bioihbjkbjnl/mcl2 huggingface dataset:
Co-induction Ketamine-propofol: Effects on Laryngeal Mask Airway Insertion Conditions in Children
Condition: Anesthesia Intubation Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Large doses of propofol needed for induction and laryngeal mask (LM) insertion in
      children may be associated with hemodynamic sides effects. Co-induction with low doses of
      ketamine 0.5 mg/ kg has the advantage of reducing dose and therefore maintaining hemodynamic
      stability.

      Aim: To examine the effect of co-induction on LM insertion, hemodynamics and recovery in
      children
    

Detailed description: 
      A prospective, randomized, double-blind, controlled study was conducted including120 ASA
      physical status I ⁄ II unpremedicated children, aged 1-8 years. Inhalatory induction with
      sevoflurane at 7% to insert an intravenous canula was first used then decreased to 2%. Normal
      saline or ketamine (0.5 mg/kg) were administered in groups P (propofol), PK
      (propofol-ketamine) respectively, 1 min prior to the administration of the induction dose of
      propofol. Propofol 3mg/kg was used for induction in the 2 groups, LM inserted 60 s later and
      insertion conditions assessed. Heart rate and blood pressure were recorded immediately after
      propofol bolus, then after LM insertion, at the 3rd ,5th and 10th minutes later. Recovery was
      assessed using Steward's Score
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia
Other intervention name(s): co-induction ketamine propofol
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After inhalatory induction with sevoflurane7%until abolition of the eye lash reflex, an intravenous canula was inserted in the dorsum of the hand. The sevoflurane concentration was then decreased to 2% in 100% O2.A nurse not involved in the study prepared two syringes with ketamine or normal saline, and administrated it according randomization , one minute before induction with propofol. The administration of propofol was realized on 60 seconds. An experimented anesthesiologist evaluated the LM conditions insertion. When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable. The LM was then inserted. For analgesia,we proceeded by a locoregional bloc adapted to the surgery. We recorded systolic and diastolic blood pressure, HR and SpO2 at the induction time at LM insertion and at the 3rd,5th and10th min.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to (1) evaluate the effect of caloric intake on the
      pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative
      to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the
      safety and tolerability of a single dose of a 330 mg pregabalin controlled release
      formulation administered following various sized caloric meals and the 300 mg pregabalin
      immediate release capsule administered fasted.
    

Detailed description: 
      To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled
      release formulation following various sized caloric meals relative to the immediate release
      formulation.
    

Intervention name(s): 330 mg pregabalin controlled release; 330 mg pregabalin controlled release; 330 mg pregabalin controlled release; 300 mg pregabalin immediate release
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal; A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal; A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal; A single dose of 300 mg immediate release capsule will be administered in the fasted state
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability
Role of K+ and Ca2+ in Development of Muscle Fatigue
Condition: Skeletal Muscle Fatigue in Humans
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle
      fatigue in trained young men.
    


Intervention name(s): Terbutaline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): K+ transport and Ca2+ release and uptake function are stimulated by administration of terbutaline
Intervention MeSH terms: Terbutaline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Feasibility Study of Take-Home LAAM Medication - 3
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects
      with take-home LAAM availability show increased clinical responsibility over subjects
      without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other
      diversion safeguards are used; (3) Does treatment response correlate with background or drug
      use variables at intake, discharge, or during treatment?
    

Detailed description: 
      1-Year study, participant will be randomly assigned to one of two groups: One will have the
      opportunity to earn take-home doses by turning in a designated number of clean urines. Two
      will not have the opportunity to earn take-home doses. Clinic visits three times per week.
      Urine sample given at each visit.
    

Intervention name(s): LAAM
Intervention type(s): Drug
Allocation: Randomized
Primary purpose: Treatment
Keywords: opiate; dependence
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long-term retention rate of topiramate in
      participants with epilepsy (seizure disorder).
    

Detailed description: 
      This is an open-label (a medical research study in which participants and researchers are
      told which treatments the participants are receiving, "unblinded"), single-arm, prospective
      (study following participants forward in time), observational (a clinical study in which
      participants identified as belonging to study groups are assessed for biomedical or health
      outcomes) and multi-center (when more than one hospital or medical school team work on a
      medical research study) study of topiramte in participants with epilesy. The study population
      will be all the epilepsy participants visiting outpatient study center over a period of two
      months. Topiramate will be administered as per Investigator's discretion for 52 weeks.
      Participants will visit the trial site for evaluation of endpoint at Baseline, Week 12, Week
      26, and Week 52. Efficacy will primarily be evaluated by percentage of participants which
      will be retained to topiramate treatment uptil Week 52. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
Intervention MeSH terms: Topiramate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include participants with epilepsy who visit an out-patient
        clinic for two months and have not received topiramate treatment for at least three months
        prior to Screening.
      
Keywords: Epilepsy; Topiramate; Topmax
Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100
      mg/day on the insulin secretion capacity of beta cells.

      Patients who meet the study enrollment criteria will undergo 2 experiments (see description
      below); a graded hyperglycemic technique and a meal test, prior to randomization and after a
      12-wk double-blind study period. The treatment effect will shed light on the magnitude of the
      beta cell capacity to increase its mass and function.
    

Detailed description: 
      Study design and duration: This will be an Israeli three center study. Study drug:
      Sitagliptin 100 mg. The study will be a double blind, randomized two arms parallel group
      study. The duration of the study will be up to 18 weeks (with 8 visits) for each patient.
      This will include: a screening period of up to 4 weeks (Visit 1 to visit 2), a 2 week single
      blind, placebo run-in period (visit 2 to visit 4), and a 12 week placebo controlled, double
      blind treatment period (visit 4 to visit 8).

      Patients with T2DM who have not been treated with an AHA, or who are on AHA monotherapy or
      low dose oral combination therapy (low dose defined as ≤50% of the maximum labeled dose of
      each agent), may participate if they meet all enrollment criteria. Patients eligible to be
      randomized will have a HbA1c ³6.5% and £10% .

      Patients who meet the study enrollment criteria will undergo 2 experiments (see description
      below); a graded hyperglycemic technique and a meal test, prior to randomization (Visit 3 and
      4). These experiments will be will be completed after a 12-hour overnight fast. The 2
      experiments will be repeated at the conclusion of the 12-wk double-blind study period (Visits
      7 and 8).

      Efficacy measurements: (1) Glycemic control : FPG, HbA1c, β-cell Function Parameters(Φs, Φd,
      Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd
      phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity
      index, glucose, insulin, C-peptide total and incremental area under the curve.
    

Intervention name(s): sitagliptin
Intervention type(s): Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Wedged Insoles for Management of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these
      insoles typically reduce knee abduction moments (KAM) - a variable associated with knee
      osteoarthritis - and thus are believed to be beneficial for OA management, recent research
      has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In
      such cases, a medial wedge may be more appropriate.

      The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months
      for patients with knee OA. It is hypothesized that pain reduction will be directly related to
      KAM reduction.

      Forty-six participants with knee OA will be recruited to participate. Each will undergo
      biomechanical gait analysis to determine the wedge type that most greatly reduces knee
      adduction moments. In addition, each participant will undergo a Dual Energy X-Ray
      Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series
      of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury
      history. Participants will be randomized into either a wait list control group (no insole) or
      experimental group (medial or lateral wedged insole), and monitored for 3 months.

      Changes to pain, function, comfort and physical activity from baseline to 3 months will be
      assessed within the control and experimental groups. Regression analyses will be conducted on
      the experimental group to determine if a relationship exists between reduced KAMs and reduced
      pain over 3 months. Comparisons will also be made between the control and experimental
      groups.
    


Intervention name(s): wedged insole
Intervention type(s): Device
Intervention description(s): Wedged insoles are designed to reduce frontal plane knee joint mechanical loads during gait. Specifically, they can alter the knee adduction moment during gait - a variable associated with progression of knee osteoarthritis. In the experimental arm of this study, participants will undergo biomechanical gait analysis to identify the wedged insole that reduces the moments the most. The two options are medial wedge, where the medial aspect of the foot is elevated relative to the lateral aspect, and the lateral wedge, where the lateral wedge is elevated relative to the medial aspect.
Other intervention name(s): orthotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Cartilage; Musculoskeletal; Biomechanics; Subtype; Footwear; Orthotics; Joint Loading
St. Jude Cancer Education for Children Program: The Feasibility of Teacher Delivery (Pilot Study)
Condition: Healthy
Study type: Observational

Summary: 
      -The St. Jude Cancer Education for Children Program was created in 2006 as part of the
      outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital.
      The curriculum is designed to teach schoolchildren about cancer and dispel common
      misconceptions, inform students about healthy lifestyle choices that can translate to reduced
      cancer risk in adulthood, and to inspire an interest in science and scientific careers. In
      the 2010-2011 school year, researchers examined the impact of the program in regard to
      knowledge.

      It has always been clear that St. Jude personnel are limited to visiting a small number of
      schools in person each year so in 2011, a teacher's kit to the education program was created.
      The kit includes all the lesson plans needed to complete the program without the presence of
      St. Jude staff members. As a result, researchers at St. Jude Children's Research Hospital
      want to test the feasibility of the intervention by schoolteachers, and how this mechanism of
      delivery will affect student knowledge, attitudes, and health behaviors associated with
      cancer and healthy living.
    

Detailed description: 
      Teachers who agree to participate will use the teacher's kit developed by the St. Jude
      International Outreach Program to deliver the St. Jude Cancer Education for Children
      curriculum to 4th grade students over the course of 1 week. Pre and post survey data will be
      collected from students to measure knowledge, beliefs, attitudes, perceptions of
      vulnerability, intentions, and behaviors associated with cancer and healthy living. Rates of
      compliance and feedback about the curriculum will be collected from teachers via curriculum
      checklist, survey, and interviews.

      Primary Objective:

        -  To determine if it is feasible for classroom teachers to implement the St. Jude Cancer
           Education for Children Program.

      Secondary/Exploratory Objectives:

        -  To determine factors that may contribute to the program's feasibility such as school and
           teacher characteristics.

        -  To measure the impact of the intervention on student knowledge, beliefs, attitudes,
           perceptions of vulnerability, intentions, and self-reported health behaviors.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fourth grade students enrolled in Memphis-area schools.
      
Keywords: Cancer education; Prevention education; Volunteers
PJ-011726 IntelliSpace Cognition MCI Study
Condition: MCI; Cognitive Function 1, Social
Study type: Observational

Summary: 
      This study aims to create a reference database of digital cognitive assessment data in
      combination with neuroimaging data of patients with mild cognitive impairment. The
      investigators will explore and derive correlations between parameters from routine MRI images
      and brain volumetric analysis and the digital cognitive data to identify parameters that are
      relevant to classify MCI patients vs preexisting healthy control data.
    


Intervention name(s): IntelliSpace Cognition
Intervention type(s): Device
Intervention description(s): Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals (HCP) in assessing the cognition of individuals. It consists of two interfaces connected to the DCDx-module in the cloud. ISC is hosted on the Philips Health Suite Digital Platform (HSDP). The first interface is the patient's interface and is presented via a tablet to collect data on how the patient performs a series of tests. The second interface is the clinician's interface and can be used on any PC or tablet. It allows for assessments to be selected and administered, observations made, data analytics performed and the generation of a report.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include N=125 patients with Mild Cognitive Impairment (MCI).
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
Condition: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to evaluate the safety and efficacy of cord blood
      transplantation for adult patients with hematologic malignancies including refractory acute
      leukemia. The transplant procedure was determined in detail according to the previously
      published report showing a high survival, so that the investigators could expect a similar
      result.
    

Detailed description: 
      Although cord blood is considered as an alternative donor source for allogeneic hematopoietic
      stem cell transplantation, its procedure has yet to be standardized. Recently, a single
      institute result of cord blood transplantation for adult patients with hematologic
      malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the
      survival was significantly better than that of bone marrow transplantation from unrelated
      donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood
      transplantation for adult patients with hematologic malignancies using the same transplant
      procedures in a multi-institutional setting.
    

Intervention name(s): Cord blood transplantation; TBI; cyclophosphamide; cytarabine
Intervention type(s): Procedure; Radiation; Drug; Drug
Intervention description(s): unrelated cord blood transplantation; Total body irradiation (TBI) 12Gy; cyclophosphamide 120mg/kg; cytarabine 3g/m2x4
Intervention MeSH terms: Cytarabine; Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cord blood transplantation; myeloablative regimen; hematologic malignancies
Association of the Neutrophil/Lymphocyte Ratio With Pulmonary Complications and Mortality in COVID-19 Patients
Condition: Covid19; Pulmonary Complication
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      The Coronavirus Disease-19 (COVID-19) pandemic is currently a priority for health services
      worldwide. Unlike the Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) epidemic in
      2012, the COVID-19 shows specific alterations in the white blood cell count, accentuated in
      severe cases, and with respiratory failure. Among the most relevant data are both
      lymphopenia, thrombocytopenia, and eosinopenia. The Neutrophil Lymphocyte Index has been
      beneficial in the evaluation of infectious respiratory processes, showing a sensitivity
      similar to scales such as CURB65 (Confusion, Uremia, Respiratory rate, BP, age ≥ 65 years).
      Because COVID-19 infection shows alterations in the blood cell ratio, these indices may be
      useful in evaluating patients with COVID-19 infection.
    

Detailed description: 
      The hematological alterations in patients with COVID-19 divided into two aspects: the main
      ones, the global leukocyte count, and the individual counts. Most of the information about
      the behavior of blood counts come from cases attended in Wuhan, China. At the Zhongnan
      Hospital in Hubei Province, identified that the lymphocyte count was lower in critically ill
      patients. At the same time, the leukocyte counts were higher in deaths associated with
      COVID-19, this elevation being mainly of neutrophils. The lymphopenia is also a constant data
      in COVID-19 (47.4%), especially in cases that entered the Intensive Care Unit. As in
      community pneumonia, severe lymphopenia has associated with a high risk of death. A
      relationship between neutrophils and lymphocytes is called the Neutrophil-Lymphocyte index.
      This index is especially useful for predicting respiratory complications, such as for
      COVID-19, where mortality ranges from 2-9% compared to the 2012 epidemic (10%) or Middle East
      Respiratory Syndrome (37%). In Mexico, there is a high prevalence of chronic diseases that
      increase the risk of COVID-19 infection. This study's main objective is to identify the
      association of blood abnormalities on respiratory complications associated with COVID-19
      infection. All data were obtained from the clinical records of patients treated by COVID-19.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Mexican patients diagnosed with active COVID-19 infection who require hospital care and who
        have peripheral blood counts at diagnosis.
      
Keywords: Pulmonary Complications; Mortality; COVID-19; Neutrophil/Lymphocyte Ratio