louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06327074: Testing the Engaged Approach to Lung Cancer Screening
Official title: Feasibility Testing the Engaged Approach to Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2024-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US.


Eligibility criteria: Inclusion Criteria:

The trial incorporates a multilevel assessment and enrollment involves inclusion criteria at two levels: (1) LCS Program and (2) LCS Program Staff member.

Program inclusion criteria (n = up to 8 sites):

* Must conduct at least 50 low-dose computed tomography (LDCT) scans per year (baseline + follow-up)
* Must be able to identify a primary contact person for LCS program operations (e.g., program coordinator, program navigator, program manager, etc.)

Staff member inclusion criteria (n \~ 5 at each site/\~40 participants total):

* Identified staff member of the LCS program site
* \>18 years of age
* Must be able to complete study surveys and interviews in English
* Willing to provide informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of the intervention group who would like to continue the EA-LCS framework
timeFrame: 7 months
measure: Percentage of the intervention group who would recommend the EA-LCS framework to other programs
timeFrame: 7 months
measure: Percentage of participants who would describe the framework as workable
timeFrame: 7 months
Secondary outcomes:
measure: Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)
timeFrame: 12 months
measure: Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)
timeFrame: 12 months
measure: Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jamie Studts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082574: Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients
Official title: Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2014-03-10
Enrollment: 655
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral (ARV) therapy

Brief summary: Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.

The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.

500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2\*).

Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.

We are expecting to prove that CSVD is more frequent in HIV+ population.


Eligibility criteria: Inclusion Criteria:

* age over 50
* chronic HIV seropositive patient infected for at least 5 years
* treated with any antiretroviral (ARV) therapy
* plasmatic HIV viral load \<40 copies/ml for at least one year with one authorized blip \< 1000 copies/ml per year

Exclusion Criteria:

* co-infection with hepatitis C virus (HCV)
* uncontrolled high blood pressure (WHO criteria)
* Personal history of cerebral infarction or cerebral ischemia
* Personal history of neurological complication of the HIV-infection
* Use of illegal drugs (except cannabis or poppers)
* Glomerular filtration rate \< 15 mL/mn
* Complicated diabetes mellitus (glomerular filtration rate \< 60ml/mn and/or proteinuria\> 300 mg and/or retinopathy)

Primary outcomes:
measure: Cerebral small vessel disease
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile de France
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Antoine MOULIGNIER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05544474: Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus
Official title: Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colon Cancer
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 100
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: Expert surgeon on radical right colectomy

Brief summary: A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy


Eligibility criteria: Inclusion Criteria:

* Experts in the fields of radical right colectomy

Exclusion Criteria:

* Panelists who were not able to commit to all rounds of the modified Delphi process

Primary outcomes:
measure: Degree of consensus
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References:
Clinical trial NCT00257374: Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenteritis
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2005-11-22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Pedialyte and Gatorade are advocated for the treatment of dehydration in viral gastroenteritis, but there is limited evidence to support their use.

Objective: To examine the efficacy, safety and palatability of Pedialyte, Gatorade, and a New Oral Rehydration Solution (NS).

Design: Randomized double blind. Setting: Inpatient, community hospital. Patients/Interventions: 75 consecutive adult patients (m/f=44/33) admitted with viral gastroenteritis were randomized to receive Gatorade, Pedialyte or NS for 48 hours. A yogurt/rice diet was allowed ad libitum.

Measurements: Stool and urine output, electrolytes, fluid intake, body weight, hematocrit and palatability of solutions.

Limitations: Smaller sample size and higher drop out (20%).


Eligibility criteria: Inclusion Criteria:

* Subjects were included if they had mild-to-moderate diarrhea, with mildly sunken eyes and a clinical assessment of dehydration of less than 5%, a serum sodium concentration between 130-150 mEq/L, adequate general health and nutrition, a BUN/creatinine ratio of \>20 and with a normal pulse rate for age and degree of fever and adequate skin turgor

Exclusion Criteria:

* Patients were excluded if they had hyperthermia (\>39.0º C), serum sodium \>150 mEq/L or \<130 mEq/L, white cell count \>15,000, bloody diarrhea (dysentery), abnormal cardiovascular or renal function or an underlying metabolic or nutritional disorder and most importantly, if the clinical assessment of dehydration was \>7% that suggested a need for intravenous fluids.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dept. of Gastroenterology & Infectious Disease, Osmania Medical College
Study officials:
affiliation: University of Iowa
name: Satish SC Rao, MD,PhD, FRCP(LON)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05918874: Postnatal Nutrition and Physical Activity in Obese Asthmatic Children
Official title: Evaluation of Postnatal Nutritional Status and Physical Activity Level in Obese Asthmatic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Asthma in Children
Keywords: Childhood asthma
Obesity
Physical activity
Postnatal nutrition
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteer children between the ages of 8-17 years with a diagnosis of asthma admitted to the Department of Pediatrics.

Brief summary: The aim of this study was to compare the duration of breast milk intake, vitamin D intake, asthma control level and physical activity levels between obese asthmatic children and non-obese children. This was a prospective study in children aged 8-17 years with asthma. Asthma control level was evaluated by asthma control test and physical activity level was evaluated by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.

Detailed description: Asthma and obesity, which are important public health problems and are common in childhood, are chronic diseases. The aim of this study was to compare breastfeeding duration, vitamin D intake, asthma control and physical activity levels between obese asthmatic children and non-obese children.

The study was a prospective study conducted in children aged 8-17 years with asthma. Demographic information of the children was recorded. Asthma control level was assessed by asthma control test and physical activity level was assessed by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.

It was conducted as a single-blind, prospective study in which the patients were randomized by simple randomization method as obese asthmatic children (experimental group) and non-obese asthmatic children (control group) according to the order of admission to the hospital.

Eligibility criteria: Inclusion Criteria:

* diagnosed with asthma by a pediatrician,
* not in the attack process,
* no mental problems,
* do not have any systemic disease accompanying asthma (diabetes, etc.)
* children who voluntarily agreed to participate in the study

Exclusion Criteria:

* severe posture disorders
* idiopathic scoliosis and idiopathic rheumatic disease
* history of orthopedic surgery
* children with mental retardation or a neurological problem

Primary outcomes:
measure: Body Mass Index
timeFrame: 4 months
measure: Sedentary time spent by children
timeFrame: 4 months
measure: Physical activity levels of children
timeFrame: 4 months
Secondary outcomes:
measure: Asthma control level
timeFrame: 4 months
measure: Demographic information questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege university faculty of health sciences
state: Karsıyaka
Study officials:
References:
Clinical trial NCT00275574: Acupuncture for Non-cyclical Breast Pain
Official title: Acupuncture for the Treatment of Non-Cyclical Breast Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast pain can go untreated due to its various etiologies and non-specific presentation. Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a release of endorphins and other chemicals in the central nervous system. Thus, it is thought to help relieve pain. To date, there has been minimal research using acupuncture for breast pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over a period of two weeks will significantly lower the level of pain experienced by these participants. Additionally, we will evaluate quality of life measures.


Eligibility criteria: * Female
* greater than 18 years
* non-cyclical unilateral or bilateral breast pain occurring daily, Greater than or equal to 2 on the BPI (average pain question)
* pain for more than 3 months
* satisfactory (non-suspicious for malignancy) breast examination within one year of enrollment (need documentation from physician or advanced practice nurse)
* satisfactory (non-suspicious for malignancy) mammogram and/or ultrasound within one year if Greater than 35 years(need written report to verify)
* able to return for acupuncture two times a week for two weeks
* speak and understand English
* hormone replacement therapy discontinued \> 3 months

Primary outcomes:
measure: Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lori A. Thicke, R.N., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423474: Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time
Official title: Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Radiotherapy
Hypofractionation
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: British Columbia Cancer Agency
First posted: 2011-08-26
Enrollment: 152
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Low or intermediate risk prostate cancer patients as defined by:

  * Clinical stage T1-2b, Gleason Score \<=7, and PSA \<=20 ng/mL
* Age \>= 18 years

Exclusion Criteria:

* Androgen deprivation therapy (LHRH-agonists or antiandrogens) \>6 months
* Prior pelvic radiotherapy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Large prostate (\>90cm3) on imaging
* Immunosuppressive medications
* Inflammatory bowel disease

Primary outcomes:
measure: Bowel related quality-of-life
timeFrame: 3 months
Secondary outcomes:
measure: Gastrointestinal toxicity
timeFrame: During radiotherapy, at 3 and 6 months, then every 6 months after
measure: Genitourinary toxicity
timeFrame: During radiotherapy, at 3 and 6 months, then every 6 months after
measure: PSA relapse rate
timeFrame: 3 and 5 years
measure: Patient Overall Quality of life
timeFrame: During radiotherapy, at 3 and 6 months, then every 6 months after
measure: Salvage androgen deprivation therapy rate
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: BC Cancer Agency - Abbotsford Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: CancerCare Manitoba
name: Aldrich Ong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Andrew Loblaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quon HC, Ong A, Cheung P, Chu W, Chung HT, Vesprini D, Chowdhury A, Panjwani D, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Loblaw A. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial. Radiother Oncol. 2018 May;127(2):206-212. doi: 10.1016/j.radonc.2018.02.029. Epub 2018 Mar 15.
Clinical trial NCT01034774: Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Lung Penetration of Intravenous (IV) ACHN-490 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Human volunteers
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 40
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: TREATMENT

Brief summary: Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Men or Women
* Within normal weight limits
* In good health with normal routine laboratory results
* Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noises

Exclusion Criteria:

* No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
* No problems with hearing or balance
* No previous injury or surgery to the ears
* No family history of hearing loss before the age of 65
* Not taking any medications other than birth control medication
* Smokers or use of tobacco products
* Recent blood donors
* No excessive alcohol intake or illegal substances
* No allergy to aminoglycosides (a type of antibiotic)

Primary outcomes:
measure: Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days
timeFrame: Throughout the study
Secondary outcomes:
measure: Lung penetration as estimated from ACHN-490 measured in ELF
timeFrame: 1 Day
measure: Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing
timeFrame: Through 24 hours after the last dose
Other outcomes:
Locations:
Study officials:
affiliation: Achaogen, Inc.
name: Nancy A Havrilla, MS, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT05833282: Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU
Official title: Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Resistance, Multiple, Bacterial
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU with EBLSE bacteremia

Brief summary: Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.

Detailed description: INCLUSION CRITERIA - Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

PRIMARY ENDPOINT

- The primary endpoint is 30-day mortality.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

Exclusion Criteria:

* Patient who is a minor, protected adult, or who refuses to participate.

Primary outcomes:
measure: The primary endpoint is all-cause 30-day mortality.
timeFrame: 30-day mortality
Secondary outcomes:
measure: Adequacy of initial antibiotic therapy to french recommendations
timeFrame: adequate within 30 days
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: Centre Hospitalier DRON
Study officials:
References: