louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01373385: Prospective Pediatric Vesicoureteral Reflux Surgery Database
Official title: Prospective Pediatric Vesicoureteral Reflux Surgery Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vesicoureteral Reflux
Keywords: pediatric urology
vesicoureteral reflux
ureteral reimplant
Deflux
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 134
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center.

Brief summary: The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux.

Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures.

Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.


Eligibility criteria: Inclusion Criteria:

* Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Exclusion Criteria:

* Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Primary outcomes:
measure: Resolution of vesicoureteral reflux
timeFrame: Date of surgical intervention (day 1) to resolution of vesicoureteral reflux or additional surgical interventions for correction of vesicoureteral reflux, whichever comes first, or until enrollee's 18th birthday.
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Christina Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156585: Predictive Value of Dynamic Contrast Enhancement MRI on a Cerebral Tumor Response to Gamma Knife Treatment
Official title: Prospective Study of Predictive Value of Dynamic Contrast Enhancement Magnetic Resonance Imaging With Gadolinium on the Response of a Cerebral Tumor to a Treatment With Gamma Knife
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Metastases
Keywords: cerebral metastases
dynamic contrast enhanced magnetic resonance imaging
DCE-MRI
gamma knife
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oncology clinic

Brief summary: Hypothesis: the pattern of MRI contrast enhancement after gadolinium injection is different in tumors that respond well to gamma knife.

We are going to acquire sequential T1-weighted images of brain lesions before, during and after injection of Gd-DTPA. This will be repeated before and after a treatment with gamma knife. We will then analyse our results to see if there are common enhancement characteristics between lesions that will respond well to the radiosurgery treatment. Response will be clinically assessed by tumor volume as determined by MRI approximately 4 to 6 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Patient with intracerebral lesion benign or malignant wich are not concerned by the exclusion criteria

Exclusion Criteria:

* Pancranial radiotherapy
* Residual postop lesion
* Gliomas
* Patients \< 18 years old
* Anterior allergic reaction to gadolinium
* Claustrophobia.

Primary outcomes:
measure: MRI parameters
timeFrame: Before treatment with the Gamma Knife
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Faculté de médecine, Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean Chenard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919685: Investigations of New Markers in Patients With Shock
Official title: Investigations of New Markers in Patients With Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock State
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs).

Detailed description: Shock is a severe deficiency in oxygen at the cell level which could lead to the death. The treatment strategy relies on the profile of plasma lactate level, which the kinetics and metabolism are inadequate for evaluating the treatment efficiency without delay. Hence, it is now critical to identify adequate markers of dysoxia.

The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate.To this purpose, a multiple approach is undertaken with the analysis of 3 independent markers of cellular ischemia : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs). Indeed, the characteristics of HIF as marker of cell dysoxia, and MPs as markers of cell apoptosis, combined with cDNA seem providing complementary information in order to describe the consequences of shock as well as the response to treatment.

Samples of patients will be collected (from rest of blood sample collected for other measurements) at each step of the management of these patients. The evolution of these markers will be compared with that of lactate plasma levels (standard of care). Subgroup analysis will be undertaken in relation with the cause of shock state (septic, cardiogenic, hemorrhagic).

Eligibility criteria: Inclusion Criteria:

* shock state defined by a rise of plasma lactate level (\> 2 mmol/L)and/or refractory low blood pressure in the volume expansion requiring an introduction of catecholamines
* admission in intensive care \< 6 hours

Exclusion Criteria:

* Pregnancy
* presumed survival lower than 48 hours
* absence of central venous way and arterial catheter

Primary outcomes:
measure: Demonstrate the superiority of at least one of 3 markers (HIF, MPs, cDNA) with regard to plasma lactate level for evaluating the treatment response in patients with shock
timeFrame: 2 years
Secondary outcomes:
measure: Improve the physiopathological knowledge of the patients with shock
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique-Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique-Hôpitaux de Marseille
name: jean GABERT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00462085: Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy
Official title: Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
ankle foot orthosis
emg
surface electromyography
gait analysis
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to investigate the change in muscle activity during gait with the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.

Detailed description: A small group of children with hemiplegic cerebral palsy is investigated by 3D instrumented gait analysis. Muscle activity is measured by surface electromyography (sEMG) of selected lower limb muscle groups. Kinematic, Kinetic, and sEMG data are compared between both lower limbs walking with and without an ankle foot orthosis. Data are also compared with those of an healthy control group.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of spastic hemiplegic cerebral palsy
* age between 8 and 18 years
* must have an equinus barefoot gait pattern
* must have a heel-toe gait pattern with ankle foot orthosis
* no prior operations

Exclusion Criteria:

* no Botulinumtoxin treatment for at least 6 months prior to investigation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Laboratory for Movement Analysis
state: BS
Study officials:
affiliation: University Children's Hospital Basel
name: Reinald Brunner, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: University Children's Hospital Basel
name: Jacqueline Romkes, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01296685: Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter
Official title: Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Surgical Procedure
Keywords: cardiovascular surgical procedure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass. Urgent and norwood procedures are excluded.

Brief summary: The goal of the study is the evaluation of the air handling of a "new" type of oxygenator versus the standard model. The new type has an integrated arterial filter. The standard model has a non integrated arterial line filter. If the air handling is as effective/ better than in the standard model this can lead to reduction of cardiopulmonary bypass circuits with their initiation of systemic inflammatory response and improve cardiopulmonary bypass safety.


Eligibility criteria: Inclusion Criteria:

* All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

* Urgent and norwood procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Layth Al Tmimi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591185: FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over
Official title: FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Keywords: Accidental Falls
Primary prevention
Pressure platform
Inertial Sensor
Lead sponsor: Escola Superior de Tecnologia da Saúde de Coimbra
Sponsor class: OTHER
Collaborators: name: Sensing Future Technologies
name: Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
First posted: 2018-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fall prevention programs should include strength and balance training, home hazard assessment and intervention, vision assessment and referral and also medication review with modification/withdrawal. Evidence exists that a tailored exercise program can reduce falls by as much as 54%.

Several studies recognize the benefits of the Otago Exercise Program (OEP) on physical functioning and falls reduction in older people. The program includes strength and balance exercises with a difficulty level progression by increasing weights and number of repetitions, in association with a walking plan.

FallSensing clinical tool includes a software, a pressure platform and two inertial sensors. The software includes a range of exercises based on Otago Exercise Program, including warming, balance and strength exercises. The software allows that healthcare professional prescribes a tailored exercise program according to the individual needs. During exercise performance, pressure distribution can be analysed by the healthcare professional, providing real time feedback to the individual.


Eligibility criteria: Inclusion Criteria:

* adults aged 50 years or over;
* Community-dweller
* independent to be standing and walking, with or without walking aids,
* interest to participate in the study.

Exclusion Criteria:

* individuals with severe sensorial impairments (deafness or blindness)
* individuals with cognitive impairments which precludes the ability to comprehend the questionnaire, functional tests and exercises included in the protocol.

Primary outcomes:
measure: Timed Up and Go
timeFrame: Change from baseline time to perform TUG up to 12 weeks
measure: Self-efficacy for Exercise
timeFrame: Change from baseline Self-efficacy for exercise score up to 12 weeks
Secondary outcomes:
measure: Grip Strength
timeFrame: Outset and up to 12 weeks
measure: 30 seconds Sit-to-Stand
timeFrame: Outset and up to 12 weeks
measure: Step Test
timeFrame: Outset and up to 12 weeks
measure: 4 Stage Balance Test "Modified"
timeFrame: Outset and up to 12 weeks
measure: 10 meters Walking Speed
timeFrame: Outset and up to 12 weeks
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Physio Mondego
Study officials:
References:
Clinical trial NCT04702685: Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery
Official title: A Single Center, Randomized, Parallel Group Study to Evaluate the Efficacy of Ropivacaine Administered by Ultrasound-guided Erector Spinae Plane Block for Major Upper Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: ropivacaine
major upper abdominal surgery
supraumbilical
liver resection
colon resection
Whipple procedure
gastrectomy
anesthetics, local
erector spinae plane block
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: National Research Oncology and Transplantology Center, Kazakhstan
First posted: 2021-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.

Detailed description: The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.

Eligibility criteria: Inclusion Criteria:

1. Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy).
2. Males or females 18-70 years of age
3. American Society of Anesthesiologists physical status class I,II, III
4. Signed informed consent

Exclusion Criteria:

1. Patients undergoing emergency surgery
2. Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies)
3. Comorbid obesity (BMI≥35kg/m2)
4. Anomalies of vertebral column
5. Use of anticoagulants and patients with hypocoagulable conditions
6. Pregnancy
7. Physician preference for therapeutic anticoagulation
8. Infection of skin at site of needle puncture
9. Known allergies to study drugs

Primary outcomes:
measure: Mean cumulative opioid consumption up to 24 hours after surgery
timeFrame: 24 hours post-operation
Secondary outcomes:
measure: Post-operative pain score
timeFrame: Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.
measure: Time to ambulation
timeFrame: Between surgery and discharge from hospital, expected time is between 1 day to 1 week
measure: Time to discharge
timeFrame: Expected time to discharge is up to 2 weeks
measure: Usage of NSAIDs post surgery
timeFrame: Total dose used during the 24 hour period after surgery.
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: National Center for Oncology
Study officials:
affiliation: philip.lafleur@nu.edu.kz
name: Philip la Fleur, RPh MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05963685: Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy
Official title: Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: mechanical thrombectomy, telestroke, drip and ship, interhospital transfer, communication
Lead sponsor: Munich Municipal Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients admitted to one of 7 nonurban primary stroke centers with subsequent interhospital transfer to a referral center for mechanical thrombectomy in Southeast Bavaria, Germany.

Brief summary: The aim of this study is to evaluate the impact of a standardized alarming system on treatment times and workflow in stroke patients with interhospital transfer for mechanical thrombectomy (MT). The main questions it aims to answer are:

* Is the implementation of a standardized alarming system associated with shorter transfer and treatment times?
* Is the implementation of a standardized alarming system associated with a better adherence on existing standard operating procedures for interhospital transfer? We will analyze data from our existing thrombectomy registry comparing time periods before and after introduction of the MT alarming system.


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* diagnosis of acute ischemic stroke
* indication for mechanical thrombectomy
* admission to one of 7 participating primary stroke centers within in the catchment area of the referral center

Exclusion Criteria:

* unclear indication for mechanical thrombectomy (patients admitted for perfusion imaging before decision for or against a MT)

Primary outcomes:
measure: decision-to-groin time
timeFrame: 24 hours
Secondary outcomes:
measure: decision-to-departure time
timeFrame: 24 hours
measure: decision-to-arrival time
timeFrame: 24 hours
measure: arrival-to-groin time
timeFrame: 24 hours
measure: rate of refusal of transfer requests due to lack of capacity
timeFrame: 24 hours
measure: decision-to-transfer request time
timeFrame: 24 hours
measure: Periprocedural complications
timeFrame: 24 hours
measure: Successful outcome of MT (mTICI > 2b)
timeFrame: 24 hours
measure: groin-to-recanalization time
timeFrame: 24 hours
measure: Adverse events within 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Munich Municipal Hospital
state: Bavaria
Study officials:
References:
Clinical trial NCT00938756: Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome
Official title: Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain and Central Nervous System Tumors
Breast Cancer
Metastatic Cancer
Keywords: leptomeningeal metastases
male breast cancer
stage IV breast cancer
tumors metastatic to brain
adult meningioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.

Detailed description: OBJECTIVES:

Primary

* Evaluate the validity of determining CA 15-3 levels in the cerebrospinal fluid (CSF) using automated immuno-enzymatic methods.

Secondary

* Determine the sensitivity and specificity of these assays in assessing CA 15-3 in CSF.
* Assess favorability of intrathecal production of CA 15-3.
* Determine threshold interpretations of CA 15-3 levels in CSF.

OUTLINE: This is a multicenter study.

Within 15 days of suspected meningeal involvement, blood and cerebrospinal fluid samples are collected. Samples are examined by immunoenzyme assays. Patients with suspected cases of carcinomatous meningitis undergo cerebrospinal MRI.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis
  * Other type of cancer with evidence suggestive of carcinomatous meningitis
  * Meningeal syndrome without context of cancer

PATIENT CHARACTERISTICS:

* No other prior cancers
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No prior intrathecal treatment
* At least 4 weeks since prior interferon
* No concurrent participation in another clinical trial

Primary outcomes:
measure: CA 15-3 levels in cerebrospinal fluid
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Emilie Le Rhun
role: PRINCIPAL_INVESTIGATOR
References: