bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Kinesio Taping in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis is the most common kind of arthritis that occurs due to degeneration of
      the joint articular cartilage, producing pain, stiffness, and impaired movement. Kinesio
      taping is a simple and inexpensive therapeutic procedure that can help with knee
      osteoarthritis symptoms. Kinesio taping is a high-stretch elastic adhesive material that
      allows the treated area to have free mobility. This technique was preferred by physical
      therapists for knee osteoarthritis rehabilitation because of its positive effects, such as
      decreased pain and increased mobility and muscular performance.
    


Intervention name(s): KINESIO TAPING; CONVENTIONAL PHYSICAL THERAPY
Intervention type(s): Procedure; Device
Intervention description(s): Kinesio taping The patient is in a supine position with full knee flexion. Prior to application, the skin surface was cleaned. This technique involved the use of two Y-cut strips and two I-cut strips.; Transcutaneous Electrical Nerve Stimulation TENS device settings, such as the frequency of 32-50 Hz, pulse width of 80 ms, and symmetrical biphasic waveform. The surface electrodes were placed on the medial and lateral superior borders of the patella, as well as the medial and lateral inferior borders of the patella.
Exercise therapy program The total duration of each exercise session was about 50 minutes, including warm-up-10 minutes, resistance exercise-20 minutes, balance and stability exercise-10 minutes, lower-limb stretching exercise-5 minutes, and cool-down exercise-5 minutes. The same assigned physical therapist supervised all of the sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee; Osteoarthritis; Kinesio taping; TENS; Stretching; Strengthening exercise
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy
      of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise
      hearing impairment.
    


Intervention name(s): OTO-413; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF); Single intratympanic injection of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hearing loss; speech-in-noise; synaptopathy; hearing impairment; hidden hearing loss
Vitamin K Supplementation in Post-Menopausal Osteopenia
Condition: Post-Menopausal Osteoporosis; Post-Menopausal Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily
      over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.
    

Detailed description: 
      Osteoporosis is major cause of morbidity and mortality in Canadian postmenopausal women. It
      is a systemic disease characterized by low bone mass and deterioration of bone
      microarchitecture, resulting in bone fragility and an increased risk of fractures. One in six
      women over the age of 50 have osteoporosis. The lifetime risk of an osteoporotic fracture for
      an average 50 year-old Canadian woman is >40%. The annual health care costs for osteoporotic
      fractures in Canada have been estimated to exceed $1.3 billion.

      Recent data suggest that vitamin K supplements may decrease bone loss and prevent fractures.
      Vitamin K is a co-factor of gamma-glutamyl carboxylase, an enzyme that catalyzes the
      gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin.
      Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo
      studies in animals. Vitamin K levels are low in individuals with osteoporosis and in patients
      with osteoporotic fractures. The few studies examining vitamin K supplementation in humans
      have showed promising results with no significant side effects, but these studies had
      significant methodological shortcomings such as inadequate sample size and lack of
      randomization.

      The primary objective of our study is to examine whether vitamin K supplementation will
      increase bone mineral density in postmenopausal women with osteopenia. Our secondary
      objectives are to examine the possible adverse effects from long-term vitamin K
      supplementation, to investigate whether vitamin K will decrease risk of fractures and to
      determine if vitamin K affects quality of life. Our hypotheses are that vitamin K increases
      bone mineral density in postmenopausal women, and that there are no significant adverse
      effects from vitamin K supplementation.
    

Intervention name(s): vitamin K1 (phylloquinone); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 pill daily
Intervention MeSH terms: Vitamin K; Vitamin K 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin K; bone mineral density; post-menopausal women; randomized double blind placebo controlled trial; osteoporosis; women's health
Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea of Adult
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      In previous review study, it was hypothesized that a comprehensive rehabilitation can combine
      both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA
      patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a
      comprehensive rehabilitation model is of innovative care strategy in this study.
    

Detailed description: 
      BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder,
      which was characterized by repetitive events of complete and partial obstructions of the
      upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including
      upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal
      muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed
      for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal
      exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation
      capability in addition to oropharyngeal function.

      OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and
      biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect
      and biomarker of inflammation expression as biological effect.

      METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into
      intervention group (N=15) and control group (N=15). In intervention group, a
      12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle
      training, threshold respiratory muscle training, and therapeutic exercise.

      ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects
      and biological effects of our comprehensive rehabilitation model. Therefore, the further
      studies should emphasize the methods to differentiate diagnosis for the indicated patients
      with oropharyngeal muscle dysfunction or ventilatory drive instability.
    

Intervention name(s): comprehensive rehabilitation
Intervention type(s): Behavioral
Intervention description(s): oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; oropharyngeal rehabilitation; cardiopulmonary rehabilitation
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      To obtain safety and tolerability information in patients with type 1 diabetes where
      Dapagliflozin is added on to Insulin (for 14 days)
    

Detailed description: 
      Study Classification : Safety, Pharmacokinetics and Pharmacodynamics
    

Intervention name(s): Dapagliflozin; Placebo matching Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 1 mg, Once daily, 14 days; Tablets, Oral, 0 mg, Once daily, 14 days
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      The purpose of this randomized, controlled trial is to estimate the safety of early weight
      bearing on post ankle surgery.

      Patients who are indicated to have surgery for unstable ankle fractures by an attending
      trauma physician will be consented for participation in the study. After surgery patients
      will be randomized to either weight bearing as tolerated at two weeks with a cam boot or
      non-weight bearing with a cam boot. Randomization will be performed by number allocation with
      odd numbers in the early weight bearing group and even numbers in the non-weight bearing
      group. The surgeon will be blinded to this until after the surgery. The patients will all be
      placed in a short leg cast post operative and made non-weight bearing for 2 weeks until
      sutures are removed which is current standard treatment. Both groups will be asked to
      initiate weight bearing at two weeks post operatively by wearing a cam boot that is non
      weight bearing in a cam boot, the latter being standard treatment.
    


Intervention name(s): Early Weight bearing + Cam Boot; Non-Weight Bearing + Cam Boot
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be transitioned to weight bearing as tolerated in a cam boot.; Subject will be transitioned to non weight bearing cam boot, standard treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Orthopedic; Post-operative; Weight bearing; Range of motion
Acupuncture for Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess whether acupuncture is more effective than artificial
      tear drop in the treatment of dry eye.
    

Detailed description: 
      Dry eye is one of the common diseases in ophthalmology. It affects not only patients' daily
      activities such as reading, carrying out professional work, using the computer, watching
      television, and driving, but also bodily health conditions such as bodily pain, discomfort
      and lower energy and vitality.

      Currently, artificial tears are easily subscribed or used in the shape of OTC drugs. However,
      preservatives in artificial tears may exacerbate ocular surface inflammation and the safety
      of anti-inflammatory treatment is not well established.

      Acupuncture, one of the most popular CAM interventions, showed some favourable effects over
      artificial tears for dry eye in several randomised controlled trials (RCTs). The evidence
      obtained from these trials is quite limited because all of these RCTs were conducted under
      high risk of biases. Therefore, well-designed RCTs are needed to establish the efficacy of
      acupuncture for dry eye.

      In a clinical trial, cost-effectiveness and qualitative researches can be carried out
      parallely. Through this kind of mixed method approaches, various compartments, consisting
      acupuncture treatment effects are able to be revealed totally.

      In this context, the investigators designed a multi-center randomized controlled trial,
      comparing acupuncture treatment and artificial tear drop with immunoassay for the change of
      tear cytokine concentration, cost effectiveness study and qualitative research in a mixed
      method approach.
    

Intervention name(s): Acupuncture; Refresh Plus
Intervention type(s): Device; Drug
Intervention description(s): Participants, allocated to this group, will have twelve times of acupuncture treatment in four weeks. Seventeen acupuncture points, which are both BL2, GB14, TE23, Ex1, ST1, GB20, LI4, LI11 and single GV23, will be selected and disposable 0.20*30mm acupuncture needles(Dongbang Co., Korea) will be inserted on these points. Strong 'deqi' sensation will be induced by twisting acupuncture needles and retained for 20 minutes before removed.; Participants, allocated to this group, will be offered preservative-free and single-use Refresh plus (Sodium carboxymethylcellulose). They should use artificial tear in both eyes at least once a day for four weeks.
Other intervention name(s): Brand name: ALLERGAN
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Dry eye; Artificial tear drop; Mixed method approach; Qualitative study; Cost effectiveness analysis; Tear cytokine analysis
Cervix Monitor for Elasticity and Length Measurements
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Preterm birth is a leading global cause of neonatal mortality despite of numerous advances
      and intensive research in perinatal medicine. Almost one million children die each year due
      to complications of preterm birth and in almost all countries with reliable data, preterm
      birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of
      disability, including learning disabilities, visual and hearing impairments. Spontaneous
      preterm delivery (SPTD) is often multi factorial event, precocious cervical softening,
      shortening and dilatation are a common denominator. The majority of preterm births happen
      spontaneously, though some are due to early induction of labor or cesarean birth, typically
      due to medical maternal of neonatal conditions.
    

Detailed description: 
      The uterine cervix has to provide structural integrity and mechanical resistance to ensure
      normal development of the fetus as the uterus expands to accommodate the fetus growth.
      Preterm delivery is closely related to a premature cervical ripening. The scientific bases
      for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter
      characterizing the stage of cervical ripening. The main component of the cervix tissue is a
      collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen
      cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of
      the cervical tissue. Therefore, assessment of cervix by a device measuring cervical
      elasticity and cervical length appears to be and adequate approach for identifying pregnant
      women at high risk of spontaneous preterm delivery. The primary cervical elasticity
      assessment currently used in clinical practice is relying on the evaluation of the cervix as
      "hard, medium or soft". In the scope of this project the investigators propose to develop and
      clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix
      conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the
      applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix
      length .
    

Intervention name(s): Measurement
Intervention type(s): Other
Intervention description(s): Measurement of cervix elasticity and length measurements is not an intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Conditions precluding patients from participation are listed in the study exclusion
        criteria below. In addition, cognitively impaired patients will not be asked to
        participate. No patients will be excluded on the basis of race.
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective of this study is to compare the two therapy regimens with regard to renal
      function by using calculated creatinine clearance. The secondary objectives are to compare
      the efficacy and safety profiles of the two therapy regimens.
    

Detailed description: 
      This phase III study shall provide detailed efficacy and safety information to compare this
      combination of sirolimus and tacrolimus with the current standard tacrolimus combination
      regimen (tacrolimus/MMF/steroids) which is widely used in European centres.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): immunosuppression
Other intervention name(s): Prograf, FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tacrolimus; Kidney Transplantation; Immunosuppression; Adult; Treatment Outcomes
Hypotensive Anesthesia With Sleeve Gastrectomy
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive
      at the end
    

Detailed description: 
      to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive
      at the end of the operation to check bleeding
    

Intervention name(s): hypotensive anesthesia; normotensive anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): hypotensive anesthesia; normotensive anesthesia group
Intervention MeSH terms: Antihypertensive Agents; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the effects of oral roflumilast with placebo on lung
      function in patients with asthma.
    


Intervention name(s): Roflumilast
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy
Condition: Airway Complication of Anesthesia
Study type: Interventional

Summary: 
      The main objective of this study was to investigate whether propofol assisted extubation
      could reduce the incidence of respiratory adverse events in children with tonsil
      adenoidectomy.
    

Detailed description: 
      In pediatric surgery, the incidence of perioperative respiratory adverse events in children
      undergoing tonsillectomy is higher than that of general surgery. Studies have shown that
      intravenous induction can reduce perioperative respiratory adverse events compared with
      inhalation induction. There are also literatures that show that intravenous anesthesia can
      significantly reduce cough and hemodynamic reactions during the wake period compared with
      balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth
      of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of
      respiratory adverse events has not been compared between intraoperative sevoflurane
      maintenance and extubation with a small amount of propofol versus total sevoflurane
      maintenance and extubation.The objective of this study was to investigate whether propofol
      can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.
    

Intervention name(s): propofol; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Propofol was mainly used in the intervention group during anesthesia extubation. Propofol was given a small amount of times about 1~2mg/kg before extubation when the patient recovered spontaneously.; Same dose as propofol.
Other intervention name(s): No Other Intervention Names; No Other Intervention Names
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pediatric patients were randomly assigned to either the propofol group or the control group. In the propofol group, after the child regained spontaneous breathing before extubation, propofol was administered in small repeated doses, each dose being 0.5mg/kg, with a total amount of 1~2mg/kg. The control group received an equivalent volume of normal saline. The occurrence of respiratory adverse events (such as laryngospasm, bronchospasm, breath-holding, coughing, decreased oxygen saturation, and airway obstruction) was observed in both groups post-extubation, with the presence of any one or more events considered indicative of respiratory adverse events.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: propofol; tracheal extubation; respiratory adverse events