louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03134209: A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Official title: A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Disease
Arthropathy
Keywords: Monocryl
Dermabond
Polyester mesh
Joint Disease
Arthropathy
Joint Replacement
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty will be compared to two groups: 1) Monocryl + Dermabond 2) Polyester mesh + Dermabond
Primary purpose: TREATMENT

Brief summary: A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

Detailed description: The zipper wound technology is a new wound closure device that is an alternative to the commonly used conventional staples and sutures. The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A randomized control trial will provide the highest level of evidence without altering the potential risks to the patient as all three wound closure techniques have been found to have comparable complication rates. The three different treatment devices will be administered following the normal standard of care. All three wound closure devices are currently being used at NYULMC. No modifications to the normal standard of practice other than the randomization process will be implemented. Given the nature of the application of the wound closure device, which will be visible to the surgeon at the time of application and the patient postoperatively, the study will not be blinded to either the surgeon or the patient. Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on comesis and overall quality of wound healing.

Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing joint arthroplasty

Exclusion Criteria:

* Treatment of total joint replacement surgery at an outside institution

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: 4 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ran Schwarzkopf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04748809: Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Official title: An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.


Eligibility criteria: Inclusion Criteria:

* Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits.

Exclusion Criteria:

* Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study.
* Food allergies
* Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results

Primary outcomes:
measure: Decrease of more than 5 points in Clinical Disease Activity Index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References:
Clinical trial NCT00011609: Clinical Evaluation of a Wheelchair Mounted Robotic Arm
Official title: Clinical Evaluation of a Wheelchair Mounted Robotic Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Robotics; Activities of Daily Living; Spinal Cord Injuries
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.

The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:

1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

Detailed description: The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.

The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:

1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

The secondary purposes of this project are the following: 1.Does quality of life (life satisfaction and health status) improve after a 4 week period of using the WMRA? 2. What are the perceived advantages of the WMRA to the veteran with SCI? Additionally, the study will evaluate the following: 1) ease of installation and usefulness of instructional manuals; 2) training requirements (time, tasks); 3) safety features; 4) reliability of the device; 5) home, community, and vocational applications; 6) user acceptability; 7) maintenance/ service; 8) portability; and possible modifications.

Eligibility criteria: Patients with spinal cord injuries

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: VAMC, Houston
state: Texas
Study officials:
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D. Asst. Director
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Nancy Rocheleau, Program Analyst
References:
Clinical trial NCT02471209: Biliary Atresia, Hepatic Buffer Response and Sevoflurane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Atresia
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants with biliary atresia scheduled for a Kasai procedure

Brief summary: To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Detailed description: Children suffering from hepatobiliary disease also have an hepatic arterial buffer response (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening.

To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Eligibility criteria: Inclusion Criteria:

* persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;
* increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (\>60%);
* elevated liver enzymes;
* ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;
* with radionuclide imaging confirmation of obstructed biliary excretion

Exclusion Criteria:

* concomitant cardiovascular or abdominal organ malformations

Primary outcomes:
measure: portal blood flow
timeFrame: 10 minutes
measure: hepatic arterial blood flow
timeFrame: 10 minutes
measure: hepatic blood flow
timeFrame: 10 minutes
Secondary outcomes:
measure: blood pressure
timeFrame: 5 minutes
measure: renal blood flow
timeFrame: 10 minutes
measure: femoral vein blood flow
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06668909: Patient Reported Outcomes With WaveLight LASIK
Official title: Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: OVO LASIK + Lens
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be 21 to 35 years of age (at the time of surgery) and who underwent Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months prior.

Brief summary: This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.


Eligibility criteria: Inclusion Criteria:

* Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
* Age: 21 to 35 years of age at the time of surgery.
* Preoperative myopic sphere of -1.00 D to -8.00 D
* Preoperative regular astigmatism of 0.00 D to -3.00 D.
* Stable refraction preoperatively defined as \< 0.5 D of change over at least 1 year.
* Refractive target of bilateral emmetropia.

Exclusion Criteria:

* Corneal ectatic disorders.
* Patients with a calculated residual stromal depth of \< 300 um.
* Pre-existing retinal or corneal pathology, or irregular astigmatism.
* Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
* Previous corneal surgeries prior to LASIK.
* LASIK enhancements.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: PROWL Questionnaire
timeFrame: 12 months postoperatively
measure: OSDI Questionnaire
timeFrame: 12 months postoperatively
measure: Percentage of subjects using artificial tears or prescription dry eye medication.
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
city: San Diego
country: United States
facility: NVISION Eye Centers
state: California
city: Brookline
country: United States
facility: Boston Vision
state: Massachusetts
city: Saint Louis Park
country: United States
facility: Ovo Lasik + Lens
state: Minnesota
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
Study officials:
References:
Clinical trial NCT02531009: Systemic Sclerosis Clinical and Biomarker Study
Official title: A Multicenter, Prospective, Longitudinal Study to Evaluate Gastrointestinal Function and Clinical and Molecular Biomarkers in Subjects With Early and Late Diffuse Cutaneous Systemic Sclerosis, Limited Cutaneous Systemic Sclerosis, and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Systemic Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be recruited at participating locations in a standard clinical practice setting.

Brief summary: The primary objective of the study is to assess the change in systemic sclerosis (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants with SSc.

Detailed description: No study treatment will be administered. Study participants will continue to be treated by their respective physicians according to standard clinical practice. Data on concomitant therapy and procedures, administered as part of standard of care, will be collected at baseline and at each study visit.

Eligibility criteria: Key Inclusion Criteria:

Healthy volunteers

* Must be in good health as determined by the Investigator, based on medical history, physical examination, and vital signs.

Participants with diffuse cutaneous systemic sclerosis (dcSSc):

* Must fulfill the 2013 classification criteria for SSc of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
* Absence of the anti-centromere autoantibody.

Participants with limited cutaneous systemic sclerosis (lcSSc):

* Must fulfill the 2013 classification criteria for SSc of the ACR and EULAR.
* Subjects with lcSSc must have disease duration of less than 5 years.

Key Exclusion Criteria:

* History of any clinically significant medical condition that can interfere with the conduct of the study, or that in the opinion of the Investigator, would compromise data interpretation.
* An active severe infection as determined by the Investigator.
* Female subjects who are pregnant or currently breastfeeding.
* A known history of malignancy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc
timeFrame: Baseline to Month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01119209: Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
Official title: Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fracture of Intertrochanteric Type
Keywords: Hip fracture
intertrochanteric
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-05-07
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.


Eligibility criteria: Inclusion Criteria:

* Intertrochanteric hip fracture
* Fracture due to low energy trauma
* Ability to understand danish and give informed consent
* Ability to walk before trauma
* Indication for osteosynthesis

  •≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
* Informed consent

Exclusion Criteria:

* Drug or medical abuse
* Drug intolerance
* Pathological fractures
* Inflammatory arthritis
* Patient included in the study with the contralateral hip

Primary outcomes:
measure: Consumption of opioids
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: Pain
timeFrame: 5 days postoperatively
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: DK
Study officials:
affiliation: Odense University Hospital, DK-5000 Odense C, Denmark
name: Soren Overgaard, MD, DmSc
role: STUDY_CHAIR
affiliation: Odense University Hospital, DK-5000 Odense C, Denmark
name: Rune Dueholm Bech, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bech RD, Ovesen O, Lauritsen J, Emmeluth C, Lindholm P, Overgaard S. Local Anesthetic Wound Infiltration after Osteosynthesis of Extracapsular Hip Fracture Does Not Reduce Pain or Opioid Requirements: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial in 49 Patients. Pain Res Manag. 2018 Nov 13;2018:6398424. doi: 10.1155/2018/6398424. eCollection 2018.
Clinical trial NCT05723809: Treatment of Lateral Epicondylitis With a Percussive Therapy Device
Official title: Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tennis Elbow
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Therabody, Inc.
First posted: 2023-02-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
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 assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow

Detailed description: The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act" (ref: FDAAA Checklist)

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years old or older are included
* Patients with atraumatic lateral epicondylitis symptoms
* Symptoms persistent and present for at least 2 weeks
* Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.

Exclusion Criteria:

* Any records flagged "break the glass" or "research opt out."
* Patients with elbow osteoarthritis,
* Patients with a history of traumatic injury to the elbow
* Patients with workers compensation
* Patients who received cortisol injection in the elbow
* MRI evidence of common extensor tear
* A history of surgery on the affected elbow,
* Cognitive or behavioral problems which would preclude informed consent.
* Patients with coagulopathies
* Patients who are pregnant
* Patients who had a cortisone injection within 3 months

Primary outcomes:
measure: Time to Improvement of Symptoms
timeFrame: 3 months
Secondary outcomes:
measure: PROMIS Upper Extremity
timeFrame: 3 months
measure: PROMIS Physical Functioning
timeFrame: 3 months
measure: PROMIS Pain Interference
timeFrame: 3 months
measure: PROMIS Depression
timeFrame: 3 months
measure: VAS pain score
timeFrame: 3 months
measure: SANE score
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Michael A Stone, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143609: Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
Official title: Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: airway disease
bronchitis
emphysema
lung
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.

Detailed description: Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).

Eligibility criteria: Inclusion Criteria:

* chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
* residents at low altitude (\<800 m)

Exclusion Criteria:

* unstable condition, COPD exacerbation
* mild (GOLD 1) or very severe COPD (GOLD 4)
* requirement for oxygen therapy at low altitude residence
* hypoventilation
* pulmonary hypertension
* more than mild or unstable cardiovascular disease
* use of drugs that affect respiratory center drive
* internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* previous intolerance to moderate altitude (\<2600m).
* exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* pregnant or nursing patients

Primary outcomes:
measure: 6 min walk distance
timeFrame: Day 2 at 2048 m
Secondary outcomes:
measure: 6 min walk distance
timeFrame: day 3 at 2048 m
measure: Arterial blood gas analysis
timeFrame: Day 2 at 2048 m
measure: Spirometry
timeFrame: Day 2 at 2048 m
measure: Perceived exertion
timeFrame: Day 2 at 2048 m
measure: Perceived exertion
timeFrame: Day 3 at 2048 m
measure: Severe hypoxemia
timeFrame: Day 1 to 3 at 2048 m
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References: