bioihbjkbjnl/mcl2 huggingface dataset:
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the change in patient-reported treatment
      satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care,
      using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for
      Medication (TSQM-9).
    


Intervention name(s): Fingolimod; Standard MS DMT
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/day oral capsule; Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Other intervention name(s): GILENYA™; Avonex®,; Copaxone®,; Rebif®,; Betaferon®,; Extavia®
Intervention MeSH terms: Fingolimod Hydrochloride; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Fingolimod; Disease Modifying Therapy; TSQM-9
Transciptomic Modification Induced by miRNAs in Endometrial Fluid
Condition: MicroRNA in Endometrial Fluid
Study type: Interventional

Summary: 
      The purpose of this study is to understand the mechanism of communication between the uterine
      environment and the preimplantation human embryo. The investigators are interested in
      understanding how the in-utero environment during the window of implantation is different in
      normal weight and overweight/obese women and how this may impact the programming of the
      developing embryo.
    


Intervention name(s): Endometrial fluid aspiration
Intervention type(s): Procedure
Intervention description(s): Patient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Normobaric Hypoxic Training and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The patient numbers with metabolic syndrome and diabetes have doubled in the last decade.
      Data that physical exercise ameliorates the metabolic syndrome are convincing, although the
      mechanisms of the effect in man are not clear. Numerous endocrine or molecular mechanisms
      modified by physical exercise are known to be hypoxia-sensitive, i.e. by hypoxia-inducible
      factor-1 (HIF-1) regulation. Thus, relative hypoxia may link physical exercise and
      modification of endogenous metabolism. Medical communities seem ill equipped to address the
      primary issues involved. The investigators have experience with normobaric "hypoxia chambers"
      and will now test a (physical exercise) training program, using state-of-the-art assessments
      available nowhere else in Germany. The investigators will compare hypoxia chamber, to ambient
      training, to test the notion that specific exercise conditions could regulate specific
      molecular pathways involved in the pathogenesis of the metabolic syndrome. Indeed, hypoxia
      chamber training could be superior to conventional training in terms of reducing
      cardiovascular risk factors or improving fitness. The investigators will test overall
      metabolism-related effects with a metabolic chamber. The investigators will test local
      metabolism with microdialysis during exercise routines, and the investigators will perform
      fat and muscle biopsies to investigate tissue-related effects. The investigators include
      experience from a broad-ranging spectrum. The investigators findings might improve
      understanding mechanisms linking physical exercise and endogenous metabolism. Furthermore,
      they could influence decision-making regarding non-pharmacological interventions.
    


Intervention name(s): Endurance training
Intervention type(s): Other
Intervention description(s): Endurance training three times per week over six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: tissue metabolism; skeletal muscle; adipose tissue; HIF
Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is benefit from providing cognitive
      rehabilitation in the group setting. Several standardized tools will be used to measure
      progress when a participant enters the group, leaves the group and at a one year follow-up.
    

Detailed description: 
      This research study will look at the outcome benefits of providing cognitive rehabilitation,
      utilizing the group process. Criteria for selecting the appropriate participants, group
      format and structure, as well as use of standardized assessments. The assessments used: Three
      Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community
      Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence
      Scale. The group setting provides an atmosphere to work on building communication skills
      through peer feedback and to develop psychological coping strategies. Techniques such as the
      problem solving format and a calendar system. Analysis and outcomes of 17 past group
      participants were analyzed supporting cognitive rehabilitation in the group setting.

      Of the 20 participants, 3 chose not to be included.
    

Intervention name(s): Cognitive Group Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Rehabilitation
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
Condition: Anterior Cruciate Ligament (ACL) Reconstruction
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators hypothesize that perioperative oral administration of pregabalin would
      reduce postoperative pain and produce reduction in postoperative opioid consumption after
      anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2
      groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after
      initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same
      points.
    


Intervention name(s): pregabalin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.; The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery
Condition: Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable
      Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native
      common iliac artery and/or native external iliac artery.
    

Detailed description: 
      The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms
      (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety
      and effectiveness of the 2 devices used in this study.
    

Intervention name(s): Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Intervention type(s): Device
Intervention description(s): Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atherosclerosis; Peripheral artery disease; Peripheral vascular disease; PAD; Claudication; Peripheral Arterial Occlusive Disease; Stent; PAOD; PVD
Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure at Different Intensities
Condition: Healthy
Study type: Interventional

Summary: 
      The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus
      on the upper trapezius at moderate intensity compared to mild intensity or non-painful.
    

Detailed description: 
      The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological
      responses within the peripheral and central nervous system responsible for pain inhibition.
      Almost all types of MT elicit a neurophysiological response that is associated with the
      descending pain modulation circuit. But it has not been demonstrated whether this inhibition
      occurs through a conditioned pain modulation mechanism induced by painful mechanical
      stimulation that is carried out with manual therapy techniques.
    

Intervention name(s): Mechanical Conditioning stimulus
Intervention type(s): Other
Intervention description(s): Mechanical stimulus on the upper trapezius of the non-dominant side.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Conditioned Pain Modulation; Manual Therapy; Physiotherapy; Physical therapy
Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg)
      and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102
    


Intervention name(s): HCP1102; Singulair and Xyzal
Intervention type(s): Drug; Drug
Other intervention name(s): Singulair and Xyzal combination tablet; coadministration of Singulair and Xyzal
Intervention MeSH terms: Montelukast; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rhinitis
Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block
Condition: Lower Limb Surgery
Study type: Interventional

Summary: 
      In the present study, the investigators will test the effect of two position on posterior
      lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.
    

Detailed description: 
      The posterior lumbar plexus block approach was described approximately 30 years ago, using
      surface anatomical landmarks and a loss-of-resistance technique, but over the years it was
      almost abandoned for its low successful rate, the huge numbers of adverse effects and its
      difficulties to be performed. The introduction of the nerve stimulator and ultrasound guided
      technique in recent years increased the success rate in various peripheral nerve blocks and
      decreased adverse effects. Ultrasound guided LPB as well as sciatic nerve block technique in
      a small patient population resulting in a encouraging result, but published clinical data on
      optimal patient position for ultrasound-guided LPB are limited. We designed this prospective
      randomized study to compare the success rate, time of performance and complications of
      ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater
      trochanter sciatic nerve block under lateral decubitus position v.s. prone position.
    

Intervention name(s): SGPP; SGTPP; SGLP; SGTLP
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position; ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position; ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position; ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbar plexus block; sciatic nerve block; position; ultrasound guidance; elective lower limb surgery
A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers
Condition: Metformin; Organic Cation Transporter 2; Polymorphism,Single Nucleotide
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians
      volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that
      renal clearance of metformin is affected in Caucasian with the known single nucleotide
      polymorphisms A270S in OCT2.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): A single dose study with one tablet of metformin 500 mg, time frame 24 hours
Other intervention name(s): Orabet
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus, Type 2; Metabolic Clearance Rate; Pharmacokinetics; Pharmacogenetics
Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy
Condition: Unilateral Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to investigate the effectiveness of an intensive somatosensory intervention
      in the upper limb of children with hemiparesis regarding structure, function, activity and
      participation

      Hypothesis:

      Intensive somatosensory activity based intervention is effective in upper limb and hand
      ability in children with hemiparesis, specially regarding activity and participation
    

Detailed description: 
      Feasibility and longitudinal study with blinding of the evaluator and the person analyzing
      the data. The study have 4 procedures:

        1. - Assessment pre-intervention

        2. - Intervention: three weeks

        3. - Assessment post-intervention

        4. - Follow-up assessment (three months after intervention).
    

Intervention name(s): Somatosensory intensive intervention
Intervention type(s): Other
Intervention description(s): The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: somatosensory intensive intervention; somatosensory processing; motor performance; participation; quality of live; occupational performance
Visual Stimulation of Preterm Infants
Condition: Preterm Infant
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Introduction: Prematurity rate has increased and is a risk factor for developmental delay.
      Preterm infants with low visual tracking might present deficits in cognition, language, and
      fine motor function in future ages. Few studies applied home stimulation of the visual system
      for preterm infant (PT) at an early age.

      Objective: To compare the effects of early visual stimulation to a standard care group in
      visual function, motor and sensory development.

      Methods: Randomized controlled trial. At home setting. Thirty healthy preterm infants,
      gestational age from 28 to 37 weeks, aged from one to two months of corrected age at the
      entrance of the study, with low visual function, will be evaluated. Participants will be
      randomly allocated to: (1) a standard care group, receiving orientation about general sensory
      and motor development, (2) an early visual stimulation group receiving a 4-week home based
      protocol applied by caregivers additional to standard care. Outcomes will be measured at
      before the beginning of stimulation, at the end of stimulation and at 6 months of corrected
      age. Primary outcome is visual function evaluated by ML Leonhardt Battery of Optotypes.
      Secondary outcomes include motor and sensory development evaluated by scales.
    


Intervention name(s): Early Visual Stimulation; standard care
Intervention type(s): Other; Other
Intervention description(s): Early visual stimulation; standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: prematurity; sensory stimulation; rehabilitation; infant
A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of 2 prototype G-025
      tablets compared with the current G-018 tablet.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-period,
      randomized (study drug assigned by chance), single-dose, 3-way crossover study. The study
      consists of 21-day screening period, 3 open-label treatment periods with a minimum 21
      (+-2)-day washout between doses, and end-of-study assessments 10 (+-2) days after the last
      dose. The duration of study is approximately 3 months. Participants will be randomized to 1
      of 6 treatment sequences as follows: Treatment sequence 1=ABC, 2=BCA, 3=CAB, 4=ACB, 5=BAC AND
      6=CBA. Treatment A=JNJ-42756493 current clinical formulation, 10 milligrams (mg) (2 tablets
      of 5 mg each). Treatment B= JNJ-42756493 Prototype Formulation I (G-025), 10 mg (2 tablets of
      5 mg each) and Treatment C=JNJ-42756493 Prototype Formulation II (G-025), 10 mg (2 tablets of
      5 mg each). Blood samples will be collected to determine pharmacokinetic parameters.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-42756493 Current Clinical Formulation (G-018); JNJ-42756493 Prototype Formulation I (G-025); JNJ-42756493 Prototype Formulation II (G-025)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.; JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.; JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; JNJ-42756493
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial was to determine the short-term effects of tolvaptan in patients
      with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal
      function.
    

Detailed description: 
      Renal function was assessed during screening with the estimated glomerular filtration rate
      (eGFR), which was calculated with the 4-variable modification of diet in renal disease (MDRD)
      equation using a minimum of 2 creatinine measurements. The eGFR values were used to
      categorize participants into 1 of 3 mutually exclusive strata (> 60 [Group A], 30 to 60
      [Group B], and < 30 [Group C] mL/min/1.73 m^2). Each of the 3 groups received the same
      tolvaptan treatment.

      During the 3-week treatment period, participants were up-titrated on a weekly basis from
      45/15 mg to 60/30 mg to 90/30 mg (AM and PM [8 hours later] split-dose) to the maximally
      tolerated dose. The 3-week treatment period was followed by a 3-week post-treatment period
      during which no study medication was administered.

      The effects of the highest tolerated split-dose of tolvaptan on renal hemodynamics and
      pharmacokinetic and pharmacodynamic parameters were assessed throughout the 6 weeks of the
      study. The reversibility of changes during the post-treatment period after withdrawal of the
      drug was determined and the acute transitory effects on kidney volume were also explored.
    

Intervention name(s): Tolvaptan
Intervention type(s): Drug
Intervention description(s): Tolvaptan was supplied as 15 and 30 mg tablets.
Other intervention name(s): OPC-41061
Intervention MeSH terms: Tolvaptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment