bioihbjkbjnl/mcl2 huggingface dataset:
Theoretical Compared With hands-on Training of Vaginal Breech Management
Condition: Vaginal Abnormality - Baby Delivered
MeSH terms: Congenital Abnormalities
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on
      a pelvic model is significantly better in terms of a technical skills scoring system compared
      to frontal teaching.
    

Detailed description: 
      Primary endpoint is a score describing technical proficiency, ie the OSATS score, consisting
      of 25 items. Each item, if done correctly, is awarded one point. The maximum OSATS score is
      25.

      Secondary endpoints are performance time in seconds, cinfidence using a scale from 1-5 with
      one being very confident and 5 having no confidence when performing the procedures, and
      self-assessment using a scale of 1-5 with 1 being the optimal grade.

      This is a two-arm study. The experimental arm uses a hands-on training and the control arm a
      frontal teaching approach. The allocation is randomized and single-blinded.
    

Intervention name(s): hands-on training; frontal teaching
Intervention type(s): Other; Other
Intervention description(s): the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech; one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A Phase II Study of CCX282-B in Patients With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether CCX282-B is effective in mitigating the
      effects of gluten ingestion in patients with celiac disease
    


Intervention name(s): CCX282-B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250mg capsule, twice daily, 13 weeks; Placebo capsule, twice daily, 13 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Muscle Damage After Downhill Running on Postprandial Lipids
Condition: Nutritional and Metabolic Diseases; Lipemia
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      All participants underwent three experimental trials, namely downhill running (DR), level
      running (LR), and the control (CON) in a cross-over design. Each trial lasted for 2 days. The
      participants were fed the same breakfast and lunch on day 1 in each trial. The participants
      arrived at the laboratory at 18:00 on day 1 and ran on the treadmill at 60% VO2max (downhill
      and level surface trials) or rested (CON trial) for 30 min. Subsequently, they were fed a
      standardized dinner (A meal box containing chicken, vegetables, and rice, 692 kcal, with 50%
      energy from carbohydrate, 32% from fat, and 18% from protein) within 20 min.

      The participants returned to the laboratory at 07:30 on day 2 after an overnight fast. After
      baseline blood and gas samples were collected, the participants were fed a high-fat meal that
      included cereal, white bread, whipping cream, cheese, and butter. The high-fat meal provided
      fat 1.2 g/kg (65% energy), carbohydrate 1.1 g/kg (27% energy), protein 0.33 g/kg (8% energy),
      and 16.5 kcal/kg.

      A 10-mL blood sample was collected from a forearm vein into nonheparinized tubes before and
      immediately after exercise or rest on day 1. On day 2, postprandial blood samples were
      collected from forearm veins into nonheparinized tubes by using an indwelling venous needle
      and a three-way stopcock. A 10-mL blood sample was collected before (0 h) and 0.5, 1, 2, 3,
      4, 5, and 6 h after the high-fat meal.
    


Intervention name(s): Exercise; Rest
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Running; sit and rest
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: triglyceride; non-esterified fatty acids; eccentric exercise; cardiovascular disease
Comparing Calories at Fast Food Restaurants
Condition: Obesity
Study type: Observational

Summary: 
      Rating systems are intended to guide consumer choices. This project will determine if a
      previously developed scale that evaluates the "healthiness" of a restaurant is correlated
      with the actual choices consumers make when they patronize the restaurants. The study will
      also assess whether a restaurant marketed as "healthy" (Subway) rates higher on this scale
      than another restaurant that makes no such claims (McDonald's). Finally, the investigators
      will compare the calorie purchases from these two restaurants among youths and their families
      who eat at each of the restaurants.
    


Intervention name(s): Fast Food Restaurant
Intervention type(s): Behavioral
Intervention description(s): Participants will purchase a meal at Subway and McDonald's, on different days.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents in a community in South Los Angeles.
Effect of Statins on Asthma Control in Smokers With Asthma
Condition: Asthma; COPD; Smoking
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Asthma is a chronic inflammatory condition of the lungs.

      There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with
      asthma do not respond as well to standard therapies as non-smokers.

      Statins are drugs which are already used to lower cholesterol. They have also been shown to
      have some anti-inflammatory properties.

      In this trial the investigators will give a randomised group of smokers Atorvastatin and the
      remaining group a placebo or blank tablet. The investigators will then monitor patients'
      responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.
    

Detailed description: 
      Despite several studies, which have shown that smokers with asthma have more severe symptoms,
      accelerated decline in lung function and diminished response to treatment with inhaled and
      oral corticosteroids, more than 25% of asthmatics continue to smoke. Smoking cessation advice
      is often ineffective.

      Statins are used as cholesterol lowering agents, however, there is now also evidence that
      they have additional anti-inflammatory effects which may be useful in treatment of smokers
      with asthma.

      This is a randomised placebo controlled double-blind parallel group study.

      Following screening to assess suitability for the study, patients will be randomised to
      treatment with either Atorvastatin 40mg or placebo (blank tablet)for 8 weeks.

      After 4 weeks of treatment, all patients will be commenced on a low dose inhaled
      corticosteroid for the remainder of the study to assess whether treatment with statins can
      overcome steroid resistance in smokers with asthma.
    

Intervention name(s): Atorvastatin; atorvastatin; matched placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): atorvastatin 40mg; Matched placebo
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; smokers; statin; atorvastatin; randomised; placebo; cigarette; blind; COPD
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this trial is to evaluate every 2 months alternating
      nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the
      progression of disease at 6 months.
    


Intervention name(s): FOLFIRI.3; nab-paclitaxel+ gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over); For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer
Vestibular Disorder and Visuo-spatial Functions
Condition: Vestibular Diseases; Vertigo
MeSH terms: Vertigo; Vestibular Diseases
Study type: Interventional

Summary: 
      The purpose of these studies is to determine whether vestibular disorders could affect
      visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire
      and a new computerized test using a digital tablet in different studies.
    


Intervention name(s): Cognitive and neuropsychological assesment
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery
Condition: Fluid Responsiveness
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume
      variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac
      surgery.
    


Intervention name(s): volume expansion
Intervention type(s): Other
Intervention description(s): fluid loading of 10 ml/kg colloid or blood product
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: stroke volume variation,; cardiac output,; fluid responsiveness,; noninvasive cardiac output monitor
Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
Condition: Enhancement of Protective Antibody Response After Probiotic Consumption
Study type: Interventional

Summary: 
      the aim of the study is to get evidence for an enhancement of immune status in subjects after
      probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium longum SP
      07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model - compared to
      placebo.
    

Detailed description: 
      probiotics are "live microorganisms which when administered in adequate amounts confer a
      health benefit on the host" . many health effects are associated with probiotics , but
      various degrees of evidence support the benefits associated to probiotics consumption .
      Impact on defences and the immune system has been shown with several strains and this may
      result in improved protection against some infections or improvment of vaccine efficacy .

      In its scientific requirments for health claims related to immune function, EFSA indicates
      that it is generally accepted that higher vaccination responses are beneficial.
    

Intervention name(s): Mixture of probiotics; Mixture of probitiocs
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): effect of the consumption a mixture of probiotics ( dietary supplement tablet - dosage at least 10x7 cfu/g) during 7 weeks , once a day , healthy volonteers ) on the antigen specific antibody respense; effect of the consumption a mixture of probiotics ( dietary supplement tablet - dosage at least 10x7 cfu/g) during 7 weeks , once a day , healthy volonteers ) on the antigen specific antibody respense
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
Condition: Social Anxiety Disorder (SAD)
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100,
      for the treatment of Social Anxiety Disorder (SAD).
    


Intervention name(s): BVR-100; BES-100
Intervention type(s): Device; Device
Intervention description(s): Experimental self-guided VR intervention for the treatment of SAD; Active at-home VR intervention comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder, Social Phobia
A Trial of SHR3162 in Healthy Caucasian Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and PK characteristics of a single oral
      dose of fluzoparib in healthy Caucasian and Chinese subjects
    


Intervention name(s): SHR3162
Intervention type(s): Drug
Intervention description(s): Fluzoparib, also known as SHR3162, is an inhibitor of human PARP
Other intervention name(s): Fluzoparib
Intervention MeSH terms: Fluzoparib
Intervention model: Single Group Assignment
Intervention model description: This study will enroll a single cohort of healthy Caucasian subjects with an approximately one-to-one ratio of male to female subjects
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371
      after a multiple oral dose in healthy male subjects.

      To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male
      subjects.
    

Detailed description: 
      Double blind, randomized, placebo control, multiple dose, dose escalation study
    

Intervention name(s): LCB01-0371 800mg; LCB01-0371 800mg BID; LCB01-0371 1200mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): LCB01-0371 800mg; LCB01-0371 800mg BID; LCB01-0371 1200mg BID; Placebo
Intervention MeSH terms: Delpazolid; Oxazolidinones
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Effect of ATX-101 on QT/QTc Intervals
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment
      on Fridericia's corrected QT interval (QTcF).
    


Intervention name(s): ATX-101 (10 mg/ml); ATX-101 (20 mg/ml); Moxifloxacin (400 mg); Placebo vehicle (PBS)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Healthy volunteers
Prediction of Fluid Responsiveness in Children With Single Ventricle
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate predictability of an abdominal compression-induced
      change of blood pressure for fluid responsiveness in children with single ventricle
      (bidirectional cavopulmonary shunt and Fontan tract).
    

Detailed description: 
      The purpose of this study is to evaluate predictability of an abdominal compression-induced
      change of blood pressure for fluid responsiveness in children with single ventricle
      (bidirectional cavopulmonary shunt and Fontan tract).

      When there are clinical signs of hypovolemia, such as hypotension, decreased urine output or
      decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds.
      Changes of blood pressure are continuously recorded during this period. About 3 min later,
      intravenous colloid fluid 10 mL/kg is infused for 20 min.

      To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography
      is performed before and after fluid administration. In addition, hemodynamic parameters
      including pulse pressure variation, systolic pressure variation, pleth variability index and
      central venous pressure are also recorded before and after fluid administration.

      Finally, patients will be divided into fluid responder group and non-responder group. If
      cardiac output measured using echocardiography increases over 15% after fluid administration,
      the patient is fluid responder. Using ROC curve, diagnostic power of abdominal
      compression-induced blood pressure change for fluid responsiveness will be evaluated
    

Intervention name(s): abdominal compression
Intervention type(s): Procedure
Intervention description(s): When there are clinical signs of hypovolemia, such as hypotension in pediatric patients with single ventricle, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers
Condition: Hemodynamic Responses to Propofol
Study type: Observational

Summary: 
      The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to
      propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3
      and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms
      on biomarkers related to nitric oxide after propofol anesthesia. In addition, the
      investigators will evaluate the effects of propofol anesthesia on biomarkers related to
      nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme
      inhibitors.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients under propofol anesthesia
Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall goal of the proposed project is to improve the treatment of individuals with AUD.
      The investigators will conduct the first pilot human laboratory study to assess the effects
      of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its
      effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking
      Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking
      Paradigm (ADP) in order to position our research team to have the capacity to conduct future,
      larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy
      of potential alcohol treatments.
    

Detailed description: 
      Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD
      will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the
      following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or
      placebo.

      The ADP session is a one day human laboratory session at the SFVA Medical Center. This human
      laboratory session involves the self-administration of alcoholic beverages by research
      participants under highly structured, observed conditions in order to evaluate the effects of
      the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on
      alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled
      crossover design in which each participant receives each of the 3 drug interventions in a
      randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the
      study.
    

Intervention name(s): Placebo; Lacosamide 100 mg; Lacosamide 200 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral medication; Oral medication; Oral medication
Other intervention name(s): Placebo capsule identical in appearance to Lacosamide 100 mg and 200 mg capsules.; Lacosamide 100 mg capsule identical in appearance to Placebo and Lacosamide 200 mg capsule; Lacosamide 200 mg capsule identical in appearance to Placebo and Lacosamide 100 mg capsules.
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol craving; human laboratory; lacosamide; non-treatment seeking