bioihbjkbjnl/mcl2 huggingface dataset:
Clock'N' Test: Development and Validation of a Test to Evaluate Emotional Disorders
Condition: Healthy
Study type: Observational

Summary: 
      This study concerns the validation of a clinical test that aims to reveal "first level"
      emotional disorders in neurological diseases.

      In order to bring to light such disorders, it is necessary to begin by establishing reference
      values in healthy individuals. This test is based on the priming effect and time estimations.
      The test procedure has two successive phases. The first phase aims to determine the judgement
      of time inherent to each participant and then to assess whether or not this judgement varies
      during the second phase with the introduction of emotional priming. First, we set out to look
      for and to calibrate video stimuli able to activate emotions. To this end, we used a battery
      of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined
      their degree of physiological activation by measuring the electrodermal response at the
      laboratory for the exploration of the nervous system in Dijon. These measurements also
      allowed us to define and refine our paradigm, notably by deciding at what moment the time
      estimation task should be done and by eliminating the influence of attention. We decided to
      select only seven video sequences because we noticed a reduction in the measurement effect on
      time estimations due to habituation of the subject. We also conducted pre-tests in a control
      population made up of twenty men and women aged from 20 to 60 years.

      This brought to light a warp in time estimation opposite to that we found using olfactory
      stimuli. This first finding suggests that there are two types of emotion, one which is
      anticipative and the other immediately experienced.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This test is based on the priming effect and time estimations. The test procedure has two
        successive phases. The first phase aims to determine the judgement of time inherent to each
        participant and then to assess whether or not this judgement varies during the second phase
        with the introduction of emotional priming.
      
Keywords: Validate the Clock'nTest
A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases
Condition: Brain Diseases; Brain Neoplasms; Central Nervous System Diseases; Neoplasm Metastasis; Nervous System Neoplasms
MeSH terms: Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given
      together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain
      metastases.
    

Detailed description: 
      This is a Phase 1, multicenter, dose-escalation study evaluating the safety, tolerability and
      pharmacokinetics of the PARP inhibitor ABT-888 in combination with conventional whole brain
      radiation therapy (WBRT) in the treatment of subjects with solid tumors metastatic to the
      brain.
    

Intervention name(s): ABT-888; Whole Brain Radiation Therapy
Intervention type(s): Drug; Radiation
Intervention description(s): Oral Capsules; 15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
Other intervention name(s): veliparib; WBRT
Intervention MeSH terms: Veliparib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: WBRT; Brain Metastases; Radiation; ABT-888; PARP
Using Models' Facial Expressions to Enhance Healthy Eating Behaviour in Children
Condition: Eating Behavior
Study type: Interventional

Summary: 
      This study examined the effect of adults' facial expressions (FEs) whilst eating raw broccoli
      on children's acceptance and intake of a typically less preferred vegetable. Investigating
      others' FEs in isolation (e.g., without statements about food tastiness) will improve
      understanding of the role of FEs in modelling of eating and contribute to developing
      strategies to help children learn pleasure from nutritious foods. Based on previous
      literature, it was hypothesised that children's acceptance (willingness to try, and frequency
      of taste exposures) and intake of raw broccoli would be higher after exposure to models
      eating raw broccoli with positive FEs, compared to models consuming raw broccoli with neutral
      FEs, or a non-food control video.
    

Detailed description: 
      Research has shown that seeing positive facial expressions towards food are effective for
      increasing children's desire to eat foods rated as disliked. However, the effect of adults'
      positive facial expressions whilst eating a raw vegetable on children's acceptance and
      consumption of nutritious foods that are less preferred (e.g., vegetables) remains to be
      established. This study examined the effect of unfamiliar adult models' facial expressions
      eating raw broccoli on children's acceptance and consumption of raw broccoli. Children aged
      4-6-year-olds were randomised to watch a video of unfamiliar adult models eating raw broccoli
      with a positive or neutral facial expression, or a non-food control video. Children's
      acceptance (willingness to try and frequency of taste exposures) and consumption of raw
      broccoli was assessed. Data about parent and child characteristics was provided by parents.
    

Intervention name(s): Facial expression video
Intervention type(s): Behavioral
Intervention description(s): Children are randomly allocated to one of three conditions: positive, neutral or no-food control, where they will watch either a positive, neutral, or no-food control video.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children were randomly assigned to one of three conditions (positive, neutral or control)
Masking: Single (Participant)
Primary purpose: Other
Keywords: Children
Brain Imaging of Psychotherapy for Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The goal of the proposed research is to examine the neural correlates of depressive symptom
      reduction in individuals with major depressive disorder using functional magnetic resonance
      imaging (fMRI), and to compare results to those obtained from a nondepressed control group.
    


Intervention name(s): Brief Behavioral Activation Treatment for Depression
Intervention type(s): Behavioral
Intervention description(s): Weekly individual therapy sessions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Control participants
Emergency Contraception (ECP): Reducing Unintended Pregnancies
Condition: Contraception; Pregnancy
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Emergency contraception is a method of birth control that can be used up to three days after
      sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she
      needs them (advance provision) or when she needs them (emergency provision). This study will
      compare these two methods of providing ECPs.
    

Detailed description: 
      ECPs can give women a "second chance" to prevent an unintended pregnancy that might arise
      because of lack or improper/defective use of contraceptives. By using ECP, a woman can reduce
      her risk of pregnancy by at least 75%; however, there is little information on what
      distribution patterns and other factors are most likely to encourage ECP use. This study will
      compare the use and cost of two ECP distribution patterns: advance provision and emergency
      provision. It will also identify environmental, situational, and behavioral factors
      associated with ECP acceptance and use.

      Participants in this study will be recruited from four family planning clinics in the
      Philadelphia area and five family planning clinics in the Pittsburgh area. Participants from
      the Philadelphia clinics will be given ECPs as part of a regular clinic visit (advance
      provision); participants from the Pittsburgh clinics will be given ECPs on an emergency basis
      (emergent provision). Each participant will complete a short intake form and will be issued a
      pager. Participants will be paged every month over an 18-month period as a reminder to
      respond to a short automated telephone survey on ECP, contraceptives, and pregnancy status.
      Approximately half of the participants will be randomly selected to participate in in-depth
      interviews at study entry and Months 9 and 18. Clinic visit data will augment the surveys to
      verify use of the clinic and contraceptive method and to develop cost data.
    

Intervention name(s): emergency contraception (estrogen/progesterone)
Intervention type(s): Drug
Intervention MeSH terms: Progesterone; Estrogens
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Female
Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU
Condition: Mechanical Ventilation Complication
Study type: Observational

Summary: 
      Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU).
      Its use requires almost always the establishment of a sedation. Sedation is a generic term
      for all procedures, pharmacological or not, ensuring physical and psychological comfort and
      the safety of patient admitted in intensive care units.

      An inadequate sedation, insufficient or excessive, has common side effects, as increase of
      the duration of mechanical ventilation and of hospital-acquired infections (in particular,
      ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or
      accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD).
      All these complications increase mechanical ventilation time and ICU length of stay. Several
      studies in adult's population have shown that the implementation of a sedation algorithm
      allowed to decrease the incidence of these complications.

      We hypothetized that the duration of mechanical ventilation would be reduced by a
      nurse-implemented sedative management protocol.
    

Detailed description: 
      1. During the first period (15 months), no protocol is used. This period consists to assess
           current analgesia-sedation procedure used in the pediatric intensive care unit (PICU),
           associated with the collection of medical and socio-demographical data about mechanical
           ventilation duration, sedation complications, PTSD development. The severity of
           pathology can be evaluated using PIM2 and POPC scores. The sedation deepness will be
           determined using COMFORT-B scale. Eight weeks after hospitalization, families will be
           phoned to assess children memories, anxious troubles, and PTSD symptoms for the patients
           of more than 18 months old.

        2. During the transition period (6 months), nurses and physicians develop the protocol and
           undergo training in its use.

      During the third period, a nurse-implemented sedation is used. The collected data are the
      same that the collected data during the first period
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The old children from 28 days to 18 years admitted in pediatric intensive care unit of
        Nantes University Hospital requiring mechanical ventilation for at least 24 hours can be
        included in this study.
      
Keywords: Ventilation; PTSD; sedation
Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to compare the skin irritation potential of two marketed gels for acne treatment,
      each applied to half of the face of healthy volunteers.
    

Detailed description: 
      At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all
      subjects will be applying two products to their faces, each on one side only. The side of the
      face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel,
      (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl
      peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing
      with study-supplied facial wash. The other group will use the same products, but on opposite
      sides of the face for three consecutive weeks after washing with the same study-supplied
      facial wash.

      Subjects will return to the study center every weekday morning for evaluation and application
      of both study products. Applications done on the weekends, will be done at home by the
      subject. At each visit the subject will be scored for cutaneous treatment effects by a
      blinded evaluator. At baseline and at the end of each week, subjects will be photographed and
      have chromometer readings.
    

Intervention name(s): Tretinoin Facial Gel; Adapalene/Benzoyl Peroxide Facial Gel
Intervention type(s): Drug; Drug
Intervention description(s): A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.; A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
Other intervention name(s): Retin-A Micro Gel 0.04% Pump; Epiduo Gel
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Tretinoin; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: acne; irritation; objective sensory methods
Insulin Glargine in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

        -  To compare efficacy of oral antidiabetics (OAD) combination therapy with either HOE901
           insulin analogue once daily or Lispro insulin analogue at mealtime in terms of change in
           HbA1c (baseline to endpoint).

      Secondary objectives:

        -  To compare the OAD combination therapy with either HOE901 insulin analogue once daily or
           Lispro insulin analogue at mealtime in terms of efficacy and safety.
    


Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Inflammation
Study type: Interventional

Summary: 
      Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral
      supplementation will improve will improve systemic inflammation and patency of peripheral
      vascular intervention (PVI).
    

Detailed description: 
      The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled
      trial with 30 patients aged ≥ 40 years with PAD. Eligible patients will be screened according
      to specified inclusion and exclusion criteria. All patients will be treated per our current
      practice as reflected in the American Heart Association Practice guidelines on PAD. n-3 PUFA
      supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals,
      Watsonville, California, USA), corresponding to a total of 4.4g/day given prior to and
      immediately after the operation. Each ProOmega capsule contains 325mg of EPA and 225mg of
      DHA. The placebo group will take the same number of capsules containing inactive substance
      (soybean; Nordic Naturals), designed to be the same color and shape as the treatment
      capsules. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific
      measurements will include established markers of inflammation and resolution of inflammation,
      as well as ultrasound measures of PVI patency. The study proposed here has the potential to
      provide important new insights on the role of nutritional interventions in PAD, as well as to
      improve outcomes related to surgical revascularization.
    

Intervention name(s): Pro-Omega; Pro-Omega Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after; Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
Other intervention name(s): Fish Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Claudication; Critical Limb Ischemia; Endovascular procedure; Atherosclerosis
Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The investigators want to relate disturbances in first-episode schizophrenic patients in
      (dopaminergic) D2 receptors, brain structure, brain function, and information processing to
      each other and to psychopathology. Additionally, the investigators want to examine the
      influence of D2 receptor blockade on these disturbances. The investigators expect
      disturbances in the dopaminergic system at baseline to correlate with specific structural and
      functional changes and with disruption in information processing as measured with
      psychophysiological and neurocognitive methods - and investigators expect D2 receptor
      blockade to reverse some of the functional and cognitive impairments. The investigators do
      not expect any effect of treatment on brain structure.
    

Detailed description: 
      The study is designed as a 4 week case-control follow-up study of 90 FE pt. with SCZ and 90
      controls matched with regard to age, gender, and parental socio-economic status. All subjects
      will be examined with a diagnostic interview (SCAN, Schedule for Clinical Assessment in
      Neuropsychiatry), medical and family history, and physical examination before inclusion. At
      baseline subjects will be examined with single photon emission computed tomography (SPECT),
      MRI, fMRI, psychophysiology, neurocognition. In addition, they will be screened for drugs,
      genetic testing, and ECG. Patients will further be examined with clinical validated rating
      scales to measure psychopathology, subjective well-being, and side-effects. After a period of
      4 weeks all assessments are repeated. During that period patients will be treated with
      amisulpride, while healthy controls will receive no treatment at all. Efficacy of
      antipsychotic treatment will be evaluated after this initial period of 4 weeks. All subjects
      will be re-assessed in the same test battery as mentioned above, except for SPECT and fMRI,
      after a period of 6, 12, and 24 months.
    

Intervention name(s): Amisulpride
Intervention type(s): Drug
Intervention description(s): 4-week open label amisulpride treatment
Other intervention name(s): Solian
Intervention MeSH terms: Amisulpride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: dopamine; first episode; reward; cognition; MRI; fMRI; PPI; P300; P50 gating; endophenotypes
Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objectives:

      To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from
      baseline to the end of the study.

      Secondary Objectives:

      To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the
      incidence of hypoglycemia and other adverse events.
    


Intervention name(s): Insulin Glulisine
Intervention type(s): Drug
Intervention description(s): subcutaneous injection of insulin glulisine at meal, 1 to 3 injections a day based on the condition of the patient in addition to a basal SC insulin injection at bedtime
Intervention MeSH terms: Insulin glulisine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
Condition: Non-erosive Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
    

Detailed description: 
      This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled,
      Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
      (Phase3).
    

Intervention name(s): YYD601 20mg; Nexium 20mg; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients should take drugs an hour before breakfast.; Patients should take drugs an hour before breakfast.; The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment