bioihbjkbjnl/mcl2 huggingface dataset:
Rotavirus Vaccine Produced by Butantan Institute
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the safety, tolerability and immunogenicity of the
      pentavalent rotavirus vaccine produced by Butantan Institute.
    

Detailed description: 
      The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine
      against rotavirus for infants in its immunization schedule since 2006. Its introduction
      increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free
      of charge. An agreement between Path Foundation and Butantan Institute has made possible the
      transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent
      rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.
    

Intervention name(s): rotavirus vaccine; placebo
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses with 6 weeks interval; 3 doses with 6 weeks interval
Other intervention name(s): brazilian rotavirus vaccine; butantan placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: brazilian pentavalent rotavirus vaccine; safety; tolerability; immunogenicity
Patient-Reported Outcomes With LASIK:PROWL-1
Condition: Laser in Situ Keratomileusis
Study type: Observational

Summary: 
      This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related
      quality of life (QOL)in up to 550 active duty subjects prior to and six months following
      state-of-the-art laser in situ keratomileusis (LASIK).
    

Detailed description: 
      The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among
      the FDA, the Department of Defense, and the National Eye Institute (NEI). This project
      examines patient-reported outcomes (PROs) following LASIK. This three-phased project is part
      of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers
      used in LASIK surgery. PROWL-1 is the second phase of the larger LQOLCP project. This
      prospective, questionnaire-based study will be conducted by the Navy Refractive Surgery
      Center San Diego in collaboration with the U.S. Food and Drug Administration's (FDA's) Center
      for Devices and Radiological Health (CDRH) and the National Eye Institute (NEI). The primary
      purpose of this study is to explore the psychometric properties of a newly developed
      questionnaire assessing satisfaction and ophthalmic-related quality of life (QOL) in 550
      active duty patients over a period of six months prior to and following state-of-the-art
      laser in situ keratomileusis (LASIK). Specific topics of interest include: functional
      limitations, dry eye symptoms, pre-operative expectations, depression, anxiety,
      post-operative symptoms, dispositional optimism, and satisfaction. Additionally,
      standard-of-care, non-invasive clinical data will be collected pre- and postoperatively
      (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, corneal
      topography, and other clinical assessments), and analyzed. The questionnaire in this study is
      a newly developed instrument which, once psychometrically evaluated in this U.S. Navy/FDA/NEI
      collaboration, will be used in future large-scale, multicenter FDA clinical studies that
      include civilian refractive surgery centers throughout the United States.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Active duty service members residing in San Diego, CA and planning to undergo refractive
        surgery using LASIK for myopia, hyperopia, or astigmatism
      
Keywords: Myopia; Hyperopia; Astigmatism; Patient-reported outcomes; Patient satisfaction; Refractive Error; Emmetropia; Dry eyes; glare; halos; patient expectations
Stereolithographic Technique for Dentures
Condition: Mouth Edentulous; Jaw Edentulous
MeSH terms: Mouth, Edentulous
Study type: Observational

Summary: 
      The aim of this observational study is: producing complete dental prosthesis with the aid of
      CAD-CAM (Computer aided design & manufacturing) - 3D printing (Stereolithography) technology
      - using as printable material Poli(methylmetacrylate) - PMMA - with Nano TiO2 nanoparticles
      composite completely characterized.
    

Detailed description: 
      In order to improve complete dentures fabrications an experimental model for optimizing the
      composite material and the execution technique for the 3D printed dental prosthesis was
      developed.

        -  A new polymer - nano-TiO2 composite system for dentures printing was obtained by adding
           0,4-1%TiO2 nanoparticle in the commercially available E-Dent 100 (EnvisionTEC, Germany).

        -  The new polymer was completely characterized and biocompatibility tests were perform.

        -  A stereolithography technique was set-up for CAD-CAM complete dentures manufacturing.

        -  3D printed dental prosthesis will be inserted to a number of 35 complete edentulous
           patients from a target group;

        -  Clinical follow-up at 6, 12 and 18 months and quality assessment of the dentures will be
           recorded in a specific chart.

        -  A statistical evaluation of data recorded during the entire follow-up period will be
           performed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fully edentulous patients: maxillary, mandible or both dental arches.
      
Keywords: Complete denture; PMMA; Stereolithography
Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Recurrence
Study type: Observational

Summary: 
      The objective of this study is to establish the performance characteristics of an assay that
      detects the recurrence of bladder cancer in patients previously diagnosed with bladder
      cancer. The study is conducted at locations within and outside of the United States. Testing
      is performed on urine specimens provided by eligible enrolled patients. Results from this
      study will not be used for patient management decisions.
    


Intervention name(s): Xpert Bladder Cancer Monitor
Intervention type(s): Device
Intervention description(s): in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Urology clinics
Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees
Condition: Exercise Therapy
Study type: Interventional

Summary: 
      Objective: To investigate the effects of a one-year worksite individual exercise intervention
      on lifestyle-related modifiable health risks, physical capacity and work performance.

      Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104
      men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical
      activity levels were assessed by the long self-administrated version of the International
      Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal
      cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were
      collected from participants at baseline survey, at 6 months and 1-year after. Components of
      the program included supervised moderate to high intensity cardiorespiratory exercise,
      resistance training, and flexibility.
    


Intervention name(s): exercise training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women
Condition: Diphtheria-Tetanus-acellular Pertussis Vaccines
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when
      compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45
      years. Infants born to mothers enrolled in this study will be followed-up in two separate
      clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].
    

Detailed description: 
      The protocol was amended to include Spain in the study. The reasons for the Spain-specific
      amendment are listed below:

        -  Based on the feedback from the Spanish Ethics Committee, the evaluation related to the
           acceptance of cocooning was added in the protocol.

        -  The objectives and endpoints to include cocooning were added in the protocol.

        -  The eligibility criteria for participation of household contacts were defined in the
           protocol.

        -  The study procedures for household contacts were included.
    

Intervention name(s): Boostrix™; Saline placebo
Intervention type(s): Biological; Drug
Intervention description(s): One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.; One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Modafinil for Smoked Cocaine Self-Administration
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2
      days/week), but the effects of modafinil on cocaine self-administration in the laboratory
      have not been studied. The present study investigated the effects of modafinil maintenance on
      cocaine self-administration by frequent users (4 days/week) under controlled laboratory
      conditions. During this 48-day double-blind, crossover design study, the effects of modafinil
      maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were
      examined in nontreatment seeking cocaine-dependent individuals (n = 8).
    


Intervention name(s): Modafinil 0 mg; Modafinil 200 mg; Modafinil 400 mg; Cocaine 0 mg; Cocaine 12 mg; Cocaine 25 mg; Cocaine 50 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Modafinil (0 mg/day); Modafinil (200 mg/day); Modafinil (400 mg/day); Cocaine (0 mg/day); Cocaine (12 mg/day); Cocaine (25 mg/day); Cocaine (50 mg/day)
Intervention MeSH terms: Cocaine; Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cocaine; modafinil; self-administration; DRD4
Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques
Condition: Circumcision
Study type: Interventional

Summary: 
      Background: Circumcision is the most commonly performed surgical procedure done among the
      pediatric age group worldwide and is considered to be one of the oldest operations done.
      Circumcision should be performed properly with safe surgical techniques, with the least
      possibility of complications.

      Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of
      infants under combined general and local anesthesia.

      Patients and Methods: This prospective randomized comparative study was carried out on 110
      infants who were candidates for elective circumcision under combined general and local
      anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group
      A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement
      of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting
      forceps with cutting foreskin and achievement of hemostasis using thermocautery.
    


Intervention name(s): Bipolar Electrosurgery; Thermocautery
Intervention type(s): Device; Device
Intervention description(s): Achievement of hemostasis using bipolar electrosurgery; achievement of hemostasis using thermocautery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Circumcision; Electrosurgery; Thermocautery
Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
Condition: Infantile Spasms; West Syndrome
MeSH terms: Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 3

Summary: 
      Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal
      treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no
      consensus on the dosage of Prednisolone required for the treatment of infantile spasms.
      Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual
      dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses.
      A higher steroid dose may also be associated with more side effects. Therefore, this study
      was planned to compare the efficacy and tolerability of the high dose versus the usual dose
      in children with infantile spasms, in a randomized open-label trial design
    


Intervention name(s): Oral prednisolone
Intervention type(s): Drug
Intervention description(s): Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites
Condition: Bone Density; Bone Loss, Alveolar
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study is a human, prospective, parallel, randomised controlled clinical trial
      conducted to explore the efficacy of injectable PRF around dental implants. The trial is in
      accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
    

Detailed description: 
      Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for
      the study. A detailed, thorough medical and dental history was obtained and each patient was
      subjected to comprehensive clinical and radiological examination. All patients were informed
      about the nature of the study, the surgical procedure involved, potential benefits and risks
      associated with the surgical procedure and written informed consent were obtained from all
      patients.

      All the patients were treated with immediate implants. The injectable -PRF was coated on
      implants as well as injected in the socket in both the maxillary and mandibular anterior
      region. The clinical and radiographic parameters were recorded at baseline, three months and
      six months postoperatively.
    

Intervention name(s): I-PRF
Intervention type(s): Biological
Intervention description(s): Local anaesthesia was administered and mucoperiosteal flap was reflected. Atraumatic tooth extraction was performed. Socket was curetted to remove the granulation tissue present in the socket with the help of curettes. The socket was well irrigated with saline. Implant osteotomies wasl performed with sequential drilling with standardized drills.I-PRF was freshly prepared 600rpm for 7 min(50g). 1ml of the i-PRF was applied in to the osteotomy site and the implant surface will be thoroughly coated followed by placing of the implant. The surgical site was thoroughly irrigated and debrided. Flap closure was achieved using 3-0 silk sutures to protect the implant site.
Other intervention name(s): injectable platelet rich fibrin coated to dental implants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups were made one test and control. All the subjects were treated with immediate implants. In the test group subjects, injectable platelet-rich fibrin was coated around dental implants and was also injected in the socket. The control group received only dental implants.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Injectable platelet rich fibrin; Bone density; Crestal bone loss; Immediate implants
Effect of rTMS in Combination With a Low-carbohydrate Diet in Patients With Obesity
Condition: Obesity; Anxiety
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In the present study the investigators want to evaluate if the application of rTMS can reduce
      the anxiety and craving in patients with obesity helping them to follow a low carb-diet, as
      well as, to assess the changes in weight, body mass index and quality of life before and
      after rTMS or sham rTMS.
    

Detailed description: 
      Participants completed a written, informed consent and rTMS adult safety questionnaire. The
      inclusion criteria are:

      individuals between 25 and 60 years of age with obesity in stage 1, 2 or 3. The exclusion
      criteria were: subjects with metabolic disorders, neurological condition, epilepsy, or
      pregnancy. The study conformed to the Declaration of Helsinki and was approved by the
      Institutional Medical Research Ethics Committee (Hospital Ajusco Medio, Mexico DF). The
      protocol will be applied as follows: 10 rTMS or sham sessions during two weeks. Following
      these two week, patients will receive 8 more sessions on weeks 4, 6, 8, 10, 12, 16, 20 and
      24. Diet will be indicated during all the protocol. The sham group will receive sham rTMS
      sessions for two weeks, the additional sessions will be performed in the same manner thar in
      rTMS group.
    

Intervention name(s): rTMS; sham rTMS; Diet
Intervention type(s): Device; Device; Other
Intervention description(s): Patients will be stimulated in the dorso lateral frontal cortex. First, the motor threshold will be determined for each patient. To induce currents to the left primary sensory-motor cortex hand area (M1/S1) the coil will be placed over the scalp oriented at 45 ° from the mid-sagittal plane while subjects will sit comfortably on a chair. The coil will be systematically moved in this area until a contraction of the abductor will be identified. Motor evoked potentials (MEPs). MEPs will be registered with surface electrodes on the left hand abductor pollicis muscle using the same Magstim equipment. Then the parameters will be adjusted for the stimulation as was described before.; As well as the rTMS group, the motor threshold of each patient will be determined. They will experience a similar rTMS session with the difference that they not will be stimulated.; This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.
Other intervention name(s): repetitive transcranial magnetic stimulation; placebo; conventional treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants will be randomly assigned to one of two groups: the experimental group receiving rTMS and a placebo group receiving sham rTMS. Both groups will be on the low-carb diet.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: transcranial magnetic stimulation; obesity; diet
Inadequate Protein Intake at Specific Meals and Functionality in Middle to Older Aged Mexican Adults
Condition: Aging
Study type: Observational

Summary: 
      This study sought to determine if the inadequate protein intake per meal (defined as eating
      <30 g protein or 0.4 g protein/kg body mass) at specific meals (breakfast, lunch, dinner) is
      associated with functionality in middle to older aged Mexican adults. Functionality was
      evaluated with self-reported questionnaires to assess their functionality score for different
      activities of daily living.
    

Detailed description: 
      Detailed dietary information was obtained for each participant to estimate dietary protein
      intake per meal (breakfast, lunch, dinner). One meal was considered with inadequate protein
      intake if its content was <30 g or 0.4 g/kg.

      Functionality was assessed with two validated questionnaires. One for instrumental activities
      of daily living (Lawton) and another for activities of daily living (Barthel). We calculated
      a score according to each author's scales. This score was divided into three possible groups
      as "low", "middle", and "high" scores.

      To analyze the association between inadequate protein intake per meal and functionality, we
      used multinomial logistic regression. The outcome variable was functionality ("High" was the
      reference group, "middle" and "low" scores were considered as impaired functionality), and
      the predictive variables were inadequate protein intake at breakfast, lunch, and dinner. They
      were adjusted for age, BMI categories, number of diagnosed diseases, sex, and inadequate
      protein intake per day (<1.2 g/kg/d).
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Cross-sectional
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Middle to older aged Mexican adults attending to the Geriatrics Department at the Western
        General Hospital (Hospital General de Occidente) for their usual medical screening or first
        time assessment.
      
Keywords: Protein intake; Older adults; Mexican adults; Functionality
Forearm Immobilization, Metabolic Health, and Muscle Loss
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will investigate the impact of altered substrate availability on muscle
      atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm
      immobilization
    

Detailed description: 
      Thirty-six healthy young volunteers will undergo 2 days of forearm immobilization combined
      with ingestion of one of two drug or placebo. Before and after immobilization, they will
      receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle
      sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle
      protein synthesis in the fasted and fed state.
    

Intervention name(s): Forearm immobilization
Intervention type(s): Behavioral
Intervention description(s): Two days of forearm immobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science