louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06542835: Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
Official title: Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer screening
telehealth
video
text messaging
patient navigation
stool testing
fecal testing
Latinx health disparities
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: AltaMed Health Services Corporation
name: Kaiser Permanente
First posted: 2024-08-07
Enrollment: 6000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

Detailed description: The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.

Eligibility criteria: Inclusion Criteria:

* Ages 45-64
* Eligible for colorectal cancer (CRC) screening
* Current patients (seen in the clinic in the last 6 months)
* Primary speaker of English or Spanish
* Cell phone listed in Electronic Health Record (EHR)
* No recent history of CRC screening
* Resides in one of the neighborhoods included in the main trial

Exclusion Criteria:

* Colorectal disease (e.g., ulcerative colitis or colectomy)
* Personal history of colorectal cancer
* End-stage or life-threatening diseases
* Known to be under hospice care
* Living in a skilled nursing facility
* Patients who decline research participation will be removed from the patient contact list

Primary outcomes:
measure: CRC Screening Completion at the Individual Level
timeFrame: 6 months
Secondary outcomes:
measure: FIT completion
timeFrame: 6 months
measure: Rate of Follow-Up Colonoscopy Completion
timeFrame: 12 months
measure: Time to follow-up colonoscopy
timeFrame: Within 12 months post abnormal FIT result
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
state: California
Study officials:
affiliation: AltaMed Health Services Corporation
name: Anne Escaron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05133635: High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
Official title: Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COVID-19 Virus Infection
Cytokine Storm
Corticosteroid
Tocilizumab
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc.

One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc.

In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

* Patients with COVID-19 Pneumonia treated in the Intensive Care Unit
* Clinical deterioration during intensive care follow-up
* First 14 days from the COVID-19 diagnosis

Exclusion Criteria:

* More than 14 days passed from the COVID-19 diagnosis
* Clinical and laboratory signs of secondary bacterial infection

Primary outcomes:
measure: Clinical condition
timeFrame: Next 7 days of the intervention.
measure: Blood analysis
timeFrame: Next 7 days of the intervention.
Secondary outcomes:
measure: Hospital stay
timeFrame: Until the hospital discharge.
measure: Mortality
timeFrame: Not relevant
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02022735: Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Official title: Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Deep Brain Stimulation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
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 evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.
* On stable dose of dopaminergic drugs
* Age 45-70 years of age

Exclusion Criteria:

* Past medical history of seizures
* Renal insufficiency
* Cardiac arrhythmia
* Severe arthritis
* Women of childbearing potential
* Dementia
* Less than 45 years of age or older than 70 years of age

Primary outcomes:
measure: Walking Speed
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Stride Length
timeFrame: Up to 1 hour
measure: UPDRS Scores
timeFrame: Up to 1 hour
measure: TUG Test
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Corneliu Luca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04227535: Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2
Official title: Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Interstitial Lung Disease
Keywords: Rheumatoid Arthritis
Interstitial lung disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2020-01-13
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of interest are individuals affected by RA with ILD (RA-ILD). Individuals affected with RA and without ILD (RA-noILD) will be included as a control population. The ILD status being systematically assessed by HRCT chest scan.

Brief summary: The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).

Detailed description: This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.

Eligibility criteria: SELECTION OF CASES :

Inclusion Criteria:

* Age ≥18 years
* RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
* ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist

Exclusion Criteria:

- Lack of signed informed consent

SELECTION OF CONTROLS:

Inclusion Criteria:

* Age ≥18 years
* RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist

Exclusion Criteria:

- Lack of signed informed consent

Primary outcomes:
measure: Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).
timeFrame: Baseline
Secondary outcomes:
measure: Identification of genetic factors implicated in RA-ILD using genome wide association study.
timeFrame: Baseline
measure: Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.
timeFrame: Every year during 5 years
measure: Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.
timeFrame: Every year during 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe DIEUDE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00526435: Evaluation of Walk With Ease in Arthritis
Official title: Evaluation of the Walk With Ease Program Among People With Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Keywords: Arthritis
osteoarthritis
rheumatoid arthritis
fibromyalgia
lupus
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2007-09-10
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Participants will be approximately 657 subjects from 20-24 rural and urban communities across North Carolina. It is expected that participants in the WWE program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.


Eligibility criteria: Inclusion Criteria:

* Self-reported, doctor-diagnosed arthritis
* Ages 18+

Exclusion Criteria:

* Non-English speaking
* Severe impairment of physical or mental function
* Co-existing condition for which exercise is contraindicated

Primary outcomes:
measure: Physical Activity Level
timeFrame: 6 weeks
measure: 6-minute walk
timeFrame: 6 weeks
measure: Walking behaviors
timeFrame: 6 weeks
measure: Exercise self-efficacy
timeFrame: 6 weeks
Secondary outcomes:
measure: Health-related Quality of Life (SF36)
measure: Health Assessment Questionnaire
measure: Arthritis Symptoms
measure: Senior Fitness Test (function)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Jennifer M Hootman, PhD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Leigh F Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322035: Erythrocyte and Adipocyte G6PD Activity Levels in Obesity
Official title: Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Obesity
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients will be morbidly obese and undergo Roux-en-Y Gastric bypass surgery. Both Type 2 diabetic and non-diabetic patients will be accepted into the study.

Brief summary: This study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).

Detailed description: Same as brief summary

Eligibility criteria: Inclusion Criteria:

* Age \> 19 years of age and \<70 years of age
* HGA1c\<6.0%
* fasting blood sugar less than 100mg/dL

Exclusion Criteria:

* Taking antidiabetic medications for other indications

Primary outcomes:
measure: Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
timeFrame: G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.
Secondary outcomes:
measure: Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
timeFrame: G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.
measure: Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
timeFrame: time of gastric bypass
measure: Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
timeFrame: time of gastric bypass
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
affiliation: University of South Alabama, Department of Surgery
name: William O Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805335: Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS
Official title: Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter Complications
Thrombosis
Displacement of Infusion Catheter
Quality of Life
Keywords: Central Venous Catheter
Catheter Bloodstream Related Infection
Economic evaluation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines it's recommended to use sutureless device. The devices actually used are unsatisfactory because of the high risk of migration, accidental removal.

A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the possibility to simplify the after care. This device may stay on patient for 4 weeks. Others devices may be changed 1/week.

The investigators aimed to compare morbidity between this new device and the old one. The investigators also want to perform an economic evaluation of this device and compare patient quality of life.


Eligibility criteria: Inclusion Criteria:

* patient with indication for PICC according guidelines
* hospitalized in a departement of your hospital
* with the possibility to use a sutureless device

Exclusion Criteria:

* infection
* thrombosis
* pediatric patient
* emergency context

Primary outcomes:
measure: morbidity assessed as a composite of:
timeFrame: from baseline up to 1 year
Secondary outcomes:
measure: quality of life
timeFrame: 1 year
measure: cost
timeFrame: 1 year
measure: efficacy of urokinase
timeFrame: 1 year
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: Medical and University Center of Caen
name: Audrey Fohlen, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05973435: Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section
Official title: Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Anesthesia Problems
Lead sponsor: University Clinic Dr Dragisa Misovic-Dedinje
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy pregnant women

Brief summary: The goal of this observational study is to assess the level of oxidative stress during cesarean section depending on the type of anesthesia applied and to determine the factors that can affect the level of oxidative stress.

The main questions it aims to answer are:

* is there any association between specific parameters of pregnancy, socio-demographic characteristics and laboratory analyses with an increased level of oxidative stress
* is there any association between type of anesthesia for ceasarean section with an increased level of oxidative stress

Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).

Researchers will compare patients that received general anesthesia with patients under spinal regional anesthesia to see if there is any difference in level of oxidative stress measured by laboratory parameters.


Eligibility criteria: Inclusion Criteria:

* ASA status I and II

Exclusion Criteria:

* ASA status III and IV
* Emergency C section

Primary outcomes:
measure: Elevated level of oxidative stress
timeFrame: 2 hours after C section
Secondary outcomes:
measure: Lactate level
timeFrame: 2 hours after C section
measure: Level of cortisol
timeFrame: 2 hours after C section
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"
Study officials:
References:
Clinical trial NCT01314235: Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel
Official title: The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulation
Keywords: anticoagulation with ASS
anticoagulation with clopidogrel
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2011-03-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients going under vascular surgery with anticagulation with both ASS and clopidogrel

Brief summary: Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but also in many other tissues. It is part of balanced anesthesia in general anesthesiology as well as a sedastive agent in intensive care units, but also serves as a third-line agent in many psychiatric diseases including ADHD, schizophrenia and PTSD.

The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The investigators will use a flowcytometric assay to determine activation of thrombozytes when they come into contact with clonidine in vitro as well as Multiplate analyses to determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or arachidonic acid-induced aggregation of thrombozytes.


Eligibility criteria: Inclusion Criteria:

* Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel
* Age above 18 years

Exclusion Criteria:

* Additional anticoagulatoric treatment woth another inhibitor of platelet aggregation
* Surgery within the last two weeks
* Patients with long-term mediaction with omeprazole
* Patients under hemodialysis
* Patients with renal insufficiency (creatinine above 1.5mg/dl, urea above 80mg/dl)
* Patients with hepatic dysfunction (GOT above 30U/I, GPT above 30 U/I, GLDH above 10 U/I)
* Age under 18 yeary
* Non-responder to ASS and / or clopidogrel

Primary outcomes:
measure: Numbers of participants with an activated area under the curve in ASPI test
timeFrame: 30 minutes
Secondary outcomes:
measure: Numbers of participants with an activated area under the curve in TRAP test and ADP test
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann-Wolfgang-Goethe University
state: Hesse
Study officials:
References: