bioihbjkbjnl/mcl2 huggingface dataset:
Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus
Condition: Hallux Valgus; Pain
MeSH terms: Hallux Valgus; Bunion
Study type: Interventional

Summary: 
      The main aim of this study was to find the initial effects of kinesiotaping on pain and joint
      alignment used in the conservative treatment of hallux valgus.

      22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was
      implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main
      outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective
      treatment option in decreasing pain and deformity in hallux valgus deformity who are
      conservatively treated. In future studies this method might be shown in larger sample groups
      at longer periods of treatment comparing with alternative treatment approaches like exercise
      or orthotics.
    

Detailed description: 
      Hallux valgus is a common pathologic entity affecting the great toe. Taping is an alternative
      method used to treat hallux valgus. The main aim of this study was to find the initial
      effects of kinesiotaping on pain and joint alignment used in the conservative treatment of
      hallux valgus.

      22 female patients diagnosed with 13 bilateral, 7 right, 2 left totally 35 with hallux valgus
      participated in this study. Kinesiotaping was implemented after the first assessment and
      renewed in the 3rd, 7th and 10th days. The main outcome measures were the change in pain was
      assessed by using Visual Analogue Scale (VAS) and hallux adduction angle was measured by the
      universal goniometry. Secondary outcome measures were Patients' functional status was
      measured by Foot Function Index (FFI) and AOFAS. The plain radiographic results were also
      measured before and after 1-month of treatment.

      Pain and disability was controlled by KinesioTape® implementation in patients with hallux
      valgus. Kinesiotaping may be an effective treatment option in decreasing pain and deformity
      in hallux valgus deformity who are conservatively treated. In future studies this method
      might be shown in larger sample groups at longer periods of treatment comparing with
      alternative treatment approaches like exercise or orthotics.
    

Intervention name(s): kinesiotaping
Intervention type(s): Device
Intervention description(s): correction method was used to align hallux.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hallux valgus; pain; conservative; treatment
Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children
Condition: Traumatic Brain Injury; Attention Deficit Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can
      help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse
      is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact
      effects this drug may have on adults with attention deficits caused by TBI have been
      investigated prior. The exact effects this drug may have on children with attention deficits
      caused by TBI are not known, but the investigators expect that Vyvanse will be of some help
      in treating this population as well.
    

Detailed description: 
      Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in children
      following traumatic brain injury (TBI). These often are among the most prominent symptoms
      manifested and may contribute to interference in a variety of other functional domains.
      Although there has been some use of psychostimulant medication to treat TBI-acquired
      attention deficits, it remains a relatively uncommon clinical practice. This study, by
      highlighting mechanisms of action, could serve to promote the appropriate use of this type of
      treatment for the patients.
    

Intervention name(s): Lisdexamfetamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.; Placebo capsule, 20-70 mg, each morning for 6 weeks.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Attention Deficit; TBI; Vyvanse
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The objective of this study was to assess bioequivalence of a potential generic 1 mg
      granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet,
      Kytril, following a single 1 mg dose, under fed conditions.
    


Intervention name(s): Granisetron
Intervention type(s): Drug
Intervention MeSH terms: Granisetron
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prevention of nausea and vomiting associated with radiation or chemotherapy
Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Condition: Refractory Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel
      when given as an adjunctive therapy in subjects with refractory partial seizures.
    


Intervention name(s): E2007 (perampanel); E2007 (perampanel); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.; 12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.; Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.
Other intervention name(s): Perampanel; Perampanel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: E2007; perampanel; refractory partial seizures; adjunctive therapy; seizure frequency; partial onset seizures; reduction in seizure frequency; safety; concomitant AED(s)
Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac
      administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject
      convenience and compliance with a comparable bioavailability, safety and tolerability profile
      to that of the approved PENNSAID solution administered four times a day (QID).
    

Detailed description: 
      PENNSAID Gel is a new topical gel formulation of diclofenac sodium that is similar in
      composition to PENNSAID solution.

      No clinical studies have been conducted using PENNSAID Gel. The current study will compare
      the pharmacokinetics, bioavailability, safety and tolerability of diclofenac after the
      topical application of PENNSAID Gel with the approved formulations of topical PENNSAID
      Solution and oral Sandoz 75 mg diclofenac sodium delayed release tablets in healthy subjects.

      The efficacy profile of PENNSAID Gel is based on the known efficacy profile of PENNSAID
      solution. Support for the BID dosing regimen includes the higher concentration of diclofenac
      sodium in PENNSAID Gel (2.0%) compared to PENNSAID solution (1.5%). In addition, compared to
      PENNSAID solution, PENNSAID Gel is designed to have better penetration of diclofenac to allow
      for a reduction in the number of applications per day from four to two while maintaining
      effectiveness.
    

Intervention name(s): 2% w/w diclofenac sodium topical gel; 1.5% w/w diclofenac sodium topical solution; 75 mg diclofenac sodium delayed release tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2% w/w diclofenac sodium topical gel; 1.5% w/w diclofenac sodium topical solution; 75 mg diclofenac sodium delayed release tablet
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy volunteers; PENNSAID; Topical NSAID; Diclofenac
Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this multicentric prospective randomized controlled clinical and economic study
      is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal
      infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe
      form of Parkinson's disease.
    


Intervention name(s): Duodopa; best médical treatment
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carbidopa, levodopa drug combination
Primary purpose: Treatment
Keywords: Advanced; Severe form
Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females?
Condition: Quality of Recovery
Study type: Interventional

Summary: 
      The aim of this study was to assess whether it was possible to improve patients'
      self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting
      in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in
      the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

      Patients were randomised to an active group receiving the intervention, and controls provided
      with standard care only. Patients were followed by questionnaire interviews preoperatively
      and at 2, 24 and 48 hours after surgery.
    

Detailed description: 
      Abstract One major goal in modern perioperative anaesthesia care is to facilitate a rapid,
      yet safe recovery process, with focus on improving time to regained consciousness and
      subsequent resuming of activities of daily living. Laparoscopic cholecystectomy and
      gynaecological laparoscopy are a "high volume" procedure commonly performed in young females
      expecting rapid resumption of health.

      The aim of this study was to assess whether it was possible to improve patients'
      self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting
      in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in
      the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

      Methods Patients were randomised to an active group receiving the intervention, and controls
      provided with standard care only. Patients were followed by questionnaire interviews
      preoperatively and at 2, 24 and 48 hours after surgery. The Quality of Recovery scale (QoR)
      15 items and 5 additional questions around gastro-intestinal symptoms were self-assessed by
      patients at each occasion.
    

Intervention name(s): ProvideXtra® Fresenius Kabi
Intervention type(s): Other
Intervention description(s): Improving wellbeeing
Other intervention name(s): standard consumer xylitol chewing gum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: quality of recovery; PONV; PDNV
Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Condition: Macular Edema; Cataract; Diabetic Retinopathy
MeSH terms: Cataract; Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Study type: Interventional

Summary: 
      Diabetes has many negative effects on patients' general health. Among many other consequences
      it speeds up the cataract formation and that is why diabetic patients need cataract surgery
      very often. The known side effect of cataract surgery even in otherwise healthy patients is
      postoperative edema of the back of the eye (what causes decrease of vision), which has
      greater incidence especially in patients who have diabetic eye problems. The cause of that
      might be the intraocular inflammation which was previously demonstrated to be significantly
      more prominent in patients with untreated diabetic eye problems. Therefore we will examine if
      the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the
      formation of the edema of the back of the eye.
    


Intervention name(s): Perioperative Diclofenac eye-drops administration; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diclofenac; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Macular edema; Cataract; Diabetic retinopathy; Anti-inflammatory agents,Non-steroidal
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
Condition: Pneumonia, Ventilator-Associated
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Interventional

Summary: 
      Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented
      by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.

      Patients are randomized to CLRT or supine position if mechanically ventilated and not
      suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is
      standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are
      length of ventilation, length of stay and mortality.
    


Intervention name(s): Continuous lateral rotation therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of ventilator associated pneumonia
A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)
Condition: Hyperlipidemia; Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the cholesterol lowering effects of an investigational
      drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
    


Intervention name(s): ezetimibe (+) simvastatin
Intervention type(s): Drug
Intervention description(s): Duration of Treatment: 6 months
Other intervention name(s): MK0653A
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mixed Hyperlipidemia
Single-Treatment, Study of Percutaneous-Temperature Controlled-RF Electrocoagulation on Axilla Tissue
Condition: Sweating Increased Armpits
Study type: Interventional

Summary: 
      This is a pilot, open-label, and single-center, single-treatment prospective evaluation of
      the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve
      excessive sweating of the axilla(s).

      In this study, "Temporary Relief" is defined as improvement on the DLQI.

      Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five
      visits are planned for this study.

      A punch biopsy will be collected (prior to and post treatment and analyzed to determine the
      degree of impact to the tissue after the electrocoagulation treatment.

      Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale,
      and adverse events reports (observed or reported).

      The total length of the study is approximately 4 months.
    

Detailed description: 
      This is a pilot, open-label, and single-center, single-treatment prospective evaluation of
      the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to alleviate
      or improve symptoms associated with axillary sweating.

      In this study, "Temporary Relief" is defined as improvement on the DLQI.

      A total of 20 male and female healthy volunteers between the age of 18 and 50 will be
      enrolled in this study. Subjects who sign the informed consent form and meet all entry
      criteria will be assigned a unique number/code to preserve confidentiality.

      A total of five visits are planned for this study as described below:

        -  Visit 1: Screening visit - (Day 0)

        -  Visit 2: Single Treatment

        -  Visit 3: Day 30 (± 7 days)

        -  Visit 4: Day 60 (± 7 days)

        -  Visit 5: Day 90 (± 7 days)

      A punch biopsy will be collected at Visit 1(screening), Visit 2 (post-treatment) and Visit 4
      (Day 60). The purpose of the punch biopsy is to evaluate the degree of impact to the axillary
      organ after the electrocoagulation treatment when compared to pre-treatment at Visit 1.

      Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale,
      and adverse events reports (observed or reported).

      The total length of the study is approximately 4 months.
    

Intervention name(s): Thermi Radiofrequency
Intervention type(s): Device
Intervention description(s): Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sweating
Crohn Disease Exclusion Diet After Single Medication De-escalation
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The primary objective of this study is to determine whether pediatric Crohn Disease (CD)
      patients in long-standing remission remain in remission longer after stopping medications if
      they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the
      CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.
    

Detailed description: 
      Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition
      of the gastrointestinal tract with a high risk for complications and need for surgical
      interventions, particularly in children. Immunomodulators and biologic therapies are
      effective at inducing and maintaining remission in pediatric CD, yet there is no proven
      strategy for reducing exposure to medications once sustained remission has been achieved.
      Diet has been proven to impact disease activity in CD and may allow for sustained drug-free
      remission. The primary objective of this study is to determine whether pediatric CD patients
      in long-standing remission remain in remission longer after stopping medications if they
      follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED
      will have longer time-to-relapse as opposed to those on an unrestricted diet.
    

Intervention name(s): Crohn Disease Exclusion Diet; Free Diet
Intervention type(s): Other; Other
Intervention description(s): The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.; This diet contains no restrictions.
Other intervention name(s): Placebo
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      Rifabutin has good chemical stability and low drug resistance rate in acidic gastric
      environment. Therefore, it is often used in combination with amoxicillin proton pump
      inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to
      evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical
      bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory
      Helicobacter pylori
    


Intervention name(s): Esomeprazole; Bismuth Potassium Citrate; Tetracycline,Metronidazole; amoxicillin rifabutin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Proton pump inhibitor; Gastric mucosal protective drug with anti-H. pylori effect; Antibiotics for H. pylori eradication; Antibiotics for H. pylori eradication
Intervention MeSH terms: Amoxicillin; Metronidazole; Tetracycline; Rifabutin; Potassium Citrate; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori Therapy
Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Randomized trial in a primary prevention population

        -  all participants have high LDL cholesterol

      Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle
      changes,and take supplements consisting of red yeast rice and fish oil
    

Detailed description: 
      This is a randomized primary prevention trial to compare the LDL lowering effects of an
      alternative regimen to statins(simvastatin) This alternative regimen is over the counter and
      available at health food stores. The alternative regimen consists of lifestyle changes
      including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice
      1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will
      take Zocor(simvastatin) 40 mg per day with standard counseling
    

Intervention name(s): simvastatin; red yeast rice; pharmaceutical grade fish oil; therapeutic lifestyle changes
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention MeSH terms: Simvastatin; Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: red yeast rice; pharmaceutical grade fish oil; simvastatin; primary prevention