bioihbjkbjnl/mcl2 huggingface dataset:
Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
Condition: Conscious Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper
      gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical
      pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol
      sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal
      anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.

      Patients will be randomized to receive a topical pharyngeal spray containing either an
      anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be
      conducted in its standard manner.
    


Intervention name(s): Lidocaine 10%; Diluted gentian root solution
Intervention type(s): Drug; Drug
Intervention description(s): 3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia; As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia
Other intervention name(s): Xylocaine 10% spray; Gentian root extract, CAS no. 72968-42-4
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Propofol; Conscious sedation; Topical pharyngeal anesthesia; Anesthetics, Local; Gastrointestinal Endoscopy
Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in
      participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This
      is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants
      will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each
      panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose
      with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax)
      after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5
      mg/kg/min.
    


Intervention name(s): MK-5160 16 nmol/kg; MK-5160 32 nmol/kg; MK-5160 64 nmol/kg; Glargine 0.4 U/kg; Placebo to Glargine; Placebo to MK-5160; Dextrose; Glargine 0.6 U/kg
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Drug; Biological
Intervention description(s): MK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days; MK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days; MK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days; Glargine 0.4 U/kg, subcutaneous injection administered daily for 12 days; Placebo to glargine, subcutaneous injection administered daily for 12 days; Placebo to MK-5160, subcutaneous injection administered daily for 12 days; 20% solution of dextrose; adjusted to maintain the various glycemic levels at 100 mg/dL given as a continuous intravenous infusion for 6-30 hours.; Glargine 0.6 U/kg, subcutaneous injection administered daily for 12 days
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Involvement of Extrapancreatic Factors on Gastrointestinal-mediated Glucose Disposal
Condition: Diabetes
Study type: Observational

Summary: 
      We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated
      glucose disposal. In order to do so we will perform oral glucose tolerance tests and
      isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy
      controls.
    

Detailed description: 
      In the current project we wish to identify the possible contribution of extrapancreatic
      effects on gastrointestinal-mediated glucose disposal (GIGD). GIGD reflects the percentage of
      an individual's glucose disposal following oral glucose tolerance test (OGTT) which is caused
      by the oral route of glucose administration. In healthy subjects GIGD amounts to ~60%. GIGD
      describes not only the impact of the incretin effect (insulinotropic substances released upon
      intestinal stimulation) but includes all factors affecting glucose disposal differently
      during oral vs. iv administration of glucose (including neural reflexes, activation of
      afferent nerves in the intestinal mucosa, differences in glucagon secretion, hepatic glucose
      production and first-pass hepatic uptake of glucose, differences in portal and venous blood
      glucose concentrations and/or at the present unknown factors. It is likely that the incretin
      effect (pancreatic effect) constitutes a major contributor to GIGD, but so far it has been
      impossible to discriminate between pancreatic and extrapancreatic mechanisms underlying GIGD
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients operated at/or cared for at the endocrinology out-patient-clinic, Rigshospitalet,
        University of Copenhagen, Copenhagen Denmark
      
Biospecimen description: 
      plasma, serum and buffycoat
    
Keywords: Gastrointestinal-mediated glucose disposal; Total pancreatectomy; Incretin hormones; Glucagon
Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa
Condition: HIV Prevention
Study type: Interventional

Summary: 
      This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral
      Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of a
      brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT) intervention
      alone and in combination against a comparison condition to reduce new cases of HIV and
      sexually transmitted infections and increase condom use and decrease sexual risk behavior,
      drug use, and intimate partner violence among young female drug users in Pretoria, South
      Africa and their primary intimate partners. In the RCT, 384 couples comprised of young female
      drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate
      heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and
      counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples'
      intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples include
      an HIV-negative drug using female aged 18 to 40 and their primary intimate partner or spouse
      who is also HIV negative. Each partner of each couple will be administered assessments with a
      rapid test for HIV and urine tests for Chlamydia, gonorrhea, trichomoniasis, and drug use at
      baseline and 3-month, 6-month, and 12-month follow-up.
    


Intervention name(s): Testing and Counseling; Brief Motivational Interview (BMI); Integrated Family and Cognitive Behavioral Therapy
Intervention type(s): Other; Behavioral; Behavioral
Intervention description(s): Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences.; The brief motivational interview (BMI) to be tested in the RCT in Pretoria is a one-session, 45 minute intervention that will coordinate three, 15-minute modules with one module each to (1) reduce hazardous drinking; (2) reduce illicit drug use; and (3) promote condom use.; The IFCBT model is 6 sessions in length and coordinates the delivery of 4 cognitive-behavioral group couples' sessions with 2 individual couples' sessions to prevent HIV and STI co-infections among adult drug users. IFCBT targets HIV risk and protective factors that operate across multiple ecological systems. The four group couples' sessions coordinate Rational Emotive Therapy and Problem Solving Therapy strategies to reduce HIV risk behavior and promote protective behaviors. The two individual couples' sessions utilize structural and strategic approaches to promote adaptive communication and shared responsibility for condom use and gender equality and to directly address and reduce any form of abuse between partners when present.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention Intervention
Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The introduction of light emitting diode (LED) devices as a novel treatment for pain relief
      in place of low-level laser warrants fundamental research on the effect of LED devices on one
      of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized
      controlled study will be conducted by measuring nerve conduction on the superficial radial
      nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation
      recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and
      peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an
      irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the
      placebo group will be treated by sham irradiation. The purpose of this study is to
      investigate the effects of LED light on the conduction velocity and amplitude of the
      superficial radial nerve.
    


Intervention name(s): Superluminous light diode
Intervention type(s): Device
Intervention description(s): 900W, 880nm, 1.6 J/cm2 for 30sec
Other intervention name(s): Dynatronics Solaris Model 705
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
Condition: Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section
Study type: Interventional

Summary: 
      Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility
      after cesarean section.
    

Detailed description: 
      this study will be conducted on 162 patients undergoing cesarean section in obstetrics and
      gynecology department at Kasr el Ainy Hospital,Kairo university.
    

Intervention name(s): sugarless gum
Intervention type(s): Drug
Intervention description(s): 81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours
Other intervention name(s): Samara Gum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve
      stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency
      modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A
      controlled clinical study and prospective developed at the School of Physiotherapy Clinic /
      UFPI. Forty students were randomized into four distinct groups of the modulation frequency
      TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off),
      group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire
      developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60
      minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration
      of TENS application was 20 minutes and all protocols were performed in a single session. The
      analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify
      differences between experimental groups for each variable analyzed. The level of significance
      was p< 0,05.
    


Intervention name(s): transcutaneous electrical nerve stimulation
Intervention type(s): Device
Primary purpose: Treatment
Keywords: dysmenorrhea; transcutaneous electrical nerve stimulation (TENS; analgesia; pain visual analog scale; McGill pain questionnaire
Cardiovascular Risk Profile Among Mexican-Americans
Condition: Cardiovascular Diseases; Atherosclerosis; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis
Study type: Observational

Summary: 
      To characterize the epidemiology and genetics of apolipoproteins A-I, A-II, B, C-II, C-III,
      and E in a population of Mexican-Americans in Starr County, Texas.
    

Detailed description: 
      BACKGROUND:

      Evidence has established that the distribution and burden of several common chronic diseases
      among Mexican-Americans differ from that in the general population. These diseases include
      diabetes (almost exclusively noninsulin dependent diabetes), hypertension, and gallbladder
      disorders. While progress was made towards an elucidation of their epidemiology within this
      population, there was a paucity of data regarding other cardiovascular risk factors, most
      notably, the distribution of lipoproteins and their constituent apoproteins. With regard to
      the apolipoproteins, there were only minimal data from any population dealing with their
      distribution and relationships in the general population or pedigrees. This project provided
      as complete a profile on the distribution of metabolic cardiovascular risk factors as could
      be claimed for any other study of comparable size and provided baseline values for apo A-I,
      A-II, B, C-II, C-III and E.

      DESIGN NARRATIVE:

      One thousand randomly selected individuals were given a complete physical examination. From
      those 1,000, 100 probands with gallbladder disease were selected. Approximately 1,200 first
      degree relatives of the probands were invited to participate in the study and given a
      physical examination. Additionally, 100 control individuals, their spouses and first degree
      relatives were followed longitudinally for five years. Blood samples were obtained for
      determination of total cholesterol, LDL cholesterol, HDL2 and HDL3 cholesterol, and genetic
      markers. Data were collected on age, sex, body mass and fat distribution, diet, smoking, and
      alcohol consumption. Annual follow-up assessed the dynamics of changes in apolipoprotein
      levels and profiles and those factors which contributed to their change. The random and
      longitudinal data were combined with pedigree data to determine the effects of major genes,
      polygenes, and the environment on the variability of each apolipoprotein and on the
      relationship between these and other risk factors. An assessment was made in 100 individuals
      of the contribution of genetic variability at the DNA level in determining apolipoprotein
      levels.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Mexican American residents of Starr County, Texas.
      
Biospecimen description: 
      Plasma, buffy coats and red cell aliquots
The Moms Online Video Exercise Study
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The purpose of this study is to test feasibility and acceptability of an online platform that
      uses mobile apps and videoconferencing tools to increase activity levels in mothers with
      young children.
    

Detailed description: 
      The investigators are testing the feasibility and acceptability of a digital health platform
      using a randomized parallel wait-list control design for mothers with young children. The
      platform incorporates home based supportive group exercise sessions using video conferencing
      tools, shared online activity tracking and exercise mobile apps for individualized exercise
      routines will help mothers increase their physical activity levels and be successful at
      maintaining this increase.

      The intervention arm consists of two main parts: home based video conferencing virtual
      exercise sessions and mobile exercise apps, which women use to tailor exercise routines to
      their own skill level and preferences. Both arms will receive an activity monitor that they
      collect continuous activity data throughout the study.
    

Intervention name(s): Virtual exercise; Mobile apps; Exercise resources and information
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Using videoconferencing, mothers assigned to intervention arm will participate in daily (weekdays) virtual exercise sessions for 6 weeks with other mothers.; During virtual exercise sessions, mothers assigned to intervention arm will follow exercise routines using mobile exercise apps that are recommended by study staff.; For all mothers, the investigators will provide standard information on the benefits of exercise and link to existing public health resources on how to start and stay active.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: mother; social support; mobile app; videoconference; sedentary; physical activity
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental
      pain.
    

Detailed description: 
      The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of
      ibuprofen/caffeine compared to ibuprofen alone and also to placebo.
    

Intervention name(s): Ibuprofen/Caffeine; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ibuprofen/Caffeine fixed-dose combination; Ibuprofen capsule; Placebo treatment
Intervention MeSH terms: Ibuprofen; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: third molar extraction; ibuprofen; ibuprofen/caffeine; post-surgical dental pain
A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate how tolerable, safe, and effective it is to give
      INO-8875 eye drops to adults with glaucoma or ocular hypertension.
    


Intervention name(s): INO-8875; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): eye drops for 14 days in one eye; Matched vehicle-control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glaucoma; ocular hypertension; adenosine agonist; eye drop; primary open angle glaucoma
The EC50 of Remifentanil Blunting Hemodynamic Response to Double Lumen Tube Intubation
Condition: Hemodynamic Responses During Tracheal Intubation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect site concentration of remifentanil
      blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.
    


Intervention name(s): Remifentanil; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during double lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.
For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. And, step size of dose is 0.5ng/ml.; According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during single lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.
For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. Step size of dose is 0.5ng/ml.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of single
      ascending doses of REGN2477 in healthy women not of childbearing potential.
    


Intervention name(s): REGN2477; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive ascending doses of REGN2477; Participants will receive matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science