bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
Condition: Healthy Volunteers; Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of three dose levels of
      ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have
      previously been administered the routine three-dose series of PCV13.

      This study will also evaluate the immunogenicity (production of an immune response) of three
      different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who
      have previously been administered the routine three-dose series of PCV13.
    

Detailed description: 
      After screening, participants will be randomized to ASP3772 or PCV13 on Day 1. A single dose
      of ASP3772 will be administered on Day 1 as an injection into the right or left thigh muscle
      at one of three dose levels. The participants randomized to PCV13 will receive a single
      intramuscular injection of the approved dose of PCV13 into the right or left thigh muscle.
      All participants will remain at the study site for approximately 30 to 60 minutes following
      vaccination in order for study site personnel to evaluate any immediate reactions, if needed.
      The participant's parent/legal guardian will observe for reactions, including daily body
      temperature measurements and tolerability assessments, from Day 2 through Day 7 and record
      observed events in the electronic diary device.

      All participants will have study visits on Day 7 (+ 1 day) and Day 30 (± 5 days)
      post-vaccination. The Day 7 visit may be conducted on site or by telephone call.The
      end-of-study visit will occur on Day 180 (± 14 days), which will be a safety follow-up by
      telephone call.
    

Intervention name(s): ASP3772; PCV13
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular (IM) injection; Intramuscular injection
Other intervention name(s): Prevnar 13
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Pneumococcal Disease; ASP3772; Pneumococcal vaccine; Vaccine
Insulin Pump vs Multiple Daily Injection on Cardiovascular Outcomes (ITALICO)
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The aim of this study was to evaluate if the positive effects recorded on glycemic control
      with CSII were maintained on the long term compared to multi-daily injections (MDI). The
      secondary objective was to evaluate if there is a reduction of type and number of
      cardiovascular events (CV) in CSII group compared to MDI group after 8 years of observation.
      This retrospective, observational trial evaluated 104 diabetic patients with prior treatment
      with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.
    


Intervention name(s): CSII
Intervention type(s): Device
Intervention description(s): This retrospective, observational trial will evaluate 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with type 1 and type 2 diabetes mellitus taking insulin
Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa
Condition: Vision Disorders; Stress, Psychological; Psychopathy; Self Efficacy
MeSH terms: Vision Disorders; Retinitis; Retinitis Pigmentosa; Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of cognitive - behavioral therapy for the
      control of psychopathological stress and the disease of people with Retinitis Pigmentosa
      (RP).
    

Detailed description: 
      This randomized controlled trial aims to evaluate the efficacy of cognitive - behavioral
      therapy for the control of psychopathological stress and the disease of people with Retinitis
      Pigmentosa (RP) on aspects such as vulnerability to stress, perceived stress,
      psychopathological state, general self-efficacy, resilience, satisfaction with social support
      and visual field. This study has two groups: 1) cognitive - behavioral therapy group, and 2)
      Standard intervention or control group. The two interventions will be conducted for 3 months
      (with a total of 12 sessions), one session per week, with a duration of 90 minutes per
      session.
    

Intervention name(s): A cognitive-behavioral intervention program; Standard intervention
Intervention type(s): Behavioral; Other
Intervention description(s): In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.; Participants receive different activities conducted by a psychologist in the association where the attend.
Other intervention name(s): Cognitive-behavioral program; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vision Disorders; Stress, Psychological
A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure Chamber
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of QAW039 alone and in combination with
      Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure
      chamber.
    


Intervention name(s): QAW039; Montelukast; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Role of the Pronator Quadratus in Distal Radius Fractures
Condition: Radius; Fracture, Lower or Distal End
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      The skin, the bones, and most muscles received branches from the source arteries of at least
      two angiosomes, thus revealing one of the important anastomotic pathways by which the
      circulation is reconstituted in those cases where a source artery is interrupted by disease
      or trauma.

      There are numerous metaphyseal-epiphyseal branches arise within the pronator quadratus and
      the anterior interosseous artery and course towards the distal radius. These branches may be
      fundamental to the healing of the distal radius fractures and make nonunion a rare
      complication. The aim of this study is the evaluation of the role of the pronator quadratus
      muscle and its repair in volar approach in distal radius fractures treated with plate
      fixation.
    

Detailed description: 
      Nonunion is an extremely rare complication in distal radius fractures and is most likely to
      occur in patients with conditions such as diabetes, peripheral vascular disease, or
      alcoholism. Diagnosis of nonunion is based on the absence of radiographic signs of union at 6
      months. Treatment should be individualized but options are reconstructive procedures or wrist
      arthrodesis. In volar plating and often by the fracture injury itself, the complete pronator
      quadratus is stripped off the volar radius. Thus, the intraosseous collateral circulation
      must be sufficient for clinical healing. Any operative approach to the distal radius fracture
      should not compromise both volar radial and the dorsoulnar arteries.

      While the branches to the pronator quadratus must be sacrificed in a palmar approach, the
      distal perforator can and should be spared. This is true even in the flexor carpi radialis
      extended approach. In distal radius fractures, when the normal outward flow of blood through
      the cortex is blocked, the periosteal arterioles have more ability than medullary arterioles
      to function and proliferate.
    

Intervention name(s): Pronatus quadratus reparation
Intervention type(s): Procedure
Intervention description(s): Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal radius fractures; pronator quadratus; osteosynthesis
Reducing Pediatric Obesity Through After-school Programs
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study will assess the impact of a national, community-based after-school program
      promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular
      risk factors among minority children. The investigators central hypothesis is that
      established community-based programs, such as America SCORES, can reduce obesity and
      cardiovascular risk among participants. The 1-year study followed 158 children from 6 public
      schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school
      program. Primary outcomes are change in body mass index (BMI), physical activity (measured by
      accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test).
      Cardiovascular outcomes include blood pressure, body composition (assessed using
      bioelectrical impedance) and waist circumference. The investigators will also measure
      academic outcomes.
    

Detailed description: 
      Baseline measures were collected in September 2009; midpoint measures were collected in
      January 2010; and final measures were collected in May 2010. Repeated measures analyses will
      compare trajectories for BMI, physical activity, and fitness between students in the SCORES
      and the usual care arms.
    

Intervention name(s): America SCORES, Bay Area
Intervention type(s): Behavioral
Intervention description(s): After-school program promoting physical activity via soccer 3 days/week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; minority; child; physical fitness; school; physical activity
Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating
Condition: Dysorthographia; Neurologic Disorder
MeSH terms: Nervous System Diseases
Study type: Interventional

Summary: 
      The main objective of the PREDICT4ALL project is to provide written communication in a
      computer, reducing the number of spelling errors for each user.

      The effectiveness of written communication is defined in this study by the number of spelling
      errors for each user. Word prediction (and therefore correction) must be able to be
      configured by a therapist (speech therapist, occupational therapist).

      Adapting the prediction to user errors should also allow it to be more relevant throughout
      the text input. This software efficiency must increase text input speed, Reduce the cognitive
      load, establish a classification of spelling errors adapted to the context of text input
      speed and develop the word prediction module tolerant of these spelling errors.
    


Intervention name(s): prediction software with spell checker
Intervention type(s): Other
Intervention description(s): test with prediction software with spell checker
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: interventionnal, prsopective, randomized, multicentric
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: word prediction; dysorthographia
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
Condition: Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether quetiapine fumarate extended release is
      effective in the treatment of alcohol dependence in very heavy drinkers.
    

Detailed description: 
      This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine
      derivative, as a potential medication for treating alcohol dependence. The immediate release
      form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of
      schizophrenia and acute manic episodes associated with bipolar disorder. The extended release
      formulation (SEROQUEL XR®) is also approved by the FDA and is undergoing clinical
      investigation for the treatment of major depressive disorders, schizophrenia, generalized
      anxiety disorder, and alcohol dependence.

      Treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in
      decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric
      diagnoses. Quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol
      use among alcoholics and drug dependent patients with co-morbid psychiatric illness.
    

Intervention name(s): Quetiapine fumarate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Quetiapine fumarate- taken daily, for 12 weeks; Placebo
Other intervention name(s): SEROQUEL XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Alcohol dependence; Quetiapine
An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
Condition: Chronic Refractory Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the antitussive effect size and dose response of
      FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability
      of FP01 lozenges in subjects with chronic cough.
    


Intervention name(s): FP01; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
Condition: Anaemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat
      in subjects with anemia associated with CKD.
    


Intervention name(s): Daprodustat; Darbepoetin alfa; Iron therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.; Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.; Iron therapy will be administered if ferritin is <=100 ng/mL and/or TSAT is <=20%.
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Daprodustat, recombinant human erythropoietin, darbepoetin, anemia, chronic kidney disease, dialysis, ESRD
Alternative Sedation During Bronchoscopy
Condition: Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the
      use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in
      less respiratory depression while providing better compliance with the procedure.
    

Detailed description: 
      All patients enrolled in the study will be undergoing bronchoscopy, which is typically
      performed with sedation. All procedural sedation carries some risk. Several features of the
      study may lower the risk of sedation relative to that of conventional sedation. An
      anesthesiologist will be present throughout the procedure. Continuous monitoring of
      respiration with RIP will be employed. Administration of sedation will be via a volumetric
      syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory
      depression and greater hemodynamic stability.
    

Intervention name(s): Dexmedetomidine load; Ketamine load; Midazolam load; Fentanyl load; Dexmedetomidine maintenance; Ketamine maintenance; Midazolam demand; Fentanyl demand; Benadryl demand
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dexmedetomidine 1 µg/kg prior to bronchoscopy; Ketamine 30 mg bolus prior to bronchoscopy; 2 mg bolus prior to bronchoscopy; 50 µg bolus prior to bronchoscopy; 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average); 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average); 0.5 mg demand bolus at discretion of pulmonologist; 12.5 µg demand bolus at discretion of pulmonologist; 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Other intervention name(s): Precedex; Dexmedetomidine Hydrochloride; Ketalar; Calypsol; Ketamin; Ketaminol; Ketanest; Tekam; Vetalar; Versed; Abstral; Actiq; Fentora; Onsolis; Precedex; Dexmedetomidine Hydrochloride; Ketalar; Calypsol; Ketamin; Ketaminol; Ketanest; Tekam; Vetalar; Versed; Abstral; Actiq; Fentora; Onsolis; Diphenhydramine Hcl; Aler-Dryl; Banophen; Ben Tann; Bromanate AF; Diphen; Diphenadryl; Diphenhist; Dytan; Unisom; Sominex; Silphen; Siladryl
Intervention MeSH terms: Diphenhydramine; Midazolam; Fentanyl; Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bronchoscopy
INTRAOPERATIVE DIFFERENT FLUID THERAPY PROTOCOLS
Condition: Intraoperative Fluid Management
Study type: Interventional

Summary: 
      We aimed to evaluate the relationship between different intraoperative fluid therapy
      protocols and postoperative renal damage and mortality.
    

Detailed description: 
      Sixty patients who 18-65 age and underwent pancreatic surgery in our hospital were included
      in the study. They were divided into two groups as liberal fluid therapy (Group 1, n=30) and
      targeted fluid therapy (Group 2, n=30).
    

Intervention name(s): Restricted Fluid Administration
Intervention type(s): Other
Intervention description(s): Restrictive fluid administration generally consists of partial or no replacement for the intravascular expansion from anesthesia, in which case vasopressors are usually administered, no replacement for the third space loss, and only partial replacement for deficits from preoperative fasting.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Liberal Fluid Therapy Group and Targeted Fluid Therapy Groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Liberal Fluid Therapy; Restrictive Fluid Therapy
Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy
Condition: Elderly Patients; Gastrointestinal Endoscopy; Midazolam; Remimazolam
Study type: Interventional

Summary: 
      Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good
      cardiovascular stability and mild respiratory depression for elderly patients. However, there
      is the concern about the the longer and less predictable recovery or the potential for repeat
      sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an
      innovative benzodiazepine with better sedation effect and less recovery or resedation issues
      than midazolam, which possibly make the drug more suitable in elderly patients. We aim to
      clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing
      gastrointestinal endoscopy.
    

Detailed description: 
      Before starting the endoscopy procedures, patients were randomized to receive remimazolam
      tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected
      for patients' sufficient analgesia during the examination. We aim to use patients' recovery
      time, cognition function and other measurement scales to clarify whether remimazolam tosilate
      is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
    

Intervention name(s): remimazolam tosilate group; Midazolam group
Intervention type(s): Drug; Drug
Intervention description(s): Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).; Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Remimazolam tosilate; Midazolam; postsedation effect; postsedation safety; cognition function; patients' satisfaction
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with
      moderate to severe plaque psoriasis.
    

Detailed description: 
      A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the
      Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with
      Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).

      This study will be conducted at about 40 study centers in central and eastern European
      countries. A contract research organization, will oversee operational aspects of this study
      on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.
    

Intervention name(s): Adalimumab
Intervention type(s): Biological
Intervention description(s): Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment