bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature Chain
Condition: Tetanus; Tetanus Vaccine
MeSH terms: Tetanus; Tetany
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness, safety and feasibility of a
      tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a
      controlled temperature chain (CTC). The CTC is defined as the storage and transport of
      vaccines within a temperature range appropriate to the heat stability profile of TT vaccine.
      In this study vaccines are transported and stored in the cold chain up to district level.
      From district to beneficiary level vaccines are exposed to ambient temperatures during a
      limited period of time.

      In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For
      this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in
      the laboratory and compared to vaccines that have been maintained in cold chain. If all
      parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the
      strategy in CTC will be used.

      Only if the laboratory results are adequate, villages will be assigned to one of the
      vaccination strategies. All women between 14 to 49 years of age in the selected villages who
      fulfill the inclusion criteria will be invited to participate.

      In order to determine the baseline anti-tetanus protection, TT vaccination history will be
      collected from all participants using a standardized questionnaire. Women who have already
      received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will
      be collected from all participants to later verify in laboratory the baseline protection.

      A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold
      chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the
      same strategy employed for the first dose. Finally, four weeks after the second dose, a blood
      sample will be collected from all participants who received two doses of vaccine. The
      serological responses will be compared in the group that received two doses of TT vaccine
      maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.
    


Intervention name(s): Tetanus toxoid vaccine
Intervention type(s): Biological
Intervention description(s): Two doses of tetanus toxoid vaccine separated at least 4 weeks. One arm receives the vaccine kept in cold chain and the other arm receives the vaccine kept in CTC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: controlled temperature chain; outside the cold chain; vaccination; prevention of mother to child transmission
Semi-automatic Response System(SARS)in Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Background

        -  Various kinds of interactive online communication systems have been introduced for
           long-term diabetes management, and their importance in managing patients is increasing.
           The investigators investigated the amount of physician time needed to maintain such a
           system, and the investigators developed software to maximise the cost effectiveness.

      Methods

        -  The investigators conducted a prospective, randomised, controlled trial to investigate
           the efficacy and safety of a semi-automatic response system (SARS) for online glucose
           monitoring over a 24-week period of patients with type 2 diabetes. In the SARS group,
           the "SARS" software filtered the recorded self-monitoring of blood glucose data
           automatically to reduce the physicians' time, and the physicians managed patients
           regularly but only manually in the control (manual) group. The investigators measured
           the time spent by the physicians for online management and compared the HbA1c levels at
           enrolment and follow-up.
    


Intervention name(s): Internet
Intervention type(s): Other
Intervention description(s): new clinical decision-supporting system for glucose monitoring, SARS, which could identify glucose data recorded by patients and make some optimal decisions.The SARS engine assigned subjects to one of three levels according to the glucose control status and glucose control method.
Other intervention name(s): clinical decision-supporting system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: semi-automatic response system (SARS); Diabetes Mellitus; Internet; ubiquitous health care system
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Chronic Disease; Schizophrenia
Study type: Interventional

Summary: 
      This was a randomized controlled behavioral intervention trial to assess the efficacy of
      investigating program of chronic disease self-management program in people on schizophrenia
      patients conditions of depression, activities of daily living, social function, work, and
      quality of life.
    

Detailed description: 
      Subjects were randomized to intervention group and control group. The primary outcome
      included eight measures, Stanford Self-Management Questionnaire, the Beck Depression
      Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of
      Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior
      Inventory, and the Schizophrenia-Quality of Life questionnaire.
    

Intervention name(s): Chronic disease self-management program; General psychiatric intervention
Intervention type(s): Other; Other
Intervention description(s): The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.; General psychiatric intervention contains the activities in psychiatric center.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic disease self-management program
Efficacy of Chronoterapy in Oral Surgery
Condition: Tooth, Impacted; Trismus; Pain; Inflammatory Response
MeSH terms: Tooth, Impacted; Trismus
Study type: Interventional

Summary: 
      Lower third molar extraction is one of the most common treatments in oral surgery practice.
      It is a treatment with inherent complications such as postoperative pain, swelling or
      trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory
      medication is prescribed. Recently, it is seen that circadian rhythm may play an important
      role on drugs metabolism, modulating its effect depending on the moment of administration.
      The aim of the study is to analyze if dosage modification of a Non Steroideal
      Anti-Inflammatory (ibuprofen) affects on postoperative pain, swelling and open mouth
      limitation comparing to the normal dosage.
    

Detailed description: 
      A randomized crossover split-mouth clinical trial will be performed. After third molar
      extractions, patients will be prescribed ramdomly in one side wit the normal medication
      dosage while the contralateral side will be prescribed a modified dosage. Moreover, a blood
      sample will be obtained to analize the inflammatory profile.
    

Intervention name(s): Ibuprofen 400 mg; Ibuprofen 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): morning and afternoon; morning, afternoon and night
Other intervention name(s): Modified dosage; Conventional dosage
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Split-mouth design
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Third molar; Chronotherapy; Ibuprofen; Randomized
Teachers Thriving Together
Condition: Social Emotional Competence
Study type: Interventional

Summary: 
      This is a randomized, controlled, hybrid implementation-effectiveness design.whose primary
      aim is to examine the impact of ParentCorps plus Thrive Professional Learning, relative to
      Thrive Professional Learning and Inspire Professional Learning alone, on teachers' classroom
      teaching (knowledge, beliefs, skills and practice related to family engagement and social
      emotional learning) and teachers' social emotional development. The study also aims to
      understand the impact of Thrive Professional Learning versus Inspire Professional Learning
      alone on teachers and classrooms.
    


Intervention name(s): ParentCorps FUNdamentals; ParentCorps 101 E-learning; Training; Coaching
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): is a series of large-group experiential PD days (in groups of 25-40 participants from across all schools) which takes place in the first summer prior to implementation. Leaders participate in a 2-day FUNdamentals series with leaders from other schools.; is a self-paced interactive web-based series with 7 modules intended to help facilitators build confidence and mastery of evidence-based practices.; group-based series to prepare facilitators (mental health professionals and teachers) to implement Programs with fidelity and to ensure high levels of exposure by parents and students. Mental health professionals are supported to facilitate the Program for Parents (day and after-school versions) with fidelity. Pre-K teachers and assistants are supported to implement the Program for Students in the classroom. In addition, early childhood staff (including Kindergarten teachers as needed) is trained to facilitate the Program for Students during after-school hours in parallel with the Parenting Program. All facilitators receive training on engaging parents to participate; is one-on-one support provided in-vivo and from a distance (phone, text, email) to help users apply evidence-based practices in daily interactions with students and parents, and to support high levels of implementation fidelity and exposure. All Pre-K teachers and mental health professionals facilitating ParentCorps receive four on-site coaching visits and 10 30-minute calls for the remaining sessions in the first year for each cycle of implementation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma
Condition: Hodgkins Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to test the the protective capacity of Goserelin compared with oral
      contraceptive
    


Intervention name(s): 8 cycles BEACOPPesc plus oral contraceptive; 8 cycles BEACOPPesc plus Goserelin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Goserelin; Contraceptive Agents; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
Condition: Neonatal Disorder
MeSH terms: Infant, Newborn, Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the position of the mother in the first two
      hours after delivery, while she is in skin to skin contact with your child, influences the
      oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful
      information for the prevention of seemingly lethal episodes or sudden death of the child
      when, following current recommendations is skin to skin contact in the first hours of life.
      These episodes are communicating in all developed countries and have caused great concern and
      interest in the scientific community. So far we only have information from case series.
    

Detailed description: 
      The early skin to skin contact between mother and child in the first two hours postpartum is
      essential for bonding and breastfeeding. Coinciding with the widespread application of this
      procedure in hospitals have been described, in different countries, cases of children who
      have suffered episodes of apparent life threatening events (ALTEs) or early sudden deaths
      during the same procedure. The cause of these events is unclarified, it is unknown whether
      the position of the mother during the first two hours of a child's life affects their
      stability.

      The investigators's hypothesis is that the frequency of episodes of oxygen saturation less
      than 91% in the first 2 hours of life of the newborn is reduced by one third in children
      whose mothers are incorporated at 45° above the horizontal plane of the bed compared with
      children whose mothers are incorporated to 15º.

      This is a multicenter, randomized and controlled study in 10 Spanish hospitals with blind
      evaluation. 5866 participants will be enrolled in this study (a total of 1275 children are
      required in each arm of the study).

      Mother/child (defined as a dyad) will be randomized in two groups:

      Group A: head-of-bed elevated 15°. Group B: head-of-bed elevated 45°.
    

Intervention name(s): Head-of-bed elevated 15°; Head-of-bed elevated 45°
Intervention type(s): Other; Other
Intervention description(s): Head-of-bed elevated 15° during 2 hours after delivery.; Head-of-bed elevated 45° during 2 hours after delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
S9031-9333-0106-0112-A Study of Biomarkers in Samples From Patients With Acute Myeloid Leukemia Treated With Standard Chemotherapy With or Without Gemtuzumab Ozogamicin
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the
      laboratory may help doctors identify and learn more about biomarkers related to cancer.

      PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid
      leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.
    

Detailed description: 
      OBJECTIVES:

        -  To determine whether measuring biomarkers in less-differentiated acute myeloid leukemia
           (AML) blasts significantly improves their predictive accuracy to predict clinical
           outcomes for patients receiving induction/consolidation chemotherapy with and without
           gemtuzumab ozogamicin.

        -  To develop and validate novel predictive biomarker models for predicting clinical
           outcomes for AML patients receiving induction/consolidation chemotherapy with and
           without gemtuzumab ozogamicin.

      OUTLINE: DNA and RNA extracted from archived bone marrow and peripheral blood samples are
      analyzed for genomic mutations (CEBPA, FLT3, IDH1/2, KIT, NPM1, RUNX1, TP53, and WT1) and
      transcriptional biomarkers (BAALC, CCNA1, CD34, CEBPA, ERG, EVI1, FLT3, IL3RA, MCL1 [two
      splice variants], MN1, RUNX1, and WT1) by PCR and real-time PCR. Data are then analyzed by
      the Gene Scan software.
    

Intervention name(s): DNA analysis; RNA analysis; gene expression analysis; mutation analysis; polymerase chain reaction; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Specimens from patients consenting to future research on S9031, S9333, S0106 and S0112
      
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,
      balanced, single dose pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fasting
      condition in healthy adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Metoprolol Succinate 200 mg Ipca Laboratories Limited, India and the corresponding Reference
      Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 200 mg of Astrazenica LP,
      USA under fasting condition in healthy adult human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 200 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Metoprolol Succinate ER Tablet 200 mg; 'TOPROL-XL®' ER Tablets 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 * 200 mg tablet per day; 1 * 200 mg tablet per day
Other intervention name(s): Test Product; Reference Product
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose
      escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in
      healthy volunteers.

      Objectives are to determine:

        1. the maximal tolerated dose of SC ND-0612

        2. the steady state plasma concentration of LD and CD following SC ND-0612 administration.

      Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential
      manner.
    


Intervention name(s): ND0612; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): levodopa and carbidopa solution for subcutaneous administration; Saline solution for SC continuous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Designing Animated Movie for Preoperative Period
Condition: Postoperative Pain; Fear; Surgery; Pain; Nursing Caries; Nurse's Role; Clinical Anxiety; Patient; Pediatric
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Background: Using visual materials is effective in education to decrease children's
      pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12
      years, are interested in technology. This study aims to investigate the effects of watching
      an educational animated movie in the pre-operative period on fear and postoperative pain in
      children who are having surgery.

      Methods: The study was a prospective randomized controlled trial. This study was conducted
      between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical
      Faculty Hospital. The current study includes data from 132 children who were chosen doing
      block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale"
      and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were
      divided randomly into three groups as the "Educational Animated Movie Group" (EAMG),
      "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and
      Documentary Movie were screened using Virtual Reality (VR). Data were collected by the
      researcher in the pre-operative period. The pre-operative fear of the child was evaluated by
      the child and the parent, and the post-operative pain of the child was evaluated by the
      child, parent, and nurse using scales about fear and pain.
    


Intervention name(s): Educational animated movie group; Documentary movie group
Intervention type(s): Other; Other
Intervention description(s): Watching educational animation movie which were designed by the researcher before operation for fear and pain.; Watching documentary movie about trees before operation for fear and pain.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: There are 3 independent working groups.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pediatric surgery; preoperative preparation; animation; fear; pain; nursing
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity
      of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate
      to severe chronic plaque psoriasis.
    


Intervention name(s): DMB-3115; Stelara
Intervention type(s): Drug; Drug
Intervention description(s): 45mg or 90mg dose subcutaneous administration; 45mg or 90mg dose subcutaneous administration
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment