bioihbjkbjnl/mcl2 huggingface dataset:
The Clinical Effects of Myofascial Trigger Points in Disc Replacement With Reduction
Condition: Temporomandibular Joint Disorders; Myofascial Trigger Point Pain; Jaw Diseases; Pain
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Syndromes; Jaw Diseases
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective, and controlled trial. 60 participants with myofascial trigger points
      and disc displacement with reduction and 60 participants with disc displacement with
      reduction will be included in the study. These two groups will be compared for clinical
      findings, pain severity and limitation of the temporomadibular function.
    

Detailed description: 
      This is a prospective, and controlled trial. 60 participants with myofascial trigger points
      and disc displacement with reduction and 60 participants with disc displacement with
      reduction will be included in the study. The participants' ages will be between 18-65 years
      of both genders.

      These two groups will be compared for clinical findings with DC/TMD Axis I- Symptom
      Questionnaire, pain levels in the last 1 month with DC/TMD Axis II-Graded Chronic Pain Scale,
      and limitation of the temporomadibular function with DC/TMD Axis II-Jaw Functional Limitation
      Scale-8.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): there is no intervention
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The participants who ages between 18-65 years of both genders with disc displacement with
        reduction with/ without myofascial trigger points in master muscles will be included in the
        study.
      
Keywords: temporomandibular joint; disc displacement with reduction; trigger point; pain level
PrEscription of Intra-Dialytic Exercise to Improve quAlity of Life in Patients With Chronic Kidney Disease
Condition: End-Stage Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise
      training intervention designed to improve quality of life (QOL) and alleviate functional
      limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.
      Exercise rehabilitation will be compared against established treatment options available
      within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the
      experience and acceptability of the intervention for both participants and members of the
      renal care team. In addition, we want to examine whether this type of additional exercise
      treatment is cost effective within the health service setting.

      PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380
      adult patients who have been on HD for at least 3 months, from 10 HD sites located in
      Scotland, England and Wales. The type of exercise programming will consist of cycling
      exercise performed during each dialysis session plus a muscle conditioning programme
      performed twice per week. All exercise sessions will be supervised by a physiotherapy
      assistant. The exercise prescription will be individualised for all patients on the basis of
      their fitness and clinical status.

      The main objective is to examine the impact of exercise rehabilitation on quality of life and
      well being of patients. We hypothesise that the exercise training delivered during
      haemodialysis treatment will significantly improve the functional limitations/abilities of
      the patients leading to the detection of clinically beneficial improvement in quality of life
      outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.
    


Intervention name(s): INTRA-DIALYTIC EXERCISE TRAINING
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quality of Life; Exercise; Functional Capacity
Tafenoquine Thorough QTc Study in Healthy Subjects
Condition: Malaria, Vivax
MeSH terms: Malaria, Vivax
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, single-blind, placebo controlled, parallel group study.
      Approximately 260 subjects will be enrolled in five groups. This study is designed to compare
      the effects of tafenoquine, administered as single dose as well as administered over three
      consecutive days, on the changes in QT duration to those observed in subjects dosed with
      either moxifloxacin or placebo.
    

Detailed description: 
      SB-252263 (tafenoquine, TQ) is a new 8-aminoquinoline antimalarial drug being developed by
      GlaxoSmithKline (GSK) and the Medicines for Malaria Venture with the assistance and
      historical support of the Walter Reed Army Institute of Research. Tafenoquine has been shown
      to be effective in the treatment of plasmodial infections in vitro, in pre-clinical models in
      vivo, and during early phase clinical studies for radical cure and eradication of liver
      hypnozoites in patients infected with Plasmodium vivax. This study is designed to compare the
      effects of tafenoquine mono-therapy, administered as a single dose or administered on 3
      consecutive days, on the changes in QT duration to those observed in subjects dosed with
      either Avelox (moxifloxacin hydrochloride) or placebo. This will be a randomized,
      single-blind, placebo controlled, parallel group study. Parallel group design is chosen
      because tafenoquine has a long half-life, about 14 to 19 days, and therefore a cross-over
      design is not a practical alternative. Moxifloxacin will be used as a positive control in
      order to validate the sensitivity of the study in detecting QTc change. Moxifloxacin has been
      shown to prolong the QT interval in a dose-dependent manner in patients and healthy
      volunteers, and the QTc prolongation has been well quantified.
    

Intervention name(s): Tafenoquine 300mg; Tafenoquine 600mg; Tafenoquine 1200mg; moxifloxacin; Placebo for Tafenoquine; Placebo for moxifloxaxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of Tafenoquine give on Day 3 only; Single dose of Tafenoquine given on Day 3 only; 400mg Dose of Tafenoquine given on each of the three consecutive dosing days; moxifloxacine given on Day 3 only; Placebo given on all three days to all groups except for group 5 on Day 3; Placebo for moxifloxacin, given to all groups on all days except for Group 3 on Day 3
Intervention MeSH terms: Moxifloxacin; Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Balance and Anti-Epileptic Drugs
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Patients with epilepsy exercise less than the general population. A barrier to exercise may
      be the effect of antiepileptic drugs on balance and reaction time. This proposal endeavors to
      study the effect of two common antiepileptic drugs (levetiracetam and lamotrigine) on balance
      and reaction time using a Wii balance board and reaction time test. This will be tested at
      descending doses in an epilepsy monitoring unit. Drug levels will be monitored, as well as
      center of pressure, and reaction time.
    

Detailed description: 
      Patients with epilepsy (PWE) exercise less compared to the general population. One barrier to
      participation in exercise is the subtle effect of anti epileptic drugs (AEDs) on balance and
      reaction time. Information on these measures in PWE is scarce, although previous data does
      suggest a detrimental effect. The objective of this trial is to study balance and reaction
      time in patients taking common AEDs. The investigators plan to study the effect of
      levetiracetam and lamotrigine on balance and reaction time. By studying patients in the
      epilepsy monitoring unit who are undergoing medication taper and withdrawal, the
      investigators can observe the effects of varying doses of these drugs within a single subject
      and also compare these data points to age matched controls. A Wii balance board (WBB) will be
      used to measure balance. It is hypothesized that levetiracetam and lamotrigine will elicit a
      dose-dependent, detrimental effect on balance and reaction time.

      Patients admitted to the epilepsy monitoring unit who are currently taking levetiracetam or
      lamotrigine either in monotherapy will be recruited for the study. The target enrollment is
      20 PWE, and 20 healthy controls.

      For the PWE in the study, baseline AED blood levels will be obtained at baseline. The WBB has
      cells which detect load shifts in the body. Participants will stand on the WBB and remain as
      steady as possible. First on both feet with eyes open for 30 seconds, and then on both feet
      with eyes closed for 30 seconds, then on one foot with eyes open for 10 seconds, and then on
      one foot with eyes closed for 10 seconds. Each task will have 3 trials, with adequate break
      between.

      Visit 2 will occur following weaning of AEDs. The investigators will measure center of
      pressure and reaction time testing similar to visit one. Blood AED levels will be checked at
      three half lives of the medication. This will be taken within 8 hours of visit 2.
    

Intervention name(s): Wii Balance Board
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will stand on the Wii Balance Board with eyes open, eyes closed, one two feet, and then standing on one leg at each study visit.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Interaction of Apelin and Angiotensin in the Systemic Circulation
Condition: Renin Angiotensin System
Study type: Interventional

Summary: 
      The apelin-APJ system is a relatively new discovery. It has generated interest in part due to
      it's apparent ability to counteract the renin-angiotensin system, which is frequently
      overactive in many cardiovascular disease.

      Apelin improves that pumping ability of the heart and we wish to know if this action persists
      in the presence of increased levels of angiotensin II.
    


Intervention name(s): Angiotensin II; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of a subpressor dose of angiotensin II will be give, this will be 0.5microG/min/kg. Thereafter thre ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.; Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: renin-angiotensin system; apelin; systemic haemodynamics
The Effects of Swedish Massage and Manual Lymph Drainage on Muscle Fatigue
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      12 healthy men aged 18-30 will be included in the study. Participants will be selected from
      students who regularly train and do active sports at the Faculty of Sports Sciences. All
      participants will do nordic hamstring exercise. Participants will rest for 20 minutes after
      the Nordic hamstring exercise protocol in the first week. In the second week, manual lymph
      drainage covering the lower extremities will be applied for 20 minutes after exercise. In the
      third week, a Swedish massage covering the lower extremities will be applied after exercise.
      The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between
      each set. The evaluations of the participants will be repeated 3 times: just before the test,
      after the test and after the application.
    


Intervention name(s): Nordic Hamstring Exercise
Intervention type(s): Behavioral
Intervention description(s): The NHE, also referred to as the nordic curl, is designed to improve eccentric strength of the hamstring muscles. Individuals start in a kneeling position, with the torso from the knees upward held rigid and straight. The training partner ensures that the individual's feet are in contact with the ground throughout the exercise by applying pressure to the player's heels/lower legs. The individual then lowers his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms are used to break his forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase.The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Manual lympatic Drainage; Swedish Massage; Muscle Soreness
The Effect of Pregabalin Given Preoperatively on the Tourniquet Induced Ischemia-reperfusion
Condition: Ischemia Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The application of tourniquet is indispensable for a bloodless surgical area in total knee
      arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can
      cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to
      investigate effects of pregabalin, GABA analog drug, on the tourniquet induced
      ischemia-reperfusion injury.
    

Detailed description: 
      Investigators will randomize patients into two groups. 1) Pregabalin group 2) Control group.

      Investigators will give orally pregabalin 150 mg to the pregabalin group patients two times
      (first dose 1 day before surgery., second dose 1 hour before surgery). On the other hand
      placebo drug will give to the control group at the same times. Investigators will perform
      combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine
      to subarachnoid space. Investigators will take blood samples for measurement of
      ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet
      deflation, and 20 minutes after tourniquet deflation. Then these samples will be analysed by
      ELISA method.
    

Intervention name(s): Pragabalin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.; empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.
Other intervention name(s): pregabalin 150 mg, Lyrica, Pfezir, Almanya; empty capsule
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pregabalin; ischemia reperfusion injury; muscle
Facilitating the Behavioral Treatment of Cannabis Use Disorder
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Cannabis use disorders remain a significant public health problem. The pharmacological
      facilitation of behavioral treatment represents a promising strategy for addressing
      disordered cannabis use. Cannabis use disorders are recognized to be associated with various
      vulnerabilities that complicate the course of treatment and that may be amenable to glutamate
      modulators. The purpose of this single blind open-label trial is to test the feasibility of
      administering glutamate modulators in conjunction with motivational enhancement therapy (MET)
      and mindfulness based relapse prevention (MBRP) for cannabis use disorders.
    

Detailed description: 
      Individuals diagnosed with cannabis dependence will receive one or two infusions of glutamate
      modulators during week 2 and week 3 or 4. The participants will also receive 2-week course of
      MET and 4-week course of MBRP. Participants will meet with staff twice weekly, except for
      week 2 and potentially week 3 or 4 during which participants will present to the clinic three
      times. Clinic visits include MET sessions, MBRP sessions, psychiatric monitoring,
      assessments, and study procedures (e.g., medication administration).
    

Intervention name(s): CI-581a
Intervention type(s): Drug
Intervention description(s): CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cannabis; mindfulness based relapse prevention; motivational enhancement therapy
Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren
Condition: Physical Activity; Obesity; Children
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a recreational physical
      activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other
      cardiovascular risk factors
    

Detailed description: 
      The prevalence of overweight in Spanish children in the puberty age is among the highest in
      the world and increasing quickly. The investigators recently evaluated an after-school
      program of recreational physical activity to control obesity and other cardiovascular risk
      factors in primary school children in Cuenca. This program, known as the Movi program,
      reduced adiposity, increased serum apolipoprotein (apo) A-I concentration and reduced apo B
      concentration over one-year period.

      Though the intervention MOVI had great acceptance between the children and his families, and
      it demonstrated to be effective opposite to the obesity, his results were relatively modest.
      For it, our hypothesis of work, which justifies this new project, is that a major intensity
      of the intervention, and a major weekly duration extending this one to the weekend, it might
      improve the efficiency on the obesity.
    

Intervention name(s): Movi2 Program
Intervention type(s): Behavioral
Intervention description(s): In the Movi2 program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors. It consisted of two 90-min after school sessions per week on school days and one 150-minute session on Saturday morning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; obesity; adiposity; children; blood lipids; blood pressure; randomized controlled trials
Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish bioequivalence at steady state of:

      1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg
      pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended
      release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet
      t.i.d. in fasted status

      To investigate dose proportionality of pharmacokinetics parameters for:

      1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.
    


Intervention name(s): pramipexole extended release; pramipexole extended release; pramipexole immediate release; pramipexole immediate release
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over); 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over); 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over); 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment
Condition: Artificial Intelligence; Enteroscope; Intestinal Polyposis, Adenomatous
MeSH terms: Adenomatous Polyposis Coli; Intestinal Polyposis; Intestinal Polyps
Study type: Interventional

Summary: 
      A clinical trial of the effectiveness and safety of intestinal polyp digestive
      endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images
      generated by electronic digestive endoscopy equipment.
    


Intervention name(s): DeFrame
Intervention type(s): Device
Intervention description(s): DeFrame can analyze colonoscopy medical images generated by electronic digestive endoscopy equipment to automatically identify, label and screen capture polyps in the colon.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Condition: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases
MeSH terms: Cystic Fibrosis; Digestive System Diseases; Gastrointestinal Diseases; Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Fibrosis
Study type: Observational

Summary: 
      This study aims at collecting the information related to the safety and effectiveness in the
      pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment
      with LipaCreon in order to evaluate the effective and safe use of LipaCreon.
    


Intervention name(s): Pancrelipase
Intervention type(s): Drug
Other intervention name(s): Lipacreon
Intervention MeSH terms: Pancrelipase; Pancreatin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in
        pancreatic exocrine insufficiency
      
Keywords: Digestive System Diseases; Cystic Fibrosis; Therapeutic Uses; Gastrointestinal Agents; Pancreatic Diseases; Pancrelipase; Exocrine Pancreatic Insufficiency