louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02590497: Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery
Official title: The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glioblastoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Imaging, using magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. If MRI can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the correlation between the genetic and neuroimaging signature of glioblastoma.

II. Determine the correlation between the neuroimaging signature of glioblastoma and prognosis.

OUTLINE:

Patients undergo MRI before and after gadolinium contrast administration, including 3-dimensional (3D) volumetric T1-weighted sequence, fluid attenuated inversion recovery (FLAIR) sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.

Eligibility criteria: Inclusion Criteria:

* Patients who will be undergoing surgery for newly-diagnosed glioblastoma
* Subtotal, gross total or biopsy patients will be eligible
* Confirmation of pathology as glioblastoma

Exclusion Criteria:

* Tissue analysis demonstrating pathology other than glioblastoma
* Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction

Primary outcomes:
measure: Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
timeFrame: Day 1
measure: Diffusional kurtosis (DK) values
timeFrame: Day 1
measure: Genetic tumor profile
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Pierre Giglio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901497: Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
Official title: Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Insufficiency
Chronic Respiratory Insufficiency
Bronchospasm and Obstruction
Keywords: non invasive ventilation
single limb circuit ventilator
bilevel
nebulization
nebulizer
vibrating mesh nebulizer
amikacin
Lead sponsor: University Hospital St Luc, Brussels
Sponsor class: OTHER
Collaborators: name: Haute Ecole de Santé Vaud
name: Université Catholique de Louvain
name: Ligue Pulmonaire Neuchâteloise
First posted: 2013-07-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.


Eligibility criteria: Inclusion Criteria:

* No contraindication of amikacin
* Written informed consent
* Negative pregnant test (for women)

Exclusion Criteria:

* History of respiratory disease
* History of renal disease
* History of otological disease

Primary outcomes:
measure: Pharmacokinetics of nebulized amikacin
timeFrame: within the first 24 hours after nebulization
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc (Service des soins intensifs)
Study officials:
affiliation: Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain
name: Jean-Bernard Michotte, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Ligue Pulmonaire Neuchâteloise
name: Emilie Jossen, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires Saint-Luc (service des soins intensifs)
name: Jean Roeseler, PhD
role: STUDY_CHAIR
affiliation: Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, Belgium
name: Giuseppe Liistro, MD, PhD
role: STUDY_CHAIR
affiliation: Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain
name: Grégory Reychler, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04155697: Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)
Official title: Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Exposure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-07
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S.

The hypotheses are that detectable levels of surface nicotine will remain on participants' fingers, regardless of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) attempts and that greater finger levels of surface nicotine will remain after alcohol sanitization compared to hand washing.


Eligibility criteria: Inclusion Criteria ():

* Any non-staff participants visiting the NICU (including friends and family members of the infants' caregivers)
* Consented to and provided a finger wipe
* Report being a smoker
* Smoking status verified by an exhaled carbon monoxide (CO) level of \>7 parts per million

Exclusion Criteria:

* Unwilling to comply with research procedures (i.e., finger wipes)
* Does not speak English.

Primary outcomes:
measure: Nicotine level on finger #1
timeFrame: baseline
measure: Nicotine level on finger #2
timeFrame: 5 minutes after hand washing or sanitizing
measure: Nicotine level on finger #3
timeFrame: 1 hour after hand washing or sanitizing
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Thomas Northrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04400097: The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
Official title: The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 60
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: To evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and multi-knot interrupted sutures.


Eligibility criteria: Inclusion Criteria:

* patients with primary pterygium

Exclusion Criteria:

* eye surgery history
* acute ocular surface imflamation
* patients with coagulation or diabetes mellitus

Primary outcomes:
measure: Patient comfort
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03037697: Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy
Official title: Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.

Detailed description: The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Forty children with dyskinetic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using Noraxons myo pressure plate and Biodex balance system.

Eligibility criteria: Inclusion Criteria:

* The levels of gross motor function will be selected between levels I and II according to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the Biodex balance equipment.

Exclusion Criteria:

* If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.

Primary outcomes:
measure: Change from baseline gait parameters at 3 months
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: Change from baseline postural stability at 3 months
timeFrame: Baseline and 3 months post-intervention
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Maternity and Children Hospital
Study officials:
affiliation: Associate Professor
name: Shamekh M El-Shamy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04076397: Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae
Official title: Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Amputation of the Fingers
Keywords: annoying pulpal dysesthesia
lipofilling
amputation
sequelae
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1: 1) with stratification on the center, the type of initial surgery (directed or flap scarring) and the duration of change of dysesthesia (≤ or\> 1 year at baseline).
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.


Eligibility criteria: Inclusion Criteria:

* Major patient (18 years old) and ≤ 75 years old
* Patient with unidigital trauma downstream of distal interphalangeal joint
* Treated by directed healing OR covered by a flap
* Presenting troublesome pulpal dysesthesia evolving for more than 6 months AND less than 24 months
* The discomfort must be objectified by a DN4 score greater than or equal to 4/10 (neuropathic pain)
* Patient does not have any allergy to the substances used, in particular anesthetic: xylocaine, adrenaline

Exclusion Criteria:

* Patient with cutaneous sepsis, or amputation upstream of distal interphalangeal, or reimplantation, or dysesthesia that has been in progress for more than 24 months, or multi-digital traumatism
* Refusal of the patient to integrate the protocol Or incapacity to consent
* Pregnant or breastfeeding woman
* Tumor history of the amputated finger

Primary outcomes:
measure: Decrease of the EVA between D0 and M6
timeFrame: Day 0, Month 6
Secondary outcomes:
measure: Subjective self-assessment of the overall functional ability of both upper limbs
timeFrame: Day 0, Day 15, Month1, Month3, Month6
Other outcomes:
measure: Neuropathic pain
timeFrame: Day 0, Day 15, Month 1, Month 3, Month 6
measure: Patient satisfaction on the esthetic aspect of the finger
timeFrame: Month 6
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Quimper
country: France
facility: CH de Cornouaille - Quimper
Study officials:
References:
Clinical trial NCT00267397: Prevalence and Clinical Spectrum of the 22q11 Deletion
Official title: Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: infant
prenatal
birth defects
22Q11 deletion
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-21
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology.

Detailed description: Since 1967, The Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects in metropolitan Atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (Clayton, Cobb, DeKalk, Fulton and Gwinnett, and has been expanded to include prenatal records. The project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. The voluntary participation of Atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the CDC, the Georgia Institute of Mental Health and Emory University).

A case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination.

Children's Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices.

Eligibility criteria: Inclusion Criteria:

* birth defect diagnosed by the child's sixth birthday
* birth defect diagnosed within 6 years of the elective date of termination

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Robert M. Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06499597: Duke Activity Score Index in Obese Individuals
Official title: Investigation of Psychometric Properties of Duke Activity Score Index in Obese Individuals Candidate for Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients who are candidates for bariatric surgery

Brief summary: Today, obesity is a global health problem and can lead to serious health complications. Bariatric surgery is recognized as an effective treatment option to achieve long-term weight loss and health improvement in overweight or obese individuals. However, appropriate tools are needed to assess the physical activity levels of patients before and after bariatric surgery and to guide rehabilitation processes after surgery. The Duke Activity Index (DAI) is a scale used to assess activities of daily living and was developed at Duke University Medical Center. The DAI has been widely used to determine patients' physical functioning and monitor their activity levels in various health conditions and post-surgical recovery processes. The aim of this study was to evaluate the psychometric properties of the DAI and to examine whether it is an effective tool for determining physical activity levels in patients who are candidates for bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Body mass index higher than 30
* No disease that may affect functional performance
* Able to adapt to the tests to be applied

Exclusion Criteria:

* Recently hospitalized due to a condition that may make it difficult to perform the test
* Inability to perform exercise tests due to neurological or musculoskeletal disorders
* Uncontrollable medical conditions (such as lung or cardiovascular disease)
* Dysfunction of the vestibular system or eyes

Primary outcomes:
measure: Duke activity status index
timeFrame: Baseline (10 day before surgery), Pre-surgery (1 day before surgery)
Secondary outcomes:
measure: 6 minute walk test
timeFrame: Baseline (10 day before surgery)
measure: Pulmonary function test
timeFrame: Baseline (10 day before surgery)
measure: mMRC (Modified Medical Research Council) Dyspnea Scale
timeFrame: Baseline (10 day before surgery)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (10 day before surgery)
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University
Study officials:
References:
Clinical trial NCT01430897: Right Ventricular Hypertrophy After Atrial Switch and Cardiovascular Magnetic Resonance (CMR) Findings
Official title: Right Ventricular Hypertrophy After Atrial Switch Operation and Its Role in a Systemic RV: Normal Adaptation Process or Risk Factor? A Cardiovascular Magnetic Resonance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right Ventricular Hypertrophy
d-TGA
Keywords: d-TGA
dextro Transposition of the great arteries
systemic right ventricle
right ventricular failure
Atrial switch procedure
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty-seven consecutive patients who came to regular outpatient visits at our tertiary care institution were referred to CMR.

Patient parameters were compared to a control group of 25 healthy age matched volunteers.

Brief summary: Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV).

In this study the investigators sought to evaluate systemic RV myocardial mass and function after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (IVS) movement.


Eligibility criteria: Inclusion Criteria:

* Eligibility criteria were an AS operation in childhood for correction of d-TGA and the absence of associated hemodynamically significant heart defects.

Exclusion Criteria:

* Exclusion criteria were usual CMR contraindications such as ferromagnetic metallic implants.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: University pf Leipzig - Heart Center
name: Matthias Gutberlet, MD
role: STUDY_CHAIR
References:
citation: Hornung TS, Kilner PJ, Davlouros PA, Grothues F, Li W, Gatzoulis MA. Excessive right ventricular hypertrophic response in adults with the mustard procedure for transposition of the great arteries. Am J Cardiol. 2002 Oct 1;90(7):800-3. doi: 10.1016/s0002-9149(02)02619-x. No abstract available.