bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of
      lacosamide (LCM) in pediatric subjects.
    


Intervention name(s): Lacosamide; Lacosamide
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: oral solution
Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)
Route of administration: oral use; Pharmaceutical form: tablet
Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)
Route of administration: oral use
Other intervention name(s): VIMPAT; VIMPAT
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacosamide; Vimpat; UCB; Epilepsy; Partial-Onset Seizures; Pediatric
Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Three patients were recruited for assessment of ICG fluorescence in burns.
    

Detailed description: 
      The early determination of healing potential in indeterminate thickness burns may be
      difficult to establish by visual inspection alone, even for experienced burn practitioners.
      This case series explores the use of indocyanine green (ICG) fluorescence using portable
      bedside assessment as a potential tool for early determination of burn depth. Three subjects
      with indeterminate thickness burns had daily perfusion assessment using ICG fluorescence
      assessment using the SPY machine (SPY®, Lifecell Corp., NJ, USA) in addition to standard burn
      care. The fluorescence was quantified as a percentage of the perfusion of intact skin, and
      areas of hypo and hyper-perfusion were indicated. The burn surgeon, blinded to the ICG
      results, made a clinical determination of the need for skin grafting or discharge. The
      perfusion in areas of differing depth of burn were compared over the entire study period to
      determine both the magnitude of difference, and the point in the time course of healing when
      these changes became evident.
    

Intervention name(s): ICG/SPY; Antibiotic Ointment
Intervention type(s): Device; Drug
Intervention description(s): indocyanine green fluorescence imaging; Antibiotic ointment
Intervention MeSH terms: Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Dragonboat Activity for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to determine how a structured and supervised physical activity
      program linked to Dragon Boat practice can improve motivation to participate in physical
      activity sessions. It is also the purpose of this study to evaluate the improvement in body
      composition, body image perception and physical function.

      For this purpose, a group of women operated on for breast cancer was recruited and divided
      into two experimental groups: one group participated in a structured program of Dragon Boat
      while the other followed a home-based program of exercises independently in the home
      environment.

      Anthropometric measures (weight, height, BMI) and arm circumference, data on lifestyle and
      psychological well-being were evaluated by means of questionnaires. Tests were also performed
      to assess shoulder strength, aerobic capacity and mobility.

      The results of this study will (a) identify the strategies used that make Dragon Boat
      activity effective in ensuring quality participation in physical activity, (b) define the
      physiological effects of Dragon Boat activity on physical functionality and (c) correlating
      objective measures with subjective perceptions thanks to the integration of new body
      composition analysis techniques (regional BIA) and validated questionnaires on the perception
      of body image.
    


Intervention name(s): Dragon Boat; Home-based Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 weeks of training, defined by a precise progressive, structured and supervised program divided into 3 weekly sessions of one hour / one hour and a half preparatory to the Dragon Boat activity.; 12 weeks of home-based training composed by 10 exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Exercise and Brain Vascular Function
Condition: Physical Exercise; Cerebrovascular Function; Cerebral Blood Flow; Glucose Metabolism; Cognitive Performance
Study type: Interventional

Summary: 
      Cognitive performance is negatively related to an impaired glucose metabolism, possibly due
      to impairments in brain vascular function. Supported by the statement from the American Heart
      and Stroke Association that physical exercise is one of the most effective strategies to
      protect against cognitive decline, we now hypothesize that exercise-induced changes in
      glucose metabolism cause beneficial effects on brain vascular function thereby improving
      cognitive performance. The primary objective of this intervention study is thus to evaluate
      in sedentary elderly men the effect of a 8-week aerobic-based exercise program on cerebral
      blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)
      perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive
      physiological marker of brain vascular function. Secondary objectives are to examine effects
      on glucose metabolism using the oral glucose tolerance test and cognitive performance as
      assessed with a neurophysiological test battery.
    


Intervention name(s): Aerobic-based exercise program
Intervention type(s): Other
Intervention description(s): Aerobic-based exercise will be carried out on a cycling ergometer three times a week for 30 minutes at 70% of the maximal workload. Every two weeks, the maximal workload will be reassessed, and training loads will be readjusted accordingly. Fully supervised training sessions will be performed with three-to-four study participants at a time. Subjects should maintain their body weight during the intervention period.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will follow in randomized order a tightly controlled, progressive, aerobic-based exercise program or control program for eight weeks, separated by a washout period of twelve weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Self-management of Anticoagulation Treatment
Condition: Long-term Oral Anticoagulant Therapy
Study type: Interventional

Summary: 
      The aim of the study was to compare self-management of anticoagulant treatment with
      conventional anticoagulant treatment in Norway.
    

Detailed description: 
      Patients (n=23) on anticoagulant treatment with warfarin participated in a 27 weeks training
      program where they learned how to analyse International Normalised Ratio (INR) using the
      point-of-care instrument CoaguChek® XS and dose warfarin. The patients had to display their
      skills through a test before considered self-managing. They continued to measure INR weekly
      for 28 weeks. All INR values during the training program and self-control period were
      collected. In addition, the patients were told to notify if they had any complications during
      this period. Ten INR values and complications before enrolment was collected from INR cards
      and/or their general practioner. The participant filled in a quality of life-questioner at
      enrolment and after 28 weeks of self-management.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): Patients were trained to monitor INR and dose warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Warfarin; Self Care; Conventional care
Ocular Characteristics in Contact Lens and Spectacle Wear
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This clinical study will investigate the difference in ocular characteristics between contact
      lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by
      2-period cross-over design. There will be a 1-week washout between the two study periods to
      eliminate any potential carryover effect.
    


Intervention name(s): Spectacles; ACUVUE OASYS®1-Day with HydraLuxe™ Technology
Intervention type(s): Device; Device
Intervention description(s): Subjects' own habitual spectacles; Test 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
      patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian
      tube, or peritoneal cancer that has not been previously treated.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in
           patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or
           peritoneal carcinoma.

        -  Determine the response rate of patients treated with this regimen.

        -  Determine the time to progression and overall survival of patients treated with this
           regimen.

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and
      gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed at 3 and 6 months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): carboplatin; gemcitabine hydrochloride; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II ovarian epithelial cancer; stage I ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer
Acute Montelukast in Asthma
Condition: Acute Asthma Exacerbation
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients presenting to hospital with an acute asthma exacerbation severe enough to require
      admission would receive full standard treatment according to British Thoracic Society
      guidelines in addition they would be offered the opportunity to take part in the study which
      would requite them to take a capsule of either montelukast or placebo.
    


Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks; 1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Asthma Exacerbation; Montelukast; Management of acute asthma exacerbation
A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine
      (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a
      significant advantage in the degree and duration of immunogenicity. Secondary: To learn more
      about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn
      and HIVAC-1e).

      Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have
      persisted in most recipients for 6 months after boosting, and responses seem significantly
      higher and more persistent than responses achieved by just two doses of soluble protein
      vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited
      cohort of volunteers whether additional boosting with soluble recombinant gp160 results in
      increased immunogenicity of longer duration.
    

Detailed description: 
      Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have
      persisted in most recipients for 6 months after boosting, and responses seem significantly
      higher and more persistent than responses achieved by just two doses of soluble protein
      vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited
      cohort of volunteers whether additional boosting with soluble recombinant gp160 results in
      increased immunogenicity of longer duration.

      Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two
      doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and
      an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.
    

Intervention name(s): HIVAC-1e; gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological; Biological
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Envelope Proteins; Viral Vaccines; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Current osteoporosis therapies produce a prompt increase in bone mass, followed by only
      modest or no further subsequent gains. This limitation, known as the "remodeling transient,"
      reflects the "coupling" of bone resorption with formation such that interventions impacting
      either of these processes lead to compensatory changes of the other. For example, medications
      which increase bone formation promptly also stimulate bone resorption. Thus, given the need
      to dramatically increase bone mass in patients with osteoporosis, it is necessary to
      "uncouple" formation and resorption. The investigators believe this to be possible using
      currently existing FDA-approved therapeutic agents, by using a novel, sequential approach.

      This pilot project will obtain preliminary data essential to support future work. In this
      study, the investigators will begin to explore the use of sequential anabolic treatment with
      teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose
      that such sequential treatment will allow opening of the "anabolic window," the brief period
      of time following initiation of teriparatide therapy in which bone formation exceeds
      resorption.
    


Intervention name(s): Teriparatide; Raloxifene
Intervention type(s): Drug; Drug
Intervention description(s): Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.; Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
Other intervention name(s): Forteo; Evista
Intervention MeSH terms: Teriparatide; Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants
Condition: Solid Tumors Harboring NTRK Fusion
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral
      forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to
      participate.

      The study will have 2 parts. In part 1 researchers want to gather information how the body
      absorbs, distributes and excretes the drug BAY2731954 given as two different tablet
      formulations. Participants will take the study drugs on 3 days separated by breaks of at
      least 3 days between each intake. The duration of this study part will be in total of up to 6
      weeks from first screening visit to follow-up visit.

      In part 2 of the study researchers want to study how the body absorbs, distributes and
      excretes the drug BAY2731954 given as two different tablet formulations with or without food
      or as 2 liquid oral formulations. Participants will take the study drugs on 4 days separated
      by breaks of at least 3 days between each intake. The duration of the second part of study
      part will be in total of up to 7 weeks from first screening visit to follow-up visit.

      During the study, researchers will collect blood and urine samples. In addition, doctors will
      check the participants' overall health. They will also ask the participants if they have any
      medical problems.
    


Intervention name(s): Selitrectinib (BAY2731954) Adult tablet; Selitrectinib (BAY2731954) Pediatric tablet; Selitrectinib (BAY2731954) Oral solution; Selitrectinib (BAY2731954) Oral suspension
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, oral administration; Tablet, oral administration; Oral solution after reconstitution; Oral suspension after reconstitution
Intervention MeSH terms: Selitrectinib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1: sequential and non-randomized design Part 2: cross-over and randomized design
Masking: None (Open Label)
Primary purpose: Other
Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries
Condition: Elective Major Abdominal Surgery
Study type: Interventional

Summary: 
      Acute postoperative pain is an important issue after major abdominal surgeries for which
      different analgesic modalities have been tried.

      Epidural analgesia is the recommended technique to relieve pain after major abdominal
      surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as
      nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier
      ability for postoperative mobility. However, it is not without complications.

      Quadratus lumborum block is an ultrasound-guided block that provides patients with both
      visceral and somatic blockade. It lessens the potential risks associated with neuraxial
      techniques, so it may represent a novel alternative approach for analgesia after major
      abdominal surgeries.
    

Detailed description: 
      The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus
      lumborum block as a postoperative analgesic modality after major abdominal surgery in
      comparison to epidural block and its effects on total rescue analgesic requirements in the
      1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative
      and postoperative hemodynamics and postoperative opioid-related side effects.

      Under complete aseptic conditions, the patients will receive either thoracic epidural block
      or bilateral ultrasound-guided quadratus lumborum block after induction of general
      anaesthesia
    

Intervention name(s): Thoracic epidural block; Ultrasound-guided bilateral quadratus lumborum block; Induction of general anaesthesia with propofol; Muscle Relaxant; Maintenance of general anaesthesia
Intervention type(s): Other; Other; Drug; Drug; Drug
Intervention description(s): Patients who will be subjected to epidural block will be placed in the lateral position then, after sterilization of the skin, 21 G spinal needle will be inserted at T9-T11 intervertebral spaces. The epidural space will be located using the loss of resistance to air technique and a mixture of bupivacaine 0.25% + 50 μ fentanyl targeting T6 level will be injected following induction of general anaesthesia.; Patients who will be subjected to major abdominal surgeries will be placed in a supine position with a pillow under their side to obtain an appropriate view of quadratus lumborum muscle. After sterilization of the skin and ultrasound-guided identification of the quadratus lumborum muscle, 20 ml bupivacaine 0.25% + 25μ fentanyl will be injected on each side following induction of general anaesthesia; propofol: 1.5-2.5mg/Kg; Atracurium : 0.5mg/Kg.; Sevoflurane 0.7-1.5 MAC in 40% oxygen
Intervention MeSH terms: Anesthetics; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind study
Masking: Single (Participant)
Primary purpose: Prevention