the foot on the incidence
      of nocturnal enuresis (bedwetting) in children
    

Detailed description: 
      Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric
      population which can have significant negative impact on a child's quality of life. Apart
      from medications which can have significant side effects limiting their use, there is a lack
      of effective and safe treatment options for children with frequent nocturnal enuresis. If
      foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may
      provide a safe and non-invasive therapeutic option.
    

Intervention name(s): TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS
Intervention type(s): Device
Intervention description(s): electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bedwetting
The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System
Condition: Diabetes
Study type: Interventional

Summary: 
      This study is carried out to determine the effect of high and low GI of local foods using
      Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles.
    

Detailed description: 
      Glycemic Index (GI) is a method of classifying foods based on the food's ability to raise the
      blood glucose level. Low GI foods are recommended as Participants will have a lower impact on
      blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour
      blood glucose profiles in healthy Chinese male participants. There will be two test sessions
      where participants will consume either a high or low GI breakfast, lunch, snack and dinner.
      Participants will take part in two test sessions (each spanning over 3 days and to monitor
      the participants' glycemic response using a Continuous Glucose Monitoring System (CGMS)
      throughout the period.This study specifically attempts to see how having high and low GI
      locally consumed meals impact on blood glucose.
    

Intervention name(s): High glycemic index; Low glycemic index
Intervention type(s): Other; Other
Intervention description(s): Wheat yellow noodle, glutinous rice, tea with sucrose, biscuits, jelly made with sucrose and teriyaki chicken rice.The foods provided have been tested as high glycemic index. Participants' blood glucose will be monitored using the Continuous Glucose Monitor.; Beta-glucan yellow noodle, basmati rice, tea with isomaltulose, biscuits, jelly made with isomaltulose and mung bean noodles.The foods provided have been tested as low glycemic index.Participants' blood glucose will be monitored using the Continuous Glucose Monitor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
Condition: Acute Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of INP105, which is an investigational drug-device combination product
      comprised of the drug component OLZ administered by a Precision Olfactory Delivery (POD®)
      nasal spray device (I231 POD® Device). The proposed indication for INP105 is the treatment of
      acute agitation associated with schizophrenia and bipolar I disorder.
    

Detailed description: 
      This is a randomized, double-blind, placebo- and active-controlled, ascending-dose, 2-way, 2-
      period, incomplete block, crossover, Phase 1 trial to compare the safety, tolerability, PK
      and PD of 3 single doses of INP105 with the safety, tolerability, PK and PD of 1 dose of
      Zyprexa IM (5 mg) and 1 dose of oral Zyprexa Zydis (10 mg). Randomization for Periods 1 and 2
      will occur for each subject on Day 1.
    

Intervention name(s): Zyprexa IM; Zydis; INP105; I231 POD® Device
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): 5mg; 10mg orally disintegrating wafer; Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC); Precision Olfactory Delivery (POD) device
Other intervention name(s): Zyprexa Zydis; OLZ or placebo; POD®
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Period 1 (n=36) assignment to 1 of 2 reference therapy treatment groups over 3 cohorts Period 2 (n=36) assignment to 1 of 3 IP treatment groups over 3 cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agitation; Schizophrenia; Bipolar I disorder; OLZ; Olanzapine; Zyprexa; POD® device