bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Physical Activity in People With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      People with schizophrenia die approximately 20 years earlier than those in the general
      population, and this is mostly due to cardiovascular disease (CVD) and related poor physical
      health. The risk factors for CVD are significantly more prevalent in people with
      schizophrenia, but they are largely preventable by, for example, engaging in regular PA.
      Existing interventions to increase PA in schizophrenia are generally atheoretical and lack
      manualisation and appropriate evaluation, thus reducing their usefulness to clinical
      practice.

      Drawing on the MRC Guidelines for the development and evaluation of complex interventions, a
      12-week intervention was developed and informed by a systematic review of the factors that
      influence PA in people with schizophrenia and a qualitative study exploring the barriers and
      motivators to PA (n=10). The feasibility and acceptability of the intervention was then
      investigated in an uncontrolled pilot study (n=20).

      The pilot study demonstrated that the intervention was both feasible and acceptable to people
      with schizophrenia. The retention rate was 90% (n=18), and reasons given for dropout were
      work commitments and other illness.

      Of the 18 who completed the intervention, 17 (94%) increased their weekly step count, 14
      (78%) met current public health guidelines of 10,000 steps per day at some point during the
      12 weeks, 10 (56%) experienced some weight loss, 12 (67%) took up an additional health
      promotion opportunity (e.g., improving diet, stopping smoking, joining a gym) and 13 (72%)
      took up another form of PA in addition to walking (e.g., swimming).

      Participants found the intervention enjoyable and thought it should be offered to everyone
      with schizophrenia. The intervention also proved to be feasible and acceptable to staff who
      referred patients to take part. Informal feedback from staff confirmed the need for such a
      service, particularly for those taking anti-psychotic medication, and indicated that, if it
      was to be implemented more widely, it would be a popular and useful resource.
    


Intervention name(s): ProActiveS
Intervention type(s): Behavioral
Intervention description(s): A 12-week behaviour change intervention, during which time participants met with the researcher weekly and used a pedometer to measure step count and completed an activity diary to monitor progress, set goals and plan how to cope with identified barriers.
Intervention model: Single Group Assignment
Intervention model description: Feasibility study
Masking: None (Open Label)
Primary purpose: Other
Keywords: physical activity; intervention; walking
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery
Condition: Colorectal Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the optimal prophylactic antibiotics administration method in elective
      colorectal surgery
    

Detailed description: 
      Use of prophylactic antibiotics in elective colorectal surgery is essential. Although
      single-dose prophylactic antibiotics are recommended, the efficacy of single-dose
      cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a
      multicenter randomized trial of single-dose vs. three doses of the second-generation
      cephalosporin, cefmetazole.
    

Intervention name(s): Cefmetazole (drug)
Intervention type(s): Drug
Intervention MeSH terms: Cefmetazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotics; Prophylaxis; Surgical wound infection
Use of Harmonic in Breast Surgery
Condition: Breast Cancer; Modified Radical Mastectomy
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL),
      operating time, drain Volume and drain Days, seroma formation, surgical site infection and
      postoperative pain in adult females undergoing MRM at a tertiary care hospital. We
      hypothesized that harmonic yields better outcome than electrocautery dissection.
    

Detailed description: 
      In this randomized controlled trial, adult females who underwent MRM between April 2010 and
      July 2011 were randomized to receive either intervention A (harmonic scalpel) or B
      (electrocautery). The procedure was standardized except elevation of flaps and axillary
      dissection, that was performed as per randomization. Patients were followed up in clinic for
      four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and
      drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and
      postoperative pain.
    

Intervention name(s): Harmonic; electrocautery
Intervention type(s): Device; Procedure
Intervention description(s): Dissection with harmonic scalpel; Dissection in modified radical mastectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Breast cancer,; Harmonic scalpel,; Electrocautery,; Modified Radical Mastectomy,; Randomized Controlled Trial
Effect of Beet Juice on Elite Swimmers.
Condition: ergogéniques
Study type: Interventional

Summary: 
      Objective: To investigate whether an acute intake of Beetroot Juice (BJ) improved performance
      factors in a repeated swimming effort at maximum speed in elite swimmers.

      Methods: A total of 13 elite swimmers (6 girls and 7 boys) participated in this randomised,
      double-blind study. In 2 different trials, the swimmers ingested an injection of Beet-It (70
      ml placebo (PL) or an injection of Beet-It 70 ml beetroot juice (BJ)) 3 hours before
      undergoing a 6x100m crawl intermittent maximal speed performance test.
    


Intervention name(s): Beetroot Juice
Intervention type(s): Dietary Supplement
Intervention description(s): The swimmers drank 3 hours before the test, mL70 of BJ (containing mmol6.4 of NO-3) (Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) or PLA (0.04 mmol of NO-3)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel allocation was carried out in the two groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Swimming; Beetroot juice; Performance; Ergogenic aid
RAPA-Keloid Study of Keloid Regression
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Early Phase 1

Summary: 
      1. To test whether topical rapamycin regresses established keloids in humans by measuring
           surface area and height changes in the scar over time (6 months)

        2. To test safety of product and feasibility of conduct for future clinical trial
    

Detailed description: 
      This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a
      petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic
      keloids in similar body regions (greater than 1-year duration). Treatment will be applied
      once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will
      receive petrolatum-only ointment as a control. Surface areas and height of keloids will be
      monitored pre- and post-treatment to evaluate responses.

      Keloid surface area and height changes will be measured pre-treatment and thereafter on a
      monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is
      camera and calipers to measure keloid height (37).

      Surface areas of all photographed lesions will be measured with Image J
      (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to
      analyze preliminary data and this study will use the same approach.
    

Intervention name(s): Rapamycin 8% Ointment; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A compounded ointment containing 8% rapamycin; Petrolatum ointment placebo
Other intervention name(s): Rapamycin ointment; Petrolatum ointment
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors; Petrolatum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Study participants will serve as their own control, using intervention on one keloid and placebo on the other
Masking: Single (Participant)
Primary purpose: Treatment
Bioavailability of Nasal Naloxone and Injected Naloxone Compared
Condition: Drug Overdose
MeSH terms: Drug Overdose
Study type: Interventional
Phase: Phase 1

Summary: 
      Opioid overdoses have in the last decade counted for about 230 untimely deaths annually in
      Norway. The government is currently implementing a strategy for combating this epidemic.
      Among the actions promoted in this strategy is the distribution of naloxone for intranasal
      administration. Such administration of naloxone is currently being implemented and tried out
      around the world, but very little has been done to pharmacologically study this new route of
      administration of this well known drug, and only 3 open label randomized controlled trials
      (RCTs) have been conducted. A recent guideline from the WHO on community management of opioid
      overdoses is a comprehensive review of many of the aspects the investigators cover in our
      research.

      Regarding both dosage, routes of administration of naloxone and care of these patients in the
      pre hospital setting. The WHO calls for nasal formulations with a higher concentration, as
      well as focuses on the current wide spread off label use of nasal naloxone as a problem and
      identifies several research questions of critical importance and very low evidence.The
      current study, together with our research group's previous and future studies, aims to
      provide data for the development of a medicinal product with marketing authorisation for use
      in pre-hospital overdoses. This to contribute to public health measures for opioid users and
      those around them.
    


Intervention name(s): Intranasal (IN) naloxone 1x; Intranasal (IN) naloxone 2; Intravenous (IV) naloxone; Intramuscular (IM) naloxone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as 100 μl 14.0 mg/ml (1.4 mg naloxone) by Aptar Unitdose device as one puff in one nostril; Administered as 2x 100 μl 14 mg/ml (2.8 mg naloxone) by Aptar Unitdose device as two puffs within the same nostril with 3 minutes interval; Administered as 1 ml Naloxon B Braun 0.4 mg/ml (0.4 mg naloxone), in an intravenous cannula in the opposite arm of which the blood samples are drawn from. IV bolus will be given rapidly (in less than 5 seconds); Naloxone administered as 2 ml Naloxon B Braun 0.4 mg/ml (0.8 mg naloxone) in a Braun Omnifix 2.5 ml syringe using a BD Microlance 3 21G (green) 0.8x40 mm needle in the deltoid muscle of the non-dominant arm
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Emergency Treatment; Morphine Derivates; Heroin; Antidotes; Administration, Intravenous; Pharmacology; Naloxone; Healthy volunteers; Administration, intramuscular; Administration, intranasal
Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
    


Intervention name(s): Brivaracetam; levetiracetam; lorazepam; placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Brivaracetam 10 mg tablets; 500mg tablets; lorazepam 2 mg over encapsulated tablets; placebo capsules
Intervention MeSH terms: Levetiracetam; Lorazepam; Brivaracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Brivaracetam; Cognitive neurophysiological tests (CNT); Neuropsychological assessments
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Disease; Influenza
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing
      by evaluating and comparing the immunogenicity of three consecutively manufactured lots of
      the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza
      season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots
      of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200
      participants.
    

Detailed description: 
      This randomized, observer-blind, multicenter, Phase 3 lot consistency study will be conducted
      at multiple sites in Canada. The composition of the Quadrivalent VLP Influenza Vaccine used
      in this study includes two influenza A virus strains and two influenza B virus strains based
      on the 2016-2017 recommended strains for vaccination in the Northern hemisphere.

      1,200 healthy male and female participants aged 18 to 49 years will be randomized in a 1:1:1
      ratio to one of three lots of the Quadrivalent VLP Influenza Vaccine (30 μg/strain).
      Participant will participate in this study for approximately 21 days, during which a first
      visit will be scheduled on Day 0 for screening, eligibility assessment, and vaccine
      administration; and on Day 21 for blood sample collection for immunogenicity assessment.
    

Intervention name(s): Quadrivalent VLP Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): Single dose of 30 µg/strain Quadrivalent VLP Influenza Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Influenza; Human; RNA Virus Infections; Lot Consistency; Immunologic; Orthomyxoviridae Infections; Infection; Virus Diseases; Vaccine; Safety; Plant-made; Virus-like particle; Hemagglutinin
Stress Management for Chronic Headaches
Condition: Headaches
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      This interventional, randomized controlled study seeks to test the effects of a novel
      emotional awareness and expression intervention against relaxation training or no
      intervention for college students with chronic headaches. These two interventions are
      conceptually quite distinct, as the former seeks to activate and process anger, whereas the
      latter, more commonly used technique, seeks to suppress or avoid it.
    


Intervention name(s): Anger Awareness and Expression; Relaxation Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Teaches patients to recognize, experience, and express emotions; Teaches patients relaxation training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: headaches; stress management; assertiveness training; relaxation training; emotional expression
Evaluation of the Safety and Performance of the NESS L300 Plus System
Condition: Foot Drop; Thigh Muscles Weakness (Hamstrings or Quadriceps); Upper Motor Neuron Injury or Disease
MeSH terms: Muscle Weakness; Paresis; Peroneal Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate the safety and efficacy of using the L300 Plus as a
      neuroprosthesis device for walking in patients following an UMN injury or disease. The
      clinical study is proposed to determine the anticipated adverse event rate and treatment
      outcomes at the conclusion of the study.
    

Detailed description: 
      This is a prospective, one-center, single group, repeated measures, non inferiority study.
      Forty-five (45) subjects suffering from foot drop and thigh muscles weakness due to upper
      motor neuron injury or disease will be evaluated for this study. Each subject will be in the
      study for six weeks. Clinical benefits will be measured through an assessment of the gait
      performance. In particular it will test the hypothesis that the NESS L300 Plus System which
      involves foot drop correction with thigh muscles activation, may achieve walking enhancements
      not inferior to those gained from using a system that only corrects foot drop (i.e. NESS
      L300).
    

Intervention name(s): NESS L300 Plus System
Intervention type(s): Device
Intervention description(s): The patients will receive the device for daily use of six (6) weeks.
Other intervention name(s): NESS L300; L300; L300 Plus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Foot drop; Thigh muscle weakness; Upper Motor Neuron injury or disease
Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure
Condition: Intracuff Pressure; ETT Size
Study type: Interventional

Summary: 
      The purpose of this current study is to evaluate whether the size of the endotracheal tube
      (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If
      there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be
      inherent risks associated with the use of a cuffed endotracheal tube that is less than the
      appropriate size. The investigators believe that the size of the tube chosen has an impact on
      the characteristics of the inflated cuff and hence the intracuff pressure and the sealing
      pressure are variable.
    


Intervention name(s): Surgery less than 60 minutes
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19
Condition: COVID-19; Olfactory Dysfunction
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019
      and rapidly spread worldwide, reaching its epidemic peak in March 2020 Coronavirus is a
      family of viruses that usually affect animals. They also can affect the respiratory system of
      humans, causing different manifestations such as difficulty in breathing, coughing, fever,
      invasive lung lesions, and viral pneumonia
    

Detailed description: 
      Coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019
      and rapidly spread worldwide, reaching its epidemic peak in March 2020 Coronavirus is a
      family of viruses that usually affect animals. They also can affect the respiratory system of
      humans, causing different manifestations such as difficulty in breathing, coughing, fever,
      invasive lung lesions, and viral pneumonia Smell and taste dysfunction is more frequent in
      the initial stages of covid-19 infection that occur within the first five days and may be
      used as pivotal symptoms in the early diagnosis of the disease
    

Intervention name(s): Administration of Systemic Corticosteroid
Intervention type(s): Drug
Intervention description(s): 10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery.
Intervention model: Single Group Assignment
Intervention model description: 67 Covid-19 patients with symptoms of ageusia and anosmia were recruited (that their covid infection was confirmed by using PCR).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; olfactory dysfunction; Gustatory dysfunction; Corticosteriods
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess
      the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma
      treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a
      1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC)
      injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair
      (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.
    


Intervention name(s): lebrikizumab; montelukast [Singulair]; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Given SC on Days 1, 29, and 57; 10 mg given orally once daily for 12 weeks; SC injection given on Days 1, 29, and 57
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of FYU-981 in Hyperuricemia With or Without Gout
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is exploratory investigation of safety and efficacy (dose response
      and optimal dose according to the percent reduction from baseline in serum urate level at the
      final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout
      for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks)
      by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel
      group comparison.
    


Intervention name(s): FYU-981 High dose, (Oral daily dosing for 8 weeks); FYU-981 Middle dose, (Oral daily dosing for 8 weeks); FYU-981 Low dose, (Oral daily dosing for 8 weeks); Placebo, (Oral daily dosing for 8 weeks)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.; Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.; Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.; Subjects randomized to the placebo arm receive placebo.
Intervention MeSH terms: Dotinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment