bioihbjkbjnl/mcl2 huggingface dataset:
Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and
      saline injection on pain, stiffness and physical function in patients with osteoarthritis.
    

Detailed description: 
      Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26) received
      intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL saline
      into painful knee for 3 times with one week intervals under USG guidance. VAS and WOMAC scale
      including pain, stiffness and physical function was used for the assessment of patients with
      osteoarthritis. Analgesic requirements were also recorded.

      The primary outcome parameter of this study was the pain scores. The sample size for the
      primary variable was calculated based on a standard deviation of 20 mm estimated from a
      previous study. A power analysis with a type II error of 20% at a two-sided 5% significance
      level estimated 22 patients per group to be included. Investigators included 26 patients per
      groups for possible missing date. χ2 test for categorical data and independent samples t-test
      for the comparison of VAS and WOMAC scores between groups were used for statistical analysis.
    

Intervention name(s): Lidocaine; Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; lidocaine; pain; ultrasound
Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases
Condition: Macula Abnormality
MeSH terms: Retinal Diseases
Study type: Observational

Summary: 
      Comparison of intradevice repeatability of thickness measurements for macular area in the
      eyes with normal and various retinal diseases using SS-OCT and SD-OCT
    

Detailed description: 
      The investigators studied the intradevice repeatability of thickness measurements for total
      retina, retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform (GC-IPL) layers of
      macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT and
      compared the repeatability between two devices.
    

Intervention name(s): Repeat exams of OCT device
Intervention type(s): Device
Intervention description(s): All 2 consecutive OCT examinations were performed by 1 experienced technician, in the order of SD-OCT and SS-OCT. The interval was 10 minutes between examinations by each OCT devices
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        normal control : 36 eyes of 36 subjects

        retinal disease group: 78 eyes of 78 patients
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to
      a control group receiving licensed Hib conjugate vaccine, when each are co-administered with
      Pediarix® to healthy infants at 2, 4, and 6 months of age.

      This protocol posting deals with objectives & outcome measures of the primary phase of the
      study. The objectives & outcome measures of the Booster phase are presented in a separate
      protocol posting (NCT number = 00345683).

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
    

Detailed description: 
      Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study
      groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.
    

Intervention name(s): GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014; ActHIB; Pediarix/Infanrix Penta
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3-dose intramuscular injection; 3-dose intramuscular injection; 3-dose intramuscular injection
Intervention MeSH terms: PENTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Prophylaxis; Neisseria meningitidis Vaccines, conjugate; Infants; Meningococcal vaccines; H. influenzae type B vaccine; Humans; Safety
Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data
Condition: NonDiabetes; Glucose Variability; CGM
Study type: Observational

Summary: 
      In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM)
      System to obtain 30 days of glucose measurements from 30 people with diabetes treated with
      insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people
      without diabetes and to compare these data to the 30 people with diabetes from a previous
      study. Through this approach it may be possible to develop a means of establishing a model of
      normal glucose patterns and a basis of comparison with glucose patterns in people with
      diabetes.
    


Intervention name(s): CGM System for Type 1 and Type 2 Diabetes Mellitus
Intervention type(s): Device
Time perspective: Prospective
Keywords: NonDiabetes; CGM
A Healthy Volunteer Pharmacokinetic Study of Single and Repeat Doses of SB-480848
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the pharmacokinetics of darapladib and its metabolites
      following single and 28 days of repeat dosing of darapladib.
    


Intervention name(s): darapladib
Intervention type(s): Drug
Intervention description(s): experimental drug
Intervention MeSH terms: Darapladib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: darapladib; pharmacokinetics; metabolite; SB-480848
Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to evaluate the efficacy, safety, and tolerability of
      NBI-827104 in adults with essential tremor.
    


Intervention name(s): NBI-827104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules for oral administration; Capsules matching NBI-827104 for oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Movement disorder; Tremor syndrome
Transcranial Galvanic Stimulation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by
      stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment
      of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective,
      but nevertheless only a few patients could use their affected hand functionally in daily life
      after robot training. Therefore the present study intends to combine both approaches, tDCS +
      AT, applied at the same time every day for six weeks. The study has three treatment arms, two
      groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned
      hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor
      area of the lesioned side directly, while the cathodal stimulation of the non-lesioned
      hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory
      inputs. The third group will receive a sham-stimulation. All patients will work with the AT
      simultaneously to the tDCS, respectively sham-tDCS.
    


Intervention name(s): transcranial galvanic stimulation
Intervention type(s): Device
Intervention description(s): for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hemiparesis; rehabilitation; upper limb rehabilitation; arm therapy
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and
      lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients
    


Intervention name(s): Esomeprazole; Lansoprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Barrett's Esophagus
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled,
      single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety,
      tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy
      subjects.
    


Intervention name(s): CS0159; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets administered orally; Tablets administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Compare the Relative Bioavailability of Two Iberdomide (CC-220) Formulations and to Assess The Effect Of Food on the Drug Levels of Iberdomide in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability for the new iberdomide
      powder for reconstitution formulation relative to the reference capsule formulation and to
      assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in
      healthy adult participants.
    


Intervention name(s): Iberdomide
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-986382; CC-220
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Iberdomide; Bioavailability; Crossover; Powder Formulation; Food Effect; Fed; Fasted
Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled, parallel group study.
    

Detailed description: 
      This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group
      study. After appropriate screening, approximately 180 male and female patients from up to 33
      study centers will be treated in this study. Patients with type 2 diabetes mellitus who are
      being treated by diet, exercise, untreated with antidiabetic medications or treated with and
      metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin)
      are eligible for enrollment.
    

Intervention name(s): ORMD-0801; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Oral Insulin; Placebo
Other intervention name(s): Oral Insulin; Placebo
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus type 2; Metformin; oral insulin
Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
Condition: Healthy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The overall objective is to validate the methodology of a metaplasticity experimental design
      by assessing change in motor excitability after administration of priming transcranial direct
      current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in
      healthy human participants.
    

Detailed description: 
      The overall objective is to validate the methodology of a metaplasticity experimental design
      by assessing change in motor excitability after administration of priming transcranial direct
      current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in
      healthy human participants. Our primary objective is to compare pre- and post-measures of
      cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after
      priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS
      [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome
      measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to
      compare pre- and post- measures of cortical excitability after inhibitory and excitatory
      priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to
      changes in cortical plasticity.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
Other intervention name(s): rapid transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, sham-controlled, double blinded crossover trial.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Metaplasticity; Motor excitability; rTMS; tDCS
Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Achilles Tendinopathy
Condition: Non Insertional Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The aim of study is to investigate the effect of Phonophoresis with topical glyceryl
      trinitrate versus traditional treatment in in patients with non-insertional Achilles
      tendinopathy.
    

Detailed description: 
      Pain in the Achilles tendon is quite common in individuals who participate in sports It is
      also common, however, in nonathletic individuals, particularly in persons of middle age who
      are of heavier weight Treating this condition can be very challenging. It is seen most
      commonly in the mid-portion of the tendon. The pathologic changes that occur to an Achilles
      tendon under repetitive stress will initially be a disruption of collagen fibers that have
      been unable to adapt to the persistent demand. This results in a cascade of events that, if
      left unchecked, will ultimately lead to significant pain and dysfunction. Repetitive loading
      leads to tendon degeneration, manifested as loss of normal collagen patterns and replacement
      of normal tissue with disorganized arrays of collagen and proliferative extracellular matrix.
      The tendon becomes infiltrated with mucoid material, calcification, fibrocartilage, and lipid
      droplets.

      Historically, one of the most well-established exercise regimens for Achilles tendinopathy is
      eccentric strength training. Eccentric exercise has been shown to improve tendon structure,
      which historically was considered a mechanism for improvement in some persons with Achilles
      tendinopathy.

      Nitric oxide is a small-free radical generated by a family of enzymes, the nitric oxide
      synthases. In a series of experiments performed over the last 15 years, nitric oxide played a
      crucial beneficial role in restoring tendon function. Oxygen free radicals, in the correct
      dose, stimulated fibroblast proliferation. Nitric oxide can enhance tendon healing. Nitric
      oxide is 1 of the 10 smallest molecules. Its size and its high reactivity allow it to travel
      across nearly all biologic structures and to readily react with other atoms or molecules to
      effect a change.

      so the aim of our study to compare between Phonophoresis with topical glyceryl trinitrate and
      eccentric strength training in treatment of Achilles tendinopathy
    

Intervention name(s): topical glyceryl trinitrate gel; Eccentric exercises
Intervention type(s): Other; Other
Intervention description(s): topical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel; stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee).
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Achilles tendinopathy; phonophoresis; topical glyceryl trinitrate
The Effects of Whole Versus Processed Orange Consumption on Satiety
Condition: Satiety Response
Study type: Interventional

Summary: 
      This is a human dietary intervention study that is randomized and crossover in design with 4
      treatment arms consisting of control, orange juice,whole orange, and processed whole orange
      to investigate the satiety effects of the treatments in healthy volunteers. Self reported
      hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different
      time points prior to and post consumption of each treatment.
    

Detailed description: 
      This is a human dietary intervention study that is randomized and crossover in design with 4
      treatment arms consisting of control, orange juice,whole orange, and processed whole orange
      to investigate the satiety effects of the treatments in healthy volunteers. Self reported
      hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different
      time points prior to and post consumption of each treatment.
    

Intervention name(s): Processed orange juice
Intervention type(s): Dietary Supplement
Intervention description(s): 3 different formulation of edible orange drinks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults
Condition: Squint
MeSH terms: Strabismus
Study type: Interventional

Summary: 
      Using various adjuvants has become a trend in regional anesthesia practice to improve the
      quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2
      agonist has been proposed as a safe and effective adjunct capable of extending the duration
      of the single-shot block
    

Detailed description: 
      Strabismus (misalignment of the eye) results from a difference in extraocular muscle
      function. Consequently, two different images, one from each eye, are transmitted to the
      brain, resulting in a loss of visual depth. In adults, cosmetic appearance is the main issue
      but sudden occurrence of strabismus may cause diplopia because the brain cannot suppress the
      overlapping images. The goal of strabismus surgery is to align the eyes, reduce diplopia, and
      restore binocular vision Ophthalmic regional block can be used as the primary anesthetic
      technique for strabismus surgery. The advantages of ophthalmic regional blockade include a
      reduced incidence of oculocardiac reflex (OCR) and emergence agitation, postoperative
      analgesia, and decreased postoperative nausea and vomiting (PONV).

      Using various adjuvants has become a trend in regional anesthesia practice to improve the
      quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2
      agonist has been proposed as a safe and effective adjunct capable of extending the duration
      of the single-shot block.

      Perineural dexmedetomidine, when added to bupivacaine, has been shown to potentiate its
      effects, providing a better quality of anesthesia and postoperative analgesia. Intravenous
      (I.V.) dexmedetomidine, when used during regional anesthesia, has been shown to prolong
      sensory and motor blockade in addition to sedation and postoperative analgesia.

      No previous studies where different routes of dexmedetomidine have been compared in adult
      strabismus surgery.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.
Other intervention name(s): alpha-2 agonist
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Condition: Spondylarthropathies, Enthesitis
MeSH terms: Enthesopathy; Spondylarthropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and
      refractory heel enthesitis.
    


Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50 mg injection once weekly; placebo
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Refractory Heel Enthesitis in Spondylarthropathy; Spondylarthropathy; Refractory Heel Enthesitis
High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients
Condition: ASCVD
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of high-intensity rosuvastatin and
      moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
    


Intervention name(s): Rosuvamibe; Monorova
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 10mg/Ezetimibe 10mg; Rosuvastatin 20mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment