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

Summary: 
      Kinesiotape is one of the treatment choices for the patients with knee osteoarthritis. Unlike
      the brace, it seems to be an important advantage in kinesiotape application in that it
      permits the movement of the joint. However, kinesiotape is conditionally recommended for knee
      osteoarthritis in the 2019 American College of Rheumatology treatment recommendations due to
      limiting the quality of evidence, using various application methods, and the lack of
      blindness concerning its use is not possible.

      The aim of the study is to determine the effects of kinesiotaping on pain, physical
      performance, knee range of motion, and postural stability in knee osteoarthritis.
    

Detailed description: 
      Non-pharmacological treatments are recommended as first-line management in knee
      osteoarthritis. Kinesiotape was regarded as a supplementary intervention for patients with
      knee osteoarthritis. Although the results are conflicting, regarding knee osteoarthritis,
      recently published studies indicate beneficial effects of kinesiotape on knee-related health
      status, pain, quadriceps muscle strength, and range of motion. On the other hand, the
      measurements were performed immediately following taping or within a short-term period. The
      inconsistency of the study data still indicates that the efficacy of kinesiotape in knee
      osteoarthritis should be evaluated in randomized controlled trials. Therefore a study that
      investigates both short and long-term follow-up results are warranted.

      This study aimed to determine the immediate and long-term effects of the single and
      repetitive application of kinesiotape on pain, knee joint range of motion, postural
      stability, and physical performance in participants with knee osteoarthritis. The results of
      this study will support evidence-based reports based on the effectiveness of kinesiotape in
      knee osteoarthritis and recommendations for future studies.
    

Intervention name(s): Kinesiotape; Sham-kinesiotape; Home-based exercise program
Intervention type(s): Device; Device; Other
Intervention description(s): The participants received kinesiotape application three times with one-week intervals. Y strip tape was used. The interventionist applied the band to the rectus femoris muscle with facilitation technique.; The participants received sham-kinesiotape application three times with one-week intervals.
In the sham group, the interventionist adhered KT to the rectus femoris transversely, without stretching.; Participants were taught exercise program training. The exercise intervention was based on quadriceps and knee flexor muscle group strengthening, and knee joint range of motion exercises, in their home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; Kinesiotape; Pain
Controlled Human Infection Model Challenge/Rechallenge
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will compare the shigellosis rate in subjects previously challenged with a
      heterologous Shigella serotype to the attack rate in naïve subjects.
    

Detailed description: 
      This is a single-center controlled human infection model (CHIM) study designed to assess the
      cross-protective efficacy and markers of protection after challenge and heterologous
      rechallenge with Shigella strains of different serotypes in naïve healthy adult volunteers.
    

Intervention name(s): S. sonnei 53G; S. flexneri 2a 2457T
Intervention type(s): Biological; Biological
Intervention description(s): Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast; Shigella flexneri strain 2457T (Lot 1617) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of
      rosuvastatin and/or simvastatin in healthy male subjects and female subjects not of
      child-bearing potential.
    


Intervention name(s): Simvastatin; Rosuvastatin; MGL-3196
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Zocor; Crestor; VIA-3196
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD
      drug-drug interactions between DWP14012 and aspirin when administered in combination.
    


Intervention name(s): DWP14012; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Potassium-competitive acid blocker; acetylsalicylic acid
Intervention MeSH terms: Aspirin; Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study in Healthy Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single
      centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial
      oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan
      cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.
    


Intervention name(s): Candesartan cilexetil; Candesartan cilexetil
Intervention type(s): Drug; Drug
Intervention description(s): Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose; Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Candesartan; Bioequivalence
Exercise Dose Response for Improving Insulin Sensitivity
Condition: Obesity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Many of the beneficial metabolic effects of endurance exercise training are not due to
      adaptations to weeks, months, or even years of training, but rather much is due to the
      response to the most recent exercise session(s). Therefore, the investigators contend that
      lifestyle interventions for obese individuals should be tailored to optimize the metabolic
      effects of the most recent exercise session(s). But the "dose" of exercise necessary to evoke
      these beneficial responses is not known, and the mechanisms responsible for these
      improvements are poorly understood. The findings from these studies will: 1) establish the
      minimum "dose" of a single exercise session necessary to improve insulin sensitivity the next
      day in obese adults, 2) characterize the underlying metabolic factors responsible for the
      improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that
      occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program.
      Findings from these studies will provide valuable information for the development of
      lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise
      session in obese patients.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): single session of exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin sensitivity; fatty acid metabolism; exercise
Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)
Condition: Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess clinical efficacy and safety of long-term orally administered thioctic acid in the
      treatment of diabetic polyneuropathy.
    

Detailed description: 
      Stage 1 or 2a diabetic (poly)neuropathy (DNP) (Appendix 3) in patients with diabetes mellitus
      (type I or II); neuropathy impairment score of the lower limbs, enlarged by 7 objective items
      (NISLL+7) ≥ 97.5 percentile (corresponding to 4.43 score points); total symptoms score of the
      feet (TSSfeet) ≤ 5.
    

Intervention name(s): Thioctic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600mg tablet once daily 4 years double-blind treatment period; 1 tablet once daily 4 years double-blind treatment period
Other intervention name(s): alpha-lipocic acid
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Elderly Healthy Subjects
Condition: Elderly Subjects
Study type: Interventional

Summary: 
      The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,
      healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory
      enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity
      typically occuring during SWS has been implicated in the consolidation effect. Recent
      evidence in young healthy subjects suggest that the sleep-associated consolidation effect can
      be amplified by the application of a weak transcranial oscillatory electric current within
      the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly, healthy subjects
      benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well
      has not been studied so far. The primary aim of the present study is to investigate the
      influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory
      consolidation applied during periods of nocturnal SWS in elderly healthy subjects.
    


Intervention name(s): Stimulation; SHAM
Intervention type(s): Device; Device
Intervention description(s): no stimulation
Other intervention name(s): oscillating direct current brain stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: old Subjects; Controls; brain stimulation; tSOS; tDCS; sleep; memory; memory consolidation
Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly
Condition: Healthy Elderly
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral
      administration in healthy elderly male volunteers.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Other intervention name(s): Diabex
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; Pharmacokinetics/ Pharmacodynamics
Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms
Condition: Covid19; Post-acute COVID-19 Syndrome
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome
Study type: Interventional

Summary: 
      The main objective of the present study is to observe the short-term effects of respiratory
      muscle training combined with an exercise training program on quality of life and exercise
      tolerance in individuals with long-term post-COVID-19 symptoms. As secondary objectives, the
      effects on respiratory muscle function, physical and lung function, as well as on the
      psychological state of these individuals.
    

Detailed description: 
      It is a double-blind randomized clinical trial study. Each participant will be randomly
      assigned to one of the following groups: 1) Exercise training program + Inspiratory muscle
      training + Expiratory muscle training, 2) Exercise training program + Sham Inspiratory muscle
      training + Sham Expiratory muscle training.

      The exercise training program will be delivered in hospital and will be applied 2 sessions
      per week during 8 weeks. The exercise component will be lasted for 1hour and it consisted of
      cardiovascular exercises.

      The respiratory muscle training program will be applied twice a day, 3 sessions per week
      during 8 weeks by a threshold device. The evening sessions will be supervised by a
      physiotherapist through a virtual platform.

      Participants received baseline assessments at the beginning of the intervention and
      post-intervention assessments at the end of the 8th week.
    

Intervention name(s): Inspiratory + expiratory muscle training group; Inspiratory + expiratory muscle training sham group; Exercise training program
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.; Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.; Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Muscle Training; Tele-rehabilitation; Quality of Life; Exercise
Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the present study was to investigate the acute and sub-chronic effect of a
      supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo
      taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a
      8-week supplementation could prevent weight-regain after initial 4-week weight loss.
    

Detailed description: 
      It has previously been shown that a combination of tyrosine, capsaicin, catechines, and
      caffeine may stimulate the sympathetic nervous system and promote satiety, lipolysis and
      thermogenesis. In addition, dietary calcium may increase fecal fat excretion.

      Method:

      80 healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age
      subjects of both gender. All subjects was be weight stable (within 3-kg) 2 months prior to
      study inclusion, non-smoking, non-athletic and have no daily use of medication except for
      anticonception and antihypertensive compounds. All subjects gave their written consent after
      verbal and written information about the study. The study protocol was approved by The
      Municipal Ethical Committee of Copenhagen and Frederiksberg as being in accordance with the
      Helsinki II Declaration.

      The total study period was 12 weeks. The intervention design was an 8-weeks randomized, 3-arm
      parallel, placebo-controlled and double-blind intervention. Prior to the randomized
      intervention a weight loss was initiated by 4 week treatment on a 3.4 MJ/d low caloric diet
      (LCD). Only subject who lost more than 4% of their initial body weight after 4 weeks LCD
      treatment was randomized and continued in the study.

      The subjects were randomized into 3 balanced groups i.e. placebo, simple or enterocoated
      release. All subjects received dietary instruction to a slightly hypo caloric diet of -300
      kcal/day after the isoenergetic educational system. The dietary advice was reinforced by
      dietetic consultations every fortnight.

      Body weight and composition were assessed by DEXA before and after the LCD period, four weeks
      into the randomized period and at completion i.e. the last day of the study.

      All participants underwent assessment of energy expenditure by indirect calorimetry in a
      ventilated hood. The first respiratory measurement was on the first day of the intervention
      and will last for 5 hours.

      All subjects collected all feces excreted three days prior to respiratory measurement and one
      day of urine excreted.
    

Intervention name(s): Metobes-compound
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Body fat loss; energy expenditure; capsaicin; caffeine; green tea; calcium; fecal fat; fecal energy
University of Michigan Youth Violence Prevention Emergency Department Brief Intervention (Project Sync)
Condition: Violence
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a brief motivational interviewing
      intervention given during emergency department care to 14-20 year olds seeking treatment,
      could reduce youth violence.
    

Detailed description: 
      This Emergency Department (ED) based study will test the effectiveness of a tailored
      therapist delivered motivational interviewing intervention, and an informational pamphlet
      control condition (IC) on reducing violence in 14-20 year olds who present to the Hurley
      Medical Center (HMC). Eligible adolescents at the Hurley Medical Center (HMC) emergency
      department (ED) (based on eligibility criteria) will complete a computerized online survey.
      The goal of the intervention was to examine ways to reduce and prevention youth violence
      using techniques to change behavior in a respectful, non-confrontational, and non-judgmental
      manner. This one-on one counseling approach emphasizes individual choice and responsibility
      and differentiates between future goals/values and current behavior. At 2-months following
      their ED visit, eligible adolescents (both from the intervention group and control group)
      will meet with a research assistant and self-administer an online computerized follow-up
      survey. An online survey tool will be used for baseline, follow up and post-test surveys.
      Participants will self-administer the survey at the time of follow up, post-test and
      baseline.
    

Intervention name(s): Project Sync
Intervention type(s): Behavioral
Intervention description(s): A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Youth Violence
To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI)
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, double-blind, single-dose, three-period balanced crossover study
      in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment
      sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg and
      FF 400 mcg/UMEC 500 mcg), in three consecutive periods, with a wash-out period of 7 to 10
      days between the periods.

      The study will include a Screening period (28 days prior to first dose), Treatment period (3
      single dose periods separated by two 7 to 10 days washout periods) and Follow-up period (7 to
      14 days post last dose).

      The pharmacokinetic (PK) and safety assessments will be performed during the study at fixed
      timepoints.
    


Intervention name(s): FF 400 mcg; UMEC 500 mcg; FF/UMEC 400/500 mcg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FF will be available as 100 mcg strength administered as 4 inhalations from a DPI; UMEC will be available as 125 mcg strength administered as 4 inhalations from a DPI; FF/UMEC will be available as 100/125 mcg strength administered as 4 inhalations from a DPI
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers; Umeclidinium; tolerability; Safety; Fluticasone Furoate; Pharmacokinetics
Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus
Condition: Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish preliminary evidence of the efficacy, safety, and
      tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease
      Post-Operative Ileus in subjects undergoing elective bowel resection.
    


Intervention name(s): LB1148; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A total of 700 mL of LB1148 will be administered orally as a split dose before surgery.; A total of 700 mL of placebo will be administered orally as a split dose before surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
Condition: Pharmacokinetics of Vepoloxamer; Healthy Volunteers; Renal Impaired
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study designed to evaluate the effect of renal disease on the
      pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with
      normal renal function.
    


Intervention name(s): Vepoloxamer
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)