bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to determine whether misoprostol administered 12 hours before
      office hysteroscopy can relieve pain more effectively compared with misoprostol administered
      3 hours before office hysteroscopy.
    

Detailed description: 
      The interval between misoprostol administration and office hysteroscopy may have an influence
      on its effectiveness in pain reduction. There are limited data on the optimal interval from
      administration of misoprostol and office hysteroscopy. In previous studies, time interval
      from administration of misoprostol and office hysteroscopy ranged between 2 hours and 24
      hours.

      Till now no studies have yet investigated the optimal timing of misoprostol administration
      prior to office hysteroscopy or operative hysteroscopy. The aim of this study was to
      determine whether misoprostol administered 12 hours before office hysteroscopy can relieve
      pain more effectively compared with misoprostol administered 3 hours before office
      hysteroscopy
    

Intervention name(s): Long interval misoprostol; Short interval misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).; A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).
Other intervention name(s): long interval misoprostol group; short interval misoprostol group
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Misoprostol, pain, office hysteroscopy
A Study of [14C]GB491 in Male Healthy Subjects
Condition: Breast Cancer; Nonsmall Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics
      of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing
      approximately 50 uCi of [14C]GB491. This study will help understand how the drug appears in
      the blood, urine, and feces after it is administered.

      In addition, this study will also evaluate the safety of a single dose of [14C]GB491 when
      given to healthy subjects.
    


Intervention name(s): [14C]GB491
Intervention type(s): Drug
Intervention description(s): A single 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Predictability of the Ability to Perform an Emergency Stop
Condition: Osteoarthritis; Total Knee Arthroplasty
MeSH terms: Osteoarthritis; Emergencies
Study type: Interventional

Summary: 
      Several studies exist on patient performance in drive simulators especially around and after
      surgery. Recommendations concerning the ability to drive preoperatively are based on these
      studies, which generated their data using drive simulators. However, in all the datasets
      driving performance remains highly individual. Since a drive simulator is not readily
      available in normal general practitioner surgeries it would be helpful to have convenient
      clinical tests to evaluate a patients individual ability to perform an emergency stop. This
      study aims at evaluating different possibilities how such performance might be predicted.
      Patients with knee osteoarthritis and patients who have received total knee arthroplasty are
      tested clinically and their results are compared with the gold standard experiment - a drive
      simulator.
    


Intervention name(s): Braking and functionality
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Driver reaction time
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
Condition: Hemiplegic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Observational [Patient Registry]

Summary: 
      "The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of
      Life"
    

Detailed description: 
      Hemiplegic shoulder pain is a common symptom. Our aim in this study is to investigate the
      relationship between hemiplegic shoulder pain and balance and upper extremity functions.
    

Intervention name(s): "The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
Intervention type(s): Other
Intervention description(s): The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        hemiplegic shoulder pain
      
Keywords: shoulder pain, hemiplegic, function, balance
Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment
Condition: Crowding
Study type: Interventional

Summary: 
      The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain.
      Several methods have been suggested to reduce the duration of orthodontic treatment
      classified to surgical and non-surgical methods.

      Researches used minimally invasive surgical methods like corticision, piezocesion,
      micro-osteoperforation, and piezo-puncture indicated that most of these methods can
      accelerate dental movement by 20 - 40% without causing additional pain as a result of using
      those methods. Applying corticision on the lower anterior teeth using a surgical blade and a
      hammer may accelerate tooth alignment during orthodontic treatment. This study consists of
      two groups, patients will be randomly assigned to one of these two groups.
    

Detailed description: 
      Pain is defined as an unpleasant emotional sensory experience associated with actual or
      potential harm. It was mentioned as one of the most common complaints related to orthodontic
      treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various
      degrees of pain.

      Corticision is one of the minimally invasive surgical procedures that is not associated with
      flap lifting. It was used to accelerate tooth movement in animals and case report studies.
      Its application on humans may aggravate their fear and anxiety towards the pain that may
      accompany this technique.

      No study in the literature has been searched in patient perception of pain, discomfort,
      levels of acceptance and satisfaction accompanied corticision application, but in this study,
      these previous variables accompanied corticision technique have been studied on crowded lower
      anterior teeth cases which are one of the most common types of malocclusion.
    

Intervention name(s): Corticision; Traditional orthodontic treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement. Three incisions are going to be made; No surgical intervention will be used, just normal orthodontic sequence of procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
In Home VR Therapy
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Virtual reality is a video game in which a person and their real-time movements are
      represented on a screen in a virtual environment. This study will compare the use of
      multi-user virtual reality (VR) to single-user VR to determine if either provides superior
      engagement in upper extremity therapy and greater motivation to perform repetitive training.

      Stroke survivors will participate in a longitudinal study in which they will have the
      opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in
      their homes. They will use each mode for 2 weeks, completing 4 session per week, each session
      is 1 hour long. Upper extremity motor control, level of engagement, and active range of
      motion will be assessed at time points during the intervention period.

      Subject evaluations will take place before the intervention, at the midpoint of intervention
      (between switching from multi-user to single-user modes, or vice versa), and at the end of
      the intervention.

      The investigators hope to address two aims:

      Aim 1: To determine if the use in-home multi-user virtual reality treatment results in
      greater engagement in therapy compared with in-home single user virtual reality treatment.

      Aim 2: To determine if in-home virtual reality treatment results in greater practice

      The investigators hypothesize that stroke survivors will be more engaged in therapy when
      training with the multi-user VR system and this will translate into greater practice.
    


Intervention name(s): Single-User Virtual Reality Upper Extremity Therapy; Multi-User Virtual Reality Upper Extremity Therapy
Intervention type(s): Other; Other
Intervention description(s): Virtual Reality games with the user as the only person required for participation; Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
Other intervention name(s): Single-User Mode; Single-User Mode first, Multi-User Mode second; Multi-User Mode first, Single-User Mode second; Multi-User Mode; Single-User Mode first, Multi-User Mode second; Multi-User Mode first, Single-User Mode second
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Stroke; Virtual Reality Therapy; Rehabilitation; Upper Extremity; Arm; Telerehabilitation
Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity is a major health issue worldwide; there is a constant raise in obesity related death
      each year.
    

Detailed description: 
      The primary aim of the study was to investigate the effect of Mate extracts in Korean
      subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.

      Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85
      for women were for 12 weeks.
    

Intervention name(s): Mate extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.; Amount and calorie of placebo are same with Mate extracts.
Other intervention name(s): Extracts of Ilex paraguariensis A. St.-Hil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Mate extracts; Obesity; abdominal fat
A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children
Condition: Executive Function; Language; Preschool Child
Study type: Interventional

Summary: 
      Background: environmental influences in the first years of life have a great impact on
      adulthood. Adequate environmental stimulation in the first years of life positively influence
      cognitive, emotional and neurological development. Studies show that high quality education
      for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional
      and cognitive development, as well as school performance. However, it is not clear why
      specific types of interventions are most effective on school readiness, an important
      precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian
      context two well-known intervention programs: (1) executive functions training developed by
      Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling
      and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years
      old) allocated to three groups: (1) adapted school curriculum focusing on executive functions
      training, (2) adapted school curriculum focusing on oral language skills training, and (3)
      regular school curriculum.
    


Intervention name(s): Executive functions training; Language skills training; Regular school curriculum
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Daily training of executive functions via activities to develop auto-regulation, attention and memory.; Daily training of language skills via activities to develop phonological awareness and vocabulary.; Ministry of Education national school curriculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Executive Function; Language; Preschool child; Development
A Multi-component Program to Reduce Obesity in Children
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      In an attempt to challenge the increasing prevalence of childhood obesity, many programs have
      been executed in order to improve childrens' lifestyle. Programs involved either school,
      family or environmental measures. In most, success was only limited.

      The purpose of this trial is to examine the ability of a low-cost multi-component program to
      improve behavioral, diet and activity habits in both school, family and afternoon settings.
      Ths ultimate goal is to construct and assess a lifestyle modification program that can be
      implemented in schools and kindergartens on a national level.

      Participants will be ~2,500 children aged 5-12 from 22 kindergartens and elementary schools,
      divided into control and intervention centers.

      Teachers and students will be provided with materials in order to perform activities on
      healthy food and drink choices and habits during the school day. Schools will offer increased
      physical activity opportunities to children, as will afternoon community centers. Children
      will be given personal exercise items. Parents will be offered lectures on topics of diet and
      activity. Diet and activity habits will be assessed by a questionnaire, and height, weight
      and body fat percentage will be measured before and after the program.
    


Intervention name(s): lifestyle program
Intervention type(s): Behavioral
Intervention description(s): a comprehensive program designed to encourage healthier food choices and eating habits and increased physical activity among children, by use of school, family and community measures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: school; prevention; overweight; children; diet; physical activity; fitness
A Study of Brain Aging in Vietnam War Veterans
Condition: Traumatic Brain Injury; Post Traumatic Stress Disorder; Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat
      related problems and may be associated with a greater risk of Alzheimer's disease (AD). The
      purpose of this study is to examine the possible connections between TBI and PTSD, and the
      signs and symptoms of AD on Veterans as they age.

      The information collected will help to learn more about how these injuries may affect
      Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in
      Iraq and Afghanistan, who also have these types of combat related injuries.
    

Detailed description: 
      The overall long-term goal of this project is to prevent AD, which affects almost 50% of the
      US population over 85 years of age, and is the most common cause of dementia. Clinical signs
      and symptoms of AD include cognitive impairments, especially memory and emotional
      disturbances. In order to accomplish this goal of prevention, a population at risk must be
      identified. Evidence suggests that both TBI and PTSD increase risk for cognitive decline, AD,
      and dementia.

      TBI and PTSD are common problems resulting from military service. Thus far, there have been
      no prospective studies using imaging and biomarkers, which directly measure changes in the
      brain and AD pathology to study the effects of TBI and PTSD. This proposed study will provide
      novel data to test these hypotheses. The results will have major implications for
      identifying, subjects at increased risk for AD, a possible need for early detection of AD in
      military Veterans with histories of TBI and PTSD, and a possible need to employ prevention
      and treatment measures to avoid accelerated development of AD in US military Veterans. This
      study is a first step toward a larger, more comprehensive study of dementia risk factors in
      Veterans. The results will lead to a design and statistical powering of a prevention trial.
      Therefore, this project could be the first step toward the prevention of AD in Veterans, and
      in the general population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Vietnam Veterans
      
Biospecimen description: 
      blood, urine, cerobrospinal fluid
    
Keywords: traumatic brain injury (TBI); post traumatic stress disorder (PTSD); Alzheimer's disease (AD); mild cognitive impairment (MCI); dementia; biomarkers; amyloid; neuroimaging; cognition disorder; tau
A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a parallel, Phase 1, single center, 2-arm, double-blind, randomized,
      placebo-controlled with a ratio 2 active: 1 placebo study for treatment of mild to moderate
      psoriasis participants. Approximately 36 participants (24 in the SAR441566 group and 12 in
      the placebo group) are to be enrolled to have a total of 33 evaluable participants (22 in the
      SAR441566 group and 11 in the placebo group).

      The objective of this study is primarily to evaluate the tolerability and safety and
      secondarily the clinical response over 4-week oral treatment with SAR441566 in participants
      with mild to moderate psoriasis. The clinical response is measured by the relative change
      from baseline in Total Lesion Severity Score (TLSS).

      The study comprises an up to 4-week screening period, a 4-week treatment period with
      SAR441566 or placebo. The end-of-study visit will be carried out 10 ±3 days after the last
      investigational medicinal product administration. The frequency of visits is once a week
      during the treatment period.
    

Detailed description: 
      -  Screening period: up to 4 weeks

        -  Treatment: 4 weeks (from Day 1 to Day 28)

        -  End-of-Study: between 7 to 13 days after the last IMP administration (from Day 35 to Day
           41) Total study duration: 37 to 69 days maximum (approximately between 6 and 10 weeks)
    

Intervention name(s): SAR441566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions; Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to
      insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine
    


Intervention name(s): Technosphere Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment