louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01255683: Oral Steroid Treatment for Chronic Rhinosinusitis
Official title: Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Rhinosinusitis
Keywords: Chronic
Sinusitis
Steroid
treatment
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health \& Science University (OHSU).

Brief summary: Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS), the natural history and efficacy of this treatment modality has not been fully elucidated. Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural history of endoscopic improvement and quality of life (QoL) outcomes, following an oral steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic grading, QoL, and olfactory function as well as defining the duration of improvement, in patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).


Eligibility criteria: Inclusion Criteria:

* Adult ( \> 18 years of age)
* CRS defined by 2007 Adult Sinusitis Guidelines.12
* Subject must be able to complete QoL questionnaires written in English
* Previous sinus surgery including unilateral or bilateral total ethmoidectomy
* Minimum nasal blockage score on SinoNasal Outcomes Test-22 (SNOT-22) \> 3
* Severe sinonasal inflammation where the next treatment option is a 12- day oral prednisone taper
* Obstruction of the ethmoid sinus region or middle meatus eligible for revision endoscopic sinus surgery
* Lund-Kennedy endoscopy score \> 4
* Elects 12-day tapering dose of oral steroids (Prednisone) as a next treatment option

Exclusion Criteria:

* Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English
* Contra-indication to oral steroids
* Endoscopic sinus surgery \< 3 months of presentation
* Completed course of oral corticosteroids within the previous 3 month period
* Subjects presenting with unilateral chronic rhinosinusitis
* Pregnancy or possibility to become pregnant during the study

Primary outcomes:
measure: Health-related quality-of-life
timeFrame: Change from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT05277883: Influence of Knee Alignment and Pelvis Rotation on Accuracy of Radiograph Measurements Before Total Knee Arthroplasty
Official title: The Influence of Lower Extremity and Pelvic Alignment on Accuracy of Hip-Knee-Ankle Radiograph Measurements Before Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: knee aligment
total knee arthroplasty
coronal alignment of the lower limb
x-ray accuracy
Lead sponsor: Valdoltra Orthopedic Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that require primary knee replacement will be enrolled in the study. Patients with prevoius surgery that might had already changed the leg aligment (hip/knee artroplasty, osteotomy) or patients with previous leg deformity are not eligible for the enrolment. Women in reproductive age are also not eligible.

Brief summary: The aim of this study is to determine the accuracy of long leg standing X-rays with respect to coronal alignment of the knee.

Detailed description: Long leg standing x-ray is a routine examination to measure the femoral valgus angle before a total knee arthroplasty. Newer studies have shown that coronal leg alignment influences the rotation of the distal femoral part. This rotation might influence the measurements obtained with a long leg standing x-ray.

The primary purpose of this study is to determine whether there is a significant difference between 2D measurements taken on the x-ray and 3D measurements obtained with a CT scan.

Eligibility criteria: Inclusion Criteria:

Knee osteoarthritis scheduled for knee arthroplasty

Exclusion Criteria:

* previous leg deformities or surgery that changes alignment

Primary outcomes:
measure: The angle difference between an x-ray and a CT scan
timeFrame: Before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankaran
country: Slovenia
facility: Orthopaedic Hospital Valdoltra
Study officials:
affiliation: Valdoltra Orthopaedic Hospital
name: Andrej Strahovnik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416283: Remote Monitoring and Social Support for Hypertension Management
Official title: Remote Monitoring and Enhanced Social Support for Hypertension Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.

Detailed description: The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN:

1. The investigators will assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control.
2. The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 75 years old with HTN (ICD-10 code I10)
* Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes)
* Must have a cellular phone with texting capabilities
* Must be prescribed at least one medication for hypertension

Exclusion Criteria:

* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has congestive heart failure
* Has dementia
* Has liver cirrhosis

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 4 months
Secondary outcomes:
measure: Percent of patients that are normotensive
timeFrame: 4 months
measure: Medication adherence
timeFrame: 4 months
measure: Diastolic blood pressure
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04807283: Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
Official title: A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Left Atrial Appendage Closure
Lead sponsor: Laminar, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).


Eligibility criteria: Inclusion Criteria:

* 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
* 2. Subject must be ≥18 years of age.
* 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
* 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
* 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
* 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion Criteria:

* 1. Subject who requires anticoagulation for a condition other than AF.
* 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
* 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
* 4. Subject with valvular disease.

Primary outcomes:
measure: Freedom from device or procedure related serious adverse events
timeFrame: 7 days
measure: Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
timeFrame: 45 days
Secondary outcomes:
measure: Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
timeFrame: 45 days and 6 months
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Asunción
country: Paraguay
facility: Sanatorio Italiano Hospital
city: San Lorenzo
country: Paraguay
facility: Hospital de Clinicas San Lorenzo, National University
Study officials:
References:
Clinical trial NCT03976583: Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions
Official title: Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: White Spot Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate.

Detailed description: The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. The remineralisation potential will be assessed both visually and by standardised photographic image analysis. the follow up will be up to 12 months.

Eligibility criteria: Inclusion Criteria:

* Males or females.
* Age: 12-25 years old.
* Patients with good oral hygiene.
* Co-operative patients who show interest to participate in the study.

Exclusion Criteria:

* Patients with bad oral hygiene.
* Lack of patient's approval and compliance.
* Presence of abnormal oral, medical, or mental condition.
* Patients who are allergic to milk products.
* Pregnant and lactating women.

Primary outcomes:
measure: Clinical index used for visual evaluation of white spot lesions
timeFrame: 12 months
Secondary outcomes:
measure: Digital photographic image analysis
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05563883: Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
Official title: Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Cancer
Thromboembolism
Bleeding
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
First posted: 2022-10-03
Enrollment: 5000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized from january 2010 to december 2019 and having an available ICD-10 code discharge.

Brief summary: Atrial fibrillation (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known.

The objective of this study is to use a very large French nationwide cohort to adress thèses questions.


Eligibility criteria: Inclusion Criteria:

* adult hospitalized patients
* with an ICD-10 code discharge from january 2010 to december 2019 in the French national hospital discharge database (PMSI Programme de Médicalisation des Systèmes d'Information)

Exclusion Criteria:

* children

Primary outcomes:
measure: atrial fibrillation
timeFrame: from inclusion in the cohort up to 10 years
measure: cancer
timeFrame: ffrom inclusion in the cohort up to 10 years
Secondary outcomes:
measure: thromboembolism
timeFrame: from inclusion in the cohort up to 10 years
measure: bleeding
timeFrame: from inclusion in the cohort up to 10 years
measure: mortality
timeFrame: from inclusion in the cohort up to 10 years
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Cardiologie, Centre Hospitalier Universitaire Trousseau
Study officials:
References:
Clinical trial NCT03022383: TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus
Official title: TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Eyes
Keywords: no known ocular pathology
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with no known eye disease.

Brief summary: To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

Detailed description: Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Eligibility criteria: Inclusion Criteria

* Participants must be at least 18 years of age
* Participants must be able to complete all testing (all OCT scans)
* Participants must volunteer to be in the study and sign the consent form

Exclusion Criteria

* Subject with history of ocular disease or ocular pathology

Primary outcomes:
measure: Measurement Variability of Signal to Noise Ratio
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems Inc.
state: New Jersey
Study officials:
affiliation: Topcon Medical Systems, Inc.
name: Wei-Chieh Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06384183: Kerecis Real-World Fish Skin Graft Registry
Official title: Kerecis Real-World Fish Skin Graft Registry - "ISACOD"
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Wounds
Pressure Ulcer
Diabetic Foot Ulcer
Venous Leg Ulcer
Surgical Wound
Soft Tissue Reinforcement
Lead sponsor: Kerecis Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will only enter previously collected clinical data from patients (all ages, demographics, and any health status) who meet all inclusion criteria and no exclusion criteria.

Brief summary: Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices

Detailed description: This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.

Eligibility criteria: Inclusion Criteria:

* Provided informed consent
* Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date

Exclusion Criteria:

* None

Primary outcomes:
measure: Fish Skin Graft Device Related failure
timeFrame: 12 months
measure: Fish Skin Graft Device related allergy
timeFrame: 12 months
measure: Target Wound Infection
timeFrame: 12 months
Secondary outcomes:
measure: Complete Wound Healing
timeFrame: 12 months
measure: Complete Wound Closure
timeFrame: 12 months
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: MCR Health
state: Florida
city: Sarasota
country: United States
facility: University Park
state: Florida
city: Greensboro
country: United States
facility: Cone Health Ortho Care Greensboro
state: North Carolina
city: Beavercreek
country: United States
facility: Feet First Institute of Beavercreek
state: Ohio
city: Columbus
country: United States
facility: ABC Podiatry
state: Ohio
city: San Antonio
country: United States
facility: South Texas Skin Cancer Center
state: Texas
Study officials:
affiliation: Kerecis Ltd.
name: Anne Swearingen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00566683: Comparison Between Nurse-Administered Propofol Sedation and Diazemuls / Pethidine in Outpatient Colonoscopy
Official title: Nurse-Administered Propofol Sedation by PCA Pump Versus Diazemuls / Pethidine in Outpatient Colonoscopy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Propofol
colonoscopy
sedation
pain
compare NAPS versus diazemuls in outpatient colonoscopy
Lead sponsor: North District Hospital
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology. Different modalities of pain control have been described in the past. Propofol is a perfect drug for endoscopic procedure since it has the characteristic of fast onset, short half-life and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness of NAPS versus traditional sedation.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 undergoing elective outpatient colonoscopy

Exclusion Criteria:

* American Society of Anesthesiologist Class III or above
* History of difficult endotracheal intubation
* Known allergy to propofol, eggs or soy products, opioid, benzodiazepines
* previous colectomy

Primary outcomes:
measure: Pain
timeFrame: after recovery
Secondary outcomes:
measure: sedation
timeFrame: thorughout the procedure
Other outcomes:
Locations:
Study officials:
affiliation: North District Hospital
name: Chi-Ming Poon, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071483: Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis
Official title: Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia, Epidural
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection

Detailed description: Cervical transforaminal epidural steroid injection (CTFESI) is useful option to improve cervical radicular pain. However, severe complication can occur by CTFESI such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred.

The incidence of intravascular injection during CTFESI was known as 20.6% \~ 32.8% and it is higher than other level of spinal transforaminal epidural injection.

To avoid complication due to intravascular injection during CTFESI, risk factors was should be evaluated. However, there was no study about risk factors of intravascular injection during CTFESI. The investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during CTFESI.

Thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during CTFESI.

Eligibility criteria: Inclusion Criteria:

* Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria:

* Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Primary outcomes:
measure: Intravascular injection
timeFrame: During procedure
Secondary outcomes:
measure: Pain intensity
timeFrame: Before treatment and at 1 month after treatment
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
References: