bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)
Condition: Children at Risk for ASD
Study type: Interventional

Summary: 
      The study will evaluate the efficacy of a novel intervention implemented in a classroom
      setting aimed at improving joint attention and joint engagement skills with infants who are
      at risk of developing an Autism Spectrum Disorder.
    

Detailed description: 
      The proposed intervention adapts a parent-mediated intervention that successfully improved
      outcomes in toddlers with autism. The intervention model (a) targets the foundations of
      social-communication (joint attention, imitation, play), (b) uses naturalistic strategies to
      increase the rate and complexity of social-communication and (c) includes parents as
      implementers of the intervention to promote generalization across settings and activities and
      to ensure maintenance over time.

      In addition to testing the primary effects of this early intervention on the developmental
      outcomes of children with signs of autism, we will examine whether this method is superior to
      an early intervention focused on global infant development. Because brain development occurs
      rapidly in infants and toddlers, we will use high density EEG to investigate (1) biomarkers
      of change in these infants as a result of intervention and (2) biomarkers predicting response
      to treatment, with focus on the neural correlates of social attention and learning from joint
      engagement.

      Study Aims:

      AIM 1: To examine the effects of the experimental intervention (Baby JASPER) on primary
      (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint
      engagement and parent use of social communication support strategies).

      AIM 2: To examine maintenance and generalization of the effects of the experimental
      intervention on children and their parents.

      AIM 3: To examine electrophysiological biomarkers of change with treatment as well as
      predictors of social communication outcomes in children after intervention.

      AIM 4 (exploratory): To examine the effect of potential child level and parent level
      moderators on the primary and secondary outcomes of the study across the two conditions.
    

Intervention name(s): Baby JASPER; Standard Baby Classroom
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum; Assessment, Education and Programming System (AEPS) for Infants and Children curriculum focused on early developmental milestones in fine and gross motor, cognitive, adaptive and social areas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Prevention of Hypertension: A Randomized Trial
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether improved nutrition to correct overweight and high sodium intake, and
      regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow
      heart rate could lower blood pressure and prevent development of hypertension in
      hypertension-prone individuals.
    

Detailed description: 
      BACKGROUND:

      Diet modification is one of the strategies in the primary prevention of hypertension. Studies
      of the association between various factors and blood pressure in different populations have
      shown the occurrence of specific dietary factors associated with elevated blood pressures.
      The factors include overweight, alcohol consumption and high sodium intake. Heart rate is
      also an independent predictor of risk of hypertension. Diet and exercise are amenable to
      intervention to influence blood pressure with the aim of reducing the risk of developing
      hypertension.

      DESIGN NARRATIVE:

      In the first phase of the trial participants were randomized to a Monitored (Control) Group
      or to an Intervention Group receiving individualized intervention to achieve changes in diet
      and physical activity. The goals of the Intervention Group were: a reduction of at least 10
      pounds or 5 percent of body weight for those above desirable weight; a reduction in daily
      sodium intake to 1800 mg; a modification of alcohol intake to no more than two drinks per
      day; and an increase in regular, moderate physical activity. The primary endpoint in the
      first phase of the trial was the comparison of mean blood pressure in the Intervention Group
      versus the Monitored Group. In the second phase of the trial, all randomized participants
      were followed for a minimum of five years. The primary endpoints in the second phase were the
      incidence of high blood pressure and/or hypertension.
    

Intervention name(s): diet, reducing; diet, sodium-restricted; alcohol restriction; exercise
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Phase I Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2256098 in Healthy Volunteers
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety of a new drug and to look at how the drug is
      handled by your body. This is the first time the drug will be given to people, the drug has
      been safely given to animals over many days at higher doses than will be given in the study.
      The study will be done in healthy men and woman to determine what effects, good or bad, it
      has on thier health. This study will find out:

      If the drug has any side effects after one dose of the drug is given? How much of the drug
      gets into the bloodstream, and how long does the body take to get rid of it? If the drug
      causes any changes to a substance that is in skin, hair or blood.
    

Detailed description: 
      This study represents the first administration of the focal adhesion kinase (FAK) inhibitor
      GSK2256098 to humans to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD),
      and preliminary food effect following single oral doses in adult healthy subjects before
      proceeding to studies in subjects with cancer that will be given at higher doses over an
      extended period of time. FAK is a protein in the body that is important in cancer
      development. Objectives of the study will be to characterize the safety of single doses of
      GSK2256098; to characterize the single dose PK of GSK2256098 in the presence and absence of
      food; to examine the dose proportionality of GSK2256098 PK parameters following single dose
      administration; and to characterize the effect of single doses of GSK2256098 on phospho-FAK
      (pFAK) tyrosine 397 (Y397) levels in skin and hair follicles. Dose- and concentration-effect
      relationships for various safety parameters will be explored as appropriate.
    

Intervention name(s): GSK2256098; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): focal adhesion kinase inhibitor given as a single dose; Placebo to be used as comparator for GSK2256098
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: focal adhesion kinase inhibitor; healthy volunteers; first time in human
The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity
Condition: Alimentary Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The aim of this study is to summarize the data on efficacy and safety of Reduxine
      administration in the routine clinical practice according to the approved indications.
    

Detailed description: 
      Secondary objectives:

        -  to study the structure of the population of patients with the diet induced obesity with
           body mass index (BMI) 30 kg/m2 or diet induced obesity with BMI ≥27 kg/m2 associated
           with type 2 diabetes mellitus in respect of comorbidities and concomitant treatment to
           determine the areas for further investigations.

        -  to introduce the elements of control of adverse cardiovascular risks into the routine
           clinical practice: questionnaire concerning enrollment criteria for Reduxine treatment
           initiation, algorithm of Reduxine administration and treatment efficacy and safety
           monitoring (assessment schedule).

        -  to assess the effects of the treatment of overweight and obesity with Reduxine on
           patients' quality of life parameters.

      The Time Frame: the follow up of the study patients will be performed during six month to one
      year. Exception - premature discontinuation from the study.

      The scheduled visits of the patients to the investigational centres are: Week0 (inclusion of
      the patient), Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and Week 48.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women of 18-65 years old, in the random gender and demographical proportion, with
        the diagnosed overweight (BMI ≥ 27 and < 30) and obesity (BMI ≥ 30).
Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety from a high-dosed subcutaneous recombinant preparation
    


Intervention name(s): AL0704rP; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): strict subcutaneous; strict subcutaneous
Other intervention name(s): "na"; "na"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Grass pollen allergy; specific immunotherapy
A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This drug-drug interaction study will evaluate the impact of two different acid reducing
      agents (from two different drug classes) co-administered with a single dose of telotristat
      ethyl.
    


Intervention name(s): Omeprazole 40 MG; Famotidine 40 mg; Telotristat ethyl 250 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omeprazole 40 mg capsule; Famotidine 40 mg tablet; Telotristat ethyl 250 mg tablet
Intervention MeSH terms: Omeprazole; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the primary preventive effect of low-dose pravastatin against coronary heart
      disease (CHD) in Japanese hypercholesterolemic patients.
    

Detailed description: 
      MEGA Study is the first prospective, randomized, controlled trial conducted in Japan to
      evaluate the primary preventive effect of pravastatin against CHD in daily clinical practice.
      Because the dose of pravastatin used in the MEGA Study was 10-20 mg/day, which is consistent
      with the approved doses in Japan and lower than the doses used in previous large-scale
      clinical trials.
    

Intervention name(s): Diet; Diet+pravastatin
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hyperlipidemia; coronary heart disease; prevention; stroke; pravastatin
Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish
Condition: Early Childhood Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Aim: This randomised controlled trial will systematically compare the efficacy of a 25%
           AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting
           caries teeth among preschool children when applied at half-yearly intervals over a
           30-month period.

        -  Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement
           will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical
           trial. Approximately 2,400 kindergarten children will be screened and at least 826
           children with caries will be recruited. This sample size is sufficient for an
           appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of
           α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into
           2 groups to treat their caries over a 30-month period: Group A - biannual application of
           a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of
           a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted
           at 6-month intervals to assess whether the caries are arrested. Information on
           confounding factors such as oral hygiene habits will be collected through a parental
           questionnaire.

        -  Possible results and implications: As the first of its kind, this study would help to
           determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting
           childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride,
           respectively, than 38% SDF, their use would be more favourable than SDF in young
           children.
    


Intervention name(s): 25% AgNO3 solution followed by 5% NaF varnish; 38% SDF solution followed by placebo varnish
Intervention type(s): Drug; Drug
Intervention description(s): Dosage of 4.4μg±1.4μg fluoride per use; Dosage of 8.8μg±2.8μg fluoride per use
Other intervention name(s): silver nitrate; sodium fluoride; silver diamine fluoride
Intervention MeSH terms: Silver Nitrate; Pharmaceutical Solutions; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: silver nitrate; sodium fluoride; silver diamine fluoride; caries; non-inferiority trial
Vitamin D and Staphylococcus Aureus in the Diabetes Study
Condition: Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      There are indications that the vitamin D status of an individual is related to susceptibility
      to staphylococcal infections. In the present study we will examine nasal colonisation rate in
      subjects participating in an ongoing vitamin D intervention study ( 20.000 IU cholecalciferol
      per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose
      tolerance.
    


Intervention name(s): cholecalciferol
Intervention type(s): Drug
Intervention description(s): 20.000 IU per week, oral
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: staphylococcus aureus; vitamin D
Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study
Condition: Patient Compliance
MeSH terms: Papilloma
Study type: Interventional

Summary: 
      There has been very limited research that has looked at electronic reminders (text messages)
      and its effectiveness in adherence to vaccination among low-income minority populations.
      Results have shown that text messages, among low-income parents and adolescents who were
      identified as having a cellphone, is an effective strategy to increase the likelihood of
      adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been
      proven to be effective when coupled with other prevention strategies for immunizations for
      influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in
      adults. Additionally, Merck and Co. recommend electronic reminders in their patient
      compliance program as a key strategy for adherence. To our knowledge, this community-based
      pilot intervention study will be the first to assess electronic reminders and HPV vaccine
      initiation and adherence among rural uninsured and Medicaid populations. The investigators
      hypothesize that adolescent whose parents who receive the intervention will be more likely to
      initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the
      control group.
    


Intervention name(s): HPV Vaccine Electronic Reminders
Intervention type(s): Behavioral
Intervention description(s): The intervention group will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment survey. Up to two reminder contacts will be used if surveys are not completed for both intervention and control group participants. Preference for receipt of reminders will be obtained from the information study card parents complete at study enrollment. Enrollment card content, educational messages and patient- reminders will all be developed with community input.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HPV Vaccine Adherence; Electronic Reminders
The Evaluation of Postoperative Pain After Caesarean Section
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The aim of this study is to determine the effect of surgical priority either emergency or
      elective on postoperative pain in caesarean section operations. Patients whose undergo
      caesarean section operation are included into this study. Patients will invite to complete
      the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be
      divided into two groups in terms of applied surgical priority whether emergency or elective.
      After caesarean section, patient controlled analgesia is used for pain relief. And the
      intensity of pain will be measured by using numerical rating scale.
    

Detailed description: 
      Pain is the main problem of postoperative period. Postoperative analgesic consumption can be
      associated with physical and psychological condition of the individual. This study is aimed
      to investigate the effect of surgical priority either emergency or elective on postoperative
      pain in caesarean section operations.

      Patients are invited to complete the pain catastrophizing scale questionnaire in preoperative
      period.

      A total of 100 patients will be included into the study. Patients are divided into two groups
      in terms of surgical priority whether emergency or elective. Spinal or general anesthesia
      will be performed to the patients. In postoperative period, patient controlled analgesia will
      be applied for pain relief and numerical rating scale is used to determine the pain intensity
      in 1st, 2nd, 6th, 12th, 24th hours. The analgesic consumption in 24 hours will be recorded.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        individuals whose underwent caesarean section operation in terms of surgical priority
        whether emergency or elective
      
Keywords: pain; pain catastrophizing; cesarean section
Exclusive Intraoperative Radiation Therapy for Breast Cancer
Condition: Breast Neoplasms; Toxicity
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim of the study is to evaluate toxicity in breast cancer patients treated with two different
      doses of Intra Operative Radiotherapy
    


Intervention name(s): 21 Gy radiation; 18 Gy radiation
Intervention type(s): Radiation; Radiation
Intervention description(s): 21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV); 18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Intra Operative Radiation Therapy; Toxicity
Do Text Message Reminders Increase Preoperative Exercise in Obesity Surgery Candidates?
Condition: Perioperative Care; Bariatric Surgery; Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      Preoperative exercise has been shown to improve physiological and functional capacity in
      patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients
      undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the
      setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is
      also thought to increase the likelihood that they will exercise postoperatively. However,
      compliance to this advice is extremely low. Text-message interventions have been shown to
      improve compliance to other lifestyle interventions. The investigators will compare the rate
      of compliance to preoperative exercise prior to bariatric surgery in patients who receive a
      daily text message to those who do not. The investigators will also compare weight loss.
    


Intervention name(s): Daily text message reminders
Intervention type(s): Behavioral
Intervention description(s): Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment