louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00580437: Pre-operative Evaluation of Kidney & Pancreas Transplant Patients
Official title: The Analysis of Data Collected During Angiography and Dobutamine Stress Contrast Echocardiograms in the Pre-Evaluation of Kidney and Pancreas Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Pancreas Transplantation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained routinely in the evaluation of patients prior to kidney or pancreas transplantation.

Detailed description: Although there is an increasing quantity of data demonstrating the value of stress echo in risk stratifying patients for cardiac risk prior to major non-cardiac surgery, the current clinical practice utilized for assessing patients being evaluated for kidney or pancreas transplantation is both a stress echocardiogram and a coronary angiogram. This gap in opinion appears to be a concern on the part of both nephrologists, endocrinologists, and surgeons that the stress echocardiogram may miss significant angiographic disease that could result in major post-operative complications in this high-risk subgroup of patients (unstable angina, non-fatal infarction, or death).

Eligibility criteria: Inclusion Criteria:

* Patients who are being evaluated for a kidney and or pancreas transplant and scheduled for a dobutamine stress echocardiogram and a coronary angiogram will be eligible to participate

Exclusion Criteria:

* Patients with unstable angina at the time of their evaluation, or who have a severe underlying cardiomyopathy or valve disease will be excluded.

Primary outcomes:
measure: Stress echocardiogram diagnostic sensitivity
timeFrame: prior to transplantation
measure: Event-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Abnormal stress myocardial perfusion rate
timeFrame: 3 years
measure: Abnormal stress wall motion rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177437: Home Screening for Chlamydia Surveillance
Official title: Home Screening for Chlamydia Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chlamydia Trachomatis
Gonorrhea
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2005-09-15
Enrollment: 403
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexually transmitted diseases.

Detailed description: This is a phase III randomized controlled trial. We enrolled 403 young women from a variety of clinical settings and neighborhoods in the Pittsburgh, PA region. Women completed a baseline questionnaire and then were randomized to either an intervention group (receive home testing kit every six months) or to a control group (receive a letter suggesting a clinic visit for screening). Participants were followed for 2 years, and medical chart abstraction was done to document tests done in clinical settings. The final study end points were number of tests completed, number of screening tests completed, number of STDs detected, and incident cases of pelvic inflammatory disease.

Eligibility criteria: Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active -

Exclusion Criteria: currently pregnant, homeless

-

Primary outcomes:
measure: chlamydia and gonorrhea tests completed
measure: chlamydia and gonorrhea infections detected
Secondary outcomes:
measure: pelvic inflammatory disease cases detected
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Roberta B Ness, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cook RL, Ostergaard L, Hillier SL, Murray PJ, Chang CC, Comer DM, Ness RB; DAISY study team. Home screening for sexually transmitted diseases in high-risk young women: randomised controlled trial. Sex Transm Infect. 2007 Jul;83(4):286-91. doi: 10.1136/sti.2006.023762. Epub 2007 Feb 14.
Clinical trial NCT01613937: Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus
Official title: Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Latinas
Gestational Diabetes
Prevention
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Objective: The current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes risk in Latinas with a history of gestational diabetes mellitus (GDM).

Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3 years participated in an 8-week group-based, peer-educator led lifestyle intervention based on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up (month-6).

Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the development of type 2 DM.


Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* Latina
* GDM within the last 3 years
* able and willing to participate in physical activity sessions

Exclusion Criteria:

* current diabetes
* severe illness that would preclude them from coming to the sessions

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: weight
timeFrame: 6 months
measure: lipids
timeFrame: 6 months
measure: blood pressure
timeFrame: 6 months
measure: composition of dietary intake at all time points
timeFrame: 6 months
measure: hours of physical activity per week at all time points
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956137: Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks
Official title: A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Keywords: spinal anesthesia
ultrasound
palpation
knee
hip
surgery
intervertebral space
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many of the patients presenting for total joint arthroplasty. This is because of obesity, previous spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an appropriate site for needle insertion in spinal anesthesia, and that this results in a high success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia is extremely useful, especially in patients with poor-quality surface landmarks. However there are no published randomized controlled trials to date that compare the efficacy of the ultrasound-assisted technique with the traditional surface landmark-guided technique of spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Planned spinal anesthesia for elective lower limb surgery; and one or more of the following:

  1. Body mass index ≥ 35 kgm-2
  2. Scoliosis or other spinal deformity
  3. Poorly palpable or impalpable spinous processes

Exclusion Criteria:

* Patient refusal
* Contra-indications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding diathesis
* Inability to provide informed consent

Primary outcomes:
measure: The success rate of dural puncture on the first needle insertion attempt.
timeFrame: within 2 hours prior to surgery
Secondary outcomes:
measure: number of needle insertions/re-directions; performance time; Pain score; Patient satisfaction; quality of ultrasound image; Correlation between palpation and ultrasound; Correlation between ultrasound and measured depth to i.t. space
timeFrame: within 2 hours prior to surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Ki Jinn Chin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853437: Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
Official title: Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Keywords: Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-03-02
Enrollment: 7
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.

Brief summary: The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.


Eligibility criteria: Inclusion Criteria:

* Patients with in situ central venous and arterial catheters
* Ability to draw blood from arterial and central venous catheters
* Presence of parent or guardian to provide consent

Exclusion Criteria:

* Patients over 16 years of age.

Primary outcomes:
measure: Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference.
timeFrame: 5-8 minutes minimum
Secondary outcomes:
measure: Measure blood volumes to compare effects of volume infusion and furosemide.
timeFrame: 5-8 minutes minimum
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Golisano Children's Hospital
state: New York
Study officials:
affiliation: Golisano Children's Hospital
name: Karen Powers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
Clinical trial NCT00250237: Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Official title: Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Operative Delirium
Hip Fracture
Keywords: Post-operative delirium
hip fracture
Lead sponsor: Bronovo Hospital
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 220
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.

Detailed description: A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.

Eligibility criteria: Inclusion Criteria:

* Hip fracture
* 75 years and older

Exclusion Criteria:

* Contra-indications for the use of haloperidol
* Pre-operative delirium
* Pre-operative use of haloperidol

Primary outcomes:
measure: Incidence of post-operative delirium
timeFrame: 72 hours post surgery
Secondary outcomes:
measure: Length of stay
timeFrame: days
measure: Complications
timeFrame: during hospitalization
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Bronovo Hospital
state: Zuid Holland
Study officials:
affiliation: Bronovo Hospital
name: Boke Linso Sjirk Borger van der Burg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262737: Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Official title: Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 50
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: patient with retinal injury who will have 3 injections as the induction protocol (1 injection per month) for one eye and that didn't had any injection before.

Brief summary: The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

Detailed description: The recrutement of the patient is done during the inclusion of the patient by the nurses of the ophtalmological service of clermont-ferrand and confirm by an ophtalmologist of the service.

A mesure of the OSDI is done before the injection, then at 1 day, on week by a phone call. Each of this mesures are done for the 2 other injections.

Before each of this injection, a clinical mesure is done by a lacrydiag: the atrophy of the meibomian glands, the non-invasive break-up time, interferometry, the heigh of the tear meniscum.

Eligibility criteria: Inclusion Criteria:

* Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
* Patient with 3 ocular intravitreal injections of anti-VEGF in one eye

Exclusion Criteria:

* pregnant or breastfeeding woman
* intravitreal injection before the study
* intravitreal injection in both eyes
* allergy of betadine
* guardianship patient

Primary outcomes:
measure: OSDI
timeFrame: before the injection and at 1 day
Secondary outcomes:
measure: OSDI
timeFrame: before the injection and at 1 week
measure: HM
timeFrame: before each injection
measure: AM
timeFrame: before each injection
measure: NIBUT 1
timeFrame: before each injection
measure: NIBUT 2
timeFrame: before each injection
measure: Interferometry
timeFrame: before each injection
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frederic CHIAMBARETTA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740437: Systematic IPP VS Symptomatic IPP in GERD Prevention After POEM for Achalasia. . A Comparative Retrospective Analysis
Official title: Interest of Systematic PPI Therapy After POEM vs Symptomatic Use of PPI Therapy in Prevention of Gastroesophageal Reflux Disease After POEM for Esophageal Achalasia. A Comparative Retrospective Analysis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Achalasia
Gastroesophageal Reflux
Keywords: GERD
POEM
Achalasia
PPI
Esophagitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 150
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 will be included from several French university hospitals that have POEM as a treatment for esophageal achalasia and which routinely perform an endoscopic evaluation of esophagitis between 6 to 9 months after the POEM.

Data collection will be retrospective from patient records at each center.

Brief summary: POEM is a minimally invasive endoscopic therapy that is highly efficacy in the treatment of achalasia of any type. POEM has an increased risk of GERD. Systematic PPI therapy has never been studied for the prevention of post-POEM GERD.

The investigators wish to retrospectively compare patients who have received routine PPI therapy vs. patients who don't.


Eligibility criteria: Inclusion criteria:

* \> 18 years old
* Consent given
* Achalasia all types with eckhardt score \> 3

Exclusion criteria:

* Patient who is a minor or under judicial protection
* Pregnant or breastfeeding woman
* Contraindication to PPIs
* Carrier of mediastinal and exogastric neoplasia
* Patient on PPIs prior to the procedure for indication that does not allow for their discontinuation
* Peptic esophagitis (Grade B, C or D) before or at the time of the procedure
* Previous treatment with Heller myotomy

Primary outcomes:
measure: Number of Esophagitis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Antoine Debourdeau
role: STUDY_DIRECTOR
References:
Clinical trial NCT04212637: Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
Official title: Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
First posted: 2019-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).


Eligibility criteria: Inclusion Criteria for all:

* Visual acuity normal or corrected to normal
* Affiliation to a social security scheme (copy of the vital card in support)
* Signed informed consent
* Medical examination according to the participation in the MRI examination
* MMSE score\> 23/30

For Parkinson patient:

* Diagnosis of Parkinson's disease
* Presence of asymmetric bradykinesia and rest tremor and / or stiffness
* Hoehn \& Yahr Stadium I-II / V

Exclusion Criteria for all:

* Unprotected Majors unable to express their consent
* Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
* Significant hearing or motor impairment
* Past or present neuropsychiatric pathology (except benign epilepsy)
* Taking narcotics and / or drugs for neurocognitive purposes
* Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous)
* Any other neurodegenerative pathology or treatment that may affect the oculomotor control

For Parkinson patient:

* Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).

Primary outcomes:
measure: MRI images
timeFrame: 1 hour
Secondary outcomes:
measure: Eye latency
timeFrame: 1 hour
measure: eye amplitude
timeFrame: 1 hour
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
Study officials:
References: