bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult
Condition: Partial-onset Seizures With or Without Secondary Generalisation
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose randomized, double-blind, placebo controlled, single and multiple dosing,
      dose-escalation phase I clinical trial to investigate the safety, tolerability and
      pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral
      administration in healthy Korean and Caucasian adult subjects
    


Intervention name(s): Zebinix 400mg; Placebo for Zebinix 400mg; Zebinix 800mg; Placebo for Zebinix 800mg; Zebinix 1600mg; Placebo for Zebinix 1600mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11); Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11); Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5~11); Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11); Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11); Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm
      parallel group study of safety and efficacy of JZP-110 in the treatment of excessive
      sleepiness in adult subjects with OSA.
    


Intervention name(s): JZP-110; Placebo oral tablet
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neurofeedback in Individuals With Substance Use Disorders
Condition: Opioid-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to train individuals with opioid use disorder to control their brain
      activity in a way that has been associated with their symptoms. Participants in the
      experimental group will be given direct feedback regarding their brain activity while they
      are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn
      to control their brain activity during these feedback sessions. A separate group of
      participants will be given a control form of feedback that we do not believe can have
      clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce
      opioid use and clinical features of opioid use disorder more than the control feedback.
    


Intervention name(s): Experimental feedback; Control feedback
Intervention type(s): Device; Device
Intervention description(s): Participants provided with feedback of target brain activation patterns (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.; Participants provided with control type of feedback (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75
      mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg
      to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs
      syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an
      objective measure of the leg movements during the time spent in bed, and a quantitative
      clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the
      efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome
      measures such as quality of life and sleep.
    


Intervention name(s): pramipexole; levodopa in combination with benserazide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levodopa; Pramipexole; Benserazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Attentional Bias Modification Treatment in OCD
Condition: Obsessive-compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no
      significant improvement is reached in about 30% to 40% of patients. Thus, the development of
      new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in
      capturing the attention of an individual compared to a neutral stimulus - has been
      extensively studied. Already training attentional bias modification has been shown effective
      in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate
      knowledge on attentional bias in individuals with OCD through the use of a standardized
      protocol developed for OCD; 2 - available to the scientific community the first specific
      paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a
      training protocol for reversing attentional bias in individuals with OCD.
    


Intervention name(s): attentional bias modification treatment
Intervention type(s): Behavioral
Intervention description(s): The attentional bias modification treatment is a behavioral computerized program (software e-prime)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attentional Bias; Attentional Bias modification treatment
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Condition: Diabetes Mellitus; Hypoglycemia Unawareness; Hypoglycemia; Hypoglycemia Acute
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      This study aims to standardize and evaluate the benefits of the Prevention to Intervention
      program offered by the Birmingham Fire and Rescue Service. This will accomplished by
      standardizing the educational materials used, offering phone based follow-up and pre-post
      data collection.
    


Intervention name(s): Hypoglycemia Education
Intervention type(s): Behavioral
Intervention description(s): Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.
Intervention model: Single Group Assignment
Intervention model description: Single arm pre-post study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Telehealth; Emergency Medicine; Paramedicine; Diabetes; Hypoglycemia; Telecoaching
Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes
Condition: Hyperemia; Intraocular Pressure
MeSH terms: Hyperemia
Study type: Interventional
Phase: Phase 4

Summary: 
      PG-analogues induce hyperemia as one of side effects in addition to IOP reduction.

      IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not
      clarified.

      Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP
      reduction may be due to secondary induced PGs.

      Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.
    


Intervention name(s): dicrofenac and travoprost
Intervention type(s): Drug
Intervention description(s): dicrofenac drop 3 times a day travoprost 0.005% once daily
Intervention MeSH terms: Diclofenac; Travoprost
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Improving upper extremity movement and function in patients with stroke has been one of the
      primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had
      been first found by a domestic research group to be effective to facilitate sensory and motor
      recovery in patients with stroke within a month. However, the immediate and long-term effects
      of TS and the mechanism of brain plasticity in patients with stroke for more than three
      months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized
      controlled trial to investigate the immediate and long-term effects of TS in patients with
      stroke at subacute and chronic stages.
    

Detailed description: 
      The study was an assessor-blinded randomized controlled clinical trial. Participants with UE
      impairment for more than 3 months poststroke were randomly assigned to either the
      experimental (EXP) group or the control group. All participants received regular conventional
      rehabilitation programs. The EXP group received an additional UE-TS protocol for 30 minutes a
      day (3 days/week for 8 weeks); the control group received the same TS protocol over the lower
      extremity (LE). The Brunnstrom's recovery stage, the Modified Ashworth Scale (MAS), the
      Stroke Rehabilitation Assessment of Movement (STREAM), the Action Research Arm Test (ARAT),
      and the Barthel Index (BI) were outcome measures and were administered at baseline, 4 weeks
      and 8 weeks post inception, and at one-month follow-up.
    

Intervention name(s): A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).
Intervention type(s): Device
Intervention description(s): The subjects meeting our criteria will be randomly assigned to either the experimental group or the control group. First stage (3 months after onset), the subjects in the experimental group will receive an upper extremity Thermal Stimulation (TS) protocol for 30 minutes (3 times a week for 8 weeks). The subjects in the control group will receive a lower extremity TS protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thermal Stimulation; Upper Extremity; Motor Recovery; Stroke
Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      The objective of this study is to assess the impacts of utilitarian exercise versus high
      frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students
      with primary dysmenorrhea.
    

Detailed description: 
      A Randomized Control Trial study will be directed at Riphah International University
      Faisalabad after synopsis approval. The Purposive examining method will be utilized to enlist
      the patients. Patients will be enrolled according to the pre-characterized criteria. Sample
      size for this examination is 40 females (18 yrs - 30 yrs) as per determination measures. The
      patients of one group will recieve exercise therapy and patients of other group will recieve
      high frequency Transcutaneous Electrical Nerve Stimulation. The patient's result will be
      assessed following a month of treatment . Informed consent will be taken from each patient.
      Data entry and analysis will be done with Statistical Package of Social Sciences version 20.
    

Intervention name(s): Functional Exercise; High Frequency Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Other; Other
Intervention description(s): Among Functional Exercises, cobra position is most effective in reducing pelvic pain while others are cat and fish position.Kegel exercises along with other strengthening activities for pelvic floor muscles have been accounted for in writing to favorably affect primary dysmenorrheal.; Transcutaneous electrical nerve stimulation, best treat primary dysmenorrhea. Transcutaneous Electrical Nerve Stimulation is proposed as an incredible spasm decrease, lessening torment, decline of analgesics and improving personal satisfaction in primary dysmenorrhea patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Functional Exercise; High Frequency; Transcutaneous Electrical Nerve Stimulation; Primary Dysmenorrhea; Menstrual Pain; Randomized Control Trial
Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The aim of this study is to determinate what are the main muscles regularly involved in the
      spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow
      flexors. Three selective motor block nerves will be carry out in order to assess the gain of
      the range of motion (passive and active) of the elbow after each Motor Block Nerve.
    

Detailed description: 
      To assess the impact of selective motor block nerves (successively brachialis motor branch,
      radialis motor nerve and musculocutaneous motor branch) on passive and active ranges of
      motion of the elbow in stroke patients with spastic flexion pattern.

      Procedure: Following the morphological landmarks already described, the brachialis motor
      nerve of 30 patients was blocked with 4cc of lidocaïne® 1% (electro stimulation 0.8 to 1mA)
      (ref). Twenty minutes after the injection, the measurement of the degree of the spasticity,
      the passive angle in extension and the active range of motion in flexion of the elbow were
      performed. Then the radialis motor nerve block was performed (at the union of the median
      third and lower third of the arm, medial view, 3 finger widths above the medial epicondyle)
      using the same procedure, in order to block the brachioradialis and the brachialis in case of
      double innervation. Twenty minutes after the injection, the measurement of the passive and
      active ranges of motion of the elbow was performed. At the end the musculocutaneous motor
      block nerve was performed (proximal quarter of the arm, medial view, at the base of the
      inferior limit of the pectoralis major and along the biceps brachii tendon) in order to make
      the final difference with muscle contracture if it existed a doubt.
    

Intervention name(s): upper limb muscle block; 4cc of lidocaïne®
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic
Condition: Teeth Loss; Bone Loss
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      The purpose of the study was to test a clinically relevant non-inferiority of Straumann
      BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting
      procedure.
    

Detailed description: 
      This is a prospective, controlled, randomised, multicenter study. The total study duration
      for each patient should be three years.

      In total 13 visits per patient are scheduled in this study.

      The study device Straumann Bone Ceramic is CE-marked.

      Height centers in Italy will participate.
    

Intervention name(s): Straumann BoneCeramic; Bio-Oss
Intervention type(s): Device; Device
Intervention description(s): Straumann BoneCeramic (500-1000 microns, 0.5g); Bio-Oss spongiosa granules, size of particle 0.25-1 mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maxillary sinus lift; Histomorphometric evaluation; bone graft; bone augmentation
a Single HYAJOINT Plus Combined With a Single PPR Versus a Single PRP for Knee OA
Condition: Knee OA
Study type: Interventional
Phase: Phase 2

Summary: 
      Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment
      for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA
      remained unclear. This study aimed to investigate the efficacy of a single intraarticular
      hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in
      patients with knee OA.
    

Detailed description: 
      Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not
      been widely used for OA because of lack of clinical evidence. Based on in vitro and animal
      studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for
      tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit
      OA inflammation, modulate the disease process, and improve joint homeostasis in OA.
      Combination of HA and PRP has much potential for the treatment of OA, but the clinical
      evidence of this combination remains unclear. The purpose of this study was to investigate
      the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP
      versus a single PRP alone in patients with knee OA.
    

Intervention name(s): a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
Intervention type(s): Combination Product
Intervention description(s): All the injections were done by the same experienced physician using aseptic procedures.
Other intervention name(s): the one-injection group received a single injection of 3 ml PRP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with symptomatic knee OA were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP (the combined-injection group) or a single injection of 3 ml PRP (the one-injection group).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyaluronan; Knee osteoarthritis; Platelet-rich plasma
A Pilot Study to Test the Acceptability and Feasibility of Relaxation Rooms to Help Reduce Occupational Stress Among Healthcare Workers
Condition: Burn Out; Stress
MeSH terms: Occupational Stress
Study type: Observational

Summary: 
      Test the acceptability and feasibility of a relaxation room to reduce work stress among
      clinicians and collect clinician-reported outcome data after using the relaxation room.
    

Detailed description: 
      The plan is to pilot test a relaxation room to demonstrate its acceptability and feasibility
      in the hospital and collect clinician-centered outcomes. This study will inform the design of
      a future trial using this intervention.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only clinicians at Mayo will be recruited as part of this study.
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment
      of migraine headache in subjects ages 6 to 11 years.

      Part 1: Approximately 20 weeks (includes screening and double-blind treatment).

        -  Screening will be performed based on the inclusion exclusion criteria specified in the
           study protocol.

        -  Randomize approximately 288 subjects into the double-blind crossover phase.

      Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter
      part 2, a 6 month open-label safety extension (OLE).

      Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in
      both the double-blind and the OLE.
    


Intervention name(s): Placebo ZNS; ZNS
Intervention type(s): Drug; Drug
Intervention description(s): Placebo Zolmitriptan Nasal Spray; Zolmitriptan Nasal Spray
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache; Pain; Efficacy; Pediatric
D-serine Adjuvant Treatment for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine
      (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced
      dyskinesias.

      D-serine will be used as add-on therapy to on-going medications received by Parkinson's
      Disease patients. The rational for this study stems from observations made in pervious
      clinical trials with schizophrenia patients, in which it was demonstrated that D-serine
      adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by
      antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted
      effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's
      Disease.

      The study will have a crossover design in accordance to which each patient will receive, in
      random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have
      the opportunity to receive the experimental treatment.
    


Intervention name(s): D-serine (~2g/day)
Intervention type(s): Drug
Intervention description(s): Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)