louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01009944: Genetic Mechanisms in Human Hypertension Renin-angiotensin-aldosterone System (RAAS) Inhibition Study
Official title: Genetic Mechanisms in Human Hypertension RAAS Inhibition Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: High blood pressure
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2009-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. The investigators will give individuals one of two medications to treat hypertension (lisinopril or atenolol). The investigators believe that depending on the individuals genetic background one medication will work better in lowering their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Male and female hypertensive participants who were previously studied in SCOR program.

Exclusion Criteria:

* Diabetes
* Taking other medications beside thyroid or estrogen supplements.

Primary outcomes:
measure: One type of blood pressure medication will better treat individuals with certain genetic backgrounds.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Gordon H. Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875444: Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT
Official title: Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with non-opered abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012

Brief summary: Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.

The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.

The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.

Detailed description: The aims of the study were :

Analyze the consequences on clinical decisions of this wide choice of methodologies for measurement of abdominal aortic aneurysm maximum diameter when using angio-CT; Identify the method of measurement that yields the best agreement for patient management.

Eligibility criteria: Inclusion Criteria:

* patients with abdominal aortic aneurysm

Exclusion Criteria:

* inflammatory aneurysm
* false aneurysm
* aneurysm after open repair or stent graft

Primary outcomes:
measure: Maximum diameter of abdominal aortic aneurysm
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT03373344: Remediation of Emotional Processing Deficits in MS
Official title: Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: emotional processing
multiple sclerosis
cognition
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 39
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: This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial. We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS as well

Detailed description: This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.

All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18-65.
* diagnosis of Relapsing-Remitting Multiple Sclerosis.
* can read and speak English fluently.

Exclusion Criteria:

* history of prior stroke or other neurological disease or injury.
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder.
* significant alcohol or drug abuse history.

Primary outcomes:
measure: Emotional Processing
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary outcomes:
measure: Emotional Function
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
measure: Self report of Quality of Life
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Research Scientist
name: Helen Genova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05163444: Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
Official title: Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiplegic Gait
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Clinical trial, randomized, crossover
Primary purpose: OTHER

Brief summary: After stroke, a lot of patients present an hemiparesis and gait disorders. They need walking aids like quadripod cane or rolling cane.

The quadripod cane confers a great stability but implies a walk in 3 times, thus consume more energy. The pause time necessary for the displacement (uplift) of the cane disappear with the Wheeleo.

The investigators will study many spatio-temporal parameters to determine which one allows to decrease the walking speed.

Detailed description: Hemiparesis affects 65% of stroke patients and cause gait disorders. During rehabilitation, patients often need technical aids to the the return to walk.

For example, they can use the quadripod cane and the rolling cane, called Wheeleo. Regarding the first one, as its name indicate, there are 4 feet while the other model has 4 wheels.

Deltombe and al. proved that the walking speed is higher with a rolling cane. The investigators will recruited stroke patients and study many spatio-temporal parameters with a gait analysis system, when participants are walking with the two walking aids.

Participants will achieve 6 minutes walking test and a 10 meters walking test, with a wearable inertial systems on their shoes.

The investigators wish to reveal which spatio-temporal parameters most influence walking speed.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Hemiparesis following a stroke
* Be able to walk with a quadripod cane independently
* Be able to walk with the rolling cane independently
* Be able to follow instructions

Exclusion Criteria:

* cognitive impairment
* acute orthopedic impairment
* other pathologies affecting walking (Parkinson's disease, severe polyneuropathy,...)

Primary outcomes:
measure: 10 meters walking test at fast speed
timeFrame: 2 days
Secondary outcomes:
measure: 6 minutes walking test at spontaneous speed
timeFrame: 2 days
Other outcomes:
Locations:
city: Esneux
country: Belgium
facility: CHUOA
state: Liege
city: Tinlot
country: Belgium
facility: CNRF
state: Liege
Study officials:
affiliation: University of Liege
name: Berengere Maillard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05302544: Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
Official title: Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autistic Spectrum Disorder
Keywords: Autistic spectrum disorder
motor skills
mixed reality training
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with autistic spectrum disorder frequently present impaired motricity, or at least different motricity from neurotypical subjects (walking; postural balance; fine motor skills; motor control, etc.). Motor impairment can have impact on the performance and learning of simple tasks (bathing, dressing, writing, using tools, etc.), especially in children and teenagers.

These last years, new therapeutics such as Virtual, Augmented and Mixed Reality technologies have developed. Their therapeutic interest has been identified in various pathologies like phobia. However, their influence on motor skills has been little studied. The first results obtained with disabled adults described a significant increase in walking speed after a 3-month Mixed Reality training.

Detailed description: The aim of the study is to assess the impact of Mixed Reality training on motor skills of children with autistic spectrum disorder.

Eligibility criteria: Inclusion Criteria:

* aged between 8 and 12 years old
* with autistic spectrum disorder
* male or female
* agreeing to participate in the study

Exclusion Criteria:

* Visually impaired or blind.
* Traumatism and physical injuries
* Epilepsy

Primary outcomes:
measure: change of walking speed
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03352544: Exercise in Severe Mental Illness. The PsychiActive Project
Official title: Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Lead sponsor: Universidad Pablo de Olavide
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 50
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 randomized controlled trial is to study the effects of exercise on body weight, body composition, anthropometric and fasting blood measures, physical fitness, pulmonary function, quality of life, and lifestyle habits in patients with severe mental illness.


Eligibility criteria: Inclusion Criteria:

Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.

Exclusion Criteria:

Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.

Primary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Lean mass
timeFrame: 12 weeks
measure: Waist girth
timeFrame: 12 weeks
measure: Hip girth
timeFrame: 12 weeks
measure: Blood glucose
timeFrame: 12 weeks
measure: Blood cholesterol
timeFrame: 12 weeks
measure: Blood triglyceride
timeFrame: 12 weeks
Secondary outcomes:
measure: Lower body strength
timeFrame: 12 weeks
measure: Upper body strength
timeFrame: 12 weeks
measure: Aerobic endurance
timeFrame: 12 weeks
measure: Lower body flexibility
timeFrame: 12 weeks
measure: Upper body flexibility
timeFrame: 12 weeks
measure: Dynamic balance
timeFrame: 12 weeks
measure: Static balance
timeFrame: 12 weeks
measure: Forced vital capacity
timeFrame: 12 weeks
measure: Health status
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Psychopathological symptoms
timeFrame: 12 weeks
measure: Anxiety symptoms
timeFrame: 12 weeks
measure: Depression symptoms
timeFrame: 12 weeks
measure: Self-Esteem
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Smoking
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad Pablo de Olavide
Study officials:
References:
Clinical trial NCT06429644: Long-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
Official title: Ong-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRCA1/2 Mutation
Breast-conserving Surgery
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Korean Surgical Society
name: Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group
First posted: 2024-05-28
Enrollment: 4010
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ON-BRCAII is multi-institution cohort study being conducted by the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Patients with primary breast cancer who underwent BCS or mastectomy and received a BRCA1/2 mutation test between January 2008 and December 2015 were retrospectively identified from 13 institutions in South Korea. The inclusion criteria comprised patients aged 20 to 80 years with invasive breast cancer (pT1-3, N0-3). The exclusion criteria consisted of patients with de novo metastasis and those with pregnancy-associated breast cancer.

Brief summary: The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients in breast cancer patients with BRCA 1/2 mutations.

Detailed description: The purpose of study is to assess the oncologic safety of BCS in patients carrying BRCA1/2 mutations by comparing long-term outcomes with mastectomy. The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients. By providing insights into the feasibility of BCS for patients with BRCA1/2 mutations, the investigators aim to present evidence to aid in surgical decision-making for the care of these patients.

Eligibility criteria: Inclusion Criteria:

* Primary invasive breast cancer who underwent BCS or mastectomy
* Received a BRCA1/2 mutation test

Exclusion Criteria:

* Patients with de novo metastasis
* Pregnancy-associated breast cancer

Primary outcomes:
measure: Locoregional recurrence-free survival
timeFrame: Duration from diagnosis until the development of recurrence up to 10year
measure: Distant recurrence-free survival
timeFrame: Duration from diagnosis until the development of recurrence up to 10year
measure: Recurrence-free survival
timeFrame: Duration from diagnosis until the development of recurrence up to 10year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang university hospital
Study officials:
References:
Clinical trial NCT00306644: Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Official title: Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone
Type 2 diabetes
intima media thickness
Insulin resistance
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 556
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.

Detailed description: RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus

Eligibility criteria: Inclusion criteria:

* insulin resistant syndrome or Type 2 Diabetes.

Exclusion criteria:

* Use of \>= 2 concomitant oral antihyperglycaemic agents within 3 months of study start.
* Initiation of anti-hypertensive or lipid lowering therapy \<= 6 months prior to study start or who increased the dose 3 months prior to study start.
* Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months.
* Any history of surgical intervention in the right carotid artery.
* Clinically significant hepatic disease.
* Creatinine clearance \<40ml/min.

Primary outcomes:
measure: Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
timeFrame: 52 weeks
Secondary outcomes:
measure: Plaque occurrence & stenosis within the right carotid artery.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. J Intern Med. 2007 Mar;261(3):293-305. doi: 10.1111/j.1365-2796.2007.01767.x.
Clinical trial NCT02924844: Impact of the Implementation of a Clinical Pharmacy Bundle on Intensive Care Unit Patient Outcomes and Cost Expenditures
Official title: Impact of the Implementation of a Clinical Pharmacy Bundle on Intensive Care Unit Patient Outcomes and Cost Expenditures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 2787
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The two study populations are composed of all patients present in the ICU on weekdays.

The first population is composed of patients present between January 2013 and December 2013.

The second population is composed of patients present between January 2014 and June 2015.

Brief summary: The aim of this before-after study was to assess the impact of a clinical pharmacy bundle of care activities on patient outcomes (length of hospital stay as a primary endpoint) and cost expenditure in two French ICUs.


Eligibility criteria: Inclusion Criteria:

* Intensive Care Unit patients on weekdays

Primary outcomes:
measure: Length of hospital stay
timeFrame: expected average of 20 days
Secondary outcomes:
measure: Intensive Care Unit length of stay
timeFrame: Expected maximum of 10 days
measure: Mechanical ventilation duration
timeFrame: Expected maximum of 10 days
measure: Intensive care unit mortality rate
timeFrame: Expected maximum of 10 days
measure: Hospital mortality rate
timeFrame: End of hospital stay (expected average of 20 days)
measure: Patient cost expenditure
timeFrame: End of hospital stay (expected average of 20 days)
Other outcomes:
measure: The rate of isolation of multidrug resistant organisms
timeFrame: End of hospital stay (expected average of 20 days)
Locations:
Study officials:
References:
Clinical trial NCT06618144: Conversational Artificial Intelligence (AI) to Improve PeRiconception Care Access
Official title: Conversational AI to Improve PeRiconception Care Access
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Early Pregnancy Loss
Early Pregnancy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Memora Health Inc
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-10-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project, Conversational Artificial Intelligence (AI) to Improve PeRiconception Care Access (CIRCA), is to engage patients in care early in pregnancy (before prenatal care starts) and safely triage concerns to PEACE to reduce unnecessary emergency department visits.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* Seeking to establish care at the Hospital of the University of Pennsylvania OR seeking care in the Emergency Department or Perinatal Evaluation Center.

Primary outcomes:
measure: Time to initiating care (days)
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
References: