bioihbjkbjnl/mcl2 huggingface dataset:
Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Observational [Patient Registry]

Summary: 
      Vistag SurPoint is a proprietary module that generates a numerical tag index which can be
      used as multiparametric lesion quality marker to guide ablation in the clinical setting for
      ablation of atrial arrhythmias. SurPoint tag index has studied to guide ablation of
      ventricular arrhythmias, such as premature ventricular complexes, but its effectiveness and
      safety for ablation of Ventricular Tachycardia in patient with Ischemic and Non-Ischemic
      Cardiomyopathies is not well established.

      In this single center prospective observation registry, a ventricular ablation strategy
      utilizing radiofrequency delivery duration cut off determined by a maximum Surpoint index
      value of 550 will be compared to conventional operator determined duration of radiofrequency
      delivery based on combination of time (i.e. 30, 60, 90, and 120 seconds), magnitude of
      impedance drop, attenuation of abnormal electrograms, and achieving non-capture with
      high-output pacing after ablation.

      The Surpoint Tag Index Ablation group will be matched with a control group of patients
      undergoing VT ablation using the conventional time-based radiofrequency strategy and the
      patients in this group will be selected using propensity matching based on relevant baseline
      patient and clinical characteristic variables.

      Primary outcomes of interest: Recurrence of sustained ventricular tachycardia or Internal
      Cardiac Defibrillator Therapy.

      Secondary outcomes of interest: Hospitalization for ventricular tachycardia, repeat ablation
      procedures, all-cause mortality, acute procedural complications, rate of steam pops during
      ablation procedures

      Follow up: Up to 24 months after ablation procedure. Follow up will be obtained by office
      visits and device interrogation reports.
    


Intervention name(s): Radiofrequency Ablation
Intervention type(s): Device
Intervention description(s): Radiofrequency Ablation using irrigated ablation catheter
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        History of Ischemic or non-ischemic cardiomyopathy with sustained ventricular tachycardia
The Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level
Condition: LDL-cholesterol Level 130-159mg/dL
Study type: Interventional

Summary: 
      The purpose of randomized, double-blind, placebo-controlled study was to determine whether
      yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the
      control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.
    

Detailed description: 
      The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g
      plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized,
      double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level
      130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink
      containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink
      without plant stanols) for 4-week. The investigators assessed blood cholesterol level.
    

Intervention name(s): Yoghurt drink containing plant stanol as esters; Yoghurt drink without plant stanol as esters
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults
Condition: Substance Use Disorder; Posttraumatic Stress Disorder
MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to determine the safety and efficacy of an integrated treatment
      for substance abuse and posttraumatic stress disorder for young adults. The integrated
      treatment includes two established psychosocial treatments for substance abuse (Contingency
      Management) and posttraumatic stress disorder (Prolonged Exposure therapy).
    


Intervention name(s): Prolonged Exposure with Contingency Management; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.; Standard care will consist of treatment as usual in a community-based substance use treatment center.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients
Condition: Fasting
Study type: Observational

Summary: 
      This study evaluates the perception and compliance with the fasting instructions given to
      parents of children undergoing surgery. A questionnaire was provided to the parents
      indicating fasting time requested and actual time of fasting.
    

Detailed description: 
      American Society of Anesthesiologists (ASA) have recommended fasting guidelines of 8 hours of
      solids, 6 hours for formula milk, 4 hours for breast milk and 2 hours of clear liquids, for
      preoperative patients undergoing elective surgery. Parents of Children undergoing surgery are
      instructed to adhere to these guidelines. Parents might not be compliant with these
      instructions. They may fast their children less than or more than the recommended time.

      Main aim of this study is to find out the incidence of non compliance with the fasting
      instructions and try to find the reasons for such non compliance.
    

Intervention name(s): study of fasting time among pediatric patients undergoing day care surgery
Intervention type(s): Other
Intervention description(s): parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Consecutive children aged 1 to 12 years of ASA I and II category, scheduled to undergo
        elective day care surgery under general anaesthesia, were included in this prospective
        study
      
Keywords: compliance; fasting guidelines
Comparative Study on the Efficacy of OliNano SEAL and Curodont D' Senz in Treatment of Dentin Hypersensitivity
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to evaluate and compare the efficacy of Olinanoseal and Curodont
      D'Senz in treatment of dentin hypersensitivity.
    

Detailed description: 
      Materials and Methods:- A total of ninety (90) samples were used in the study, for dentin
      permeability test (dye penetration test) and Scanning Electron Microscopic examination (SEM)
      which were randomly divided into two main groups; group A1, completely removed smear layer,
      group A2, partially removed smear layer. Each group was subdivided into three subgroups
      according to the desensitizing agent applied: OliNano SEAL, Curodont D'Senz and the control
      group that were left untreated. Seventy (70) hypersensitive teeth in ten patients were
      enrolled for the current study. The subjective assessment of dentin hypersensitivity was done
      prior to the application of the desensitizing agent (baseline) then immediately, 2 weeks, 4
      weeks and 3 months after application of the tested materials. Patients were informed to rate
      their perception to tactile, air and cold stimuli by using Verbal Rating Score (VRS) and
      Visual Analogue Scale (VAS).
    

Intervention name(s): Olinanoseal; Curodont D'senz
Intervention type(s): Drug; Drug
Intervention description(s): it contains nanometer particles of fluoroapatite and calcium fluoride - guarantees the resistance to cracks and abrasion. At the same time insoluble nano-fluoroapatites fill all enamel microcracks and closes open dentinal tubules.; This agent contains p 11-4 peptide in addition to fluoride
Other intervention name(s): silicone polymer protector varnish; Self assembling peptide containing desensitizing agent
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of ninety (90) samples were used in the study, for dentin permeability test (dye penetration test) and Scanning Electron Microscopic examination (SEM) which were randomly divided into two main groups; group A1, completely removed smear layer, group A2, partially removed smear layer. Each group was subdivided into three subgroups according to the desensitizing agent applied: OliNano SEAL, Curodont D'Senz and the control group that were left untreated. Seventy (70) hypersensitive teeth in ten patients were enrolled for the current study. The subjective assessment of dentin hypersensitivity was done prior to the application of the desensitizing agent (baseline) then immediately, 2 weeks, 4 weeks and 3 months after application of the tested materials. Patients were informed to rate their perception to tactile, air and cold stimuli by using Verbal Rating Score (VRS) and Visual Analogue Scale (VAS).
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: OLiNano SEAL; Curodont D'Senz; Dentin Hypersensitivity; Dye penetration; Dentin permeability
Safety and Pharmacokinetics of Probucol and Cilostazol
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      to investigate the safety and pharmacokinetics, in healthy adult male subjects
    

Detailed description: 
      Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health
      Subjects
    

Intervention name(s): Cilostazol; Probucol
Intervention type(s): Drug; Drug
Intervention description(s): cilostazol, then cilostazol/probucol; Probucol probucol/ cilostazol
Intervention MeSH terms: Cilostazol; Probucol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety and Pharmacokinetics in healthy subjects
Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial
Condition: Paranoia in People With Schizophrenia-spectrum Diagnosis
MeSH terms: Schizophrenia; Delusions; Paranoid Disorders
Study type: Interventional

Summary: 
      People with a schizophrenia spectrum diagnosis often experience distressing worries or
      beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs
      are associated with significant distress and disruption to the person's life. This results in
      high use of services and costs to mental health providers.

      The National Institute of Clinical Excellence recommends that cognitive behavioural therapy
      for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The
      latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp,
      making it a cost effective intervention.

      Although improved outcomes have been obtained by therapies, CBTp has only small to moderate
      effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is
      intensive, expensive and takes up to a year. CBTp is therefore not widely available to
      service users, resulting in inequalities in access to care.

      The investigators are seeking to improve outcomes and accessibility of CBTp for people with
      distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility
      study of a brief therapeutic intervention, aimed at targeting and improving anxiety processes
      that are causally implicated in paranoia (Freeman et al, 2015).

      The investigators have preliminary evidence indicating that the pilot intervention, with
      interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et
      al, 2015). Participants also reported they found the therapy acceptable, enjoyable and
      useful. Based on these results, the investigators have further modified the intervention. The
      feasibility and efficacy of the therapy will be investigated in a randomised controlled
      design (n = 34).

      Please note the protocol has been been amended to exclude a pilot trial of a second brief
      intervention targeting reasoning styles in paranoia, as since the initial protocol was
      developed we have obtained data from two randomised pilot studies demonstrating its
      feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot trial
      of the reasoning styles intervention is therefore not indicated.
    


Intervention name(s): Anxiety intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paranoia; CBT; Reasoning; Anxiety
Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
Condition: Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Obesity is constantly increasing, causing an important risk to develop diseases such as heart
      disease, diabetes,... Some recent studies have shown that obese people present modifications
      of colon microflora and a low-grade inflammation.

      In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake,
      body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to
      an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans
      are also able to restore the microflora disturbed by a high fat diet and to prevent
      endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al,
      Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in
      healthy human. An intervention study in obese patients is thus needed to study the effects of
      fructans in the target population.
    


Intervention name(s): Synergy 1; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 grams/day during the first week and then 8 grams twice a day during 3 months; 8 grams/day during the first week and then 8 grams twice a day during 3 months
Other intervention name(s): inulin; oligofructose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: fructans supplementation
Abdominal Exploration Without Incisions
Condition: Pancreatic Cancer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is being conducted to determine whether an endoscope, (a small, flexible tube with
      a camera mounted on the end) passed down through the throat, through the stomach, and into
      the abdomen can safely and accurately examine the organs and tissue of the abdomen and take
      biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient
      as the laparoscopic diagnostic route, which is currently the standard of care.
    

Detailed description: 
      We propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with
      endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a
      concurrent gastrotomy for placement of a PEG, gastrojejunostomy or gastric resection.

      We hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate
      visualization of the abdominal cavity to direct clinical treatment.
    

Intervention name(s): Transgastric endoscopic peritoneoscopy.
Intervention type(s): Procedure
Intervention description(s): Exploration of the abdominal area
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Transgastric; Endoluminal; Peritoneoscopy; Diagnostic; Feasibility
Trial of Pre-Pregnancy Supplements
Condition: Anemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether daily oral supplements of multivitamins
      (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant
      women results in lower prevalence of anemia in preparation for pregnancy when compared to
      daily iron and folic acid supplements or folic acid alone.
    

Detailed description: 
      Globally, more than half a million women die from pregnancy or childbirth-related
      complications, most of them in developing countries. The global community committed to
      reducing the maternal mortality ratio by three quarters between 1990 and 2015 (MDG5). Women
      die from a range of complications in pregnancy, childbirth or the postpartum period. 80% of
      maternal deaths are due to severe bleeding (mostly bleeding postpartum), infections,
      hypertensive disorders in pregnancy and obstructed labor. Additionally, low birth weight and
      neonatal mortality are common problems in developing countries. The benefit of periconceptual
      folate on preventing congenital anomalies has been established in randomized trials; however,
      the role of other nutrients needs to be examined further. Anemia is strongly associated with
      adverse perinatal outcomes including maternal mortality and low birthweight.
    

Intervention name(s): Multivitamins, Folic Acid, and Iron; Folic Acid and Iron; Folic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily oral dose containing 2500 IU Vitamin A, 1.4 mg Vitamin B1, 1.4 mg Vitamin B2, 2.6 mg Vitamin B12, 1.9 mg Vitamin B6, 18 mg Niacin, 70 mg Vitamin C, 14.9 IU Vitamin E, 30 mg elemental iron, 0.4 mg folic acid; Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid; Daily oral dose of 0.4 mg folic acid
Intervention MeSH terms: Iron; Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: multivitamins; folate; iron; periconception
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control
      in patients with type 2 diabetes by making their own insulin work more efficiently.
    

Detailed description: 
      Single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in
      subjects with type 2 diabetes mellitus. Two parallel treatment groups include double-blind
      colesevelam or placebo. A screening period may be up to 18 weeks to withdraw non sulfonylurea
      antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. To evaluate
      hepatic and peripheral insulin sensitivity, subjects will undergo a two-step
      hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and
      after 8 weeks of treatment. To evaluate oral glucose absorption, subjects will undergo two
      oral glucose tolerance tests (OGTT) at pre randomization, one without colesevelam and one
      with colesevelam, and one OGTT at the end of the treatment period..
    

Intervention name(s): Colesevelam hydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Welchol tablet 625mg; placebo
Other intervention name(s): Welchol
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI)
      when used as an adjunct to stable, standard therapy in the setting of partial or full
      remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive
      Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult
      Version (BRIEF-A).
    


Intervention name(s): SPD489 (Lisdexamfetamine dimesylate); Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily; oral, once daily
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg,
      300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained
      symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).
    


Intervention name(s): Placebo; Vernakalant (oral)
Intervention type(s): Drug; Drug
Intervention description(s): Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other intervention name(s): RSD1235-SR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Atrial Fibrillation