bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effectiveness of a New Malaria Vaccine Candidate by Infecting Vaccinated Volunteers With Malaria Parasites
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Malaria affects around 515 million people each year, about a million of whom die from the
      disease. It is a major problem for those who live in affected areas as well as for travellers
      to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose
      of this study is to test 2 new vaccination regimes that include a new malaria vaccine
      candidate, for their ability to prevent malaria infection.

      The vaccines are different types of virus which contain genetic information (DNA) from the
      malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to
      help the body make an immune response against the malaria parasite. Both viruses are
      inactivated so that they are unable to multiply within the body.

      The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur
      in many strain types and commonly infect chimpanzees as well as people and this vaccine uses
      a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP.

      The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the
      vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA
      ME-TRAP.

      This study will enable the investigators to assess:

        1. The ability of different vaccine combinations to prevent malaria infection

        2. The safety of the vaccine combinations in healthy volunteers

        3. The response of the human immune system to the vaccines
    


Intervention name(s): AdCh63 ME-TRAP; MVA ME-TRAP; Sporozoite challenge; Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly
Intervention type(s): Biological; Biological; Other; Biological
Intervention description(s): 5 x 10*10 vp IM; 2 x 10*8 pfu ID; Infected mosquito bite; AdCh63 ME-TRAP 5 x 10*10 vp MVA ME-TRAP 2 x 10*8 pfu
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Vaccine
Efficiency of GDS Method for Lumbar Stabilization for Non-Specific Low Back Pain in Primary Care
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized controlled trial was to assess the effectiveness of GDS
      Treatment Method for patients with subacute or chronic non-specific low back pain in Primary
      Care of Spanish National Health Service.
    

Detailed description: 
      Low back pain is one of the most frequent ailments in industrialized countries, with a
      lifetime prevalence of more than 70%. It is responsible for a major portion of work
      absenteeism and is actually among those conditions which generate the greatest expense due to
      health and labor costs.

      The Spanish National Health Service is a universal and free health care system. Non-specific
      low back pain (LBP) is a prevalent disorder, generating large health and social costs.

      There is considerable variation in LBP related clinical practice and a considerable number of
      clinical guidelines have been developed for the management of subacute and chronic LBP
      patients.

      Experience in Primary Care Centers of Madrid shows that physiotherapeutic intervention based
      on GDS Method for Articular and Muscular Chains is an efficient technique in the treatment of
      patients with diagnosis of non-specific low back pain compared with conventional
      physiotherapy treatment in Primary Care based on electrotherapy (TENS and microwave)

      Currently, no randomized studies examining the effects of this method for patients with
      subacute or chronic non-specific low back pain have been published.
    

Intervention name(s): GDS Method (muscular chains physical therapy method); Conventional Physical Therapy in Primary Health Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks.; Conventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices.
Conventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back Pain; Physical Therapy Modalities; Exercise Movement Techniques; Primary Health Care
Peripheral Endothelial Function in Asthmatic Patients
Condition: Endothelial Function
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of the study is to assess the peripheral endothelial function in adult asthmatic
      patients and the relationship between the peripheral endothelial function and the pulmonary
      function.
    

Detailed description: 
      The primary criteria is the peripheral endothelial function that will be assessed by the
      measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The
      pulmonary function will be assessed by the measures of the FEV1, the forced vital capacity
      (FVC) and the expiratory flow between 25% and 75% (FEF25-75%). The relationship between these
      parameters of the pulmonary function and the peripheral endothelial function will be
      analyzed. In addition, a relationship between peripheral endothelial function and the level
      of asthma control (Asthma Control Test (ACT)), the cardiovascular risk factors (SCORE INdex)
      and the treatment for asthma (controllers) will be also assessed.
    

Intervention name(s): Endopat
Intervention type(s): Device
Intervention description(s): measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: asthma, endothelial function
Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK
      Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.
    


Intervention name(s): Herpes Zoster Vaccine GSK 1437173A
Intervention type(s): Biological
Intervention description(s): Investigational vaccine (GSK 1437173A) administered intramuscularly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; Japanese; Herpes Zoster; immunogenicity; Herpes Zoster in healthy ethnic Japanese adults; Vaccine
Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, randomized, open-labeled, positive controlled phase 2&3 combined study
      to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily
      somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone
      deficiency.
    

Detailed description: 
      This multicenter, randomized, open-labeled, positive controlled study is divided into two
      stages. The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin,
      while the second one is aimed to confirm the efficacy and safety of the study drug. A total
      of 400 prepubertal children with growth hormone deficiency were expected to enrolled.
      Subjects will firstly undergo a 52 weeks treatment, and then followed for 5 weeks.
    

Intervention name(s): Y-shape pegylated somatropin; Y-shape pegylated somatropin; Y-shape pegylated somatropin; Norditropin®; Y-shape pegylated somatropin; Norditropin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Y-shape pegylated somatropin 100μg/kg, subcutaneous injection, Once weekly.; Y-shape pegylated somatropin 120μg/kg, subcutaneous injection, Once weekly.; Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.; Norditropin 245μg/kg/week, subcutaneous injection, Once daily.; Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.; Norditropin 245μg/kg/week, subcutaneous injection, Once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth Hormone Deficiency; somatropin; recombinated human growth hormone; Growth Hormone
Web-based Intervention to Prevent Risky Driving
Condition: Adolescent; Accidents, Traffic; Attention; Motor Vehicles
Study type: Interventional

Summary: 
      The specific aim of this study is to assess the feasibility of a web-based intervention to
      prevent risky driving with teen drivers licensed in the previous 90 days.
    

Detailed description: 
      The specific aim of this study is to assess the feasibility of a web-based intervention to
      prevent risky driving teen drivers licensed in the previous 90 days. The intervention will
      focus on promoting teen driver attention to the roadway.

      The investigators will use a randomized controlled trial (RCT) experimental design for this
      feasibility study, randomizing to the intervention or control group. The investigators will
      complete a baseline assessment and follow up with participants at 1-month, 3-months and
      6-months post-intervention delivery.

      This study will provide information on the feasibility of the web-based intervention to
      prevent risky driving and estimation of effect size of the intervention on simulated driving
      performance, self-reported driving behaviors, crash and citation data.
    

Intervention name(s): Risky driving prevention; Control group general health promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.; The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A new diabetes education program for the initiation of non-intensive insulin therapy in type
      2 diabetic patients (MEDIAS 2 CT) was developed.

      In the evaluation, this new developed program is compared with an education programs which is
      currently used for diabetes education. It is expected that the new developed program (MEDIAS
      2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic
      control. If non-inferiority can be demonstrated superiority of this program will be tested.
    

Detailed description: 
      The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted
      as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help
      patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused on
      controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk
      of late complications, and reducing the emotional burden of diabetes and its treatment.

      The active comparator condition (ACC-CT) consisted of an established patient education
      program for type 2 diabetic patients with conventional insulin treatment. This education
      program was developed in the 1980s and 1990s and is more didactic-oriented, focusing
      primarily on the acquisition of knowledge, skills, and information about the correct
      treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 lessons,
      which were conducted as group sessions.
    

Intervention name(s): MEDIAS 2 CT; Current CT program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).; The Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes self-management education; insulin therapy
Effects of Acute Ingestion of Dark Chocolate on Endothelial Function in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      We aimed to identify clinical and vascular parameters of treated hypertensive patients who
      present beneficial effects of dark chocolate for one-week period on vascular function.
    

Detailed description: 
      Recent findings indicate an inverse relationship between cardiovascular disease and
      consumption of flavonoids. We aimed to identify clinical and vascular parameters of treated
      hypertensive patients who present beneficial effects of dark chocolate for one-week period on
      vascular function. Twenty-one hypertensive patients in drug therapy, both genders, aged 40-65
      years, were included in a prospective study with measurement of blood pressure, brachial
      flow-mediated dilatation (FMD), peripheral arterial tonometry (EndoPAT) and central
      hemodynamic parameters by SphygmoCor. After seven days of eating dark chocolate (70% cocoa)
      75g/day, the clinical and vascular evaluation were repeated. Patients were divided into two
      groups according to the response in FMD: responders (increase in FMD, n=12) and
      non-responders (no improvement in FMD, n=9).
    

Intervention name(s): Dark chocolate
Intervention type(s): Dietary Supplement
Intervention description(s): 70% cocoa
Other intervention name(s): Cocoa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hypertension; Endothelial dysfunction; Vascular stiffness; Use of one or two antihypertensive drugs
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
Condition: Neurodermatitis
MeSH terms: Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the efficacy of dupilumab on itch response in participants with prurigo
      nodularis (PN), inadequately controlled on topical prescription therapy or when those
      therapies are not advisable.

      Secondary Objectives:

      To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with
      PN, inadequately controlled on topical prescription therapy or when those therapies are not
      advisable.

      To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in
      health-related quality of life. To evaluate safety outcome measures. To evaluate
      immunogenicity of dupilumab.
    

Detailed description: 
      The duration of study for each participant included 2-4 weeks of screening period, 24 weeks
      of treatment period and 12 weeks of post treatment period.
    

Intervention name(s): Dupilumab SAR231893; Placebo; Moisturizers; Low to medium potent topical corticosteroids; Topical calcineurin inhibitors
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:
Route of administration: Topical; Pharmaceutical form:
Route of administration: Topical; Pharmaceutical form:
Route of administration: Topical
Intervention MeSH terms: Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Phytochemicals on Aspects of Cognitive Performance
Condition: Cognitive Performance
Study type: Interventional

Summary: 
      The primary purpose of the research is to test the short-term effects of the consumption of
      beverages containing phytochemicals and caffeine on several aspects of cognitive performance.
    


Intervention name(s): Cherry Flavored Beverage
Intervention type(s): Other
Intervention description(s): Intervention involves consuming one beverage at the beginning of each visit of the crossover sequence.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cognitive; phytochmicals; caffeine; cognitive performance after ingestion of test beverage
Eliminating Learning Curve Related Morbidity in Fast Track Laparoscopic Roux-en-Y Gastric Bypass
Condition: Postoperative Complications; Operative Time; Surgical Volume
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant
      learning curve. We report the results of a systematic training programme from a high volume
      bariatric center measuring the outcome by comparing the results with data from a consecutive
      series of 1000 fast track LRYGB.

      Method: Using a stepwise training programme the RY gastric bypass operation was divided into
      an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic
      surgeon without experience in upper GI surgery was mentored by an experienced bariatric
      surgeon. During 6 months full time fellowship 300 operations were performed.

      Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which
      the mentor surgeon did the other part of the operation. In 110 patients the trainee performed
      both procedures. Two percent had peri-operative complications compared to 1% of 1000
      patients. All were repaired and had an uneventful recovery. Two percent had postoperative
      complications < 30 days compared to 2.8% in the clinic. In the trainees series there were no
      leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation
      0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic.
      Concerning time to discharge there was no difference between patients operated by the trainee
      and the standard of the clinic.

      Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery
      eliminates morbidity of the learning curve without affecting the volume.
    


Intervention name(s): laparoscopic gastric bypass
Intervention type(s): Procedure
Intervention description(s): laparoscopic gastric bypass
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        300 consequtive patients already sceduled for laparoscopic gastric bypass surgery
      
Keywords: laparoscopic gastric bypass; learning curve; complications; operative time
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human; Chickenpox; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      -  To compare immune responses to measles, mumps, rubella, and varicella antigens following
           vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in
           children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ
           (Group 2 vs. Group 1).

        -  To compare immune responses to the three strains of influenza (H1N1, H3N2, and B)
           following a two dose regimen of FluMist in children who receive the initial FluMist dose
           concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist
           alone (Group 2 vs. Group 3).Secondary:

        -  To assess the safety and tolerability of concurrent administration of FluMist with
           MMRIIÒ and VARIVAXÒ.
    


Intervention name(s): FluMist; FluMist; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Nasal Sprayer of one dosage of FluMist and other experimental; Nasal sprayer of FluMist; Nasal Sprayer of Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, single-center, double blind, double dummy, randomized trial. Platelet function
      tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with
      Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary
      artery disease
    

Detailed description: 
      This was a prospective, double blinded, randomized trial that compared platelet inhibition
      and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg BID) versus
      prasugrel (60mg loading dose, followed by 10 mg QD) .

      Patients were eligible if they were between 18 and 75 years old, were on aspirin without
      P2Y12 inhibitor at baseline and > 1 year after documented ACS. Platelet aggregation was
      compared with the Multiplate ADP® assay, performed at baseline and after 15 days on study
      medication. Adenosine plasma levels were measured with high performance liquid chromatography
      at the same time points
    

Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Compared platelet inhibition and adenosine levels at baseline and after 15 days; Compared platelet inhibition and adenosine levels at baseline and after 15 days
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment