louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03605017: The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
Official title: The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: cognitive rehabilitation
attention
executive function
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2018-07-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (TBI). The study is designed to evaluate how well this technique can help people with TBI increase their attention and ability to function better in everyday life.

Detailed description: A pilot study will be conducted to evaluate the effectiveness of a technique designed to improve higher level attention (switching between tasks and multi-tasking) for persons with a traumatic brain injury. 32 individuals with TBI will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Participants are random assigned to either the experimental or control groups. Experimental and control treatments include two 60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on several objective and functional measures of divided attention and set-shifting.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18-65
* diagnosis of TBI
* can read and speak English fluently

Exclusion Criteria:

* prior stroke or neurological disease other than TBI
* unstable or uncontrolled seizures
* currently taking benzodiazepines

Primary outcomes:
measure: Total divided attention post-treatment (covarying for baseline performance)
timeFrame: 7 weeks (between pre- and post-testing)
measure: Total set-shifting post-treatment (covarying for baseline performance)
timeFrame: 7 weeks (between pre- and post-testing)
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT03151317: Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV
Official title: Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home Continuous Positive Airway Pressure or At-home Non-invasive Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Positive Airway Pressure
Noninvasive Ventilation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Association pour l'Assistance et la Réhabilitation à Domicile (APARD)
First posted: 2017-05-12
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is composed of patients that have been equipped by the Association for Home Assistance and Rehabilitation (APARD) with either a continuous positive airway pressure (CPAP) device or a non-invasive ventilation (NIV) device.

Brief summary: The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.

Detailed description: The proposed study calendar refers to the beginning and completion of work on the APARD database.

Eligibility criteria: Inclusion Criteria:

* Patients that have been equipped by the Association for Home Assistance and Rehabilitation (APARD) with either a continuous positive airway pressure (CPAP) device or a non-invasive ventilation (NIV) device.

Exclusion Criteria:

-

Primary outcomes:
measure: Treatment adherence
timeFrame: a period of 28 days (retrospective study)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Apard Database
Study officials:
affiliation: University Hospitals of Montpellier
name: Nicolas Molinari, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01643317: Screening Cardiovascular Patients for Aortic Aneurysms
Official title: Screening Cardiovascular Patients for Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 35
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease or carotid arterial disease

Brief summary: Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown a significant reduction in AAA related mortality. In addition, the cost-effectiveness of screening for AAA in men in the Netherlands has been demonstrated by using a Markov model. Screening might be even more (cost-) effective if targeted on high risk groups, such as patients with a particular cardiovascular disease with a known increased risk of having an AAA.

Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm that eventually may rupture. This pilot project aims to study the value of a screening protocol in daily practice to detect AAA's in high risk patients.

Detailed description: 1. Offering PAD and CAD patients a non-invasive abdominal ultrasound after a careful process of shared-decision making
2. Recording data on aneurysm detection on all PAD and CAD patients screened:

   1. General information (age, gender)
   2. Medical history on CardioVascular risk factors (such as smoking history, hypertension, and other cardiovascular medical conditions - only information that is already recorded in the patient's medical history chart)
   3. AAA - Yes/ No (Yes if ≥3 cm AAA)
   4. If ≥3 cm aneurysm, record exact size and outcome in time (surveillance, treatment, no treatment)
   5. If treated, record treatment type (EVAR or Open) and outcome

Eligibility criteria: Inclusion Criteria:

* male and female patients
* peripheral arterial disease (ankle brachial index \< 0,90 and/or reduction of \> 0.15 after exercise test) or a carotid stenosis (stenosis ≥ 50%)
* age \> 55 year

Exclusion Criteria:

* Patients unfit for endovascular or open surgery (as judged by vascular surgeon)
* Failure to master the dutch language

Primary outcomes:
measure: AAA prevalence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
References:
Clinical trial NCT00005117: Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Keywords: endothelial dysfunction
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-04-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. It has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. Blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. This primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. Secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.


Eligibility criteria: Inclusion Criteria:

* No history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: 4200 E. 9th Avenue, Box B133
state: Colorado
Study officials:
References:
Clinical trial NCT03231917: Water Immersion and Polyp Detection: A Randomized Controlled Trial
Official title: Water Immersion and Polyp Detection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Colonic Neoplasms
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Indiana University
First posted: 2017-07-27
Enrollment: 121
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one
Primary purpose: SCREENING

Brief summary: We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one


Eligibility criteria: Inclusion Criteria:

* all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University

Exclusion Criteria:

* includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.

Primary outcomes:
measure: Adenoma Miss Rate
timeFrame: Through procedure, an average of 1 hr
Secondary outcomes:
measure: Patient-level Miss Rate
timeFrame: 1 hour or the duration of the procedure
measure: Adenoma < 6mm Detection Rate
timeFrame: 1 hour or the duration of the procedure
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References:
citation: Anderson JC, Kahi CJ, Sullivan A, MacPhail M, Garcia J, Rex DK. Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach. Gastrointest Endosc. 2019 Mar;89(3):591-598. doi: 10.1016/j.gie.2018.09.046. Epub 2018 Oct 24.
Clinical trial NCT01083017: Resistant Arterial Hypertension Cohort Study
Official title: Interventional Prospective Cohort Study, Multi-center With Nested Case-control Studies (Family-based and Non-family Based) on Individuals With Resistant Arterial Hypertension.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Essential Hypertension
Resistant Hypertension
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 74
Sex: ALL
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: patients addressed to a speciality consultation at Geneva University Hospital

Brief summary: The purpose of this study is to investigate the epidemiology of resistant hypertension, evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the randomization of two doses of the diuretic used - chlorthalidone), study two interventions in the group of patients that is non-compliant, and study environmental and genetic variables of individuals with resistant hypertension in a family design.


Eligibility criteria: Inclusion Criteria:

* informed consent
* resistant hypertension at the moment of inclusion
* 18 years or more, both sexes are included
* women at reproductive age: consenting to use oral contraception

Exclusion Criteria:

* patients mentally impaired or unable to give informed consent
* patients speaking only a foreign language other than French, German, or English
* patients living far away, making the study visits not practical

Primary outcomes:
measure: blood pressure control
timeFrame: at 12 weeks after initiation of standard treatment
Secondary outcomes:
measure: cardiovascular morbidity and mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital, CHUV
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Geneva University Hospitals, Switzerland
name: Antoinette PECHERE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geneva University Hospitals, Switzerland
name: Georg B EHRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908817: Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
Official title: Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: postoperative sore throat
tracheal intubation
lubrication
triamcinolone
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2009-05-27
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.

Detailed description: Sore throat is a common postoperative complaint after tracheal intubation. When the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II, aged between 20 and 70 years
* scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation

Exclusion Criteria:

* recent respiratory tract infection or sore throat
* who were using analgesics or steroid preoperatively
* who have risk factors for oral cavity infection
* the surgical duration \< 60 minutes or \> 300 minutes

Primary outcomes:
measure: the incidence of postoperative sore throat
timeFrame: postoperative day 1
Secondary outcomes:
measure: the severity of postoperative sore throat
timeFrame: postoperative day 1
Other outcomes:
Locations:
city: 1174 Jung-Dong, Wonmi-Gu, Bucheon-Si
country: Korea, Republic of
facility: Soonchunhyang University, College of medicine Bucheon Hospital
state: Gyeonggi-Do
Study officials:
References:
citation: Park SY, Kim SH, Lee SJ, Chae WS, Jin HC, Lee JS, Kim SI, Hwang KH. Application of triamcinolone acetonide paste to the endotracheal tube reduces postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 May;58(5):436-42. doi: 10.1007/s12630-011-9478-6. Epub 2011 Feb 26.
Clinical trial NCT02565017: Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System
Official title: Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lung Cancer
Colorectal Cancer
Keywords: IBM Watson
Clinical Decision Support System
Patient Preferences
15-226
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 70
Sex: ALL
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: MSKCC clinics

Brief summary: The purpose of this study is to learn what cancer patients think about IBM Watson Oncology. IBM Watson Oncology is a computer program designed to help inform oncologists about the best chemotherapy choices for their patients. The investigators will conduct focus groups with cancer patients who have received chemotherapy treatment at MSK in order to understand cancer patients' thoughts about IBM Watson Oncology.


Eligibility criteria: Inclusion Criteria:

* MSKCC patient 18 years or older
* Breast, lung, or colorectal cancer MSK patient as per EMR or clinician judgment having either:

  * Chemotherapeutic adjuvant or neoadjuvant treatment with the first chemo visit occurring within the past 8 months and primary treatment (i.e., surgery), occurring within the past 6 months)at MSK
  * OR chemotherapeutic treatment for metastatic disease with the first chemo visit occurring within the past 8 months at MSK
  * OR chemotherapeutic treatment through an on-going MSK clinical trial as per clinician
* Residing in New York metro-area

Exclusion Criteria:

* Non-English speakers because we do not have the resources to conduct and translate the focus groups into other languages
* Patients who are not or will not receive their cancer care at MSKCC.
* Patient unwilling or unable to provide informed consent

Primary outcomes:
measure: Acceptability of IBM Watson Oncology
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jada Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04082117: Uptake of Genetic Counseling Among African American Women
Official title: Creating a Culturally-Tailored Intervention to Improve Uptake of Genetic Counseling Among Underserved African American Women With Increased Breast Cancer Risk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Risk
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 960
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Educational genetic counseling video
Primary purpose: OTHER

Brief summary: A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center

Detailed description: African American (AA) women with a family history of breast cancer who are eligible for genetic counseling and express an interest in participating in the study will be consented and complete a brief survey before and after viewing an educational video on genetic counseling. Survey questions will be read to each participant. The questions capture data on the following constructs regarding genetic counseling: knowledge, attitudes, normative beliefs, motivation, perceived social norms, intention, efficacy beliefs, skills, environmental constraints and opinions on the video. The research team will conduct a review of the UI Health Electronic Medical Record (EMR) 3-6 months after study enrollment to determine if the participant attended a genetic counseling session.

Eligibility criteria: Inclusion Criteria:

* African American female age 25-69 years
* Presenting for mammogram at UI Health mammography clinic
* No prior history of breast cancer
* Completed cancer genetic risk assessment (CGRA) in UI Health mammography center
* Recommended for genetic counseling based on CGRA performed at the time of the mammogram.

Exclusion Criteria:

* Unable to complete the informed consent and survey in English
* Previously had genetic counseling for hereditary breast cancer risk
* Prisoners

Primary outcomes:
measure: Knowledge and intentions regarding genetic counseling
timeFrame: 1 hour
Secondary outcomes:
measure: Attendance at genetic counseling appointment
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Health System
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Kent Hoskins, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henderson V, Madrigal JM, Kendall LC, Parekh P, Newsome J, Chukwudozie IB, Comer-Hagans L, Coffey V, Grumbach G, Spencer S, Rodgers C, Kaur R, Balay L, Maga T, Ramamonjiarivelo Z, Balthazar C, Winn R, Watson K, Odoms-Young A, Hoskins KF. Pilot study of a culturally sensitive intervention to promote genetic counseling for breast cancer risk. BMC Health Serv Res. 2022 Jun 25;22(1):826. doi: 10.1186/s12913-022-08193-x.