bioihbjkbjnl/mcl2 huggingface dataset:
Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome
Condition: Sedation Problems; Breathing Complications
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of patient positioning during
      colonoscopy on patient safety and diagnostic outcome.
    

Detailed description: 
      Sedative drugs are widely-used during endoscopic procedures. The administration of these
      drugs contain the potential hazard of breathing and cardiac complications. Moreover it is
      well-known that the dorsal position is in some ways associated to breathing problems while
      patients are asleep. We assume this also to be true related to short anesthesia during
      colonoscopy. Patient positioning may therefore have a positive effect on the safety during
      colonoscopy by reducing the absolute time that sedated patients spend in a supine position.
      We compiled a randomized trial which compares the appearance of breathing and cardiovascular
      complications by performing colonoscopy either in a dorsal or in a left lateral position.
    

Intervention name(s): Position the patient during colonoscopy; pulse oximeter
Intervention type(s): Procedure; Device
Intervention description(s): Position the patient either in a left lateral position during colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sedation; endoscopy; patient positioning; hypoxemia
Riluzole in Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Cognitive aging is a major source of disability in an increasingly aging population. The
      paucity of effective treatments for cognitive aging disorders, and most importantly in
      Alzheimer's disease instigates a need for further research into novel therapeutic
      possibilities. Alzheimer's disease is the most common neurodegenerative disorder and its
      prevalence steeply increases. Glutamate-mediated excitotoxicity in neuropsychiatric disorders
      and in particular in Alzheimer's disease has been shown to cause significant cerebral damage.
      Early effective therapeutic intervention in Alzheimer's disease is critical in order to
      prevent or at least slow down neuropathological progression that will lead to widespread
      irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a glutamate
      modulator agent, will be tested in mild Alzheimer's disease patients. Cognitive functional
      changes along with two established in vivo biomarkers, namely, Magnetic Resonance
      Spectroscopy (MRS) and Fluorodeoxyglucose (18F) positron emission tomography (FDG-PET) will
      be evaluated.
    

Detailed description: 
      A double-blinded, randomized, placebo-controlled study will be performed. Forty-two
      individuals with a diagnosis of mild Alzheimer's disease between 50-95 years old will
      complete the study. All forty-two individuals will have been on an acetylcholinesterase
      inhibitor, which is FDA approved for the treatment of Alzheimer's disease, for at least 2
      months prior to initiating the study, unless the medication was not previously tolerated.
      Twenty to twenty-two mild Alzheimer's disease patients will receive riluzole and another
      20-22 will receive a placebo. All patients will have a neurological evaluation and
      neuropsychological tests performed to confirm that they meet criteria for probable
      Alzheimer's disease set out by the National Institute on Aging - Alzheimer's disease
      Association that recently revisited the NINCDS-ADRDA criteria along with FDG-PET biomarker
      consistent with Alzheimer's disease.
    

Intervention name(s): Riluzole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20-22 subjects between the ages of 60-85 will receive study drug.; 20-22 subjects between the ages of 60-85 will receive placebo
Other intervention name(s): no other names; no other names
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Dementia
New Protein Bar for Physically Active People
Condition: Muscle Mass; Inflammation; Regeneration Muscle
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Post-exercise nutrition is an important factor in a nutrition plan for physically active
      subjects. Focusing on that, the Serbian group is developing protein bars enriched with sports
      supplements. Slovenian partner group will investigate the effect of new protein bar
      consumption on body composition, biochemical parameters, and muscle regeneration after
      training. The new bar will be compared with a commercially available bar.
    

Detailed description: 
      The clinical study will be performed on 10 elite handball players from Slovenia handball
      club. It will be designed as a crossover study. Half of the participants will consume the new
      bar for five days and the other half will consume the control bar. After the five-day washout
      period, the groups will consume the bar which was not consumed in the first period.

      At baseline, at the end of every intervention and washout period, the blood samples will be
      withdrawn, and the body composition will be analyzed.

      The analyzed biochemical parameters will be basic serum parameters, such as fasting glucose,
      total cholesterol, LDL, HDL, triglycerides, aspartate aminotransferase (AST), alanine
      aminotransferase (ALT), C-reactive protein (CRP), and parameters related to the muscle
      regeneration and inflammation, such as creatine kinase, lactate dehydrogenase, insulin-like
      growth factor (IGF), tumor necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), monocyte
      chemoattractant protein 1 (MCP-1).

      In the second part of the study, the acute effect of consuming each bar after training will
      be tested. Each participant will consume both bars on separate days. The mentioned parameters
      will be assessed after training and immediately and 3h after bar consumption.
    

Intervention name(s): DrRip - high protein, high fibre and creatine load; Voltage energy bar
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption; A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
Other intervention name(s): Protein product; control protein bar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: protein bar; physical activity; muscle
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)
Condition: HIV/AIDS; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The objectives of the study are to assess the feasibility, reach and preliminary efficacy of
      a brief intervention that trains Black men who have sex with men [referred to as Index] (a)
      to use home-based testing for HIV and sexually transmitted infections and (b) promote
      home-based testing to their peers and sexual partners.
    

Detailed description: 
      Sexually transmitted infections (STIs) increase one's risk of HIV infection, are serious
      co-infections that affect HIV clinical outcomes, and remain a risk for individuals using
      PrEP. Self-testing methods address barriers to clinic-based testing by offering convenience
      and privacy and have been shown to be well accepted by MSM. Therefore, use of self-testing is
      a potential approach through which to improve HIV and STI testing rates in MSM.
      Internet-based distribution (herein: web-based) of STI self-test kits enables an individual
      to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a
      laboratory for testing, and view test results through a web-based account. Web-based self-HIV
      oral testing enables an individual to request a test kit, collect an oral specimen, and
      receive results within 20 minutes. Despite these potential benefits and reports of
      willingness to use free self-testing, uptake has been low due to barriers such as concerns
      about accuracy of the tests, apprehension to collect specimens, low risk perception, and the
      desire for counseling. In the proposed study, investigators will pilot test an intervention
      that address these barriers by training BMSM with information about the accuracy of the HIV
      rapid oral test kit, demonstrating how to properly collect specimens for HIV and STIs
      (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to HIV
      and STI treatment and PrEP services. Study participants will utilize a secure website to
      request test kits.
    

Intervention name(s): Peer Mentor; Website only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be trained to be Peer Mentors and promote home-based testing to their social network; Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Black MSM; Social network
Treatment of Anal Fistulas With Obsidian RFT®
Condition: Anal Fistula; Minimal Invasive Surgery; Platelet-rich Fibrin Foam
MeSH terms: Rectal Fistula; Fistula
Study type: Observational

Summary: 
      The study conducted a retrospective analysis from January 2018 to December 2022 on patients
      who received anal fistula closure with Obsidian RTF® at the Department of General Surgery,
      Medical University of Vienna.
    

Detailed description: 
      Anal fistulas present a significant challenge in colorectal surgery, featuring abnormal
      passages between the anal canal and surrounding tissues. Traditional treatments, while
      effective, may risk damaging the anal sphincter complex and subsequent fecal incontinence.
      Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have
      gained popularity, offering potential for better functional outcomes in anal fistula
      treatment. In this context, our retrospective study aims to evaluate the efficacy and safety
      of autologous compound platelet-rich fibrin foam, specifically Obsidian RFT®, analyzing its
      success in fistula closure and functional outcomes, thus contributing to the advancement of
      sphincter-preserving methods in anal fistula management.

      The study conducted a retrospective analysis from January 2018 to December 2022 on patients
      who received anal fistula closure with Obsidian RTF® at the Department of General Surgery,
      Medical University of Vienna.

      Clinical diagnosis, complemented by radiographic imaging, was employed to confirm
      inconclusive cases.

      Demographic, comorbidity, fistula characteristics, and postoperative data were collected from
      electronic records.
    

Intervention name(s): Obsidian RFP anal fistula surgery
Intervention type(s): Procedure
Intervention description(s): Anal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF®
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients, receiving an anal fistula closure with Obsidian RTF®, were included into the
        final analysis.
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the
      efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days
      for the treatment of allergic asthma and allergen-induced asthma.
    

Detailed description: 
      Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic
      responses after an allergen challenge during a 3-way cross over design. Sputum inflammation ,
      mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK
      profile will be studied.
    

Intervention name(s): TPI ASM8; TPI ASM8; TPI ASM8
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ASM8 4mg/mL (low dose) daily for 14 days by inhalation; ASM8 4mg/mL (high dose) daily for 14 days by inhalation; Placebo PBS solution daily for 14 days by inhalation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild to moderate asthma; Allergen inhalation challenge
Identifying Residential Hazards Using Home Test Kits
Condition: Poisoning, Lead
MeSH terms: Poisoning; Lead Poisoning
Study type: Observational

Summary: 
      The purpose of this project is to help families and communities identify and reduce health
      risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered
      with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the
      Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The
      first specific aim of this project is to evaluate a sampling kit for families to assess
      levels of lead and pesticides in their home environment. This aim will strengthen
      right-to-know laws by providing families with tools to assess environmental contamination in
      their own homes. The second aim is to increase community awareness of the role of
      environmental agents in developmental disorders, hearing loss and school problems.
    

Detailed description: 
      A cross-sectional random, stratified study design will be used for this project. All children
      who are younger than 5 years of age and have a venipuncture blood sample taken at the babies
      Milk Fund Clinic will be eligible for this study. After checking the lists for errors and
      duplications, we will randomly permute the sampling frame, stratifying on children's blood
      lead concentration. Stratification will be used to enroll about 33% of the sample with blood
      lead concentrations below 5 mg/dl, 33% between 5 to 10 mg/dl, and 33% of 10 mg/dl or higher.
      Stratifying the sample will improve our chances of testing the predictive validity of home
      sampling kits to identify children who have blood lead concentration > 10 mg/dl collected by
      families. In addition this study will:

        1. Develop a pesticide wipe sampling kit to accompany our lead-sampling kit.

        2. Evaluate the predictive validity of home sampling kits for lead-contaminated floor dust
           to identify children who have blood lead levels of 10 mg/dl or higher by community
           participants compared with repeat samples taken by trained, community workers.

        3. Evaluate the reliability of home sampling kits for pesticides in dust collected by
           community participants compared with trained, community workers.

        4. Disseminate data on the reliability of home sampling tests and provide tools for
           families to collect environmental samples for large, population-based studies.

        5. Develop a Healthy Homes Resource Center at the Better Housing League to disseminate
           information to the community about residential hazards.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children <5 years receiving care via Babies Milk Fund Clinics
      
Keywords: Blood Lead; Pesticides; Community-based; Sampling Kits
Safety and Efficacy of Iron Sucrose in Children
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney
      disease (CKD) patients
    

Detailed description: 
      Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin
      (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse
      events) and efficacy (clinical success)
    

Intervention name(s): Venofer (iron sucrose injection); Venofer (iron sucrose injection); Venofer (iron sucrose injection)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron; Anemia; CKD
Cannabinoid Therapy for Pediatric Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 trial to determine the tolerability and optimal dose of CBD rich cannabis
      extract as an adjunct treatment in children with severe drug resistant epilepsy due to Dravet
      Syndrome. This is an open label intervention. Study duration is 20 weeks to primary analysis
      with continued follow-up until 64 weeks completed.
    


Intervention name(s): TIL-TC150
Intervention type(s): Drug
Intervention description(s): The active ingredients in TIL-TC150 are tetrahydrocannabinol (THC) and Cannabidiol (CBD), isolated from the Cannabis sativa L. strains produced by Tilray, and formulated into an oral liquid drug product.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?
Condition: Osteoarthritis
MeSH terms: Osteolysis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there are any clinical or ROM differences in
      total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.
    

Detailed description: 
      We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than
      standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical
      assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis
      will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.
    

Intervention name(s): legacy posterior stabilized high-flexion (NexGen LPS-Flex); legacy posterior stabilized standard (NexGen LPS)
Intervention type(s): Device; Device
Intervention description(s): NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system; NexGen legacy posterior stabilized standard (NexGen LPS) total knee system
Other intervention name(s): NexGen LPS-Flex; NexGen LPS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Improve Oxygenation and Capnographic Detection During Sedative EGD
Condition: Upper Airway Obstruction; Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive; Airway Obstruction
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of mandibular advancement bite block and
      high flow nasal cannula to standard bite block for oxygenation, capnographic measurement,
      prevention of hypoxemia, intervention events and adverse effects during endoscopic
      examinations.
    

Detailed description: 
      During endoscopic examinations, especially during those performed via oral insertion of
      endoscopes, an oral bite is used to protect the examination instruments and patients. During
      sedated endoscopic examinations, the patients are under influence of anesthetics. Upper
      airway obstruction often occurred due to respiratory depression and airway collapse resulting
      in desaturation. Airway management with high percentage oxygen, jaw thrust, or insertion of
      nasal airways by trained anesthetic personnel is required during upper airway obstruction
      emergencies. Nasal airway is invasive and causes nasal bleeding, sinusitis and other
      problems. Jaw thrust and bag-mask ventilation requires training and is a burden to anesthetic
      personnel to perform. Oxygenation and capnography are important ventilatory monitors during
      sedative procedures. These are often influenced by open mouth breathing during upper
      gastrointestinal endoscopic examinations making oxygenation and capnographic measurements
      unreliable. In this study, we group the patients into A group using standard of care, B group
      using mandibular advancement oral bite and C group using high-flow nasal cannulas. After
      anesthetic induction, gastric endoscopy will be performed. Oxygenation, end-tidal carbon
      dioxide, and degree of upper airway obstruction will be evaluated and recorded. Differences
      between the groups will be evaluated.
    

Intervention name(s): Olympus standard bite block; YX mandibular advancement bite block; Optiflow High flow nasal cannula
Intervention type(s): Device; Device; Device
Intervention description(s): Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min; Intravenous sedative upper gastrointestinal endoscopy performed under mandibular advancement bite block for endoscopy (Yong Xu breathing mouth piece, Yong Xu) and oxygen connected to mouth piece 5L/min; Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula
Other intervention name(s): A; B; C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: intravenous sedation; esophagogastroduodenalscopy; upper airway; mandibular advancement device; high flow nasal cannula