louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03228927: Characterization of the Facial and Gut Microbiome in Rosacea
Official title: Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rosacea
Lead sponsor: The Acne Cure Alliance
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Attendees at the Twins Days Festival Monozygotic or dizygotic twin sets Facial Rosacea

Brief summary: Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis.

Detailed description: 1. Twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.
2. Subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. Eyes will be examined for signs of ocular rosacea.
3. Facial microbiome sampling will be performed on-site utilizing a kit manufactured by UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun metagenomics to identify resident bacterial genera and species. (16) This can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects.
4. Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from toilet paper is collected and placed in the sample medium. Subjects can either ship directly or return to the study site for shipping.

Eligibility criteria: Inclusion Criteria:

1. Presenting with monozygotic or dizygotic twin
2. One or both twins with facial rosacea
3. Willingness to allow facial and fecal samples to be analyzed -

Exclusion Criteria:

1. Non-twin siblings
2. Absence of facial rosacea in both twins -

Primary outcomes:
measure: Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea
timeFrame: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04410627: HoPE (Hospice Preparation and Education)
Official title: Pilot Trial Evaluating Usability, Acceptability, and Feasibility of the HoPE (Hospice Preparation and Education) Web-Based Tool
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hospice Care
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigator will conduct a two-site, randomized, controlled study of the HoPE (Hospice Preparation and Education) web-based tool versus usual care to assess: Technology usability (primary), study feasibility (secondary), user acceptability (secondary), and hospice service conversion rate (exploratory). Technology usability will be assessed through a one-time quantitative survey using established instruments. Study feasibility and user accessibility will be assessed through trial enrollment and retention alongside analytics assessing tool usage (e.g. time spent on each page of the website). Conversion rate is the percent of patients introduced to hospice who eventually enroll. The investigators will evaluate in an exploratory manner the differential effect of HoPE versus usual care.


Eligibility criteria: Inclusion Criteria:

* Eligible for and referral made for home hospice services (Note: this excludes home palliative care, home infusion, home nursing, home physical therapy, and bridge services)
* Aged between 21 and 89
* Capacity to give consent
* Ability to speak and understand English

Primary outcomes:
measure: Technology usability as measured by System Usability Scale
timeFrame: At study completion, up to 4 months.
Secondary outcomes:
measure: Study Feasibility as measured by enrollment efficiency
timeFrame: At study completion, up to 4 months
measure: Study Feasibility as measured by intervention completion
timeFrame: At study completion, up to 4 months
measure: User Accessibility as measured by Net Promoter score
timeFrame: At study completion, up to 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
Study officials:
affiliation: Duke University
name: Arif Kamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06085027: Comparison of the Epifaith® Syringe With the Plastic Syringe
Official title: Compare the Epifaith® Syringe With the Plastic Syringe for Identification of the Epidural Space in Parturients: A Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epidural; Anesthesia, Headache
Analgesia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are:

* Whether it consume less time identifying epidural space with the Epifaith® syringe
* Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.


Eligibility criteria: Inclusion Criteria:

* ASA II to III
* Require labor analgesia
* Has submitted inform consent

Exclusion Criteria:

* ASA IV or above
* Coagulopathy
* Spinal deformity
* Neurological, psychological, cardiopulmonary disorder
* Active liver or kidney injury

Primary outcomes:
measure: Time consumed to identify the epidural space
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00407927: A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
Official title: A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Safety, Efficacy, and Tolerability Study of Two Doses of Epinastine Nasal Spray (0.05% and 0.1%) vs. Placebo in Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 571
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* A documented history of seasonal allergic rhinitis to mountain cedar pollen

Exclusion Criteria:

* Significant medical condition
* Cardiovascular abnormality
* Have a significant physical obstruction in the nose
* Started or had a change in immunotherapy within the 30 days prior to

screening

* Have nasal ulceration(s) or any active nasal bleeding
* Require use of allergy medications during the study
* Require use of asthma medications other than as needed albuterol

Primary outcomes:
measure: Change in nasal symptom scores
Secondary outcomes:
measure: Change in non-nasal symptom scores and quality of life scores
measure: Standard safety assessments
Other outcomes:
Locations:
city: Austin
country: United States
facility: Allergy & Asthma Associates
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
Study officials:
References:
Clinical trial NCT04456127: CO2 Laser Revision for Burn Related Donor Site Scars
Official title: Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burn Scar
Scar
Skin Graft Scar
Keywords: laser
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-subject comparison
Primary purpose: BASIC_SCIENCE

Brief summary: Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars.

This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* At least 1 second or third degree burn wound that required treatment with split-thickness skin grafts
* Donor site with at least a 4 x 4 inch surface area
* Able to return to clinical site for treatments and assessments of burn injuries

Exclusion Criteria:

* Pregnancy or nursing
* Oral retinoid medication use within the past 6 months
* Medical history of Ehlers-Danlos syndrome, AIDS
* Nutritional deficiencies in the opinion of the investigator that would affect wound healing
* Wounds complicated by clinically significant infection within past 30 days

Primary outcomes:
measure: Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT02641327: Monitoring Changes in Blood Pressure
Official title: Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: Inhospital patients
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 2 groups will be recruited:

1. Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke)
2. Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement

Brief summary: The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard clinical care.

Detailed description: The study objective is to collect data to assess the accuracy and reliability of Earlysense contactless monitoring for blood pressure monitoring vs. gold reference methods such as ABPM (Ambulatory blood pressure measurement) for patients hospitalized in Internal Medicine department and vs. Arterial Line measurements for patients hospitalized in ICU. In addition the collected data will be used to further enhance and improve the existing algorithms.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and up
2. Patients hospitalized that require stabilization of his/ her blood Pressure
3. Is willing to sign the consent form.

Group II: Patients hospitalized in Intensive Care

1. Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements
2. Patient or next of kin or legal guardian are willing to sign consent form

Exclusion Criteria:

1. Age \< 18 years
2. Does not sleep on a mattress that allows placing EarlySense sensor under it
3. Patient or next of kin or legal guardian is not willing to sign consent form

Primary outcomes:
measure: Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Hospital
Study officials:
References:
Clinical trial NCT05871827: THA With and Without Computer Navigation
Official title: The Use of Intraoperative Fluoroscopic Computer Navigation on Hip Arthroplasty Component Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Osteoarthritis
Avascular Necrosis of Hip
Keywords: total hip arthroplasty, computer navigation
Lead sponsor: Southeast Orthopedic Specialists
Sponsor class: NETWORK
First posted: 2023-05-23
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent DA THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup.

Brief summary: The goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (THA) with and without the use of a computer navigation program. The main questions this study aims to answer are:

* Can using computer navigation produce better THA implant placement?
* Can using computer navigation make surgery more efficient?

Participant data collected include their postoperative x-rays and total operative time.

Detailed description: The goal of this retrospective study is to compare implant placement and operative time of patients who underwent direct anterior total hip arthroplasty with and without the use of a computer navigation program. X-rays are used to measure acetabular cup orientation, leg length discrepancy, and total operative time.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent Direct Anterior (DA) THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup with or without computer navigation

Exclusion Criteria:

* Patients who underwent subsequent revision THA, conversion arthroplasty, hybrid procedures, experienced native or postoperative dislocations, and missing or inadequate radiographs at time of data collection.

Primary outcomes:
measure: Cup inclination
timeFrame: 12 weeks post op
measure: Cup anteversion
timeFrame: 12 weeks post op
measure: Leg length discrepancy
timeFrame: 12 weeks post op
measure: Operative time
timeFrame: Immediate post op
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Southeast Orthopedic Specialists
state: Florida
Study officials:
affiliation: Southeast Orthopedic Specialists
name: John Redmond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538027: Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy
Official title: Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Duration of symptoms
Outcomes
Lumbar Microdiscectomy
Oswestry disability index
Roland-Morris Questionnaire
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6 months. These patients were followed for 3 years for the clinical and functional outcomes.

Detailed description: 150 patients were enrolled in this study and only 97 patients were finally analyzed for primary outcomes measures of Oswestry disability index and Roland-Morris Questionnaire and secondary outcome measures of Visual analogue scale for back pain and leg pain as well as length of hospital stay and time to return for daily activities. Assessments done at different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.

Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Disc herniation of L3-4, L4-5 or L5-S1
* MRI showed disc protrusion or extrusion with nerve root compression corresponding to clinical features.

Exclusion Criteria:

* Spondylolysis or spondylolisthesis.
* Spinal deformity like scoliosis.
* Previous spinal surgery or infection.
* Cauda equina syndrome.
* Lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees
* Smoking
* Diabetes Mellitus
* Disc herniation other than levels L3-L4, L4-L5 and L5-S1
* More than single level disc hernaition.
* Body mass index 30 or more than 30
* Contained disc herniation by MRI

Primary outcomes:
measure: Oswestry disability index
timeFrame: Oswestry disability index was measured the functional disability at 2 weeks
measure: Roland-Morris Questionnaire
timeFrame: Roland-Morris Questionnaire was measured the functional disability at 2 weeks
Secondary outcomes:
measure: Visual analogue scale
timeFrame: Visual analogue scale was measured at 2 weeks
measure: Length of hospital stay
timeFrame: Measuring the days of postoperative hospital stay immediately after the surgery
measure: Return to daily activities
timeFrame: Measuring the time needed t return to daily activities immediately after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02844127: Effect of Right Ventricular Lead Position on Defibrillation Threshold
Official title: Effect of Right Ventricular Lead Position on Defibrillation Threshold
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection.

Detailed description: The investigators propose a prospective, pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator (ICD).

There are two locations in the heart in which ICDs are normally implanted: the apex and the septum. The purpose of this study is to determine whether the ICD performs better in one location or the other, as measured by defibrillation threshold. In this study, both locations will be tested in each patient. The final location will be determined by the implanting physician as the location that is best for the patient.

Eligibility criteria: Inclusion Criteria:

* Patient indicates for single-chamber (VR), dual-chamber (DR) or resynchronization CRT-D) implantable defibrillator
* Left-sided implant
* Single coil or dual coil (single coil for testing)
* Age ≥ 18 years of age
* Ability to consent
* Medically stable, in the opinion of the implanting physician, to undergo defibrillation safety margin testing
* Procedure performed under conscious sedation
* English-speaking

Exclusion Criteria:

* Patient unable to understand and consent to the procedure on his or her own
* Pregnant or breastfeeding patients
* New York Heart Association (NYHA) Class IV
* Patients with pre-existing RV leads
* Pacemaker dependent
* Patient medically unstable to undergo defibrillation testing (e.g., high risk for deep sedation; patients that develop respiratory compromise or hemodynamic instability from the sedation)
* Patients that require general anesthesia instead of conscious sedation
* Patients \<18 years of age
* Non-English-speaking

Primary outcomes:
measure: Defibrillator threshold
timeFrame: At the time of each surgery through study completion, or up to 12 months
Secondary outcomes:
measure: Percentage of patients with improved defibrillation threshold at the septum versus the apex
timeFrame: At the time of each surgery through study completion, or up to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Grant Medical Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Seth J Rials, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: