bioihbjkbjnl/mcl2 huggingface dataset:
Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury
Condition: Shoulder Pain; Rotator Cuff Tendinitis; Rotator Cuff Syndrome; Spinal Cord Injury
MeSH terms: Shoulder Pain; Tendinopathy; Spinal Cord Injuries; Wounds and Injuries; Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by
      overuse injuries to the muscles and tendons that can occur during wheelchair propulsion,
      transfers, and other activities of daily living. Normally, shoulder pain resolves with
      conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen,
      naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery
      may be the only option.

      Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and tendon
      injuries such as those that cause shoulder pain in persons with SCI. Using one's own blood,
      cells within the blood called "platelets" are concentrated and then re-injected into the
      muscle and tendon of the shoulder. These platelets release substances known as "growth
      factors" that lead to tissue healing. By concentrating the platelets we increase the growth
      factors up to eight times which will promote the healing of tendons. PRP therapy has shown
      promise in treating tendon and muscle injuries in able-bodied persons; however, its
      effectiveness in persons with SCI is unknown. The purpose of this study is to explore the
      feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with
      SCI. The human body has a remarkable ability to heal itself and we hypothesize that
      re-injecting concentrated platelets will facilitate the natural healing process and will
      reduce shoulder pain in persons with SCI.
    


Intervention name(s): Platelet-rich plasma (PRP) therapy
Intervention type(s): Biological
Intervention description(s): Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
Other intervention name(s): Autologous blood injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder pain; Rotator cuff disease; Spinal cord injuries; Platelet-rich plasma therapy; Rehabilitation
Turkish Validity and Reliability of The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Kinesiophobia
Study type: Observational

Summary: 
      Objective: The aim of this study is to evaluate the validity and reliability of the Turkish
      version of the 'The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)'
      questionnaire used to assess kinesiophobia in temporomandibular joint disorders.

      Method: The "Tampa Kinesiophobia Scale in Temporomandibular Disorders" (TSK-TMD), which
      consists of 12 item, was adapted to Turkish with the translation and back-translation method.
      111 patients (75 females, 36 males) who had been diagnosed with temporomandibular joint for
      at least 6 months and diagnosed as Temporomandibular Joint Disorder were participated to fill
      out the questionnaire. In the present study, participants were assessed with the
      Temporomandibular joint disorders evaluation form, Turkish TSK-TMD-12 item, Visuel Analogue
      Scale (VAS) and Pain Catastrophizing Scale (PCS). The internal consistency and test-retest
      reliability with a 3-5 days time were used to evaluate the reliability of the TSK-TMD. The
      reliability of the corelatıon was checked with PCS. Construct validity was assessed based on
      conﬁrmatory factor analysis (CFA).
    

Detailed description: 
      We used Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale
      (PCS) questionnaires in our study.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pre-test: 10 patients temporomandibular disorders evaluated. Inclusion and exlusion
        criteria listed above.

        Validation and reliability: 111 patients with temporomandibular disorders
        evaluated.Inclusion and exlusion criteria listed above.
IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The principal scientific objective of the trial is to identify the factors that are
      associated with differential blood pressure responses between drugs. This may allow
      investigators to produce new hypotheses on the pathophysiology of hypertension and on the
      mechanisms of drug action.

      These factors can be of different types:

        -  Environmental factors (sodium or alcohol intake);

        -  Morphological (height, weight, body mass index, body surface area);

        -  Initial blood pressure;

        -  Electrocardiogram (ECG) parameters of left ventricular hypertrophy;

        -  Biological parameters as the activity level of the renin angiotensin aldosterone system;

        -  Genetic polymorphisms.
    


Intervention name(s): Indapamide (T2); Perindopril (T1); Placebo of Perindopril (P1); Placebo of Indapamide (P2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.5 mg/day during 4 weeks; 4 mg/day during 1 week then 8 mg/day during 3 weeks; 1 pill/day during 1 week then 2 pills/day during 3 weeks; 1 pill/day during 4 weeks
Intervention MeSH terms: Perindopril; Indapamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      Effectiveness of music therapy on blood pressure and anxiety among patients undergoing
      haemodialysis
    

Detailed description: 
      Abstract Introduction:- dialysis is one of the technological innovation in medicine in which
      patients are being reported to face psychosocial and physiological problems such as anxiety,
      stress and hypertension etc. To relieve these problems, music therapy has been widely used as
      a non-pharmacological intervention with the aim to assess the effectiveness of music therapy
      on blood pressure and anxiety among haemodialysis patients.

      Methods:- current study using true experimental pre-test post-test design was conducted among
      60 haemodialysis patients which were randomly allocated to experimental (30) and control (30)
      group using simple random sampling. The data was collected through sample characteristics
      performa, blood pressure monitoring data sheet and beck anxiety inventory. Patients in
      experimental group were provided with 30 minutes of music therapy using slow and calm
      relaxing instrumental piano music whereas in control group only usual care was given.
    

Intervention name(s): music therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
Masking: None (Open Label)
Primary purpose: Prevention
Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Spinal pain or misalignment is a very common disorder affecting a significant number of
      populations resulting in substantial disability and economic burden. Various manual
      therapeutic techniques such as spinal manipulations and mobilizations can be used to treat
      and manage pain and movement dysfunctions such as spinal malalignments and associated
      complications. These manual therapeutic techniques can affect the cardiovascular parameters .

      -
    

Detailed description: 
      Group A group (n=20). All participants will receive only single session of neck mobilization.
      Grade IV unilateral posteroanterior pressure and sustained extension to be applied restricted
      joints and muscle energy technique.

      - Group B (n=20) will receive single session of neck manipulation with high-velocity,
      low-amplitude thrust over restricted joints (one at a time) with the goal of restoring normal
      range of motion in the joint.
    

Intervention name(s): cervical mobilization; cervical manipulation
Intervention type(s): Other; Other
Intervention description(s): All participants will receive only single session of cervical mobilization; All participants will receive only single session of cervical manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effects of two different antihypertensive medications in the drug class of
      beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.
    


Intervention name(s): carvedilol; metoprolol
Intervention type(s): Drug; Drug
Other intervention name(s): carvedilol
Intervention MeSH terms: Metoprolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes; hypertension; beta-blockers
Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single center, open-label, two-way crossover, drug-drug-interaction study to
      determine the effect of multiple dosing of omeprazole on 4 consecutive days on the
      pharmacokinetics of a single dose of an immediate-release capsule of CG5503 (tapentadol) in
      healthy participants.
    


Intervention name(s): Tapentadol IR capsule; Omeprazole capsule
Intervention type(s): Drug; Drug
Intervention description(s): Tapentadol IR capsule containing 93 mg tapentadol hydrochloride.; Omeprazole capsule containing 40 mg omeprazole.
Intervention MeSH terms: Tapentadol; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomized to 1 of 2 treatment sequences (AB or BA). There was a washout of at least 7 days between the CG5503 administrations.
Masking: None (Open Label)
Primary purpose: Treatment
Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery
Condition: Congenital Hip Dysplasia
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
Study type: Interventional

Summary: 
      Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric
      population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of
      congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction
      or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed
      during this surgical treatment and cause severe postoperative pain. Pericapsular nerve group
      (PENG) block has been recently recommended for use as postoperative analgesia in hip
      surgeries. It is a new regional anesthesia method based on blocking the articular branches of
      femoral nerve (FN) and accessory obturator nerve (AON) in the region between the anterior
      inferior iliac spine (AIIS) and iliopubic eminence (IPE).The aim of this study was to
      evaluate the analgesic effect of ultrasound guided pediatric pericapsular nerve group (PENG)
      block in pediatric patients undergoing CHD surgery.
    


Intervention name(s): Saline Solution; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 ml/kg saline; 0.5 ml/kg %0.25 bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to
      evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for
      treatment of depression in Chinese population.
    


Intervention name(s): Trazodone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 75mg tablet/150 mg tablet; Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: losing interest and feelings of guilt; poor concentration; loss of appetite; suicide
Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms; Barrett Esophagus
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Celecoxib may be effective in preventing cancer in
      patients with Barrett's esophagus.

      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing
      cancer in patients who have Barrett's esophagus.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and efficacy of celecoxib for regression of Barrett's dysplasia in
           patients with low or high-grade dysplasia of the esophagus.

      OUTLINE: This is a randomized, parallel, double-blind, placebo-controlled, multicenter study.
      Patients are stratified according to center and grade of dysplasia at baseline (low vs high).
      Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive oral celecoxib twice daily for 48-96 weeks.

        -  Arm II: Patients receive oral placebo as in arm I. Treatment continues in both arms in
           the absence of unacceptable toxicity or development of adenocarcinoma of the esophagus
           or cancer at other sites.

      Patients are followed at 12 weeks.

      PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study.
    

Intervention name(s): celecoxib
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: esophageal cancer
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of
      dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).
    


Intervention name(s): 250 mg LX1033 tablets; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg LX1033 tablets administered orally; Matching placebo tablet administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Registrar Performances in MIDP
Condition: Minimally Invasive Distal Pancreatectomy
Study type: Observational

Summary: 
      This study aimed to determine whether registrar involvement in minimally invasive distal
      pancreatectomy (MIDP) was associated with adverse outcomes.
    

Detailed description: 
      From January 2009 to March 2020, data of all consecutive patients requiring distal
      pancreatectomy in our public tertiary hospital were prospectively collected and
      retrospectively analyzed.

      Registrars were progressively involved for MIDP since 2009 and their experience was: < 5 open
      pancreatic resections, < 5 MIDP and at least 30 advanced minimally invasive gastrointestinal
      resections.

      Outcome of patients who underwent either distal pancreatectomy by the consultant or
      registrars were compared.

      Our primary outcome was the conversion rate. The secondary outcomes were 90-days
      postoperative outcomes including CR-POPF defined and classified according to the 2016 ISGPF
      definition.
    

Intervention name(s): Minimally invasive distal pancreatectomy
Intervention type(s): Procedure
Intervention description(s): Minimally invasive distal pancreatectomy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent minimally invasive distale pancreatectomy for benign or borderline
        pathology
      
Keywords: Benign or borderline pathology (non-pancreatic cancer); laparoscopy; registrar; postoperative outcomes; pancreatectomy; surgery; pancreas
Cardiopulmonary Resuscitation by Children
Condition: Cardiopulmonary Arrest With Successful Resuscitation
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Children's education students are able to identify a possible emergency and in their case act
      appropriately.

      The authors think that the propsed training will improve the knowledge, change the attitude
      and improve their practical skills, and also retain the information over time.
    

Detailed description: 
      Cardiopulmonary Resuscitation (CPR) formation in children and teachers is a current and high
      impact topic in public health: with an appropriate training anyone can save life (Böttiger,
      2015). Primary school students are willing to learn CPR and they are also Carriers of
      knowledge among their surroundings like family or friends (Martínez, 2015).

      The authors propose a clinical trial to evaluate the knowledge, attitudes and skills in
      primary education students of various schools, before and after a CPR formation.

      The schools will be previously randomized in intervention group and control group. Once the
      intervention has been completed and the results obtained, training equal to the intervention
      will be offered to the control schools. In the bibliographic search no validated
      questionnaires in CPR learning among primary education students has been found.
    

Intervention name(s): Training on emergency telephone numbers and mnemonics; Sham generic formation on the cardiopulmonary arrest.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will consist in carrying out an initial theoretical training on how to act in case of attending an emergency, with graphic support of slides (power-point) during 5 minutes, followed by a practical part with the projection of the video of a song and with a "role play" activity for 15 minutes, to remember the helpline number for emergencies (112) and relate it to the mnemonic mouth-nose-eyes. At the beginning and at the end of the theoretical-practical activity, the evaluation questionnaires will be administered to each one of the students.; The sham intervention for the control group will consist in providing a generic formation on the cardiopulmonary arrest, with graphic support of slides (power-point) during 10 minutes, without specifying the telephone number of assistance for emergencies or the mnemonics mouth-nose-eyes. At the beginning and at the end of the theoretical activity, the evaluation questionnaires will be administered to each one of the students.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicentric clinical trial based on an ad hoc questionnaire
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cardiopulmonary Resuscitation; Teaching Material; Primary education
Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The aim of this prospective study is to evaluate the clinical performance of habitual wearers
      of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of
      daily wear.
    


Intervention name(s): methafilcon A contact lenses; fanfilcon A contact lenses
Intervention type(s): Device; Device
Intervention description(s): Bilateral daily wear of methafilcon A contact lenses; Bilateral daily wear of fanfilcon A contact lenses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Safety and Efficacy of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to
      evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers
      and patients with chronic kidney disease.

      48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease
      will be enrolled in Part B.
    


Intervention name(s): DDO-3055; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
Condition: Randomized Versus Placebo; Controlled; Double Blind
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Clinical intervention on overweight or moderately obeses adults. The objective of this trial
      is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a
      low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in
      cardiometabolic risk factors through the intervention have been evaluated as secondary
      endpoints
    


Intervention name(s): Alpha-galacto-oligosaccharides
Intervention type(s): Dietary Supplement
Intervention description(s): 6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment