louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04372485: Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
Official title: Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexually Transmitted Diseases
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 270
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence will be 20% higher among patients randomized to receipt of two-way text messaging services.


Eligibility criteria: Inclusion Criteria:

* Adolescent patients seen in the Emergency Department who test positive for gonorrhea, chlamydia, or pelvic inflammatory disease and are prescribed outpatient antibiotic treatment.

Exclusion Criteria:

* Patients will be excluded if they are unable to understand English, are critically ill, have cognitive impairment or if they do not have access to a cellular telephone with text messaging capabilities.

Primary outcomes:
measure: STI treatment adherence
timeFrame: 1-21 days after prescription filling
Secondary outcomes:
measure: STI treatment receipt
timeFrame: 1-21 days after STI diagnosis
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Monika Goyal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06442085: Virtual Reality Training for Trauma Resuscitation
Official title: Immersive Virtual Reality Versus Mannequin-based Simulation Training for Trauma Resuscitation: a Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: Virtual reality
trauma
simulation-based education
resuscitation
Lead sponsor: Riga Stradins University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This was a prospective, single-center, randomized, controlled, non-inferiority, simulation-based trial comparing the use of virtual reality simulation vs. mannequin based simulation in a simulated trauma scenario.
Primary purpose: OTHER

Brief summary: This study individual training with an immersive virtual reality Trauma Simulator was compared to live mannequin-based simulation training in a facilitated group. The results showed that virtual reality simulator led to non-inferior effects on trauma resuscitation skills to mannequin-based simulation. Trauma Simulator had good usability, was well received by the participants, and had minimal adverse effects.

Detailed description: Background: Despite its high potential, the effect of immersive virtual reality simulation (VRS) in trauma resuscitation training has not been studied. The aim of this study was to test the hypothesis that VRS is non-inferior to mannequin-based simulation (MBS) in trauma resuscitation training.

Methods: In a single-center, randomized controlled non-inferiority trial, we compared individual training with an immersive virtual reality Trauma Simulator to live MBS training in a facilitated group. The primary outcome was the Trauma Score (ranging from 55 (worse) to 177 (best outcome)) during the MBS assessment. The secondary outcomes were the Trauma Score VRS assessment, System Usability Scale (ranging from 0 (worse) -100 (best outcome)), and Simulation Sickness Questionnaire (ranging from 0 (worse) to 235.62 (best outcome)).

Eligibility criteria: Inclusion Criteria: fluency in English. Exclusion Criteria: history of motion sickness

Primary outcomes:
measure: Trauma Score
timeFrame: Within a Day
Secondary outcomes:
measure: Trauma Score in VRS
timeFrame: Within a VR session (less than 10minutes per person)
measure: Pre- and Post-Surveys
timeFrame: Within a Day
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Medical Education Technology Centre of Riga Stradins University
Study officials:
affiliation: Institute of Public Health, Riga Stradiņš University
name: Ainars Stepens, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bangor A, Kortum P: Determining what individual SUS scores mean: adding an adjective rating scale. Journal of Usability Studies. 2009;4:114-123.
citation: Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG: Simulator Sickness Questionnaire: an enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology. 1993;3:203-220.
Clinical trial NCT02335385: Single Incision Laparoscopic Varicocelectomy
Official title: Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicocele
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds.

Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.


Eligibility criteria: Inclusion Criteria:

* patients with palpable varicoceles

Exclusion Criteria:

* unfit for anesthesia or laparoscopy

Primary outcomes:
measure: number of patients with improvement in semen parameters and resolution of testicular pain
timeFrame: 2 years
Secondary outcomes:
measure: number of patients developing postoperative complications
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Youssef T, Abdalla E. Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study. Int J Surg. 2015 Jun;18:178-83. doi: 10.1016/j.ijsu.2015.04.048. Epub 2015 May 1.
Clinical trial NCT01322685: Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens
Official title: Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Lung Cancer
Keywords: Tuberculosis
Lung cancer
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health people Tuberculosis or lung cancer

Brief summary: The purpose of this study is to study the Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens. Subjects are divided into two groups which are health group and Tuberculosis or lung cancer group in order to compare with the difference.


Eligibility criteria: Inclusion Criteria:

* Health group: between 17 to 90 years old
* Tuberculosis group: people who are tuberculosis or lung cancer patients and between 17 to 90 years old

Exclusion Criteria:

* Women subjects are before or after the period within two days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Kuo-Sheng Hung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105285: Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-07
Enrollment: 193
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Subjects with ocular conditions as defined by the protocol

Primary outcomes:
measure: Decrease From Baseline in Intraocular Pressure at Week 8 Predose
timeFrame: Baseline, Week 8 Predose
Secondary outcomes:
measure: Intraocular Pressure at Week 8 Predose
timeFrame: Week 8 Predose
measure: Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
timeFrame: Week 8 at 2 hours after IMP administration
measure: Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
timeFrame: Week 8 at 8 hours after IMP administration
measure: Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
timeFrame: Baseline, Week 8 at 2 hours after IMP administration
measure: Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
timeFrame: Baseline, Week 8 at 8 hours after IMP administration
Other outcomes:
Locations:
city: Kansai Region
country: Japan
Study officials:
References:
Clinical trial NCT03809585: Observational Study of Iris Tumors
Official title: Observational Study of Iris Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iris Tumor
Keywords: Iris
Tumor
Melanoma
Optical Coherence Tomography (OCT)
Angiography
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2019-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults age 18 or older with either healthy eyes or iris tumors

Brief summary: This is an observational study using OCT angiography to assist with tumor characterization in melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be compared to eyes with various types of iris tumors.


Eligibility criteria: Inclusion Criteria for tumor group:

* Eyes with diagnosis of melanotic or amelanotic iris tumors

Inclusion Criteria for healthy control group:

* Eyes without iris defects or lesions

Exclusion Criteria (both groups):

* Inability to give informed consent
* Inability to maintain stable fixation for OCT imaging
* Inability to commit to required study visits
* Eyes with concurrent retinal diseases, glaucoma, or conditions that in the opinion of the investigators might affect iris circulation
* Mature cataracts if found to limit visual potential to worse than 20/40

Primary outcomes:
measure: Tumor Thickness in Benign vs Malignant Iris Lesions
timeFrame: 6 months
Secondary outcomes:
measure: Tumor Area in Benign vs Malignant Iris Lesions
timeFrame: 6 months
measure: Tumor Volume in Benign vs Malignant Iris Lesions
timeFrame: 6 months
measure: Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01401985: A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Official title: A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Induced Constipation
Keywords: Opioid induced constipation
OIC
Constipation
Opioid side effects
morphine induced constipation
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2011-07-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation


Eligibility criteria: Inclusion Criteria:

* stable dose of opioids for at least 12 weeks before screening visit
* less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
* willing to stop laxatives and other bowel treatments; rescue laxative allowed

Exclusion Criteria:

* Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
* History of chronic constipation prior to opioid therapy
* Females who are pregnant or breast feeding
* Have any condition that may affect drug absorption (e.g. previous GI surgery)

Primary outcomes:
measure: Safety and tolerability of TD-1211
timeFrame: 14 days
Secondary outcomes:
measure: Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
timeFrame: Weekly assessments throughout Treatment Period
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Theravance Biopharma Investigational Site
state: California
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06351085: Enhancing Lung Cancer Screening Through Human-Centered Intervention
Official title: Enhancing Lung Cancer Screening Through Human-Centered Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer Screening
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 2869
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal.
Primary purpose: SCREENING

Brief summary: The purpose of this study is to further understand the factors involved in increasing lung cancer screening.

Detailed description: The study aims to identify patient, primary care team and health system factors that facilitate participation in lung cancer screening. Additionally, conduct a two-arm randomized comparative effectiveness intervention study to increase lung cancer screening compared with a usual care control arm and further evaluate the differential impact of the intervention conditions compared to usual care.

Eligibility criteria: Inclusion Criteria:

Interviews:

* UC Davis Health Systems (UCDHS) primary care providers and clinic staff who provide services to patients ages 50-80.
* Patients who are eligible for lung cancer screening.

Screening Intervention:

- Patients ages 50-80 who have a history of smoking per review of their electronic medical record and who receive care at the following UCDH ambulatory care clinics: Ellison Ambulatory Care Clinic; Elk Grove; Midtown.

Exclusion Criteria:

Interviews:

* Non-consenting patients and patients who do not speak English or Spanish
* Patients aged 49 and younger
* Non UCDHS primary care providers and clinic staff

Screening Intervention:

* UCDHS patients who have already received Lung Cancer Screening
* Patients with existing Cancer diagnosis

Primary outcomes:
measure: Lung Cancer Screening
timeFrame: 156 Weeks
Secondary outcomes:
measure: Completion of Interviews with Staff and Patients
timeFrame: 156 Weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
References:
Clinical trial NCT03588585: Tension Versus no Tension With Foley Bulb Induction
Official title: A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Detailed description: Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.

Eligibility criteria: Inclusion Criteria:

* Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
* Cephalic presentation
* Intact fetal membranes
* Bishop score less than or equal to 6
* Age greater than or equal to 18 years

Exclusion Criteria:

* Multiparas
* Multiple gestation
* Previous uterine/cervical surgery
* Ruptured fetal membranes
* Fetal malpresentation
* Any contraindication to vaginal delivery at time of admission

Primary outcomes:
measure: Time to Delivery
timeFrame: Will measure length of time from beginning of induction with the foley balloon until delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
Study officials:
References:
Clinical trial NCT04395885: Sexual Function During COVID 19 Pandemic
Official title: Sexual Function Among Egyptian Healthcare Professionals During COVID 19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: health care staff, regardless of gender, who is actively working during the outbreak, will be invited to participate in this study by filling anonyms electronic survey. And an age matched group of non-health worker individuals.

Brief summary: The outbreak of a new Coronavirus disease (COVID-19), caused by the 2019-nCoV infection in December 2019 is one of the most severe global epidemic health problems.The rapid contagion of this Novel virus has provoked the World Health Organization (WHO) to classifying the outbreak as a "Public Health Emergency of International Concern" on January 30 2020 to a "Pandemic" on March 11th 2020


Eligibility criteria: Inclusion Criteria:

* health care staff
* working during the outbreak

Exclusion Criteria:

* refuse to participate

Primary outcomes:
measure: The percentage of study participants diagnosed with sexual dysfunction
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT03749785: Carbohydrate Feeding Frequency, Muscle Glycogen and Exercise Capacity in Runners
Official title: The Effect of Carbohydrate Feeding Frequency on Muscle Glycogen and Exercise Capacity in Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effects of regular sucrose feeds compared to a single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity and other markers of metabolism during running


Eligibility criteria: Inclusion Criteria:

* Self-identify as a trained runner
* Regularly participate in running activity (\>2 times a week)
* Participated in running based training for a minimum of 2 years
* Be willing to undertake exercise sessions until volitional exhaustion
* Be willing to have the necessary samples taken during the testing protocols
* Not a habitual smoker
* Have the capacity and willingness to provide informed consent (oral and written)
* Successful completion of the physical activity readiness questionnaire (PAR-Q)

Exclusion Criteria:

* Female
* \<18 or \>50 years old
* Not regularly participating in running activity (\<3 times a week)
* Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
* Habitual/previously habitual smoker

Primary outcomes:
measure: Muscle glycogen concentrations
timeFrame: Estimated to be between 90 and 145 minutes
measure: Exercise capacity
timeFrame: Estimated to be between 90 and 145 minutes
Secondary outcomes:
measure: Ratings of perceived exertion
timeFrame: Estimated to be between 90 and 145 minutes
measure: Ratings of stomach discomfort
timeFrame: Estimated to be between 90 and 145 minutes
measure: Carbohydrate oxidation
timeFrame: Estimated to be between 90 and 145 minutes
measure: Fat oxidation
timeFrame: Estimated to be between 90 and 145 minutes
measure: Plasma glucose concentrations
timeFrame: Estimated to be between 90 and 145 minutes
measure: Plasma lactate concentrations
timeFrame: Estimated to be between 90 and 145 minutes
measure: Heart rate
timeFrame: Estimated to be between 90 and 145 minutes
measure: Rate of oxygen consumption
timeFrame: Estimated to be between 90 and 145 minutes
measure: Rate of carbon dioxide production
timeFrame: Estimated to be between 90 and 145 minutes
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References: