bioihbjkbjnl/mcl2 huggingface dataset:
Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children
Condition: Catheterization; Pain; Complication
Study type: Interventional

Summary: 
      This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex)
      to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance
      the visualization of veins by using orange and red color that are absorbed in venous blood.

      The investigators' hypothesis for this study was that the vein imaging would reduce the
      complications related to catheter and the pain that the participants would feel.
    

Detailed description: 
      Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential
      morbidities. Patients with PIC-associated complications have longer length of stay, higher
      clinical and economic burden, and greater risk of death than patients without. The most
      serious complications due to intravenous (IV) catheters are infiltration and extravasation.

      The primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related
      complications.

      The secondary endpoint were;

        1. to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous
           catheterization

        2. to evaluate the efficacy of the vein imaging device on catheter dwell time.
    

Intervention name(s): Veinlite; Standard care
Intervention type(s): Device; Other
Intervention description(s): Use of vein imaging device for visualization of veins during peripheral IV placement; Patients received standard intravenous catheterization.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a prospective randomized controlled clinical study of children treated in a pediatric surgical ward who required PIC. The aim of the research was to evaluate whether the Veinlite would prevent catheter-related complications
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pain; children; vein imaging device; intravenous complications
Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      This prospective, randomized, double blind, controlled study evaluates the effect of
      perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.
    

Detailed description: 
      This investigation is a prospective, randomized, double-blind, controlled trial testing
      peri-operative steroids versus saline and the effect on swallowing after anterior cervical
      spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz)
      scale and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained
      pre-operatively, one day and two days post-operatively and then one week, two weeks, four
      weeks, three months, six months, and one year post-operatively. Patient clinical outcomes
      will be captured using web-based progress reports. Patients will complete the Quality of Life
      (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires
      electronically pre-operatively and at one year post-operatively. This outcome data will help
      us analyze the swallowing function or symptoms with the overall clinical course of the
      patients enrolled in this study.
    

Intervention name(s): Treatment 1; Dexamethasone; Treatment 0; Saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.; Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
Other intervention name(s): Steroid; Saline
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease
Condition: Mild Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      IONIS-MAPTRx in patients with Mild Alzheimer's Disease
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study, followed by an Open-Label
      Extension in up to 44 participants. This study will consist in two parts:

      Part 1: a randomized, double-blind, placebo-controlled multiple ascending dose period in
      participants with Mild Alzheimer's Disease, followed by Part 2: the open-label, long-term
      extension period.
    

Intervention name(s): IONIS MAPTRx; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Part 1: IONIS MAPTRx is administered intrathecally at 4 week intervals over the course of a 13 week treatment period for dose levels A, B, C, and D.
Part 2: IONIS MAPTRx is administered intrathecally at quarterly intervals for 48 weeks.; A placebo is administered intrathecally at 4 week intervals over the course of 13 weeks in Part 1. No placebo is given in Part 2.
Other intervention name(s): ISIS 814907
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Mild Alzheimer's Disease; ISIS 814907; Memory Loss; Alzheimers; MAPT
Prospective Translational Study Investigating Possible Molecular prEdictors of Resistance to First-Line pazopanIb
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, single-arm, monocentric translational study designed to evaluate
      possible biomarkers of resistance to the first line of therapy with pazopanib in patients
      with metastatic renal cell carcinoma (mRCC) who have not received systemic therapy in both
      the adjuvant and metastatic phases.
    

Detailed description: 
      a prospective, single-arm, monocentric translational study
    

Intervention name(s): Pazopanib
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT)
Condition: Mental Health
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of the "Supporting Carers of Children and Adolescents with Eating Disorders in
      Austria" (SUCCEAT) - study is to compare Workshop, Internet-based and Conventional Parental
      Support Groups for carers of chilren and adolescents between 10 and 18 years in a randomized
      controlled trial for the first time in Austria.
    

Detailed description: 
      According to NICE guidelines, eating disordered patients should be managed on an outpatient
      basis. This challenge seems to put a heavy burden on most caregivers. Schmidt and Treasure
      (2006) argued that obsessive compulsive personality traits, emotional avoidance,
      pro-anorectic beliefs and responses of close others like dysfunctional communication styles
      impair the outcome. The construct of expressed emotions reflects on the amount of criticism,
      hostility and emotional over-involvement expressed by relatives of psychiatric patients
      towards them. A special program for parents is developed to equip caregivers with knowledge
      and skills to change maintaining factors and therefore improve the patient's outcome.
      Furthermore coping strategies are provided to help carers to reduce their burden. We start a
      randomized controlled trial comparing two interventions with a conventional group. We compare
      Workshops (Intervention Group 1), Internet-based (Intervention Group 2) and Conventional
      (Control Group) Carers´ Support Groups. Before starting the intervention (T0, baseline), at
      the end of the intervention (T1) and 1 year after the intervention (T2, follow up)
      assessments will be conducted via questionnaires and interviews. Parents of 48 children and
      adolescents within the age group of 10-17 years suffering from anorexia or bulimia nervosa
      will be involved in each group, resulting in an overall sample size of 144. The investigators
      aim is to equip parents with knowledge and skills in order to support their children's
      recovery, prevent relapse and improve their own wellbeing. The long term goal is to provide
      low-threshold, cost-effective, time-efficient and superregional support for parents in the
      future.
    

Intervention name(s): Workshop Group; Internet-based support group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Workshop support group; Internet based support group with E-mail coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eating disorders; caregivers; parents; skills training; workshops; support; internet; online; family
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
Condition: Digital Sedation
Study type: Interventional

Summary: 
      The main purposes of this study are as follows:

      Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on
      healthy volunteers.

        -  Use of sensors and captors to monitor physiological and neurophysiological changes by
           painful stimulus

        -  Monitor level of pain and anxiety with and without HVR

        -  Monitor level of unpleasantness of the pain with and without HVR

        -  Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and
           without HVR
    

Detailed description: 
      The control of pain and anxiety in a hospital environment is usually managed by
      pharmacological means that involve a series of risks and side effects.

      For many years, non-drug solutions have been of interest to the public and the care staff.
      The benefits of hypnosis and of virtual reality are highlighted in many studies and today
      allow a different approach to medicine. It is important to invest in tools that are less
      expensive and also effective for the well-being of the patient and the care staff. The use of
      a blended solution using both clinical hypnosis and virtual reality has been only scarcely
      documented.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
Masking: None (Open Label)
Primary purpose: Other
Keywords: Virtual reality , hypnosis, pain, anxiety, anesthesia
Physical Fitness and Nutrition Intake in Bariatric Surgery Population
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this research study is to determine how bariatric surgery affects physical
      activity and nutrient intake.

      This research study is being done because the investigators want to determine better
      recommendations to provide to bariatric surgery patients.
    

Detailed description: 
      This is a two-pronged study. The first phase is a cross-sectional study design meaning each
      participant will only be tested once. The investigators wish to test patients from each of
      the groups listed below to determine CR fitness, activity level, and nutrient intake. The
      investigators wish to determine if any improvements from bariatric surgery can be maintained
      over a 2-year period following surgery. If this is the case, our next project will be to
      track the patients recruited at their new visit longitudinally at all of the five time points
      listed below.

        1. New visit with GI Nutrition

        2. 1 month prior to bariatric surgery (at the time of the patient's initial visit with the
           surgeon (6-7 months after their new visit))

        3. 6 months after bariatric surgery

        4. 12 months after bariatric surgery

        5. 24 months after bariatric surgery
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 210 Geisinger subjects will participate in this study. Participants will be
        volunteers from the patient population of the Center for Nutrition and Weight Management
        between the ages of 18 and 70 years.
      
Keywords: Obesity; Bariatric surgery; Physical Activity; Nutrition; Weight Loss
Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms
Condition: LDL Hyperlipoproteinemia; Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia; Triglyceride Storage Type I or II Disease
MeSH terms: Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional

Summary: 
      In this study, 102 patients will be evenly randomized into two groups: one set to receive
      omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that
      neither the researchers nor the participants will know which group they are in. Each
      participant will take two capsules daily for a duration of 90 days, with the active group
      receiving capsules containing 1000 mg of fish oil each. All participants will be instructed
      to maintain their usual diet, lifestyle, and medication regimen.

      At the beginning and end of the study, various health assessments, including lipid panels and
      C-reactive protein measurements, will be conducted. Additionally, DNA samples will be
      collected for genotyping to identify patients with specific PPARG gene polymorphisms, leading
      to the creation of four distinct subgroups: those receiving omega-3 with and without
      polymorphisms, and those receiving placebo with and without polymorphisms.
    


Intervention name(s): omega-3 fatty acids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The active treatment, supplied by Soloways, LLC., contained omega-3 fatty acids (1000 mg of fish oil, of which 600 mg were eicosapentaenoic acid and 300 mg docosahexaenoic acid) per capsule. The subjects will take 2 capsules daily.; placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule
Other intervention name(s): omega-3 fatty acids 1000mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: PPARG polymorphisms; omega-3 fatty acids; LDL-C; triglycerides; cardiovascular health; personalized medicine
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Condition: Lupus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic
      lupus erythematosus in male and female adults. Patients who qualify will be randomized to
      either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the
      initial 24 weeks of treatment and who are responding to therapy will have the option to
      continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and
      safety will be assessed over the course of the study through laboratory values, various
      rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
    

Detailed description: 
      1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an
           optional LTE period

        2. The LTE period will remain blinded but will no longer have a placebo arm:

             -  Subjects will remain on their originally assigned treatment arm unless they were on
                placebo

             -  Subjects initially randomized to placebo arm will be automatically re-randomized
                into one of the existing active arms at Day 169 (24 weeks)
    

Intervention name(s): BMS-931699; Placebo matching BMS-931699
Intervention type(s): Drug; Drug
Other intervention name(s): lulizumab pegol
Intervention MeSH terms: Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Cystic Fibrosis Related Diabetes Screening.
Condition: Cystic Fibrosis-related Diabetes
MeSH terms: Cystic Fibrosis; Diabetes Mellitus; Fibrosis
Study type: Interventional

Summary: 
      Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose
      prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring
      relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.

      The aim of this study is to compare sensitivity and specificity of different methods for GM
      monitoring in children and adolescents with CF.

      Continuous GM system (CGMS) will be used as the reference method. Results will be compared to
      those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT),
      homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model
      assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C).
      Patients will be classified into three groups according to CGMS: normal glucose tolerance,
      impaired glucose tolerance and diabetes mellitus.
    


Intervention name(s): glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT; HGPIV diagnosis test; HOMAR-IR diagnosis test
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): At the first visit at day 1an OGTT will be performed then the CGMS is implanted. Capillary glycaemia will be taken four times a day to set up the CGMS. A second visit is scheduled at day 4, where the intravenous glucose tolerance test is performed as well as the HbA1C level.
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
Condition: Inflammation; Infection
MeSH terms: Infections; Communicable Diseases; Inflammation
Study type: Interventional

Summary: 
      The goal of this study is to characterize the function and efficacy of the bioactive
      nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The
      three specific aims of this study are 1) To address the impact of maternal vitamin D status
      on inflammation and infections across pregnancy using retrospective data, 2) To address the
      impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections
      across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D
      status during pregnancy on inflammatory mediators at the level of the placenta.
    

Detailed description: 
      Archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and
      delivery will be analyzed for inflammatory cytokines. The impact of these inflammatory
      markers will be assessed by comparing the data to measures of vitamin D (25(OH)D, calcitriol
      and parathyroid hormone) and infections and inflammatory complications abstracted from
      medical charts. Placental samples were collected from a subset (n=132) of these pregnant
      teens and these tissues will be analyzed using genome wide microarray of messenger
      ribonucleic acid (mRNA) and microRNA (miRNA) related to inflammatory processes. A separate
      group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a
      vitamin D supplementation trial. Teens will be randomly assigned to one of two supplements
      (200 IU D3/d vs. 2000 IU D3/d). Similar to the retrospective analysis, maternal calciotropic
      hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation
      (23-28 weeks) and at delivery. Inflammatory processes and infections reported across
      pregnancy will be evaluated in relation to vitamin D status and inflammatory markers.
    

Intervention name(s): Vitamin D3 Supplementation
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; Pregnancy; Inflammation; Infection; Placenta; Cytokine; Microbiome
High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin.
      Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has
      examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori
      treatment.This study is designed to evaluate the efficacy and safety of the addition of
      bismuth to high dose of dual therapy for H. pylori eradication.
    


Intervention name(s): Esomeprazole; Amoxicillin; Bismuth Potassium Citrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Proton pump inhibitor; Antibiotic for H. pylori eradication; Gastric mucosal protective drug with anti-H. pylori effect
Intervention MeSH terms: Amoxicillin; Potassium Citrate; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Therapy