louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05282966: Assessment of QSant™ for Underlying Allograft Rejection
Official title: Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Transplant Failure and Rejection
Keywords: kidney transplant
kidney biopsy
allograft rejection
subclinical allograft rejection
kidney
kidney health
kidney function
urine sample
urine test
kidney disease
Lead sponsor: NephroSant
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients of all ages

Brief summary: The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.

Detailed description: The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. Each participant will be tracked for 24 months. QSant testing will be performed according to the intended use guidelines specified in "LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (SCr/eGFR) as described in the study schedule. Participants will be compared to a site-specific retrospective cohort of KTRs without QSant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from UNOS (United Network for Organ Sharing) data.

Eligibility criteria: Inclusion Criteria:

1. Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant.
2. Able to understand risks and requirements of participation and provide informed consent
3. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Inability to provide a voided urine sample per collection protocol
2. Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.

Primary outcomes:
measure: QScore specificity and sensitivity in relation to kidney biopsy
timeFrame: 6 weeks before each biopsy-proven rejection (BPAR)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01072266: A Dose-escalation Study in Subjects With Advanced Malignancies
Official title: A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Advanced Cancer
Metastatic Cancer
Keywords: Refractory, Advanced malignancies
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2010-02-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available
* Subjects with life expectancy of 12 weeks or longer.
* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

* Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
* Subjects with history of brain metastases or spinal cord compression.
* Subjects who have undergone a bone marrow or solid organ transplant.
* Subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment.
* Subjects with clinically significant non-healing or healing wounds or subjects with lung tumor lesions with increased likelihood of bleeding
* Subjects with a history of any gastrointestinal condition

Primary outcomes:
measure: Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs
timeFrame: Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit.
Secondary outcomes:
measure: c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation
timeFrame: Predose, specific hours post-dose on day and Day 15 of Cycle 1.
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold
role: STUDY_DIRECTOR
References:
Clinical trial NCT05984966: Supported Employment COVID-19 Rapid Testing for PWID
Official title: Supported Employment to Create a Community Culture of COVID-19 Rapid Testing Among People Who Inject Drugs: PeerConnect2Test
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This community-engaged project aims to improve the accessibility of rapid tests through a supported employment program for people who inject drugs (PWID). The program is called Peer Connect2Test (PeerC2T). PWID will be recruited by a community partner who provides syringe exchange services. PWID will the trained by the community partner to become peer health workers (PHW) to distribute SARS-CoV-2 rapid tests to other PWID. Investigators expect that PeerC2T will improve knowledge, self-efficacy, and health behaviors among PHW (Aim 1). The study will use the RE-AIM framework in Aims 2 and 3 to evaluate whether PeerC2T improves SARS-CoV-2 testing uptake among other PWID (RE; Aim 2), and identify intervention considerations (AIM; Aim 3). The overall goal of this project is develop a transformative community-driven intervention in partnership with a community partner to promote widespread access to rapid testing among PWID.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older, understand English

Exclusion Criteria:

-

Primary outcomes:
measure: Qualitative semi-structured interview with PWID Peer Health Worker
timeFrame: 3 months post intervention involvement
measure: Change in Self-efficacy of PWID Peer Health Worker
timeFrame: Change from Baseline Self-efficacy at 3 months
measure: Change in Behavioral Intentions of Peer Health Worker
timeFrame: Change from Baseline Behavior at 3 months
measure: Change in Flourishing Scale (Well-Being)
timeFrame: Change from Baseline Flourishing (well-being) at 3 months
measure: Percent of people who inject drugs who agree to testing for COVID-19
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References:
Clinical trial NCT02198066: A Comparison of Post-Sternotomy Dressings
Official title: A Comparison of Post-Sternotomy Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Wound Healing
Postoperative Wound Infection-deep
Keywords: Sternotomy incision
Silver dressing
Sternal wound infection
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: DeRoyal Industries, Inc.
name: Smith & Nephew, Inc.
First posted: 2014-07-23
Enrollment: 351
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to determine which of three types of dressings, a dry sterile dressing, a metallic silver dressing or an ionic silver dressing provided better patient outcomes for the post-sternotomy cardiac surgery patient population. In this prospective, randomized controlled trial, the hypothesis was that subjects who received either of the silver impregnated dressings would have better outcomes (better wound healing, less discomfort, and less incidence of infection). Investigators also evaluated dressing factors such as adherence, time for application and ease of use.

Detailed description: No other information included.

Eligibility criteria: Inclusion Criteria:

* Adult (at least 21 years of age) inpatients awaiting cardiac surgery or outpatients seen in the pre-surgical testing area prior to admission for surgery
* Having surgery at the study setting
* English-speaking
* Able to understand and give consent
* Had the approval of their cardiothoracic surgeon to participate
* Had no known sensitivity to silver
* Had no known sensitivity to alginates

Exclusion Criteria:

* Known sensitivity to silver
* Known sensitivity to alginates

Primary outcomes:
measure: Wound Healing
timeFrame: 5 days postoperatively or day of discharge, whichever came first
Secondary outcomes:
measure: Patient Comfort
timeFrame: 5 days postoperatively or day of hospital discharge, whichever came first
Other outcomes:
measure: Dressing Factors
timeFrame: 5 days postoperatively or at day of discharge, whichever came first
measure: Sternal Wound Infection
timeFrame: 30 days postoperatively
Locations:
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Cathy D. Jennings, DNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01836666: Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management
Official title: Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Eques Indolor AB
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 873
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to a specialized interventional pain management clinic in northen sweden

Brief summary: How are the health related quality of life among patients with chronic pain effected by interventional pain managment?

Hypothesis:

Health related quality of life can be improved by interventional pain management both among patients with localizable pain focuses and among patients among whom no pain focuses can be found.

Method:

Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the time of treatment for pain focuses an during the following 12 months.


Eligibility criteria: Inclusion Criteria:

All patients

Exclusion Criteria:

-

Primary outcomes:
measure: EQ-VAS
timeFrame: 1 year
measure: EQ-5D
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vallentuna
country: Sweden
facility: Smärtkliniken Eques Indolor
Study officials:
name: Johan Hambraeus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05362266: Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization
Official title: Incidence and Risk Factors of in Hospital Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization Treatment: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Adverse Cardiac Events
Adverse Effect of Unspecified General Anesthetic
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age more than 18, with acute limb ischemia undergoing revascularization procedure

Brief summary: Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.


Eligibility criteria: Inclusion Criteria:

* age more than 18 years
* undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis)

Exclusion Criteria:

* incomplete data during perioperative period

Primary outcomes:
measure: Incidence of major adverse cardiac events
timeFrame: during hospital stay, up to 4 weeks
Secondary outcomes:
measure: Incidence of the perioperative complication
timeFrame: during hospital stay, up to 4 weeks
measure: Factors contribute to the adverse outcome
timeFrame: during hospital stay, up to 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: MahidolU
Study officials:
References:
Clinical trial NCT05659966: Nutritious Eating with Soul Dissemination and Implementation
Official title: NEW Soul D&I: Expanding the Reach of the Nutritious Eating with Soul (NEW Soul) Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Eating Behavior
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228).

Using a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control).

The investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year.

Lastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff.


Eligibility criteria: Inclusion Criteria:

* Self-identify as African American
* Be between the ages of 18-65 years
* Body Mass Index between 25- 49.9 kg/m2
* Able to travel to restaurant for classes
* Be able to attend all monitoring and weekly class visits
* Be willing to be randomized to either group

Exclusion Criteria:

* Currently following a plant-based diet
* Diagnosed with diabetes that is controlled by medication
* Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* Under the age of 18 years old
* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Potential eating disorder

Primary outcomes:
measure: Changes in body weight
timeFrame: 3-months
measure: Changes in diet quality
timeFrame: 3-months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 3-months
measure: Implementation
timeFrame: 3-months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Mimsy's Restaurant
state: South Carolina
Study officials:
References:
Clinical trial NCT00354666: Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
Official title: A Randomised, Double-blind, Placebo-controlled, Dose Ascending Crossover Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled GSK159797 Delivered by Dry Powder Inhaler in Mild to Moderate Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: inhaled
asthmatic subjects
GSK159797
safety and tolerability
efficacy
dry powder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.


Eligibility criteria: Inclusion criteria:

* Subjects with mild to moderate stable asthma but no other lung problems.
* Male subjects or females who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
* Non-smokers.
* Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol.

Exclusion criteria:

* Any significant illness.
* Subjects with heart problems.
* Subjects who have had a cold or chest infection 2-4 weeks prior to the study.
* Subjects who take medication for their asthma, or other conditions, not compatible with the study.

Primary outcomes:
measure: Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.
Secondary outcomes:
measure: Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04786366: Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
Official title: Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Epidemiology
Keywords: Atrial Fibrillation
healthcare contacts
Electronic Health Records
epidemiology
comorbidity
health inequality
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 5601803
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators implement two study designs, first a longitudinal cohort study to assess AF incidence and second a matched case-control study for mortality, cause of death and hospitalization.

The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of AF before study entry. For the nested case-control study, controls are matched to incident AF patients according to sex and age (10-year age strata).

Brief summary: The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.


Eligibility criteria: Inclusion Criteria:

* The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

* Individuals are excluded if they had a prior history of AF before study entry.

Primary outcomes:
measure: Incidence of Atrial fibrillation
timeFrame: Jan 1st 1998 - May 31st 2016
measure: Mortality of Atrial fibrillation
timeFrame: Jan 1st 1998 - May 31st 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: