bioihbjkbjnl/mcl2 huggingface dataset:
Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Case-control comparison of clinical population, interventional and single-center research.
    

Detailed description: 
      The main objective of this study is to define and characterize electrophysiological markers
      of the existing social cognition disorders in schizophrenia. Two groups of subjects are
      recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during
      theory of mind judgment is tested.
    

Intervention name(s): Theory of mind without visual cues; Theory of mind without visual cues
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Theory of mind stimulation without visual reinforcement while performing EEG recordings; Theory of mind stimulation with visual reinforcement while performing EEG recordings
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In this study, subjects with insufficient metabolic control despite optimized basal-bolus
      injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin
      pump (PRT), an insulin pump that can receive and display CGM data from a separate
      subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6
      months.
    

Detailed description: 
      The long-term clinical benefit of tight glycemic control in people with diabetes is well
      known . HbA1c generally assesses the average/long term quality of glycemic control, it has
      been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic
      patients
    

Intervention name(s): Minimed paradigm Real Time Sytem; Minimed Paradigm 512/712 Insulin pump
Intervention type(s): Device; Device
Intervention description(s): Minimed paradigm Real Time Sytem; Minimed Paradigm 512/712 Insulin pump
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Improvement of the blood glucose control
Delirium Assessment in the Pediatric Intensive Care Unit
Condition: Pediatric Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      Objective: Studies documenting the prevalence of delirium among critically ill children are
      still rare. Emerging literature from psychiatric specialists reports the prevalence of
      delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely
      to be an underestimation of the true prevalence, as demonstrated in early adult delirium
      literature, especially given the absence of validated bedside tools to diagnose delirium in
      the PICU.

      The primary aim of this study is to validate the German version of the Pediatric Confusion
      Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is
      to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence
      Delirium (PAED) Scale.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric Intensive Care Unit Patients
Analysis of Neurodegenerative Process Within Visual Ways In Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study will interest in the pathophysiology of silent retinal axonal loss in multiple
      sclerosis. Recent studies have suggested that silent retinal axonal loss (no past history of
      optic neuritis [ON]) may be due to inflammatory lesions within the optic radiations and a
      transsynaptic degenerative process. The objective is to measure the exact role of silent
      optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain
      and optic nerve MRI in a cohort of patients without recent disease activity.
    

Detailed description: 
      This study will interest in the neurodegenerative process reported in multiple sclerosis
      within the visual ways.

      Symptomatic and asymptomatic retinal axonal loss in multiple sclerosis (MS) have largely been
      described. Many recent optical coherence tomography (OCT) studies have suggested that
      subclinical retinal axonal loss (no past history of optic neuritis [ON]) observed in MS
      mainly due to inflammatory and demyelinating lesions within the optic radiations and a
      retrograde transsynaptic degenerative process. None of these studies clearly tried to
      investigate the role of asymptomatic optic nerve lesion(s) in subclinical retinal axonal loss
      occurence.

      The main objective of the study is to measure the exact role of silent optic nerve lesion in
      the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI.
      The study will focus on a cohort of patients without recent disease activity in order to
      exclude or minimize the risk of recent and old lesion occurence on the visual ways, which
      could be a bias in our analysis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        RRMS treated by natalizumab for more than 6 months in order to measure patients with a
        lower risk of relapse
      
Keywords: MRI; axonal loss; MS; OCT
The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral
      resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of
      50-120gm size.
    

Detailed description: 
      For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical
      intervention for small and moderate prostates, however it has high morbidity and prolonged
      hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the
      risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate
      (B-TURP), especially in large prostates was a promising procedure for urologists, but
      unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally
      invasive procedures have been introduced to provide alternative surgical options to TURP.

      Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to
      the international guidelines as a choice for medical treatment resistant lower urinary tract
      symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water
      vapour therapy as a treatment option for BPH patients with small prostate size <80 gm and for
      those wishing to maintain antegrade ejaculation. While they still offer no clear
      recommendation to Rezūm use for those with large prostates. Early studies on this topic have
      found out promising results.
    

Intervention name(s): Rezum procedure; B-TURP procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): In Rezūm procedure, the Rezūm System (NxThera Inc., Maple Grove, MN, USA) consists of a radiofrequency (RF) power supply generator and single-use transurethral delivery device. Starting 1 cm distal to the bladder neck, injection was done at 3 and 9 o'clock sites. The needle was inserted for 9 s duration, retracted, and then delivered to another treatment site in 1 cm distance distal to the previous one.; In B-TURP, Olympus SurgMaster™ UES-40 bipolar generator (Olympus Europe, Hamburg, Germany) was used. Current's settings used were cut/coag 200/120. Using continuous flow 26Fr resectoscope first resection of the median lobe from the level of the bladder neck to the apex of the prostate was done followed by resection of the lateral lobes. Using Ellic evacuator, Prostatic chips were extracted from the field. A 22 fr three-way silicon Foley catheter was placed with traction applied and the balloon inflated by normal saline of 30-80 cc according to the size of the prostate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rezum; LUTS; B-TURP
The Oil, Fats and Oleogel Study
Condition: Glycaemic Response and Energy Balance
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of dietary fats, ingested in two physical
      forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI
      18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.
    

Detailed description: 
      This will be a randomised, crossover study. Randomisation will be performed with an online
      randomisation software (www.randomizer.org). Participants will be screened (1 screening
      visit) and attend five test visits conducted in a whole room calorimeter (WRC). During each
      test visit, participants will arrive at the laboratory after an overnight fast, enter the WRC
      and rest for 15 minutes in a supine position,have their resting energy expenditure (REE)
      measured for 30 minutes and consume congee and juice alone(control), or with one of the 4
      dietary fats: sunflower oil (SO) or gel (SG) and coconut oil (CO) or gel (CG) (total 5 test
      visits). Post-meal energy expenditure, fat oxidation, glycemia and appetite (visual analog
      scales) will be measured continuously for 3 hours in WRC, followed by a meal challenge where
      participants will eat until sated. Participants will return and repeat the protocol until all
      fat types and forms are completed.
    

Intervention name(s): Congee and juice with coconut gel; Congee and juice with coconut oil; Congee and juice with sunflower gel; Congee and juice with sunflower oil
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 25g coconut oleogel; 25g coconut oil; 25g sunflower oleogel; 25g sunflower oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Warm Acupuncture for Breast Cancer Related Lymphedema
Condition: Breast Cancer Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      The purpose of this study is to clarify whether local-distal point association is more
      effective than local point association by warm acupuncture in the management of breast cancer
      related lymphedema.
    


Intervention name(s): local distribution points association; local-distal points association
Intervention type(s): Other; Other
Intervention description(s): Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.; Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction Study of TRK-100STP
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and
      to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120
    

Detailed description: 
      Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between
      TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers
      will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will
      concurrently be measured.
    

Intervention name(s): TRK-100STP (BERASUS LA); AST-120 (Kremezin®)
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): beraprost; Careload LA; BERASUS LA; Kremezin®; sopherical carbon adsorbent
Intervention MeSH terms: Beraprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TRK-100STP,; beraprost sodium,; Careload LA; AST-120; Spherical carbon adsorbent; Drug-drug interaction
Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients
Condition: Diabetes Mellitus; Stress; Depression
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine whether the psychological benefits of expressive writing extend to
      diabetic patients, how long the benefits will last, and whether additional expressive writing
      "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms
      and well-being.
    

Detailed description: 
      Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower
      extremity amputation in the United States. Conditions such as stress and depression have been
      shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during
      which individuals deal with stressful experiences by writing about them on paper) has
      beneficial effects on psychological and physiological outcomes. This study will determine
      whether diabetes patients can benefit from expressive writing. This study will also determine
      the duration of the benefits and the effectiveness of booster sessions in improving their
      diabetic symptoms.

      Participants will be randomly assigned to engage in expressive writing or neutral writing for
      18 months. Participants in the expressive writing group will write about traumatic or
      stressful events; participants in the neutral writing group will write about neutral topics
      that do not affect them emotionally. Some participants in the expressive writing group will
      receive an additional 4 months of booster sessions of expressive writing. All participants
      will undergo interviews, blood collection, physical exams and complete clinical scales on
      their disease status, quality of life, and psychological well-being; these assessments will
      occur at study entry, every 4 months during the study, and at the end of the study.
    

Intervention name(s): Expressive writing; Neutral writing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Writing as therapeutic intervention; Non-expressive writing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Emotions; Blood glucose; Expressive Writing
Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting
Condition: Sinus Floor Augmentation; Graftless Sinus Elevation
Study type: Interventional

Summary: 
      Graftless sinus lift with simultaneous implant placement is one of the new techniques, this
      new technique is presented based on the physiology of intrasinus bone repair.

      Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered
      autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate,
      and regenerate bone.

      The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium
      platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with
      simultaneous implant placement in comparison to a negative control group.
    


Intervention name(s): Fibrin Glue; T-PRF; Negative control
Intervention type(s): Other; Other; Other
Intervention description(s): Blood samples were collected from the antecubital vein of the right or left arm of the patient and drawn into sterile Titanium tubes immediately. The tubes were then centrifuged for 12 minutes at 2800 rpm and room temperature; The contents of the two containers (human fibrinogen, human thrombin) will be mixed with distilled water and then aspirated by two syringes after that, the two solutions will be mixed together and injected into the empty compartment around the dental implant under the sinus mucosal lining using auto mixing applicator.; this group will not receive any material.
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tenting implant; Fibrin glue; T-PRF
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children
Condition: Children
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators believe a readily available drink containing a high dose of probiotics has
      the potential to improve compliance through many of these mechanisms. This product also has
      the potential to positively impact the health of children and adults around the world, as
      yogurt will likely be more appealing to both children and their parents for long term
      consumption than pharmaceutical-like preparations. In addition to the benefits associated
      with the consumption of probiotics, there is an increased health benefit from consuming
      yogurt, a nutrient dense food.

      More specifically, the rationale for this Phase I study is to determine safety of this yogurt
      drink and comply with FDA recommendations pertaining to an Investigational New Drug
      application. The investigators hypothesize that BB-12 is safe in generally healthy children
      ages 1-5 years.
    

Detailed description: 
      Probiotics are live microorganisms that, when administered in sufficient amounts, may improve
      health. A common use for probiotics is in addressing gastrointestinal issues, such as
      antibiotic-associated diarrhea (AAD). As an alternative to supplements, probiotics are also
      included as ingredients in fermented dairy products to produce functional foods, which are
      foods providing health benefits beyond their nutritional value. Yogurt, for example, is a
      fermented milk product often considered a functional food. One of the most commonly used
      probiotics is Bifidobacterium animalis ssp. lactis (BB-12).

      Our Primary Aim in Years 1-2 is to conduct a pediatric randomized controlled study to
      establish the safety of BB-12 fortified yogurt in children. Our Secondary Aims are to examine
      the fecal microbiota of children prior to, during and following consumption of probiotics.
      This study will evaluate whether a well-defined, probiotic-containing yogurt can safely be
      used as an effective delivery vehicle for probiotics. This study is important to help advance
      probiotic research forward in a systematic, well-accepted manner. Our long-term goal is to
      create yogurt with sufficient probiotic dosages to positively impact many different aspects
      of childhood and adult health.
    

Intervention name(s): BB-12 supplemented strawberry yogurt; Strawberry flavored yogurt
Intervention type(s): Drug; Other
Intervention description(s): Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days; Placebo, strawberry yogurt, 4 ounces taken orally for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study
Condition: Deep-Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to assess efficacy and safety of 3 doses of
      apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional
      treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the
      treatment of subjects with acute symptomatic deep-vein thrombosis.
    


Intervention name(s): Apixaban
Intervention type(s): Drug
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adults
Condition: Obesity; Appetitive Behavior
Study type: Interventional

Summary: 
      The present study aims to evaluate in adults with normal weight and with overweight or
      obesity who live in the city of La Plata the circulating levels of various hormones that
      regulate appetite and the gene expression of their receptors in peripheral blood mononuclear
      cells before and after food intake.
    

Detailed description: 
      the investigators plan a single test meal study in males and females with normal weight (NW)
      or overweight/obesity (OW/OB) assessing whether plasma appetite regulatory hormones levels
      are associated with different metabolic and anthropometric variables as well as with appetite
      sensations.
    

Intervention name(s): food (breakfast)
Intervention type(s): Dietary Supplement
Intervention description(s): The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds
Intervention model: Single Group Assignment
Intervention model description: Participants will be given a test meal (breakfast) that provides 20% of the individual's daily energy requirement. The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds. Participants will be asked to consume the entire breakfast in less than 15 min and to complete a visual analog scale (VAS) questionnaire every 15 min. Blood sampling will be repeated at 60 min after starting breakfast (postprandial).
Masking: None (Open Label)
Primary purpose: Prevention