bioihbjkbjnl/mcl2 huggingface dataset:
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana
Condition: Covid19; Vaccine Refusal; Vaccine Hesitancy
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among
      vulnerable communities in the Southeastern Louisiana region. This study will be used to track
      COVID-19 vaccine completion among patients who seek testing, either as in-person or
      purchasing at home COVID testing, from pharmacies, urgent cares and clinics using a rapid
      vaccine education model delivered at the point of care.
    

Detailed description: 
      This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among
      vulnerable communities in the Southeastern Louisiana region. This study will be used to track
      COVID-19 vaccine completion among patients who seek testing, either as in-person or
      purchasing at home COVID testing, from pharmacies, urgent cares and clinics. The proposal
      will introduce a rapid vaccination education model to be delivered at the point of COVID-19
      testing by pharmacy students, pharmacy technicians, nurse's aides and other health care
      personnel and includes monitoring for COVID-19 vaccine completion among enrolled patients.
      Investigators anticipate an increase in COVID-19 vaccine completion rates for those who
      participate in the rapid vaccination education model.
    

Intervention name(s): COVID-19 Vaccine Education at the Point of COVID-19 Testing
Intervention type(s): Behavioral
Intervention description(s): A rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel. The intervention will include: 1) 15 minute vaccine counseling, 2) print material 3) referral to a dedicated vaccine website with feedback forums and 4) opportunity to sign-up for one-on-one vaccine counseling with a clinical pharmacist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine Completion; COVID19 Testing; COVID19 Education; Point of Care Testing; Healthcare Personnel Education; Healthcare Disparities
Training Quality in Anaesthesia and Intensive Care: Tunisian Residents Feed Back
Condition: Training Objectives Achievement
Study type: Observational

Summary: 
      Opinion survey to assess the level of satisfaction and the expectations of the residents in
      anesthesiology and intensive care in Tunisia ( North Africa)
    

Detailed description: 
      The first national anonymous survey to assess the theoretical and practical training quality
      in anesthesia and intensive care and the improvements propositions.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Residents in anesthesiology and intensive care
      
Keywords: anesthesiology and intensive care, quality, training
Sunphenon in Progressive Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG)
      treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more
      effective than an oral placebo treatment regarding following parameters: increase in brain
      atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of
      the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in
      patients with MS.
    

Detailed description: 
      The hypotheses of our study are:

      Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation
      and the inhibition of the activity of NF-Kb.

      Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical
      scavenger.

      A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.
    

Intervention name(s): Sunphenon EGCG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200-800mg (1-4 capsules); 1-4 capsules
Other intervention name(s): Epigallo Catechin Gallate
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: primary or secondary chronic-progressive; sunphenon egcg; brain atrophy; T2 lesions
Comparison of Muscle Atrophy After Direct Anterior & Posterior Total Hip Arthroplasty
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip; Muscular Atrophy; Atrophy
Study type: Observational

Summary: 
      This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific
      aims of this project are three-fold. First, the investigators intend to compare the amount of
      muscle atrophy and tendon damage that occurs around the hip between two commonly-used
      operative approaches: the direct-anterior approach and the posterior approach. Second, the
      investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage
      that should reasonably be expected to occur with both of these approaches. Third, the
      investigators will document the degree of recovery of the periprosthetic soft tissues
      post-surgery in both patient groups.

      The investigators first hypothesis is that the posterior approach will demonstrate
      significantly more damage to the abductors, piriformis, and short external rotators than the
      direct anterior approach, which will demonstrate minimal soft tissue damage. The
      investigators second hypothesis is that both surgical approaches will cause some degree of
      baseline muscle damage and atrophy, in a predictable pattern. The investigators third
      hypothesis is that each of the surgical approaches inherently cause some degree of soft
      tissue damage, and that the periprosthetic soft tissues that are incised during the surgical
      exposure will recover in a predictable pattern which is consistent but unique within each
      group
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing Total Hip arthroplasty by one of the two fellowship trained
        arthroplasty surgeons.
Octaplas Pediatric Plasma Exchange Trial
Condition: Adverse Effects in the Therapeutic Use of Plasma Substitutes
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring
      serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs),
      thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric
      patients who require therapeutic plasma exchange.
    


Intervention name(s): Octaplas™
Intervention type(s): Biological
Intervention description(s): octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.
Other intervention name(s): octaplas
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Octaplas
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
Condition: Epilepsy; Bipolar Disorder
MeSH terms: Epilepsy; Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release
      tablets under fed conditions.
    


Intervention name(s): Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA); Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment of Epilepsy and Bipolar Disorder
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Condition: Renal Function Impairment in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on
      renal function and perfusion in 16 healthy subjects.
    

Detailed description: 
      Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects.

      Primary objective:

      Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular
      Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg
      VAS203.

      Secondary objective:

      To analyse the effects of VAS203 on

        -  filtration fraction

        -  hemodynamics (afferent and efferent resistance, intraglomerular pressure)

        -  markers of kidney injury and renal function

        -  systolic, mean and diastolic brachial blood pressure

        -  Plasma Pharmacokinetic of VAS203 and its first metabolite.
    

Intervention name(s): VAS203; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of NO-Synthase inhibitor VAS203; Infusion of saline
Other intervention name(s): Ronopterin; 0.9% sodium chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Bariatric Embolization of Arteries for the Treatment of Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is evaluate the safety and effectiveness of bariatric embolization
      as a minimally-invasive image-guided procedure for morbid obesity. In this procedure,
      specific blood vessels to the stomach are blocked in order to suppress some of the body's
      signals for feeling hungry, leading to weight loss.

      Morbid obesity is currently treated with diet and exercise, medications, and surgery. This
      study is designed to help treat obesity using a minimally invasive, non-surgical,
      angiographic (through the blood vessel) approach. This procedure is similar to a common
      procedure used to treat bleeding within the stomach. This version of the procedure has been
      named "bariatric embolization".

      Although there are over 40 hormones that limit food intake, there is only one hormone,
      ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating
      fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and
      to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has
      been a target for the treatment of obesity and weight loss. More recently, ghrelin has been
      shown to have a significant role in the long-term effect of weight loss in bariatric
      (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated
      patients.

      Recent data collected in animals in has shown that blocking blood vessels to a particular
      portion of the stomach (bariatric embolization) can temporarily decrease levels of the
      appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5
      people, there was a decrease in ghrelin levels and weight loss in the first month after the
      procedure, but there is no information about the effects of the procedure over longer periods
      of time.

      The investigator hopes to learn if bariatric embolization results in safe and effective
      weight loss in people who are morbidly obese.
    


Intervention name(s): Artificial Embolization Device
Intervention type(s): Device
Intervention description(s): Embosphere Microspheres
Other intervention name(s): Device Product Codes: 85 NAJ; Classification Name: Artificial Embolization Device; Regulation Numbers: 21 CFR 882.5950
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Morbid Obesity; Bariatric Surgery; Embolization; Minimally Invasive; Weight Loss
Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy
      participants to test in the laboratory may help the study of cancer in the future.

      PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic
      cancer and healthy participants.
    

Detailed description: 
      OBJECTIVES:

        -  Establish a central pancreatic cancer specimen (including serum and peripheral blood
           lymphocytes) repository to serve as a resource for current or future scientific studies.

        -  Utilize the clinical database to perform clinicopathologic correlation with the results
           of those studies.

        -  Test new hypotheses as they emerge.

      OUTLINE: This is a prospective study.

      Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months
      for up to 2 years. All other participants have blood collected at baseline and complete
      questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral
      blood lymphocytes obtained from the blood samples are frozen and stored.

      PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for
      this study.
    

Intervention name(s): This is a non-intervention study for all groups.; study of socioeconomic and demographic variables
Intervention type(s): Other; Other
Intervention description(s): This is a non-intervention study.; Non-intervention study.
Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        The three cohorts are: 1) Healthy individuals, 2) At risk individuals and 3) Cancer
        patients.
      
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer
NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection
Condition: Hepatitis C; HIV; Anemia
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to describe the time course and extent of hemoglobin (Hb)
      changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and
      Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus)
      co-Infected subjects.
    

Detailed description: 
      Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection
      (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV])
      frequently develop moderate to severe anemia. In large, prospective, clinical trials of
      PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5
      g/dL, and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard
      interferon/RBV-treated patients had hemoglobin decreases of at least 3 g/dL. It is important
      to understand the causes, natural history, and risk factors associated with HCV
      therapy-induced anemia, because such decreases in hemoglobin can result in RBV dose reduction
      or discontinuation, which may decrease the likelihood of a virologic response by patient.
      Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number
      of erythroid progenitor cells (red blood cells). Normally, a decrease in the hemoglobin level
      is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately
      normalize the Hemoglobin level. The relationship between hemoglobin and serum erythropoietin
      is less apparent in patients with chronic diseases such as cancer and human immunodeficiency
      virus (HIV) infection. It is not known whether HCV/HIV co-infected patients receiving
      combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to
      anemia. The objective of this study is to document the pattern of hemoglobin changes and
      erythropoietic response (from baseline to final assessment) in HCV/HIV co-infected patients
      receiving combination therapy with IFN / RBV. N/A
    

Intervention name(s): Pegylated Interferon and Ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Natural History, Hepatitis C Infection, HIV Infection, HCV/HIV co-infection Ribavirin, Pegylated Interferon, Interferon
Randomized Controlled Trial of Voice on Children With Vocal Nodules
Condition: Vocal Fold Nodules
Study type: Observational

Summary: 
      The primary objective of this study is to determine the impact of voice therapy on
      voice-related quality of life in children age 6-10 years old with apparent vocal fold
      nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument
      (PVRQOL)administered 4 weeks after completion of voice therapy.
    

Detailed description: 
      Voice disorders place over five million school-aged children at increased risk for inferior
      school performance, dysfunctional social development, and higher participation in criminal
      activities. The lesions most commonly associated with pediatric vocal dysfunction are
      reported to be vocal fold nodules, which are present in up to 21% of the general pediatric
      population and are associated with behavioral problems and inferior quality of life. Voice
      therapy with a speech-language pathologist is recommended by 95% of otolaryngologists for
      management of vocal fold nodules. When implemented, this voice therapy requires significant
      time investment and typically results in regular absence from the classroom over a period of
      1-3 months or longer, depending on the protocol and the setting. Regular absence from school
      has been shown to place children at risk for poorer scholastic performance but the benefits
      of this voice therapy have yet to be demonstrated in any rigorous prospective, controlled
      trial. Thus, the most widely used treatment for the most common lesion associated with
      pediatric voice disorders has not been rigorously tested in a randomized controlled trial to
      determine whether it may have benefits.

      A randomized clinical trial addressing whether voice therapy improves voice-related quality
      of life for children with apparent vocal fold nodules is a logical step toward developing an
      evidence-based treatment plan to optimize outcomes for this sizable population of at-risk
      children. There are currently no well-powered, prospective, controlled studies which compare
      voice therapy versus control in children who present with apparent nodules. Our goal is to
      remedy this deficiency through testing of the following primary null hypothesis: There is no
      difference in the change in PVRQOL scores after 3 months of treatment with voice therapy
      versus office instructions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children ages 6-10 who have hoarseness and vocal nodules
      
Keywords: pediatrics; voice; voice therapy; vocal therapy; hoarseness
Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function
Condition: Lung Function
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA;
      propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl;
      maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30
      minutes after emergence from the general anesthesia.
    


Intervention name(s): propofol; propofol; remifentanil; fentanyl; Sevoflurane/Nitrous Oxide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour; propofol 2mg; remifentanil 0,25mcg/kg/hour; fentanyl 100mcg; maintenance of anesthesia with sevoflurane and nitrous oxide
Intervention MeSH terms: Fentanyl; Remifentanil; Nitrous Oxide; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: forced vital capacity; forced expired volume in 1 s
Effects of Soft Tissue Lengthening on Gait in Children With Spasticity
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Study type: Observational

Summary: 
      This research project is being conducted to investigate changes in secondary impairments,
      functional mobility skills, and gait variables in children with spasticity following
      selective percutaneous myofascial lengthening. The research project proposed here will be the
      first to use instrumented three-dimensional motion analysis to investigate the effects of
      selective percutaneous myofascial lengthening on gait kinematics and kinetics. The objectives
      of the study are to:

        1. Compare gait kinematics and kinetics in children and young adults with lower extremity
           spasticity before and after selective percutaneous myofascial lengthening to determine
           the effects of this procedure on functional mobility.

        2. Identify changes in impairments and activity limitations following selective
           percutaneous myofascial lengthening .

        3. Identify changes in a family or caregivers perceived quality of life after their child's
           selective percutaneous myofascial lengthening .

      The aim of this study is to identify and describe the specific changes in secondary
      musculoskeletal impairments, activity limitations, and gait kinematics and kinetics after a
      selective percutaneous myofascial lengthening procedure. Gait kinematics and kinetics
      includes the motion of joints and body segments, and force and power, at each lower extremity
      joint, respectively. The results of this study will provide preliminary information on how
      this form of soft tissue lengthening affects functional mobility skills in children with
      spasticity. The study is expected to run for two years and the primary study endpoint is when
      participants have completed their second post- operative data collection session.
    


Intervention name(s): selective percutaneous muscle release
Intervention type(s): Procedure
Intervention description(s): Children will be evaluated before and two times after they undergo a selective percutaneous myofascial release. Investigators make no determination about the need for the surgery or which muscles are released, nor do they participate in the surgery. The investigators are assess outcomes on gait and motor function.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between the ages of 4.0 and 20.11 years