bioihbjkbjnl/mcl2 huggingface dataset:
Physiotherapy in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis symptoms can be managed with non-drug treatments such as patient education,
      exercise or weight loss interventions. Cryotherapy is one of the effective method to reduce
      joint inflammation, pain and improve function. Another method is joint mobilization, which
      can also reduce pain and improve function. Based on this theory, it was hypothesized that
      cryotherapy will have better effect on pain and the quality of life, whereas joint
      mobilization will be more effective on knee function. The aim of the study was to compare the
      effects of different physiotherapy methods on pain, knee joint function and quality of life
      in individuals with osteoarthritis.
    

Detailed description: 
      Study included 63 participants with knee osteoarthritis. All subjects were randomly assigned
      to one of 3 groups: exercise group (n=21), exercise + cryotherapy group (n=21), or exercise +
      joint mobilization group (n=21). VAS scale was used to assess the pain, quality of life was
      evaluated with Short Form 36 Health Survey Questionnaire (SF-36) questionnaire, knee ranges
      of motion were measured using a goniometer, strength of the muscles was assessed on the
      Oxford 5 point scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
      was used to evaluate knee osteoarthritis. All the participants received 30 intervention
      sessions.
    

Intervention name(s): Therapeutic exercise; Exercise + cryotherapy; Exercise + joint mobilization
Intervention type(s): Other; Other; Other
Intervention description(s): 32 sessions in total, 2 times a day, 30 min. one session. Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.; Exercise program - 16 sessions in total, once a day, 30 min. one session. Cryotherapy - 8 sessions in total, two-three times a week, one session - 2 min. duration, temperature -60 to -140 C degrees.
Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.; Exercise program - 16 sessions in total, once a day, 30 min. one session, two-three times a week.
Joint mobilization - 8 sessions in total, anterior - posterior tibia femoral glide, patella motion, lateral and medial movement.
Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: knee function; womac; quality of life; joint mobilization; physiotherapy
Multi-device Testing for Autonomic Nervous System Stimulation
Condition: Vagus Nerve Stimulation
Study type: Interventional

Summary: 
      The Vagus nerve (VN) serve as an "unconscious inner brain" that integrates messages from the
      body and provides metabolic homeostatic regulation to various organs.In this study the
      investigators want to compare different ways to stimulate the vagus nerve to assess their
      respective effects compared to a sham stimulation.

      Each participant will be exposed in a random way to 7 different ways to stimulate the VN:

        -  Manual Head Massage

        -  Mechanical Head Massager (BREO Inc. Helmet)

        -  Low laser Therapy (LLT)

        -  Sham LLT

        -  Transcutaneous Electrical Nervous Stimulation (TENS) ear stimulation (as testing phase
           prototype device)

        -  Deep and slow breathing (as testing intervention based on video app)

        -  Relaxed reading time (as control situation)

      Therefore, within the same design the investigators want to conduct two separate studies that
      should lead to two separate publications:

        -  Study 1: comparison of manual head massage to mechanical Helmet massager and relaxed
           reading

        -  Study 2: comparison of LLT with sham LLT and relaxed reading

      The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely
      observational to gain knowledge in context of a convenient design.
    

Detailed description: 
      OBJECTIVES Overall objective is to assess the respective effects of the different ways to
      stimulate the Vagus Nerve on the Heart Rate Variability (HRV) parameters: High Frequency
      (HF), Low Frequency (LF), Total Power (TP), Heart rate (HR), and blood pressure (BP).

      Specific objectives:

        -  Comparison of Manual Head Massage to Mechanical Head Massager to Control situation

        -  Comparison of Low Laser Therapy (LLT) to sham LLT to control situation

        -  Effects of TENS ear stimulation (descriptive)

        -  Effects of Deep and Slow breathing (descriptive)
    

Intervention name(s): Manual Head Massage; BREO Helmet Massager; Low Laser Therapy (LLT); Sham LLT; TENS ear stimulation; Deep and Slow breathing; Relaxed Reading time
Intervention type(s): Other; Device; Device; Device; Device; Behavioral; Behavioral
Intervention description(s): Duration 10 minutes.; Duration 10 minutes.; Duration 7 minutes.; Duration 7 minutes.; Duration 7 minutes.; A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.; Duration 10 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: It is a crossover randomized trial where each participant is exposed to one of the 7 types of intervention, allocated randomly. Up to 20 healthy volunteers will be recruited.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parasympathetic Nervous System; Vagus Nerve Stimulation; Head Massage; Low Laser therapy
A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects
      who were given aged garlic powder over a period of 12 weeks. We measured serum lipids,
      including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL)
      cholesterol, and triglycerides, and monitored their blood pressure.
    

Detailed description: 
      An increased serum cholesterol level is an important risk factor for the development of
      cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through
      dietary modification, behavioral changes, and medicinal intervention has already
      substantially decreased the incidence and mortality from cardiovascular and cerebrovascular
      disease. Supplementation of the diet with certain biofactors may further reduce such risk
      factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence
      of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing
      platelet responsiveness to activating agents.
    

Intervention name(s): Aged garlic powder; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Aged garlic powder(6.0g/day); Placebo powder(6.0g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Aged garlic; Hyperlipidemic; LDL; HDL; Triglyceride
Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Observational

Summary: 
      Small bowel involvement is still recognized to be associated with great morbidity and
      mortality in SSc patients, leading particularly to malabsorption and intestinal
      pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported
      to be one of the most common causes of death.

      In a previous prospective study, we have demonstrated the high prevalence of small intestinal
      involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc
      patients had upper intestinal motor disturbances. However, to date, no authors have yet
      analyzed the course of upper intestinal motor dysfunction in SSc.

      The aims of this study were therefore to assess the 5-year course of small bowel motor
      disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for
      an association between upper intestinal motor dysfunction outcome and other clinical
      manifestations of SSc.
    


Time perspective: Prospective
Intervention for the Promotion of Gratitude
Condition: Affect
Study type: Interventional

Summary: 
      This study aims to analyze the effects of a psychological intervention to promote wellbeing.
      To do so, a brief intervention is developed to enhance a sense of gratitude through a
      multiple baseline across components design. Traditional measures will be used together with
      the incorporation of a novel evaluation methodology such as the EMA, which allows the
      collection of data in the context of people's daily lives and at different specific times,
      that is, in real time.
    


Intervention name(s): Psychological intervention for the promotion of gratitude
Intervention type(s): Behavioral
Intervention description(s): A brief intervention protocol has been developed for the promotion of gratitude. The protocol is manualized and the content will be explained to each participant in the videoconference sessions, and a copy of the manual will be given (or sent) to the patients at the end of the therapy sessions.
The structure and contents of the intervention are summarized below:
Psychoeducation about gratitude and its effects on health (both physical and psychological).
Gratitude towards life:
Gratitude walk
Three positive things
Sharing gratitude
Social gratitude:
Daily thanks to others
Gratitude letter
Proof of gratitude
Self-gratitude: this part includes an exercise aimed at fostering self-gratitude in three different areas:
Gratitude for the things I do to take care of my physical health.
Gratitude for what I do to take care of my mental health, my self-esteem and my personal development.
Gratitude for what I do to take care of others.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gratitude; Wellbeing; Positive affect; Ecological momentary assessment
Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback.
Condition: Hypertension; Coronary Disease; Cardiac Diseases
MeSH terms: Coronary Disease; Heart Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the efficiency of a minimal intervention on risk
      perception of physical inactivity in patients with known coronary heart disease (CHD) and
      patients at risk for CHD. Therefore half of the patients (intervention group) get a personal
      feedback on their individual level of physical activity measured by pedometers and
      self-report questionnaires plus information about the risk factor 'physical inactivity' for
      heart diseases. Following the hypotheses the feedback should increase the patients risk
      perception of physical inactivity and furthermore increase physical activity.
    


Intervention name(s): Patient-targeted individual physical-activity-feedback; Pedometer
Intervention type(s): Behavioral; Device
Intervention description(s): At cardiac consultation receive an individual feedback on their personal physical activity level.; Patients receive a pedometer two weeks prior to cardiac consultation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: physical activity; patient feedback; risk perception; pedometer
Urdu Version of National Institutes of Health Stroke Scale: Reliability and Validity Study
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The goal of this study was to translate and culturally adapt NIHSS into Urdu language and to
      evaluate its reliability and validity in Pakistani stroke population. Also assess its
      correlation with Glasgow Coma Scale, Modified Rankin Scale and Barthel Index for severity and
      location of post-stroke impairment.
    

Detailed description: 
      As per preceding commendation, NIHSS has been translated into Urdu language from its English
      version and adapted culturally in Pakistan. Among stroke population, NIHSS-U has been
      administered in 225 patients recruited by convenience sampling technique under the
      pre-defined inclusion and exclusion criteria after signing consent forms. For testing
      inter-observer reliability and intra-observer reliability of NIHSS-U, GCS, mRS, and BI,
      questionnaires has been administered by two observers, on the same day, with a time interval
      of 2 hours between 1st and 2nd administration. As for the 3rd administration, it has been
      carried out after seven days by the first observer (re-testing), for intra-observer
      assessment. SPSS software version 24 has been used for the purpose of data entry and
      analysis. Internal consistency has been analyzed with Cronbach alpha value. Test-retest
      reliability has been assessed by using an intraclass correlation coefficient (ICC). The
      NIHSS-U has evaluated for content validity, construct validity, criterion validity and
      responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We targeted the Pakistani stroke population with post-stroke impairments in our study.
      
Keywords: Stroke; Urdu version of National Institute of Health Stroke Scale; Reliability and Validity Study.; Glasgow Coma Scale; Modified Rankin Scale; Barthel Index
Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety
      of valaciclovir (VACV) in the adult and pediatric HSCT patients.
    

Detailed description: 
      This clinical study is a multicenter open-label study on the adult and pediatric
      hematopoietic stem cell transplantation (HSCT) patients. The primary objective is to confirm
      the preventive efficacy for herpes simplex virus (HSV) infection of 256U87 (VACV:
      valaciclovir) due to the treatment before or immediately after hematopoietic stem cell
      transplantation. The secondary objective is to confirm the safety of VACV in the case of its
      use for such a purpose.

      This clinical study consists of the following two periods: the screening period lasting 7
      days at the longest and the administration period from 7 days before HSCT to 35 days after
      HSCT (43 days in total). During the administration period, adult patients are orally given a
      VACV tablet twice daily, while pediatric patients are orally given VACV granules twice daily
      at a dose of 25 mg/kg b.w. (maximum dose per treatment: 500 mg). Pediatric patients weighing
      40 kg or over may be orally given a VACV tablet twice daily.
    

Intervention name(s): VACV tablets (Adults or pediatrics) or granules (pediatrics)
Intervention type(s): Drug
Intervention description(s): A white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor.
Other intervention name(s): 256U87 tablet or granule
Intervention MeSH terms: Valacyclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Herpes simplex infection; valaciclovir; herpes simplex virus; hematopoietic stem cell transplantation
Acute Effects of Beetroot Juice on Isometric Knee Extension Strength, Explosive Strength and Local Muscular Endurance
Condition: Healthy Adults
Study type: Interventional

Summary: 
      This is a double-blind placebo-controlled cross-over trial that aims to determine the acute
      effect of beetroot juice ingestion on isometric knee extension strength, explosive strength
      and local muscular endurance.
    

Detailed description: 
      The study aims to determine whether concentrated beetroot juice has an acute effect on
      isometric strength of the knee muscles and the rate of force development in knee extension,
      as well as endurance of the same muscle. This will be a cross-over study. 20 subjects will be
      randomly selected to the experimental group or control group; after 1 week, participants will
      repeat the measurements in the other condition. Subjects will consume 140 ml of beetroot
      juice extract 2.5 hours before the measurement or placebo (140 ml of blackcurrant juice with
      added appropriate amount of sugar to equalize the carbohydrate value and lemon juice fort the
      taste). An isometric dynamometer will be used to measure the isometric strength of the knee
      extensors. Investigators will quantify peak force, rate of force development, endurance of
      knee extensors at 50 % of the maximal force, and the force recovery after a fatiguing
      protocol.
    

Intervention name(s): Beetroot juice concentrate (140 ml); Blackcurrant juice (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A beetroot juice concentrate (140 ml) will be administered to participants in experimental conditions.; 140 ml of blackcurrant juice with added appropriate amount of sugar to equalize the carbohydrate value and lemon juice fort the taste.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: isometric strength; beetroot; nitrates; local muscle endurance; supplementation
Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Interventional

Summary: 
      This is a randomized, controlled study that will compare two medication adherence strategies
      in adults with moderate or severe persistent asthma as a method for improving or maintaining
      treatment adherence.
    

Detailed description: 
      Low-income minority adults have excessively high rates of morbidity from asthma. Poor
      medication adherence has been documented in these individuals and contributes to the high
      morbidity level. This study will compare a Problem Solving intervention with an Attention
      Control intervention to improve and sustain asthma self-management in a clinical setting.
      This study will include strategies to address contextual factors related to adherence.
      Participants will be recruited from clinics that serve minority and low-income individuals.
    

Intervention name(s): Problem Solving; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Problem solving intervention; Attention control intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
Condition: Pain Management
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This study looks at the effect of combined breathing-controlled electrical stimulation
      (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after
      spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of
      combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the
      study in a population of spinal cord injury patients. Note that this study will also enroll
      healthy volunteers, brain injury patients, and amputation patients and that this study as
      applied to these other populations will be covered in separate ClinicalTrials.gov records.
    


Intervention name(s): BreEStim; tDCS; tDCS sham
Intervention type(s): Device; Device; Device
Intervention description(s): BreEStim will applied for 10 to 20 minutes.; tDCS will be applied for 20 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dysport in the Treatment of Glabellar Lines in Chinese Subjects
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to demonstrate the efficacy of Dysport for the improvement in
      appearance of moderate to severe glabellar lines and to assess the short term and long term
      safety of Dysport, used for the improvement in appearance of moderate to severe glabellar
      lines in Chinese subjects.
    

Detailed description: 
      The first treatment cycle will be double blind and subjects will be randomised to receive
      Dysport, Botox or placebo. After the first treatment cycle, all subjects will receive a
      maximum of four treatment cycles with Dysport, occurring at intervals of no less than 84 Days
      (12 weeks) between each treatment cycle, depending upon individual duration of response to
      Dysport treatment.
    

Intervention name(s): Botulinum toxin type A; Botulinum toxin type A; Placebo; Placebo
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): 50 Units; 20 Units
Other intervention name(s): AbobotulinumtoxinA (Dysport®); OnabotulinumtoxinA (Botox®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment