bioihbjkbjnl/mcl2 huggingface dataset:
Effect of TENS for Pain and Function After Total Knee Replacement
Condition: Unilateral Primary Osteoarthritis of Knee; Primary Osteoarthritis of Knee Nos
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia.
      Minimizing the severe pain experienced during required activities in the immediate
      postoperative period will promote functional recovery and prevent the development of new
      chronic pain syndromes.
    


Intervention name(s): Placebo TENS; Active TENS
Intervention type(s): Device; Device
Intervention description(s): Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.; High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee OA; TENS; Total knee replacement; Knee arthroplasty; total unilateral knee replacement
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Condition: Healthy Subjects; Dyslipidaemias
MeSH terms: Dyslipidemias; Flushing
Study type: Interventional
Phase: Phase 1

Summary: 
      To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin
      are co-administered as single doses to HVTs.
    


Intervention name(s): GSK256073A tablets + IR niacin tablets
Intervention type(s): Drug
Intervention description(s): single dosing for 4 to 5 sessions
Intervention MeSH terms: Niacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Flushing; GSK256073A,; Dose Escalation,; Immediate Release Niacin,
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
Condition: Vernal Keratoconjunctivitis
MeSH terms: Keratoconjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the efficacy of two different dosing regimen of
      NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of
      the formulation) administered four times a day in patients with severe vernal
      keratoconjunctivitis after 4 months of treatment.
    


Intervention name(s): NOVA22007 ''Ciclosporin''; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.; Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vernal keratoconjunctivitis; ciclosporin; cyclosporine
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 2

Summary: 
      We have identified focussing problems related to myopia getting worse. Our trial uses optical
      and orthoptic interventions that correct the focussing problems to see if this retards myopia
      progression.
    

Detailed description: 
      Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical
      treatment that prevents progression. This study is a double masked placebo controlled block
      randomized clinical trial of two interventions, to treat accommodative factors we have
      identified as being significantly correlated to myopia progression (rather than to the
      presence of myopia). We have shown that the interventions normalise the accommodative
      factors, and this trial examines the effect of these interventions on myopia progression.
    

Intervention name(s): Aberration controlled contact lens; Vision training
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Aberration control; Accommodative facility; Accommodative response; Peripheral refraction; Accommodative convergence to accommodation ratio
Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures
Condition: Type 2 Diabetes; Non Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to identify eyes that show worsening and disease progression
      (progressor phenotypes).
    

Detailed description: 
      To identify "progressors" in retinal vascular disease and central retinal edema in type 2
      diabetic patients with early NPDR, based on retinal disease progression from baseline to the
      12-month visit, assessed by the following biomarkers:

        -  Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA
           from baseline to the 12-month visit) computed from color fundus photographs using the
           RetmarkerDR software; and

        -  Retinal thickness increase in eyes with retinal thickening (Increase in retinal
           thickness above normal range) in the central subfield, the inner ring and/or the outer
           ring Constantly Present, Present or Absent (as measured by OCT and considering the
           macula thickness normative data.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type-2 diabetes, NPDR
Persistent Readiness Through Early Prediction Immunization Study
Condition: Inflammatory Response
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will enroll volunteers in an open-format (outside hospital) setting, to complete
      novel data collection/analysis of biomarkers, facial images, and audio-recording to establish
      an optimal set of parameters to predict emergent cases of infection via an early warning
      score, along with actionable personalized information.
    

Detailed description: 
      The objective of the study is to collect data from participants for a period of 4 weeks.
      These data will be used for developing and testing an algorithm for early detection of
      infection.

      At the end of week two, subjects will receive an immunization in a double-blind randomized
      placebo-controlled fashion. Vaccines to be administered will be pneumococcal (PPSV23),
      typhoid (inactivated), or saline. Administration of these vaccines often cause mild
      'infection-like' inflammation response. Pneumococcal infection causes pneumonia and can lead
      to sepsis and the PPSV23 vaccination will induce mild symptoms related to the immune system
      activation including local reaction in 50% of the cases and fever and malaise in 1% of the
      cases. Typhoid fever is caused by salmonella Typhi bacteria and its effects can range from
      gastrointestinal symptoms to sepsis. Injectable typhoid vaccine (inactivated) side effects
      will induce mild symptoms related to the immune system activation and can include local
      reaction in 6% of the cases and fever, malaise, headache and sometimes diarrhea in 1% of the
      cases.
    

Intervention name(s): Pneumovax 23; Typhim VI; Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.; At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.; At +14 days from enrollment in the trial, participants will receive a vaccine administered via intramuscular route only.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind randomized placebo-controlled vaccine administration (pneumococcal (PPSV23), typhoid (inactivated), or saline)
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: commercial off the shelf wearable devices; large-scale machine learning; biomarkers; early warning of infection; predictive model of illness severity; predictive model of recovery
Serum Preptin and Amylin Levels in Polycystic Ovary Syndrome Patients
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This
      study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary
      syndrome (PCOS) patients and healthy women based on BMI groups .
    

Detailed description: 
      Materials and Methods: This is a cross-sectional review of 40 PCOS patients and 40 healthy
      women who were matched with respect to BMI (<25 kg/m2 and ≥25 kg/m2).
    

Intervention name(s): preptin and amylin level
Intervention type(s): Diagnostic Test
Intervention description(s): we will take both of group blood samples to compare them serum preptin and amylin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Polycystic ovary syndrome
      
Keywords: amylin; obesity; polycystic ovarian syndrome; preptin
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study evaluates the impact of highly active antiretroviral therapy on the size of the
      latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The
      activation state of the cells will be assessed, by measuring the activation of Akt, to
      determine its influence on the size of the viral reservoirs.
    


Intervention name(s): additional blood sample
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy
Condition: Cerebral Palsy; Spasticity
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of one or both arms alone or in combination with injections into one or both legs are
      effective and safe in treating children/adolescents (age 2-17 years) with increased muscle
      tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
    


Intervention name(s): IncobotulinumtoxinA (8 Units per kg body weight); IncobotulinumtoxinA (6 Units per kg body weight); IncobotulinumtoxinA (2 Units per kg body weight)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Mode of administration: intramuscular injection into spastic muscles.; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Mode of administration: intramuscular injection into spastic muscles.; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Mode of administration: intramuscular injection into spastic muscles.
Other intervention name(s): Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Upper limb spasticity; lower limb spasticity; combined upper and lower limb spasticity
The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients
Condition: Heart Rate Variability; Diabetes; Spinal Anesthesia
Study type: Observational

Summary: 
      Cardiac autonomic neuropathy is a common complication of diabetes and is associated with
      resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central
      sympathetic blockade. The investigators evaluate the relation of severity of diabetes and
      heart rate variability, also the impact of spinal anesthesia on the change of heart rate
      variability.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing lower limb surgery with spinal anesthesia
      
Keywords: Heart Rate Variability; spinal anesthesia; DM; cardiac autonomic dysfunction
Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
Condition: Peripheral Arterial Occlusive Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
Study type: Observational

Summary: 
      The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in
      patients with peripheral arterial occlusive disease.
    

Detailed description: 
      First, the original version of WIQ will be translated into Korean, then it will be translated
      into English, again. The translated version will be sent to the original author to compare
      with the original version. After correcting, the Korean version will be completed.

      The patients with peripheral arterial disease will fill in the Korean version of WIQ before
      starting treatments. Baseline results of arterial function test, toe-brachial index and
      treadmill test will be recorded. Three months later, the patients will complete the
      questionnaire again. Arterial function test, toe-brachial index and treadmill test also will
      be taken again after treatment and the correlation of WIQ and other exams will be evaluated.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with peripheral arterial disease
      
Keywords: Walking Impairment Questionnaire; Peripheral arterial occlusive disease; Korean version
Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease; End-Stage Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney
      disease are treated with growth hormone to assess effect on nutritional status.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the
      highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors
      such as the fragile membrane, etc. Cytochalasin D serves to facilitate spindle or pronuclear
      transfer procedures helping to reduce the damage rate with no harm reported. Using
      Cytochalasin D during ICSI could serve to rescue some oocytes from the degeneration allowing
      for more chances of viable zygotes.
    


Intervention name(s): Medium Supplemented with Cytochalasin D
Intervention type(s): Other
Intervention description(s): A medium with in-house supplementation of Cytochalasin D to decrease oocyte degeneration after ICSI and improve the survival rate
Intervention MeSH terms: Cytochalasin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and pharmacokinetics of double-blind
      S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes
      mellitus
    

Detailed description: 
      Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical
      laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry
      monitoring, and physical exams. Specific study withdrawal criteria during washout periods of
      metformin have been established for loss of glycemic control, i.e., glucose monitoring.
      Pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed
    

Intervention name(s): S-707106; Placebo; Metformin, S-707106 plus metformin; Metformin, placebo plus metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, taken once daily with morning meal; Placebo tablet, taken once daily with morning meal; Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily; Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin
Parental Consanguinity and Family History of Kidney Disease in Turkish Kidney Disease Population
Condition: Hereditary Diseases
MeSH terms: Kidney Diseases; Genetic Diseases, Inborn
Study type: Observational [Patient Registry]

Summary: 
      Inbreeding and consanguineous marriages are known to increase the risk of autosomal recessive
      disorders. The aim of this study was to examine the association between consanguinity and
      kidney diseases in the adult Turkish population.
    

Detailed description: 
      This was a national, cross-sectional study recruiting patients from nephrology out-patient
      clinics and dialysis units. All patients between 18 and 70 years of age who were on follow up
      in outpatient clinic and dialysis unit at the Istanbul Medical Faculty from October 2009 to
      October 2015 were included in the study. All patients and healthy controls enrolled in this
      study gave informed consent to participate in the survey. They were all asked to answer a
      questionnaire including socio-demographic data, history of familial kidney disease and
      consanguineous marriage. Additional information was obtained from their private physicians
      and medical files. To ensure reliability of administration of the questionnaire, all
      interviewers underwent training using a standardized protocol.
    

Intervention name(s): Patients
Intervention type(s): Other
Intervention description(s): In this study we aimed to investigate effect of family history and consanguineous marriage in the development of CKD in the adult Turkish population.
Other intervention name(s): Inbreeding marriage
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients between 18 and 70 years of age who were on follow up in outpatient clinic and
        dialysis unit at the Istanbul Medical Faculty from October 2009 to October 2015 were
        included in the study
      
Keywords: Consanguinity-associated kidney diseases; Turkey population
Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare pharmacokinetics after single oral administration
      of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and
      valsartan in healthy male volunteers.
    


Intervention name(s): Rosuvastatin+Valsartan (Sequence 1); Rosuvastatin+Valsartan (Sequence 2); Rosuvastatin+Valsartan (Sequence 3); Rosuvastatin+Valsartan (Sequence 4); Rosuvastatin+Valsartan (Sequence 5); Rosuvastatin+Valsartan (Sequence 6)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days); Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days); Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days); Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days); Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days); Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Intervention MeSH terms: Valsartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction; YH14700; Rosuvastatin; Valsartan; Yuhan