bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
Condition: Multifocal Motor Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of subcutaneous administration of
      immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy

      NB. ONLY RECRUITING FROM DENMARK
    

Detailed description: 
      Introduction Intravenous immunoglobulin (IVIG) treatment is the only established treatment
      modality in Multifocal Motor Neuropathy (MMN). In order to maintain neuromuscular performance
      patients require lifelong treatment. Hospital-based treatments have high cost and
      inconveniences to patients, particularly in chronic disorders. Immunoglobulin preparations
      are now available for subcutaneous use as IgG replacement therapy. The safety and efficacy of
      subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied
      successfully in other autoimmune disorders. However patients with MMN have not previously
      been treated with subcutaneous immunoglobulin.

      Hypothesis:

      Subcutaneous immunoglobulin treatment is efficacious and safe with less patient
      inconvenience.

      Primary endpoint:

      Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.)

      Secondary endpoint:

      Medical research council score (MRC-score), 9-hole peg test, 10m walking, Nerve conduction
      parameters, SF-36.
    

Intervention name(s): Subcutaneous immunoglobulin; Intravenous immunoglobulin
Intervention type(s): Drug; Drug
Intervention description(s): Individually dosed, given twice a week.; Individual dose and frequency
Other intervention name(s): Subcuvia; Endobulin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: multifocal motor neuropathy; subcutaneous; IVIG; gammaglobulin
EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations
Condition: Bronchial Neoplasms
MeSH terms: Bronchial Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II
      dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a
      continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB
      or IV) lung cancer patients with activating mutations in the epithelial growth factor
      receptor (EGFR).
    

Detailed description: 
      The population of interest for this trial is defined by patients with non-small cell lung
      cancer (NSCLC) harbouring the sensitizing EGFR mutations del19 or p.L858R. Patients may be
      enrolled in first- or later lines of therapy and independently of the prior (approved) EGFR
      inhibitor administered and independently of the EGFR p.T790M-status. Those individuals whose
      tumors harbour high-level amplifications of MET or other EGFR mutations except for del19,
      p.L858R or p.T790M will be excluded from the trial. The molecular status must have been
      determined in a biopsy collected at progression to the last systemic and prior to the
      initiation of the trial treatment

      The aim of the trial is to identify the maximum tolerated dose (MTD)/recommended phase II
      dose (RP2D) for a continuous treatment with the 3rd generation EGFR inhibitor EGF816 and the
      MEK inhibitor trametinib.

      The recommendations for dose level escalations will be based on an "up-and-down" design
      proposed by Storer, 1989. The dose limiting toxicity (DLT) period comprises the first 28 days
      of treatment with EGF816 and trametinib at the designated dose level (Cycle 1).

      PK parameters of the combination treatment will be assessed for every dose level in every
      patient during the dose-escalation part.

      Preliminary efficacy of EGF816 and trametinib in the trial population will be assessed by
      RECIST (v1.1) analysis of scheduled CT scans (every 8 weeks or as clinically indicated.

      Throughout the study blood samples will be collected to monitor cell free plasma DNA (cfDNA).

      Patients who develop resistance upon treatment with the study drugs will undergo a rebiopsy
      to identify potential mechanisms of resistance.
    

Intervention name(s): EGF816; Trametinib
Intervention type(s): Drug; Drug
Intervention description(s): Continuous oral treatment (once daily) with the 3rd generation EGFR inhibitor EGF816.; Continuous oral treatment (once daily) with the MEK inhibitor trametinib.
Other intervention name(s): Nazartinib; Mekinist
Intervention MeSH terms: Trametinib; Nazartinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acquired resistance; EGFR p.T790M-positive; osimertinib resistance; EGFR p.T790M-negative
Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The study aimed to figure out brain structural and functional reorganization evidence after
      repetitive transcranial magnetic stimulation through the method of neuroimaging brain network
      analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor
      imaging.
    


Intervention name(s): real Repetitive Transcranial Magnetic Stimulation; sham Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.; The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ischemic stroke; Functional magnetic resonance imaging (fMRI); Repetitive transcranial magnetic stimulation (rTMS); Brain Reorganization
Hyoscine Butyl Bromide in Reducing Pain During HSG
Condition: Pain Relief With HSG
Study type: Interventional
Phase: Phase 4

Summary: 
      Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to
      relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an
      antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to
      relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor
      gynecological procedures. So the efficacy of hyoscine use are still controversial and no
      previous studies investigated its efficacy for pain relief in HSG procedure.
    


Intervention name(s): hyoscine butyl bromide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure; oral placebo; 2 tablets 30 minutes before the procedure
Other intervention name(s): BUSCOPAN
Intervention MeSH terms: Scopolamine; Bromides; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo
Condition: Vertigo; Dizziness; Benign Paroxysmal Positional Vertigo; Labyrinthitis
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Labyrinthitis; Labyrinth Diseases; Dizziness
Study type: Interventional

Summary: 
      Western University of Health Sciences is seeking men and women to participate in a study on
      the effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation
      Therapy (VRT) in patients with vertigo. The purpose of this study is to examine the efficacy
      of OMT in the treatment of individuals with vertigo, alone and in combination with Vestibular
      Rehabilitation Therapy (VRT). Because of the health care costs associated with vertigo, the
      cost effectiveness of OMT and VRT will also be examined.
    


Intervention name(s): Osteopathic Manipulative Treatment (OMT); Vestibular Rehabilitation Therapy (VRT)
Intervention type(s): Other; Other
Intervention description(s): Direct action OMT procedures, including HVLA, involve the application of a force in the direction of restricted joint motion in order to resolve somatic dysfunction. Indirect techniques, including counterstrain, balanced ligamentous tension and myofascial release, entail applying a force away from the restrictive barrier of a joint or soft tissue structure.; Participants categorized as having a peripheral motion hypersensitivity will receive habituation exercises that reproduce the provocative motion, seated and standing balance exercises with gaze stabilization, kinesthetic and proprioceptive retraining. Participants will be given a monthly exercise log at onset and will be asked to report exercise levels at subsequent follow up periods.
Other intervention name(s): Osteopathic Manipulative Medicine (OMM)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Dizziness; Vertigo; Benign Paroxysmal Positional Vertigo; Labyrinthitis; Osteopathic Manipulative Treatment; Vestibular Rehabilitation Therapy
The Effect of Lidocaine Patch for Postoperative Pain
Condition: Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The lidocaine patch is currently only permitted for post herpetic neuralgia but the
      investigators want to study its effectiveness in post operative pain after inguinal
      herniorrhaphy
    

Detailed description: 
      After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and
      group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the
      incision site. Group P attaches two placebo patches for 12 hours, above and below the
      incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after
      surgery.
    

Intervention name(s): Group L
Intervention type(s): Drug
Intervention description(s): Attach two lidocaine patches for 12 hours, one above and below the incision site.
Other intervention name(s): lidotopcaplasma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted
      weight management program in a randomized controlled trial (RCT). Primary objective: to
      assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on
      cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming
      component on attendance and participation.
    

Detailed description: 
      Eighty-four overweight pediatric subjects will be enrolled sequentially and randomized 2:1 in
      experimental and control groups for six months of weight management programming. The
      experimental group and their parents/guardians will participate in ten weekly 2-hour
      sessions, comprised of 1 hour of exergaming or exergaming combined with traditional exercise
      and 1 hour of didactic classes focusing on nutrition and psychosocial behaviors related to
      weight management. Following these 10 weeks, they will attend monthly 1-hour maintenance
      didactic classes. The control group and their parents/guardians will participate only in the
      didactic portion of the curricula for the same duration of time, 10 weeks, followed by
      monthly maintenance classes for the remainder of the 6 month period. The control group will
      then be offered participation in the Exergaming for Health program upon study completion.

      Comparisons between the two groups will be obtained through changes in the measurements of
      weight, height, BMI z-scores, shuttle run times, and responses to questionnaires about screen
      time, self-perception, and nutrition. Measurements of both groups will be obtained at
      baseline and 6 months and another set of measurements will be obtained on the experimental
      group at 12 months.
    

Intervention name(s): Exergaming; Didactic health teaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 months of weight management programming consisting of 10 weekly sessions:1 hour of session was spent "exergaming", which included active video game play and traditional group exercises. Some examples include: Dance, Dance, Revolution, Exerbike, Treadwall, Yoga, Spin class, etc.; 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1 hour didactic health teaching sessions for the remainder of the 6 month period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exergaming, Weight management
Radial Artery Versus Saphenous Vein Patency (RSVP) Study
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the radial artery (artery in the arm) or
      saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass
      surgery, have a greater patency rate (degree of opening)at 5 years after surgery.
    

Detailed description: 
      Arteries differ from veins both in morphology and physiology. Thus the way they behave as in
      vivo conduits when used in coronary artery bypass grafting is also likely to be different.
      This may partly explain the predisposition of veins used as coronary conduits to accelerated
      atherosclerosis in comparison with the internal mammary artery grafts. There are presently
      few data describing the properties of the radial artery as an in-vivo coronary conduit over
      the longer-term.

      The study will compare angiographic patency of the radial artery or saphenous vein graft
      anastomosed to the native left circumflex coronary territory at 3 months and 5 years after
      surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo
      radial artery and saphenous vein grafts in response to endothelium-dependent and
      non-endothelium-dependent stimuli when patients attend for their scheduled follow-up
      angiogram.
    

Intervention name(s): Coronary artery bypass graft (CABG) surgery
Intervention type(s): Procedure
Intervention description(s): Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary artery bypass; Coronary arteries; Atherosclerosis; Angiography; Blood flow
A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study is a prospective unblinded randomized trial to evaluate the feasibility of
      conducting a sleep extension intervention trial and the sleep extension intervention among
      the young adults. The study also wants to assess whether a sleep-extension intervention has
      an impact on the insulin resistance levels of young adults. The intervention consists of an
      education session and to extend the sleep time at least one hour but can be up to 2 hours per
      night for 4 weeks.
    

Detailed description: 
      Insulin Resistance has been shown to put a person at risk for developing Type II diabetes.
      There is a correlation between sleep deprivation and insulin resistance.The study wants to
      assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the
      feasibility of the sleep extension intervention among young adults by examining the number of
      subjects that are randomized to intervention arm will complete the study.

      Another intent of the study is to examine how sleep behaviors affect risks for developing
      type 2 diabetes and to determine their willingness to participate in a 4-week home-based
      program (intervention) focused on personal sleep behaviors.

      Subjects enrolled in the study and are randomized to intervention group and control group.
      The intervention group will receive one education session consisting of strategies for sleep
      hygiene which is the routine for going to sleep and instructions on extending time in bed by
      at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks
      subjects will have a blood draw and will complete the questionnaires.
    

Intervention name(s): SLEEP-Extend intervention; Control
Intervention type(s): Behavioral; Other
Intervention description(s): One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep
Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later; Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized and unblinded
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sleep Behavior; Insulin resistance
Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid
Condition: Drug Overdose
MeSH terms: Drug Overdose
Study type: Interventional

Summary: 
      Overdose with potential deadly outcome is a serious problem among opioid abusers, not least
      in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is
      required. The purpose of this study is to explore the pharmacokinetics and pharmacodynamics
      of naloxone in healthy volunteers under opioid influence.
    

Detailed description: 
      Healthy volunteers will be brought into a state of opioid influence in a well-known, short
      acting, controlled and safe manner using remifentanil. This will create a strong opioid
      effect inducing a miosis, reduced respiration and reduced sensation to pain, all three strong
      indicators of opiates. Naloxone will counteract these effects, which can be measured as a
      change in pupillary size. Blood samples for both naloxone and remifentanil will be also be
      taken.

      Naloxone is a well-known, well-tolerated drug with an excellent safety profile over many
      decades of use. The formulation used in this trial holds market authorization. Care will be
      taken not to include opioid users in this study as naloxone would precipitate acute
      withdrawal. Also possible drug misusers will be excluded as well as people who have access to
      remifentanil and infusion equipment in their daily work, although the abuse potential of this
      highly specialised drug is minimal. By weighing syringes before and after discharge the
      reliability of the dose delivered will be confirmed.
    

Intervention name(s): Intravenous naloxone; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Administer 2,5 mL, dose intravenous naloxone 1,0 mg; Administer remifentanil intravenously by way of Target Control Infusion, Minto's model at a target of 1,3 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone.
Other intervention name(s): Naloxone B Braun 0,4 mg/ml
Intervention MeSH terms: Remifentanil; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Emergency Treatment; Morphine Derivates; Heroin; Antidotes; Administration, Intravenous; Pharmacology; Naloxone; Healthy volunteers
Gastric Procedures for Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      This is a prospective case series study; all morbidly obese patients that need surgical
      management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic
      Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic
      gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The
      outcome measures will be percentage of excess weight loss, BMI, operative time, hospital
      stays, complications and improvement of comorbidities.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Morbidly obese patients aged from 18 to 65.
Bridging Recovery Allies in Virtual Environments
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The Bridging Recovery Allies in Virtual Environments (BRAVE) study aims to evaluate the
      acceptability and feasibility of implementing a virtual environment (VE) social support group
      for social communication training among adults with traumatic brain injury (TBI).
    


Intervention name(s): Virtual Envrionment for Social Communication
Intervention type(s): Behavioral
Intervention description(s): Once the Virtual Envrionment for Social Communication intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks).
Weekly sessions will follow a standardized format:
15 minutes- Social support group (guided discussion of experiences related to weekly topic)
20 minutes- Didactic instruction
15 minutes- Role playing
10 minutes- Debriefing and group feedback
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Virtual Environments; Social Communication