louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00385034: Computer-assisted Screening for Intimate Partner Violence in Family Practice
Official title: Computer-assisted Screening for Intimate Partner Violence in Family Practice - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening for Partner Violence
Keywords: randomized controlled trial
RCT
partner violence
IPV
screening
family practice
computer
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-10-06
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study tested the effectiveness of computer-assisted screening for identifying patients at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized that the use of computer-assisted screening among female patients would lead to higher rates of IPV discussion-opportunity and IPV detection during medical consultations, compared to patients receiving standard medical care.


Eligibility criteria: Inclusion Criteria:

* woman
* at least 18 years of age
* visiting one of the participant physicians
* in a current or recent intimate relationship during the last 12 months
* having the ability to speak and read English and give consent

Exclusion Criteria:

* visiting a provider other than the regular family physician
* new patient
* previously approached for the study
* very sick
* had a dual appointment (herself and accompanied dependent)

Primary outcomes:
measure: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data)
measure: Detection of partner abuse during physician-patient medical encounter (audio taped data)
Secondary outcomes:
measure: Patient acceptance of the computer-assisted screening(paper-pencil exit survey)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital and University of Toronto
name: Wendy Levinson, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital and University of Toronto
name: Farah Ahmad, PhD(student)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad F, Skinner HA, Stewart DE, Levinson W. Perspectives of family physicians on computer-assisted health-risk assessments. J Med Internet Res. 2010 May 7;12(2):e12. doi: 10.2196/jmir.1260.
citation: Ahmad F, Hogg-Johnson S, Stewart DE, Skinner HA, Glazier RH, Levinson W. Computer-assisted screening for intimate partner violence and control: a randomized trial. Ann Intern Med. 2009 Jul 21;151(2):93-102. doi: 10.7326/0003-4819-151-2-200907210-00124. Epub 2009 Jun 1.
Clinical trial NCT06073834: LUNG INFECTION in ICU (LUNG-I3)
Official title: LUNG INFECTION in ICU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: VAP - Ventilator Associated Pneumonia
Keywords: VAP - Ventilator Associated Pneumonia
Sepsis
Lung Infection
Broncho-alveolar Lavage
ICU
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 68
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: ICU Adult patients hospitalized and managed for septic shock or severe trauma (including severe burn) and undergoing mechanical ventilation (within 24h of admission) with an expected length upper than 3 days.

Brief summary: objective of LUNG-I3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (BAL) fluid after an infection, with a special focus on alveolar macrophages and neutrophils


Eligibility criteria: Inclusion Criteria:

All the following criteria

* Age 18 years or greater
* Severe ICU patients hospitalized for one of the above diseases:

  * Septic shock (requirement of vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia) caused either by pneumonia (n=20) or another source n=20)
  * Severe trauma (level I and II), Injury Severity Score ≥ 25 OR
  * Burn with TBSA over 20%
* NAD \> 0.1 µg/kg/min
* At least 2 SOFA criteria ≥ 2 points

Exclusion Criteria:

* Aspiration pneumonia
* Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this includes in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1121-8 of the French Public Health Code.)
* COPD
* Smoke inhalation in burn patients
* Participation in an intervention study
* Pregnant or breastfeeding women
* Immunocompromised patients, defined as

  * patients with solid tumors with chemotherapy in the last 3 months or a progressive metastatic disease
  * hematologic malignancies
  * solid organ transplantation
  * HIV infection with or without AIDS
  * treatment with corticosteroids (\> 3 months at any dosage or ≥ 1 mg/kg prednisone equivalent per day for \> 7 day)
  * treatment with other immunosuppressive drugs.

Primary outcomes:
measure: immune cells patterns in VAP
timeFrame: before and at time of VAP diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
Study officials:
References:
Clinical trial NCT01960634: Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma
Official title: Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage IV Skin Melanoma
Lead sponsor: Grupo Español Multidisciplinar de Melanoma
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed melanoma and BRAF V600 mutation

Brief summary: This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.

Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.

The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of melanoma and BRAFV600
* Signed Informed Consent Form
* Unresectable phase III or phase IV melanoma
* The patients should be starting a treatment for melanoma (either first line or subsequent lines)

Primary outcomes:
measure: Rate of patient in which BRAF V600 in blood samples is present/absent
timeFrame: two years
Secondary outcomes:
measure: Rate of patients with BRAFV600 present in tumor sample vs blood sample
timeFrame: two years
Other outcomes:
measure: BRAF V600 blood levels and illness evolution
timeFrame: two years
measure: NRAS and p61BRAFFV600 serum levels and clinic evolution
timeFrame: two years
measure: BRAFV600 blood levels vs progression-free survival
timeFrame: two years
Locations:
city: Madrid
country: Spain
facility: Hospital Infanta Cristina
state: Badajoz
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria
state: Las Palmas
city: Marbella
country: Spain
facility: Hospital Costa del SOl
state: Málaga
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Quirón Dexeus
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitario Quirón Dexeus
name: María González Cao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01909817: A Novel Method for Enhancement of Standard Rest Electrocardiograms (ECG) Provides New Parameters for Early Detection of Coronary Artery Disease (CAD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine coronary angiogram

Brief summary: The investigators aim to determine whether a new method of enhancing and improving ECG acquisition, analysis and display is effective. The investigators will perform superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal alignment to the peak R wave and voltage alignment to an improved baseline at the T-P segment.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine coronary angiogram

Exclusion Criteria:

* Patients with significant irregular heart rhythm
* Patients with heart failure

Primary outcomes:
measure: ECG Voltage spread
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00691717: Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Open-angle Glaucoma
Oular Hypertension
Keywords: Anecortave acetate
Open-angle glaucoma
IOP
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 201
Sex: ALL
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 was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patients with any form of glaucoma other than open-angle.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure at 8 am
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)
timeFrame: Month 3, 8 am
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston
state: South Carolina
Study officials:
References:
Clinical trial NCT03975517: Sexual Risks in Prep Users
Official title: Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Prep Prescription
Vaccinations
Sexually Transmitted Diseases
Keywords: Prep
Sexual behavior
HIV
Syphilis
Chlamydia infection
Hepatitis
Gonococcus
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non HIV-infected subjects, who have a high risk to be infected by HIV, mostly because of non protected sexual intercourse.

Most of them are MSM (men who have sex with men). And who started Prep (emtricitable/tenofovir disoproxil fumarate), or will initiate Prep

Brief summary: Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.

Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.


Eligibility criteria: Inclusion Criteria:

* non HIV-infected subjects
* men aged 18 years or older
* having non protected sexual relationship
* taking Prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand
* affiliated to social security

Exclusion criteria:

* HIV-infected patients
* refusal of study participation
* not on Prep
* not fluent in French language
* safeguarding justice
* on guardianship or trusteeship

Primary outcomes:
measure: Analysis of sexual behavior in Prep users
timeFrame: 6 months
Secondary outcomes:
measure: Description of the medical profile of the Strasbourgeoise active file
timeFrame: 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: David REY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663517: Gestational Age Specific Thyroid Function Reference Range
Official title: Gestational Age Specific Thyroid Function Reference Range in Hong Kong
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid
Reference Values
Pregnancy
Keywords: Thyroid
Reference values
Pregnancy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 599
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hong Kong women

Brief summary: It has been well accepted that maternal thyroid dysfunction has adverse affects on both mothers and fetuses. However, the dramatical changes during pregnancy make the interpretation of thyroid function test (TFT, i.e. free triiodothyronine \[FT3\], free thyroxine \[FT4\] and thyrotropin \[TSH\]) very difficult. Previous studies have shown that the level of thyroid hormones differs from non-pregnant population and varies from gestational ages. Moreover, studies have shown the agreement among different instrument platforms was quite low. This study is aimed to determine gestational age specific TFT reference ranges of the local pregnant population for all available platforms currently used under Hospital Authority and Department of Health.


Eligibility criteria: Inclusion Criteria:

* Pregnant women receiving pregnancy and postnatal care in the Department of Obstetrics \& Gynaecology, Prince of Wales Hospital, Hong Kong

Exclusion Criteria:

* 1. Previous history of thyroid dysfunction (hypothyroidism or hyperthyroidism);
* 2. Autoimmune disease, particularly those receiving corticosteroid or immunosuppressant: e.g. systemic lupus erythematosus;
* 3. Disease associated with thyroid dysfunction: e.g. molar pregnancy

Primary outcomes:
measure: Change of free triiodothyronine (FT3) during pregnancy
timeFrame: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.
measure: Change of free thyroxine (FT4) during pregnancy
timeFrame: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.
measure: Change of thyrotropin (TSH) during pregnancy
timeFrame: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Wing Hung Tam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821417: Performance of MicroTextured Dental Implants
Official title: A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Jaw
Keywords: dental implants
screw-vent dental implants
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Zimmer Dental
First posted: 2013-04-01
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.

The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.

Detailed description: Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.

Eligibility criteria: Inclusion Criteria:

1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient
2. Existence of one or more missing teeth scheduled to be replaced with dental implants
3. Healthy enough to undergo proposed therapy without compromising existing health
4. Able to consent for their own inclusion
5. Able to read and understand the informed consent form
6. Demonstrated willingness to comply with protocol requirements and timeline

Exclusion Criteria:

1. Any health condition that in the opinion of the investigators may adversely affect bone healing
2. Any medication that in the opinion of the investigators may adversely affect bone healing
3. Any indication of an inability to make autonomous decisions
4. Reported pregnancy at the time of enrollment -

Primary outcomes:
measure: Change in Millimeters of Bone Loss Surrounding the Implant Device
timeFrame: Implant insertion, 12 months post-insertion
Secondary outcomes:
measure: Changes in Peri-implant Gingivitis Score
timeFrame: 1 year after placement
measure: Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
timeFrame: 1 year after placement
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Nicolaas C. Geurs, DDS.MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04581317: Connecting Seniors to Care
Official title: Connecting Seniors to Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: nutrition
virtual assistant device
frailty
social determinants of health
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: U.S. Administration for Community Living
First posted: 2020-10-09
Enrollment: 53
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of implementing the virtual assistant devices into the daily routine of participants and their caregivers,to measure social determinants of health,depression,cognitive impairment,nutritional and functional status in the cognitively impaired participants


Eligibility criteria: Inclusion Criteria:

* cognitive impairment as reported in the Mental Health Screening/Assessment section on the Interfaith Ministries of Greater Houston's Meals on Wheels Program (IMGH MOW) intake form
* are on the IMGH MOW waiting list
* medically stable

Exclusion Criteria:

* do not have cognitive impairment
* have a pre-diagnosed terminal illness
* unable to ambulate, and/or are unable to use their upper extremities.

Primary outcomes:
measure: Feasibility as measured by the technology acceptance measure (TAM)
timeFrame: 12 weeks from baseline
measure: Feasibility as measured by the technology acceptance measure (TAM)
timeFrame: 18 weeks from baseline
Secondary outcomes:
measure: Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)
timeFrame: Baseline,18 weeks
measure: Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline,18 weeks
measure: Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline,18 weeks
measure: Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)
timeFrame: Baseline,18 weeks
measure: Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)
timeFrame: Baseline,18 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jessica Lee
role: PRINCIPAL_INVESTIGATOR
References: