bioihbjkbjnl/mcl2 huggingface dataset:
A Participatory Parental Intervention Promoting Physical Activity in Preschools
Condition: Obesity; Physical Activity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to test whether a parent-focused participatory intervention in
      addition to gym lessons can enhance preschoolers physical activity compared to gym lessons
      alone.
    

Detailed description: 
      Over the last 20 years, physical activity (PA) in children has rapidly decreased in both
      developed and developing nations. More effective interventions to prevent inactivity in
      childhood thus are urgently needed. The preschool years, including the adiposity rebound
      period, might represent a good window of opportunity. Study literature suggests that
      targeting parents is crucial for lasting changes in young childrens' behavior. However, it is
      not known which methods are effective for involving parents in physical activity promotion.
      Consistent with experience from community-based participatory research, encouraging parents
      to participate the intervention in terms of content and structure might lead to higher
      intervention effectivity and sustainability. In our study, we therefore "enriched" a
      child-centered physical activity intervention in preschools (twice weekly gym lessons over 6
      months) with a parent-focused participatory community intervention component.
    

Intervention name(s): parent-focused intervention; twice weekly gym lessons
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families. The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film. During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools. Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together.; twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
Other intervention name(s): Ene mene fit - Eltern machen mit; child-centered physical activity intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: preschool; participatory intervention; cluster-randomization; children; obesity prevention
The Effect of Different Types of Spinal Needles on the Success of the Procedure
Condition: Spinal Needle Diameter and Design, Click Feeling
Study type: Observational

Summary: 
      The effects of spinal needles with different tip designs on the success of the application
      and the number of attempts required to get the spinal click feeling.
    


Intervention name(s): Spinal anesthesia application
Intervention type(s): Other
Intervention description(s): The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        213
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an
      investigational basal insulin patch in type 1 diabetes patients.
    

Detailed description: 
      The study is looking for patients that meet the following criteria:

        -  Duration of type diabetes greater than or equal to 10 years

        -  HbA1C less than or equal to 9.0%

        -  C-peptide negative

        -  Ages 18 - 65, male or female

        -  Body Mass Index (BMI) 18.5 - 32

        -  Non-smoker

        -  No advanced diabetes complications

        -  Not pregnant or breast feeding
    

Intervention name(s): PassPort(R) Transdermal Insulin Delivery System
Intervention type(s): Other
Intervention description(s): The PassPort(R) Transdermal Insulin Delivery System is a drug-device combination product used to create micropores in the skin to enable transdermal delivery of insulin.
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; insulin; blood sugar; type 1 diabetes; insulin dependent diabetes; transdermal
Double-Blind Naltrexone in Compulsive Sexual Behavior
Condition: Compulsive Sexual Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in
      compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will
      receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will
      be effective in reducing the urges to act out sexually in patients with compulsive sexual
      behavior. The proposed study will provide needed data on the treatment of a disabling
      disorder that currently lacks a clearly effective treatment.
    

Detailed description: 
      The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in
      20 subjects with compulsive sexual behavior.
    

Intervention name(s): Naltrexone; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): daily; daily
Other intervention name(s): Revia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Impulse Control Disorder; Compulsive Sexual Behavior
A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Tivozanib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile
      of tivozanib.
    

Detailed description: 
      This Phase 1, open-label, two-period, single-sequence study is designed to evaluate the
      effect of steady-state rifampin on the PK profile, safety, and tolerability of a single
      1.5-mg tivozanib dose. On Day 1 of the first period, subjects will receive a single 1.5 mg
      dose of tivozanib, and remain at the unit for at least 48 hours postdose followed by
      outpatient visits for PK sampling and safety assessments up to 3 weeks postdose. For Period
      2, subjects will be administered 600 mg of rifampin once daily (QD).for 6 days. On the 4th
      day of Period 2, 1.5mg of tivozanib will be administered with 600mg of rifampin. PK sampling
      will continue for 3-weeks postdose while the subjects continue to receive 600mg of rifampin
      daily. An end of study visit will be completed 1-week after the last dose of rifampin.
    

Intervention name(s): Tivozanib
Intervention type(s): Drug
Intervention description(s): Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity.
Intervention MeSH terms: Tivozanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AV-951; Tivozanib; Healthy Subjects; rifampin; Pharmacokinetics
Endoscopic Submucosal Dissection Versus Gastrectomy
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic
      submucosal dissection (ESD) has been accepted as standard treatment in selected patients with
      negligible risk of lymph node metastasis. However, there are limited data regarding the
      long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall
      survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.
    

Detailed description: 
      The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea,
      the detection rate of EGC has increased with mass screening for the prevention of gastric
      cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional
      lymph node metastasis. The presence of lymph node metastasis has been reported to range from
      2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as
      the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year
      survival rate above 90%.

      In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the
      basis of large scale retrospective data. Thereafter, the result was adopted as expanded
      criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along
      the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal
      resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor
      recurrence rate.

      Although curative resection is pathologically achieved by ESD, post-resection surveillance is
      needed to confirm the presence of nodal metastasis. Recently, several studies reported that
      5-year overall and disease-specific survival rate were highly favorable in EGC patients who
      underwent curative ESD. However, there is no comparative study about long-term outcomes after
      ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor
      recurrence, development of metachronous cancers between ESD and surgery groups.
    

Intervention name(s): Surgery
Intervention type(s): Procedure
Intervention description(s): Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with early gastric cancer were treated by surgery or ESD at a single,
        tertiary-care, academic medical center.
      
Keywords: Endoscopic submucosal dissection; Gastrectomy; Survival; Outcome
BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will primarily compare the long-term effects of an early and continued treatment
      with Betaferon/Betaseron (patients who were treated with active medication during the
      double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple
      Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with
      placebo during the double-blind BENEFIT study).

      Analyses are based on the integrated data of the initial BENEFIT study and this follow-up
      study.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare Pharmaceuticals Inc..

      Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.
    

Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug; Drug
Intervention description(s): Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase; Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Activity Choices Everyday- A Pilot Study
Condition: Obesity
Study type: Interventional

Summary: 
      This study aims to test two strategies for weight loss. Participants will be randomly
      assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program
      that involves recording weekly weight, physical activity, and caloric intake plus daily
      exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral
      weight loss program that involves recording weekly weight, physical activity, and caloric
      intake plus daily exercises in which descriptions of positive future events are reviewed.
      Throughout the study, participants will complete assessments that examine the effects of the
      interventions on delay discounting, physical activity, weight, and other important health and
      psychosocial outcomes.
    


Intervention name(s): Behavioral Weight Loss + Future Thinking; Behavioral Weight Loss + Healthy Thinking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.; Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Reliability and Validity of iOS in IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Observational

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds
      up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff,
      and reduces the amount of oxygen that the lungs can take up. People with IPF complain of
      worsening breathlessness, which limits their day to day activities.

      Lung function tests are breathing tests that measure how well the lungs are working, and are
      used by doctors to decide whether to start or stop medicines in people with IPF. However,
      people with IPF tell us that lung function tests require a lot of effort, can make them cough
      and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung
      function results accurately.

      Impulse oscillometry (iOS) is a new type of breathing test. It uses sound waves to measure
      the stiffness of the lung. The test is very quick (30 seconds), does not require any effort
      from the patient, and only requires a patient to breathe in their usual way. iOS has been
      used successfully in children who are unable to perform normal lung function tests.

      The investigators will assess whether people with IPF can perform iOS tests accurately and to
      compare their experiences of having iOS tests with their experience of performing current
      lung function tests. The investigators will also compare whether there is a relationship
      between iOS tests and the information gathered from the tests currently used by doctors to
      measure the impact of IPF (lung function tests, exercise tests, lung scans and questionnaires
      that measure quality of life).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with IPF
A Study of Semorinemab in Patients With Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of
      semorinemab in patients with moderate AD. The study consists of a screening period, a
      double-blind treatment period, an optional open-label extension (OLE) period, and a safety
      follow-up period. There may be up to two study cohorts.
    


Intervention name(s): Semorinemab; Placebo; [18F]GTP1
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive semorinemab every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period. Semorinemab will be administered Q4W in the OLE period.; Participants will receive placebo every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period.; [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Other intervention name(s): MTAU9937A; RO7105705
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study
Condition: Pediatric Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      When children suffer from a critical-illness, the investigators focus on resuscitating and
      saving lives. Once these children leave the pediatric intensive care unit, very little is
      known about what happens to them - how long it takes for them to recover, how families cope,
      and what factors that impede their recovery. The specific objective of this research project
      is to evaluate how children and their families recover after a critical illness.

      Research Hypotheses: Following a critical illness in children, 1) the rate and degree of
      health and functional recovery is influenced by the following factors: age, pre-admission
      co-morbid status, critical illness severity, discharge functional status, and time to
      initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and
      health-related quality-of-life (HRQoL).
    

Detailed description: 
      The Specific Objective of this study is to evaluate the trajectory of health and functional
      outcomes in children following a critical illness, define poor functional recovery, and
      evaluate predictors of poor recovery.

      The Research Questions for this study are: 1) What are the health and functional outcomes in
      children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care
      Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of
      poor functional recovery in critically ill children? 4) What are the most important and
      relevant outcomes in critically ill children, from the patient and caregiver's point of view?

      Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study
      Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London
      Health Sciences Centre.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In order to enrol children at potential risk for the outcomes of interest, and avoid
        "healthier" participants with short PICU stays, we considered the following: the patient
        should have: a) a minimum age (when one is expected to be ambulatory/mobilizing), and b) a
        threshold severity of illness. In order to understand how different subsets of PICU
        populations are affected by critical illness, we chose not to restrict the selection of
        patients to a specific diagnosis, nor did we exclude patients with underlying functional or
        cognitive abnormalities at baseline. This study will evaluate the epidemiology of recovery
        in a general critically ill pediatric population over time.
      
Keywords: pediatrics, critical illness, recovery, function, health
Surgeon Infiltration QL Block Comparison
Condition: Quadratus Lumborum Block; Surgical Wound Infiltration
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection
      technique (also called a "nerve block") that numbs the nerves going to the abdominal area
      improve pain control after surgery compared to administration of local anesthetic directly to
      the surgical incision. The QL block technique uses a numbing solution (local anesthetics)
      that is injected next to nerves located along muscles in the back to reduce pain. This block
      will not affect movement in the leg and/or make the legs weak. Some institutions, including
      Duke, use the QL block for patients having various abdominal surgeries, with the hope of
      providing good pain relief combined with improved mobility after surgery.
    


Intervention name(s): Liposomal Bupivicaine; QL Block
Intervention type(s): Drug; Procedure
Intervention description(s): Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound; Patient will receive ultrasound guided QL Block
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bupivacaine; Living donor nephrectomy
Multi-Center Pivotal Study of Radiofrequency Device
Condition: Body Fat
Study type: Interventional

Summary: 
      This is a prospective, controlled, multi-center study. Patients will be enrolled and treated
      with a radiofrequency device in this study if they have unwanted fat in the flank (love
      handle) area.
    

Detailed description: 
      Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. A maximum
      of 55 subjects will be enrolled at up to 6 study centers. Subjects will receive up to 5
      treatments with the TempSure® Firm on one flank. The other flank will be left untreated to
      serve a control. Subject will be required to return for follow-up visits at 6 weeks and at 12
      weeks after the subject's final treatment. All subjects will receive a phone call 1 week
      (1-10 days) post each treatment.
    

Intervention name(s): TempSure
Intervention type(s): Device
Intervention description(s): Non-invasive radiofrequency treatments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the percentage of Korean dyslipidemic subjects in the total group and each
      cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at
      starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment