bioihbjkbjnl/mcl2 huggingface dataset:
Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is
      characterized by a pain in the lateral epicondyle of the humerus and the common extensor
      tendon. The incidence of LE is approximately one to three percent of general population. LE
      is mostly the result of the overuse and repetitive movements of wrists and hands because of
      occupational or recreational activities. Diagnosis depends on clinical symptoms, history and
      physical examination including manual provocation tests. Magnetic resonance imaging,
      ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not
      response to conservative treatments. It is known that the radial nerve cross sectional-areas
      (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal.
      There is insufficient evidence to prove the superiority of any of conservative treatments to
      the others in patients with LE. The literature indicates that Kinesio taping decreases pain
      intensity, recovers grip strength, and improves functional status in patients with LE. The
      investigators design a randomized, single-blind, controlled trail to evaluate the effects of
      Kinesio taping both clinical and using ultrasonography.
    

Detailed description: 
      After obtaining written informed consent, patients of clinically diagnosed with LE are
      randomized into intervention and control group. To all patients, activity modification is
      suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in
      intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6
      sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the
      Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs.
      The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the
      treatment.
    

Intervention name(s): Kinesio Tape; oral naproxen
Intervention type(s): Other; Drug
Intervention description(s): To all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions.; 750 mg/day oral naproxen is administered for 10 days.
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study
Condition: Late Life Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Background: Depression in the elderly, also known as late life depression (LLD) is common and
      its prevalence ranges from 2 to 6% in the community. Heart Rate Variability (HRV), a
      physiological autonomic variable is reduced in LLD and this might have implications for
      cardiovascular events including death. Methods to improve HRV in LLD have not been adequately
      assessed. Automatic Self-Transcending Meditation (ASTM) is a simple yet powerful technique
      that allows the mind to become calm and peaceful. HRV biofeedback is a method of teaching
      individuals to voluntarily improve HRV and other physiological functions to a prescribed
      range.This pilot study attempts to investigate feasibility of these interventions and provide
      preliminary data regarding the effectiveness of these techniques.

      Hypothesis: ASTM and HRV biofeedback are feasible and their effectiveness for improving HRV
      in patients with LLD can be assessed.

      Methods: Participants with LLD between the ages of 66 and 80 will be randomized to either
      ASTM or HRV biofeedback after optimizing them on antidepressant therapy. Participants will
      receive training and continue practice in either of these techniques over a period of twelve
      weeks. HRV and secondary measures will be assessed pre and post at the end of study period.

      Expected Results and Significance: The investigators expect to find both techniques to be
      feasible treatments for those with LLD. Results from this pilot study will help to assess the
      potential for successful implementation of a future larger study which will evaluate the
      efficacy of these treatments for improving HRV.
    


Intervention name(s): HRV biofeedback; ASTM
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Automatic Self Transcedental Meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart rate variability biofeedback; automatic self transcedental meditation
Maintenance Treatment for Abstinent Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and cost-effectiveness of long-term
      pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate
      associated with stopping smoking.
    

Detailed description: 
      The goal of this study was to assess relapse prevention outcomes among individuals able to
      stop smoking when pharmacotherapy is extended beyond the standard duration of treatment. We
      hypothesized that maintenance treatment with prolonged bupropion use and/or "as needed" use
      of nicotine gum will reduce relapse to smoking. Participants were recruited through
      advertisements on radio, television, newspapers, the Internet, and various community outlets.
      Respondents were pre-screened by telephone using a standard interview. The first participant
      entered the OLT phase in February 2001; the final NTFU visit took place in October 2005.

      The study was multi-phased consisting of: 1) eight-week open-label treatment (OLT) with
      bupropion and nicotine patch; 2) randomized double-blind assignment of OLT successes to 16
      weeks of placebo-controlled maintenance treatment (MT); and 3) 24 weeks of non-treatment
      follow-up (NTFU). Participants received $25 compensation for completing the NTFU visits at
      Weeks 36 and 48. The Institutional Review Board of the New York State Psychiatric Institute
      approved the study. The study was performed at the Columbia University Medical Center Smoking
      Cessation Clinic in New York City.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Maintenance treatment; Smoking relapse; Bupropion; Nicotine replacement
A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes
Condition: IDDM
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This research project will investigate the effects of pramlintide (Symlin) given by
      continuous subcutaneous (under the skin) infusion throughout the day and night, along with
      meal doses similar to those injected during conventional pramlintide (Symlin) treatment,
      delivered using a second insulin pump, in subjects with inadequately controlled type I
      diabetes mellitus who are already using insulin pump therapy. Study participants will wear
      two pumps for a four month period, taking insulin in their usual manner and pramlintide
      (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three
      occasions during the study to assess blood glucose responses to continuous pramlintide
      (Symlin) treatment.
    

Detailed description: 
      DESCRIPTION OF STUDY:

      To participate in the study, you must have Type I diabetes mellitus and be taking insulin
      using an insulin pump, and have a hemoglobin A1c level between 7.0% and 10.0%. You will not
      be permitted to participate in the study if you have taken pramlintide (Symlin) during the
      previous three months. The study will consist of seven visits to the Study Center over a
      four-month period. Subjects will undergo meal tolerance testing at beginning and end of study
      period. Continuous blood glucose monitoring will be performed on three occasions during the
      study.

      Pramlintide will be begun at a single basal rate of 1.5 units/hr. Bolus therapy will be begun
      thereafter per standard manufacturer protocol. Subjects will be monitored for three months on
      basal-bolus pramlintide therapy.
    

Intervention name(s): Continuous Pramlintide infusion
Intervention type(s): Drug
Intervention description(s): pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
Other intervention name(s): pramlintide
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; insulin; pramlintide; IDDM
Effectiveness of a Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
Condition: COVID-19; Physical Therapy Modalities; Telerehabilitation; Primary Health Care
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The evolution of Coronavirus disease 2019 (COVID-19) pandemic makes it more necessary the
      intervention of Primary Health Care Physiotherapy Units in patients with respiratory and/or
      functional sequelae after suffering from SARS-CoV-2 (acute respiratory sindrome by
      coronavirus) virus infection.

      Since some months ago, Primary Health Care use telerehabilitation tools to connect patients
      and health care professions while maintaining social distancing and restrictions.
      Tele-physiotherapy is a field of physiotherapy which has the advantage of providing physical
      therapy interventions to patients' complications after COVID-19 by using a videoconferencing
      method. The aim of this study is to evaluate the effectiveness of a multimodal Physical
      Therapy telerehabilitation program in persistent post COVID-19 symptoms in Primary Health
      Care.
    

Detailed description: 
      Coronavirus disease 2019 (COVID-19), is a multisystem infectious disease which has led to a
      global pandemic. The evolution of COVID-19 disease makes it more necessary the intervention
      of Primary Health Care Physiotherapy Units in patients with respiratory and /or functional
      sequelae after suffering from SARS-CoV-2 infection. Problems such as breathlessness, exercise
      intolerance and loss of peripheral muscle strength can be observed in individuals who have
      been diagnosed with persistent post COVID-19.

      Since some months ago, Primary Health Care use telerehabilitation tools to connect patients
      and health care professions while maintaining social distancing and restrictions.
      Tele-physiotherapy is a field of physiotherapy which has the advantage of providing physical
      therapy interventions to patients' complications after COVID-19 by using a videoconferencing
      method. The aim of this study is to evaluate the effectiveness of a multimodal Physical
      Therapy telerehabilitation program in persistent post COVID-19 symptoms in Primary Health
      Care.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): A Tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility.
Other intervention name(s): Therapeutic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly allocated to Tele-physiotherapy or control groups.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; Physical Therapy; Telerehabilitation; Primary Health Care
A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy
      and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry
      Eye Disease
    


Intervention name(s): Reproxalap Ophthalmic Solution (0.25%); Vehicle Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention description(s): Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days; Vehicle Ophthalmic Solution dosed six times over two consecutive days
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry eye disease; reproxalap; Aldeyra; ADX-102
Plasma Exchanges in Multiple Sclerosis (MS) Relapses
Condition: Multiple Sclerosis; Multiple Sclerosis, Acute Relapsing
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual
      disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used
      but there is no established evidence of their efficacy.
    

Detailed description: 
      Multiple sclerosis (MS) relapses are usually treated by steroids but some patients did not
      respond well to this treatment. In more than 40 % of MS patients experiencing relapses,
      residual disability accumulates in spite of steroid treatment and did not recover. Plasma
      exchanges (PE) are frequently used to treat the severe attacks of inflammatory demyelination
      in the central nervous system resistant to steroids (Tumani, 2008). This strategy has been
      evaluated so far only in few studies. Only one randomized controlled study has been performed
      (Weinshenker et al, 1999) including patients with very severe attacks of inflammatory
      demyelinating diseases of various origin (MS, acute transverse myelitis, acute disseminated
      encephalomyelitis, neuromyelitis optica), not improved after a treatment by steroids. A
      moderate or important improvement of incapacity was observed in 8 cases out of 19 (42.1%)
      after treatment by PE against 1 out of 17 (5.9%) after sham treatment. This study concerned
      only 12 patients having a relapse of MS. Based on this first controlled study and the
      experience of treatment of 42 MS patients in the department of Neurology of the University
      Hospital Pellegrin (CHU de Bordeaux) we designed a randomized controlled study of PE against
      sham PE in moderate to severe acute exacerbations of MS not responding to steroid treatment.

      The purpose is to compare plasma exchanges versus sham exchanges on residual disability in MS
      patients with a demyelinating inflammatory episode (MS or syndrome with high risk of MS)
      experiencing a disabling relapse not improved after steroid treatment. The primary end-point
      will be evaluated one month after start of therapy. Secondary endpoints include safety and
      evaluation of improvement at 3 and 6 months and evaluation of safety
    

Intervention name(s): plasma exchange; sham exchanges procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): 6 plasma exchange each 48 hours during 2 weeks after randomization; 6 sham exchanges each 48 hours during 2 weeks after randomization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: multiple sclerosis; plasma exchange
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
Condition: Erosive Esophagitis; GERD
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive
      esophagitis and resolution of heartburn.
    


Intervention name(s): Ilaprazole; Lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): 20mg/Tap, QD; 30mg/Tap, QD
Other intervention name(s): Noltec
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Erosive Esophagitis; Ilaprazole; GERD
Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain
Condition: Abdominoplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after
      mini-abdominoplasty
    

Detailed description: 
      This is a randomized, double-blind, study to evaluate the safety, PK profile of CPL-01 for
      the management of postoperative pain after mini-abdominoplasty surgery.
    

Intervention name(s): CPL-01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CPL-01 will be administered; Placebo will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
Condition: Mania; Hypomania; Cocaine Abuse; Cocaine Dependence
MeSH terms: Mania; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to determine if a citicoline supplement is associated with a
      reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder
      marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar
      type (a psychotic disturbance in which there is a mixture of schizophrenic and
      manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore
      if citicoline supplements are associated with greater improvement in symptoms of mania and on
      memory and cognition (the mental faculty of perception, reasoning, and judgement) in these
      patients.
    

Detailed description: 
      Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after
      completing an Institutional Review Board (IRB)-approved informed consent process. Baseline
      evaluation included a medical and psychiatric history, structured diagnostic interview using
      Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of
      Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and
      cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but
      equivalent versions of the RAVLT were used to minimize practice effects with repeated
      administration. Cocaine use was assessed at each biweekly visit with urine drug screens.
      Citicoline or placebo was given beginning at one tablet (500 mg)/day with an increase to two
      tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4, and four tablets
      (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.
    

Intervention name(s): Citicoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Citicoline or placebo will be given beginning at one table (500mg)/day with an increase to two tablets (1000mg)/day at week 2, three tablets (1500mg)/day at week 4 and four tablets (2000mg)/day at week 6. Patients will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects.; Placebo matching active medication in all other aspects.
Other intervention name(s): Cytidine-5'-diphosphocholine; CDP-choline; Identical placebo
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18
      through 49 years of age with no history of pneumococcal vaccination will be randomized in a
      2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
      13vPnC.
    


Intervention name(s): 20vPnC; 20vPnC; 20vPnC; 13vPnC
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 20vPnC; 20vPnC; 20vPnC; Pneumococcal conjugate vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Sitting Meditation and Hatha Yoga in Adolescents
Condition: Anxiety; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present study was a randomized controlled trial that explored the feasibility,
      acceptability, and effectiveness of short-term mindfulness training among adolescents. The
      primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress
      Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and
      mindfulness. The influence of daily home practice compliance on intervention outcomes was
      also examined.
    

Detailed description: 
      The present study was a randomized controlled trial that explored the feasibility,
      acceptability, and effectiveness of short-term mindfulness training among adolescents. The
      primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress
      Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and
      mindfulness. The influence of daily home practice compliance on intervention outcomes was
      also examined. Participants (N = 198 adolescents) were recruited from a large public middle
      school in southern California. Participants were randomly assigned to sitting meditation,
      hatha yoga, or a waitlist control group. Participants were asked to complete a computerized
      working memory task, and self-report measures of perceived stress, anxiety, and mindfulness
      at pre- and post-intervention/waitlist, as well as one-month follow-up. A series of
      mixed-design analyses of variance (ANOVAs) were used to examine changes in working memory,
      stress, anxiety, and mindfulness between groups at pre- and post- intervention.
    

Intervention name(s): Sitting Meditation; Hatha yoga
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4 weeks Sitting Meditation; 4 weeks of Hatha yoga
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness; adolescents; working memory; stress; anxiety