louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06580418: Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
Official title: Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Keywords: IBD
Lead sponsor: Inotrem
Sponsor class: INDUSTRY
Collaborators: name: IRCCS San Raffaele
First posted: 2024-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population that will be recruited for this study will be composed of patients with UC or CD under endoscopic surveillance for monitoring the clinical activity of their disease.

The recruited patients will firstly sign the informed consent before undergoing the same day the blood withdrawal and endoscopy according to standard of care practice in the dedicated department, under the direction of the Gastroenterology and Digestive Endoscopy operative unit of the San Raffaele Hospital.

Brief summary: TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease.

The main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 60 years
* Signed informed consent
* Ulcerative colitis (UC) patients with active disease
* Crohn's disease (CD) patients with active disease

Exclusion Criteria:

* UC or CD patients in remission
* Patients between 18 and 60 years without informed consent

Primary outcomes:
measure: Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist
timeFrame: 20 months
Secondary outcomes:
measure: Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound
timeFrame: 26 months
measure: Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound
timeFrame: 26 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
Study officials:
References:
Clinical trial NCT00721318: A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County
Official title: A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population Matched by Gender, Age and Place of Residence in Tallinn and Harjumaa County
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Widespread Pain
Keywords: chronic widespread pain
fibromyalgia
rheumatoid arthritis
Estonia
Lead sponsor: Estonian Society for Rheumatology
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 6000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population: Tallinn and Harju County (Estonia), population 552,000. The residents of both Tallinn and Harju County receive national health care services.

Brief summary: The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the same time they are not life threatening and they cannot be detected by any laboratory tests. The problems connected with these conditions have gained little attention in Estonia so far. It can be assumed that the CWP and FM often remain undetected and the sufferers live without treatment they need.

So far, there are no data on the prevalence of the CWP and FM in Estonia available.

The goal of the current research is to assess the prevalence of the CWP and local pain syndromes among Estonia's RA patients and among the control population in Tallinn and Harju County; also the factors connected with the presence of the pain and the pain treatment in use.

At the same time there will be a similarly designed research conducted in Jyväskylä Central Hospital, which provides the opportunity to compare results in Estonia's and Finland's research groups. The study on the distribution of the chronic pain among RA patients and control population will allow to assess the magnitude of the problem in Estonia and to raise the awareness of physicians about CWP and significance of its treatment.

Performing the study will provide an experience which forms the base for further epidemiological and clinical research on CWP and FM


Eligibility criteria: 2000 RA patients from the East Tallinn Central Hospital's and the North Estonian Regional Hospital's in- and outpatients who live in Tallinn or Harju County

The control sample will be found from the Population Register through matching by gender, age (the same year) and place of residence (living in the city or in the countryside) with the subjects from RA sample according to the official procedure. If required, the research subjects from the control sample will be contacted by a rheumatologist participating in the study.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
Study officials:
References:
Clinical trial NCT04202718: VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Official title: VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arrythmia, Cardiac
Keywords: ECG Interpretation
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.

Detailed description: This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old,
* No skin trauma to the site where the patch will be applied
* No known allergies to hydrocolloid or silicone based adhesives
* Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician

Exclusion Criteria:

* Pacemaker or Implanted Defibrillator (ICD)
* Pregnancy
* Adults unable to provide informed consent
* Individuals who cannot read and understand English
* Prisoners
* Not recommended for use in MRI

Primary outcomes:
measure: Reduction in false alarms received from current telemetry monitoring technology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Mercy Hospital Washington
state: Missouri
Study officials:
References:
Clinical trial NCT01357018: Quality of Life in Chronic Arthritis
Official title: A Study on Quality of Life in Patients With Chronic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Rheumatoid Arthritis
Keywords: Ankylosing spondylitis
Disease activity
EQ-5D
Quality of life
Rheumatoid arthritis
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with rheumatoid arthritis or ankylosing spondylitis

Brief summary: Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it can not only affect patient's working ability but also produce indirect cost in patient's family. Quality of life will also be affected. Health-related quality of life issues are assuming increasing importance in chronic rheumatic diseases. However, studies on quality of life in rheumatic patients are limited. Factors related to quality of life are not clear. Application of quality of life measurement for improving clinical care of RA and AS patients is still difficult. The objective of this study was to evaluation the validity of EQ-5D life quality measurement in chronic arthritis patients in Taiwan. Factors associated with life quality will be addressed. This will also provide useful information for public health policy making.


Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis or ankylosing spondylitis

Exclusion Criteria:

* Patients with mental illness which interfered with questionaire answering

Primary outcomes:
measure: Validity of life quality measurement EQ-5D in chronic arthritis patients
timeFrame: EQ-5D at recruitment and 6 months later in chronic arthritis patients
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chien-Sheng Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03856918: Optimal Level of PEEP in Protective One-lung Ventilation
Official title: Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-assisted Thoracic Surgery
Postoperative Atelectasis
Positive End-expiratory Pressure
Keywords: Protective ventilation
One-lung ventilation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 142
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

Exclusion Criteria:

* Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
* Chronic kidney disease
* Coronary artery disease
* Pulmonary hypertension
* Bilateral lung surgery
* Conversion to thoracotomy
* American Society of Anesthesiologists physical status IV or more
* Refusal to participate

Primary outcomes:
measure: Modified lung ultrasound score
timeFrame: Postoperative 1 hour
Secondary outcomes:
measure: Intraoperative desaturation
timeFrame: Average time of 60-90 minutes
measure: Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
timeFrame: Average time of 60-90 minutes
measure: Postoperative desaturation
timeFrame: Postoperative 24 hours
measure: plasma Tumor Necrosis Factor-α
timeFrame: 10 minutes after initiation of one-lung ventilation
measure: plasma Interleukin-6
timeFrame: 10 minutes after initiation of one-lung ventilation
measure: plasma Interleukin-10
timeFrame: 10 minutes after initiation of one-lung ventilation
measure: Postoperative pulmonary complication
timeFrame: Postoperative 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Hyon Bahk, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05585918: The R-CITY Project: A Collaborative Intervention With Teachers and Youth
Official title: R-CITY: A Collaborative Intervention With Teachers and Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
name: Sheppard Pratt Health System
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-10-19
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: School-level randomization of teachers to arm.
Primary purpose: PREVENTION

Brief summary: "R-CITY" refers to the Collaborative Intervention with Teachers and Youth to practice and apply the 4 "Rs" of equity literacy skills in the classroom - Recognizing, Responding, Restoring Relationships, and Resilience. R-CITY is a collaborative teacher- and youth-focused prevention intervention that offers equity literacy lessons to accompany the Second Step social and emotional learning (SEL) curriculum. The lessons are designed to build teachers' and students' "equity stamina" and promote SEL skills to create safe and positive learning environments for all.

The R-CITY Project uses a school-level randomized controlled trial (RCT) design to test the integration of the Second Step universal classroom-based evidence-based SEL program that Anne Arundel County Public Schools (AACPS) had been scaling up district wide with the R-CITY equity lessons. The purpose of the RCT is to determine the "value-added" of the SEL + Equity Condition, compared to the SEL curriculum alone (SEL Only) in AACPS elementary and middle schools. Students in both conditions get access the Second Step SEL content, there is no true control condition, but rather an active comparison condition.

Detailed description: The study aims to test the R-CITY intervention in 30 elementary and middle schools in AACPS in Maryland. The investigator team plans to enroll the schools across 3 cohorts. The first cohort of schools included 8 elementary schools (2021-2022). Seven to 8 elementary and middle schools are in the process of being recruited for cohort 2 (2022-2023). The third and final cohort will be recruited in fall 2023.

Eligibility criteria: Inclusion Criteria:

- General education teachers of core subjects (Mathematics, Science, Social Studies, English/Language Arts).

Primary outcomes:
measure: ASSIST Classroom Observations
timeFrame: Post-intervention, within one month following the completion of the intervention.
Secondary outcomes:
measure: R-CITY Teacher Self-Report Survey
timeFrame: Post-intervention, within one month following the completion of the intervention.
measure: Suspensions
timeFrame: Post-intervention, within one month following the completion of the intervention.
Other outcomes:
Locations:
city: Towson
country: United States
facility: Shepard Pratt Health System
state: Maryland
Study officials:
References:
Clinical trial NCT00422318: Treatment of Hyperuricemia in Patients With Heart Failure
Official title: Hyperuricemia and the Effects of the Uricosuric Agents Benzbromarone in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Hyperuricemia
Keywords: Heart Failure
Insulin
Metabolism
Pharmacology
Uric Acid
Lead sponsor: Tottori University Hospital
Sponsor class: OTHER
First posted: 2007-01-15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.

Detailed description: Hyperuricemia is often observed in patients with congestive heart failure (CHF). It has been reported that hyperuricemia is related to exercise capacity, inflammation markers and diastolic dysfunction in such patients. In addition, hyperuricemia in CHF relates to both symptomatic status (i.e. morbidity) as well as impaired prognosis (i.e. mortality). Hyperuricemia is likely to play an important role in the pathophysiology of CHF. Up-regulation of xanthine oxidase (XO) activity in CHF has been shown to contribute to higher uric acid (UA) in CHF and the therapeutic concept of XO inhibition has shown beneficial effects in a number of surrogate markers in these patients. The XO inhibition accounts for substantial decrease in oxygen radical load, the latter is discussed as the main benefit of XO inhibition treatment in hyperuricemic patients. However, whether high uric acid itself is important or merely a marker of XO activity (and hence of increased radical accumulation) is currently under discussion. Therefore, this study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.

Eligibility criteria: Inclusion Criteria:

* chronic heart failure
* hyperuricemia

Exclusion Criteria:

* renal dysfunction (Cr \> 2.0 mg/dl)
* under treatment with anti-diabetic agents

Primary outcomes:
measure: parameters of echocardiography at 16 weeks
measure: BNP levels at 16 weeks
Secondary outcomes:
measure: parameters of glucose metabolism at 16 weeks
measure: Parameters of lipid metabolism at 16 weeks
Other outcomes:
Locations:
city: Yonago
country: Japan
facility: Tottori University Hospital
Study officials:
affiliation: Tottori University Hospital
name: Kazuhide Ogino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogino K, Kato M, Furuse Y, Kinugasa Y, Ishida K, Osaki S, Kinugawa T, Igawa O, Hisatome I, Shigemasa C, Anker SD, Doehner W. Uric acid-lowering treatment with benzbromarone in patients with heart failure: a double-blind placebo-controlled crossover preliminary study. Circ Heart Fail. 2010 Jan;3(1):73-81. doi: 10.1161/CIRCHEARTFAILURE.109.868604. Epub 2009 Nov 20.
Clinical trial NCT06503718: Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents
Official title: Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents: Should Osteosynthesis Be Favored From the Start?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tibial Fractures
Keywords: Tibial Fractures
Osteosynthesis, Fracture
Closed Fracture
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject (under 18 years old) treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months

Brief summary: Most displaced tibial shaft fractures in pediatric patients have traditionally been treated after reduction by cast immobilization with good long-term results. Recently, there has been a growing trend towards surgical intervention by osteosynthesis from the outset. This study aims to describe the results of orthopedic treatment and osteosynthesis from the outset.


Eligibility criteria: Inclusion Criteria:

* Minor subject (under 18 years old)
* Subject treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months
* Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
* Non-displaced and/or displaced fracture not located at the level of the tibial diaphysis
* Open fracture
* Incomplete or unusable file

Primary outcomes:
measure: Evaluation of the result of orthopedic treatment and osteosynthesis from the outset
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05762718: Validation of a Food Frequency Questionnaire: VioScreen
Official title: Validation of a Food Frequency Questionnaire: VioScreen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Not Determined
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women and women of child-bearing age

Brief summary: The purpose of this study is to learn more about how well a questionnaire about food intake works. The study team will compare questionnaire responses to several other measurements of food intake. There is a special emphasis on fruit and vegetable intake.


Eligibility criteria: Inclusion Criteria:

* Age 18-40 as we are aiming to recruit women of child-bearing age
* Pregnant women up to 26 weeks' gestation
* Women assigned female sex at birth who are not pregnant

Exclusion Criteria:

* Women below the age of 18 or over the age of 40 years
* Pregnant women more than 26 weeks' gestation at the time of enrollment
* Women who are experiencing limited or reduced food intake related to nausea will not be approached for recruitment and are considered ineligible
* Women who are unwilling to participate in the study due to time commitment or other reasons
* Women whose capacity for study compliance is diminished due to conditions such as active untreated substance use disorder, untreated/uncontrolled schizophrenia, bipolar disorder, active psychosis will not be approached for recruitment and are considered ineligible

Primary outcomes:
measure: Concurrent validity of VioScreen against 24-hour recalls
timeFrame: 6 weeks
measure: Test-retest reliability of VioScreen
timeFrame: one month
Secondary outcomes:
measure: Concurrent validity of VioScreen against Veggie Meter
timeFrame: 6 weeks
measure: Concurrent validity of VioScreen against Fruit and Vegetable Screener
timeFrame: 6 weeks
measure: Test-retest reliability of Veggie Meter
timeFrame: one month
measure: Test-retest reliability of Fruit and Vegetable Screener
timeFrame: one month
measure: Concurrent validity of Veggie Meter against 24-hour recalls
timeFrame: 6 weeks
measure: Concurrent validity of Fruit and Vegetable Screener against 24-hour recalls
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Carina Venter, PhD
role: PRINCIPAL_INVESTIGATOR
References: