bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
Condition: Exercise-induced Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and
      inflammatory immune response over a period of 72 hours after a second bout of strenuous
      concentric exercise on bicycle (exercise #2).
    


Intervention name(s): Traumeel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning; oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle; exercise; soreness; Damage; Traumeel; homeopathy
Addition of Six Short Lines on Pulmonary Vein Isolation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter
      ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended
      outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of
      right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter
      at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial
      tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from
      AF recurrence between 91 and 365 days after catheter ablation. The secondary end points
      included the AF burden, procedural parameters, and complications.
    

Detailed description: 
      We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter
      ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended
      outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of
      right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter
      at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial
      tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from
      AF recurrence between 91 and 365 days after catheter ablation. The secondary end points
      included the AF burden, procedural parameters, and complications.
    

Intervention name(s): PVI; CPVI+6L
Intervention type(s): Procedure; Procedure
Intervention description(s): Pulmonary vein isolation; After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Paroxysmal Atrial Fibrillation; Ablation
Metformin in Intracytoplasmic Sperm Injection Cycles
Condition: Intracytoplasmatic Sperm Injection
Study type: Interventional
Phase: Phase 2

Summary: 
      The relationship between serum progesterone level on the day of human chorionic gonadotropin
      administration and outcome of in vitro fertilization /intracytoplasmic sperm injection and
      embryo transfer has been controversial for several decades. some studies presented data
      against the negative effect of premature luteinization and reported that elevated serum
      progesterone had no adverse effect on pregnancy rates in fresh embryo-transfer cycles within
      different ovarian responses. However, most studies have evaluated the association between
      serum progesterone level and clinical outcome in fresh in vitro fertilization
      /intracytoplasmic sperm injection cycles and advocated that serum progesterone elevation on
      the day of human chorionic gonadotropin administration may adversely affect the clinical
      outcome by jeopardizing endometrial receptivity.

      In addition, the underlying mechanism through which premature luteinization influences
      clinical outcomes is elusive. some proposed that premature luteinization cause impairment of
      the endometrial receptivity, which may indicate a change in the implantation window, is more
      likely to be affected than the oocyte.whereas some documented that the compromised quality of
      oocytes might also be a cause.

      The cut-off point of premature luteinization is not well established until now. Premature
      luteinization has been variously defined based on serum P levels, with thresholds of 0.9-1.5
      ng/mL being used.

      Previous studies have shown that metformin inhibits the first steps of steroidogenesis
      dose-dependently reducing granulosa cells progesterone output. Moreover, other authors have
      recently reported that low dose metformin could improve in vitro fertilization outcome in non
      poly-cystic ovarian syndrome repeaters. So, considering the safety of this drug before
      pregnancy, metformin can be given to consenting patients from first ultrasound monitoring
      until ovulation triggering.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): will receive metformin (1500 mg/day) starting with the commencement of oral contraceptive pills in the preceding cycle until the day of human chorionic gonadotropin triggering.; will receive corn-flour placebo tablets (three tablets daily).
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible women who gave their informed consent were randomized into two groups: (I) metformin group and (II) placebo group. Randomization was conducted using a computer generated table of random numbers with allocation concealment. Randomization was not changed after it had been done.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
Condition: Organic Cation Transporter 1; Morphine
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the trial is to investigate the effect of known genetic variants in
      organic cation transporter 1 (OCT1) on the effect of morphine after major surgery
    

Detailed description: 
      The purpose of the experiment is to investigate the effect of known genetic variants in
      organic cation transporter 1 (OCT1) on the effect of morphine after major surgery. This is
      primarily done by investigating systemic exposure of morphine in a cohort of patients
      undergoing scheduled laparoscopic colon or laparoscopic rectum surgery, and as pain treatment
      with intravenous (iv) morphine at the end of and after surgery (primary endpoints). As a
      secondary endpoint, we will investigate the effect (pharmacodynamics) of morphine in the same
      patients by registering pain during rest and activity, side effects and the degree of
      sedation at appropriate time intervals.
    

Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): The study was designed as an open, non-controlled drug trial, with scientists and participants blinded to the patients OCT1 status. Morphine will be given as a single dosis (0,15 mg/kg) at the end of the Surgery and later as boluses of 0,04mg/kg administrated by patient-controlled analgesia, (PCA). Blood samples with drug concentrations will be used to determine a difference in morphine AUC due to the patients OCT1 status. Questionnaire answers will be used to determine the effect of morphine due to the patients OCT1 status
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Prognostic Features for Mortality in Young Adults With Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      Pneumonia is a major cause of mortality and morbidity. A large body of evidence concerning
      the mortality risk factors in elderly patients with pneumonia has been reported; however,
      less is known about causes of mortality in patients of sixty and less. We noted a relatively
      substantial rate of short term mortality in this group of patients that were admitted to our
      institution. Therefore, we aimed to estimate the mortality rate and to identify risk factors
      for mortality among patients of sixty years old and less that were admitted with community
      acquired pneumonia.
    

Detailed description: 
      Community acquired pneumonia (CAP) is a major cause of morbidity and mortality. While there
      is much data about risk factors for severe outcome in the general population, there is less
      focus on younger group of patients. Therefore, we aimed to detect simple prognostic factors
      for severe morbidity and mortality in young patients with CAP.

      Patients 60 years old or younger, who were diagnosed with CAP (defined as Pneumonia
      identified 48 hours or less from hospitalization) between March 1, 2005 and December 31, 2008
      were retrospectively analyzed for risk factors for severe morbidity or mortality.

      Complicated hospitalization was defined as at least one of the following parameters:
      hospitalization longer than ten days, admission to intensive care unit and in- hospital
      mortality. Otherwise, the hospitalization was defined uncomplicated
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that were admitted with community acquired pneumonia to Rambam Medical Center
        between the dates January 1, 2004 until December 31, 2008
      
Keywords: Age; Mortality
A Pilot Study to Investigate the Effect of Motor Imagery on Dynamic Balance of Asymptomatic Students
Condition: Balance
Study type: Interventional

Summary: 
      This study intended to investigate the effect of imagining a movement task on dynamic balance
      of sedentary university students. Two groups with good mental imaging ability were studied;
      one group receiving instructions on mental imagery and the other served as a control
      receiving no particular intervention. Any improvement in the balance ability was measured
      using the star excursion balance test (SEBT); for it has good to excellent test-retest
      reliability and validity as established by several researchers.
    

Detailed description: 
      Motor imagery (MI) refers to a cognitive process during which the representation of a
      specific motor action is internally simulated without producing an overt body movement. Motor
      imagery is now widely used as a technique to enhance motor learning and to enhance recovery
      during rehabilitation of various conditions such as sports injuries, stroke, etc. Several
      studies have also shown improvement in strength, function, and use of both upper and lower
      extremities in chronic stroke. Present study aimed to identify its effectiveness in improving
      dynamic balance of individuals without any clinical problem. Such improvement, if any, may be
      useful in early balance and proprioceptive training during the maximum protection phase of
      joint injuries, fractures, or even rehabilitation of other clinical conditions affecting
      balance. It may have benefits in maintaining / improving movements in athletes after injuries
      as well as the general less active population, including the elderly population.
    

Intervention name(s): Mental Motor Imagery
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group received Mental Motor Imagery training, and the other group acted as a control with no specific intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mental motor imagery; SEBT
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
Condition: Supraclavicular Brachial Plexus Block
Study type: Interventional

Summary: 
      The aim of this study is to determine the minimum effective volume of local anesthetic
      (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for
      surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle
      aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal
      to the shoulder.
    

Detailed description: 
      The study is based on biased coin design, and the volume of LA for the next patient is
      determined by the result of the last one. In the case of block failure, the volume will be
      increased by 2ml. Conversely, block success will result in either a reduction in volume by
      2ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will
      assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and
      musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block.
      Finally, MEV90 is calculated by isotonic regression.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB (young group) brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB (middle-aged group)
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: minimum effective volume; ropivacaine; ultrasound-guided supraclavicular block
Non-invasive Brain Stimulation for People With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Every five minutes someone in the UK has a stroke. It is the main cause of long-term
      disability among adults in the UK despite a fall in age-specific stroke incidence, with a
      growing number of survivors remaining dependent for activities of daily living. While most
      people with stroke regain walking ability, upper limb problems with no voluntary arm and hand
      activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct
      current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through
      the application of weak direct currents and has the potential to develop into a useful aid to
      treatment strategies in neurorehabilitation. Recent literature into the application of tDCS
      in people with arm and hand impairments after stroke has shown promising results on upper
      limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot
      study evaluated a six-week training programme combining tDCS with robot-assisted hand
      training and reported significant improvements in upper limb function. However, the robot in
      the latter study focused on single-plane distal movements only and long-term effects of the
      tDCS were not assessed. Recent robotic developments included robots with three rotational
      degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined
      with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES
      Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.
    


Intervention name(s): Robot therapy and transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Administration of Robot Therapy:
Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS:
Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with
           Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)

        2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients
           with CAP after continuous oral administration and determine the pharmacokinetic
           (PK)/pharmacodynamic (PD).
    

Detailed description: 
      Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and
      developed countries. In the choice of antibacterial agents used to treat CAP,
      fluoroquinolones have received considerable attention because of their wide spectrum of
      bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a
      selective bacterial topoisomerase inhibitor. This study will test the safety and efficacy of
      TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired
      Pneumonia (CAP).

      Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after
      continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
    

Intervention name(s): Levofloxacin; Nemonoxacin
Intervention type(s): Drug; Drug
Intervention description(s): levofloxacin 500 mg,QD,7~10 days; Nemonoxacin 500mg,QD,7~10 days
Intervention MeSH terms: Levofloxacin; Nemonoxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ofloxacin; Levofloxacin; Ofloxacin hydrochloride
Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device
Condition: Intraosseous Access; Resuscitation
MeSH terms: Cadaver
Study type: Interventional

Summary: 
      The investigators sought to compare the intraosseous access success rates of the proximal
      tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver
      model during simulated resuscitation.
    


Intervention name(s): NIO
Intervention type(s): Device
Intervention description(s): Intraosseous access device NIO (Defibtech)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intraosseous access; cardiopulmonary resuscitation; paramedic; simulation; cadaver
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The study to be conducted is a prospective, open label trial. It is designed to evaluate the
      pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate
      in patients with chronic kidney disease.
    


Intervention name(s): Dabigatran Etexilate
Intervention type(s): Drug
Intervention description(s): Dabigatran Etexilate 75mg twice daily
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
REVEAL Study: Vessel Healing After Angioplasty
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      To address early vessel healing and thrombus formation after deployment of three distinct
      groups of stents
    

Detailed description: 
      A prospective, randomized study providing new evidences on early vessel healing and thrombus
      development after stenting with different devices.
    

Intervention name(s): Catania Stent
Intervention type(s): Device
Intervention description(s): coronary stent implantation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that have two significant short lesions
      
Keywords: Coronary Stent
Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
Condition: Leukemia; Lymphoma; Myeloma
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label palifermin will be administered to subjects who are at a risk of developing
      mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount
      of palifermin in the blood following administration will be evaluated. The safety of
      palifermin administration and its effect on reducing mucositis will also be evaluated.
    

Detailed description: 
      Mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of
      erythema and ulcerative lesions in the mouth. Mucositis can be serious, resulting in pain
      requiring interventions such as analgesic medications and the use of parenteral feedings.
      Currently, no standard therapy is available to prevent or treat mucositis.
    

Intervention name(s): Palifermin 6 x 60 μg/kg/day; Palifermin 2 x 180 μg/kg/day; radiotherapy; Chemotherapy
Intervention type(s): Drug; Drug; Radiation; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mucositis; chemotherapy; radiation therapy