louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01222013: Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Official title: Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Lead sponsor: Hospital Santa Marcelina
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+.


Eligibility criteria: Inclusion Criteria:

1. Diagnose: therapy-naïve ALL, except for patients that performed Induction for ALL (33 days) exactly as this protocol and; documented Ph+, to be confirmed by conventional cytogenetic - t(9;22) (q34;q11) or FISH and/or gene BCR-ABL presence by RT-PCR or FISH.
2. Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used during treatment. Pregnant women won't be included.
3. Life expectation \> 8 weeks.
4. Medications: antineoplastic treatment-naïve, including corticotherapy, except for patients that performed Induction for ALL (33 days) exactly as this protocol.
5. Signed ICF by child legal responsible.
6. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP/TGO \< 10 x ULN and albumin \> 2 g/dl.

Exclusion Criteria:

1. Any inclusion criteria missing.
2. Pregnant patient or breastfeeding.
3. Patient considered incapable to follow purposed treatment.
4. Subject with infectious process, in activity, grade IV.

Primary outcomes:
measure: Evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+.
timeFrame: Up to 24 months.
Secondary outcomes:
measure: Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+.
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06281613: Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients
Official title: Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skeletal Malocclusion
Keywords: hyperdivergency
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Orthodontic patients

Brief summary: The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.

Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.

Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).

Detailed description: The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.

Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.

Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).

Eligibility criteria: Inclusion Criteria:

* mixed or permanent dentition
* skeletal class II malocclusion diagnosed with ANB angle \> 4° from cephalometric radiograph
* skeletal hyperdivergency calculated from AnsPns\^GoGn angle \> 25°, and at least S-Ar\^Go \> 149° or Ar-Go\^Gn \> 137°

Exclusion Criteria:

* lack of compliance in the use of the orthodontic appliance
* syndromic patients, cleft lip or cleft palate, severe malformations and asymmetries of the jaws.

Primary outcomes:
measure: Change in cephalometric angular measurements
timeFrame: Baseline (T0) and after 18 months (T1)
measure: Linear regressions
timeFrame: Baseline (T0) and after 18 months (T1)
measure: Change in cephalometric linear measurements
timeFrame: Baseline (T0) and after 18 months (T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, Mac
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821613: Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer
Official title: Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Real Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 1827
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.

Brief summary: Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Gender: female
* Age: 18 years and older
* Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
* Subject who have signed an informed consent form.

Exclusion Criteria:

* Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being "imaged" by RI4.0.
* Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
* Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
* Subjects who have undergone a mastectomy.
* Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who have a fever on the day of their biopsy.
* Subjects who are pregnant.
* Subjects who are breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Ramat Hachayal Hospital
Study officials:
References:
Clinical trial NCT06089213: Strategies for Preventing Falls in the Elderly
Official title: Effects of Two Strategies for Preventing Falls in the Elderly Through Telerehabilitation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Elderly
Prevention
Telehealth
Physical Therapy
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO). Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults. However, the application of these programs may not be accessible to a large part of the elderly population. The lack of continuity in the treatment of the consequences of falls, as well as the dissemination of prevention measures for this patient profile, could be minimized through the use of information and communication technologies. Method: This will be a randomized clinical trial that aims to evaluate the effects of two fall prevention strategies via telerehabilitation for elderly fallers after admission to an emergency room. It will be carried out by a multidisciplinary team with interventions for eight weeks and monitoring of outcomes over a period of four months. Patients will be evaluated regarding aspects of functionality in the second and month after the interventions and regarding the recurrence of falls during the four-month period. Discussion: The hypothesis is that the programs are viable in terms of accessibility to home training. However, to date, there is no evidence about the differences between these forms of interventions to prevent falls via telecare.

Detailed description: To compare the effects of two different strategies for preventing falls through telerehabilitation for elderly fallers after admission to an emergency room.

Eligibility criteria: Inclusion Criteria:

* elderly fallers

Exclusion Criteria:

* neurological diseases

Primary outcomes:
measure: Rate of Falls
timeFrame: four months
Secondary outcomes:
measure: Concern of falls
timeFrame: through study completion, an average of 1 year
measure: Balance
timeFrame: through study completion, an average of 1 year
measure: Arms Muscle strength
timeFrame: through study completion, an average of 1 year
measure: Legs Muscle strength
timeFrame: through study completion, an average of 1 year
measure: Functionality
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Pronto Socorro
state: RS
Study officials:
References:
Clinical trial NCT00530413: Study of Phenobarbital Inhibition of Catamenial Epilepsy
Official title: Study of Phenobarbital Inhibition of Catamenial Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2007-09-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.

We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.


Eligibility criteria: Inclusion Criteria:

* Adult female patients seeking medical attention for seizures
* Regular menstrual cycles
* At least 2 seizures per month
* Must be on at least one form of birth control other than abstinence
* Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
* If taking benzodiazepines for therapeutic purposes, must be on a stable regular dose
* Must be willing to take at least 400mcg of folic acid a day while in the study
* Must be able to detect, count or record seizures

Exclusion Criteria:

* Can not be pregnant or trying to become pregnant
* Can not have used hormonal birth control methods for at least 3 months prior to enrollment
* Can not have an allergy to Phenobarbital
* Can not have a history of non-epileptic seizures
* Can not have a know liver dysfunction or history of chronic hepatitis
* Can not have a history of neurological disorder or history of status epilepticus in the preceding year
* Can not ahve a physical or psychiatric condition which in the PIs opinion could compromise her ability to participate

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Screening, 3 month and final visit
measure: Depression Epworth Sleepiness Scale (ESS)
timeFrame: Screening, 3 month and final visit
measure: Quality of Life in Epilepsy (QOLIE-10)
timeFrame: Screening, 3 month and Final Visit
measure: Addenbrooke's Cognitive Examination (ACE)
timeFrame: Screening, 3 month and Final Visit
Secondary outcomes:
measure: Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above
timeFrame: Screening, 3 months, final visit
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo Health Science Campus
name: Lazar J Greenfield, Jr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03182413: Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
Official title: Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Deprivation
Keywords: modafinil
connexin
sleep deprivation
cognitive performance
Lead sponsor: Theranexus
Sponsor class: INDUSTRY
Collaborators: name: Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
First posted: 2017-06-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).

Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.


Eligibility criteria: Main inclusion Criteria:

1. Male subjects considered healthy and aged between 18 and 40 years
2. Subject with a body mass index (BMI) between 18 and 30 kg/m2

Primary outcomes:
measure: Sustained attention (PVT)
timeFrame: 5 hours post treatment
Secondary outcomes:
measure: Sustained attention (PVT) AUC
timeFrame: AUC of PVT speed during TSD
measure: Mental flexibility
timeFrame: 16,5 hours post treatment
measure: Mental inhibition
timeFrame: 16,5 hours post treatment
measure: Working memory
timeFrame: 16,5 hours post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Institut de Recherche Biomedicale des Armees
name: Fabien Sauvet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brunner Naga
name: Françoise Brunner-Ferber, PhD
role: STUDY_DIRECTOR
References:
citation: Duchene A, Perier M, Zhao Y, Liu X, Thomasson J, Chauveau F, Pierard C, Lagarde D, Picoli C, Jeanson T, Mouthon F, Dauvilliers Y, Giaume C, Lin JS, Charveriat M. Impact of Astroglial Connexins on Modafinil Pharmacological Properties. Sleep. 2016 Jun 1;39(6):1283-92. doi: 10.5665/sleep.5854.
citation: Sauvet F, Erblang M, Gomez-Merino D, Rabat A, Guillard M, Dubourdieu D, Lefloch H, Drogou C, Van Beers P, Bougard C, Bourrrilhon C, Arnal P, Rein W, Mouthon F, Brunner-Ferber F, Leger D, Dauvilliers Y, Chennaoui M, Charveriat M. Efficacy of THN102 (a combination of modafinil and flecainide) on vigilance and cognition during 40-hour total sleep deprivation in healthy subjects: Glial connexins as a therapeutic target. Br J Clin Pharmacol. 2019 Nov;85(11):2623-2633. doi: 10.1111/bcp.14098. Epub 2019 Sep 15.
Clinical trial NCT02866513: Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).
Official title: Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Mechanically Ventilated With APRV Mode
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.

The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians


Eligibility criteria: Inclusion Criteria:

* Adult
* Patient mechanically ventilated for more than 48 H for acute respiratory failure
* Decision to use of the APRV mode by clinicians in charge of the patient

Exclusion Criteria:

- Contraindication for the use of a nasogastric tube

Primary outcomes:
measure: Transpulmonary pressure
timeFrame: 24 hours
Secondary outcomes:
measure: Maximal value of transpulmonary pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille hôpital de la Timone
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT00722813: Cost Effectiveness and Utility of Computed Tomography Angiography (CTA) and Cardiac Cath
Official title: Cost Effectiveness and Utility of Coronary Artery Computed Tomography Angiography (CTA) in Screening for Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have had both CTA and Cardiac catherizations

Brief summary: This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease.

Detailed description: This is a single site study that will retrospectively and prospectively identify and enroll 100 subjects, both male and female, 18 years of age and older who undergo both coronary angiography and coronary artery computed tomography (CT), using the electronic radiology and cardiology databases. The purpose is to conduct a survey to assess their preference for either test to diagnose coronary artery disease. Subjects should be within six months of having the tests to avoid memory and recall problems.

Eligibility criteria: Inclusion Criteria:

* Subjects who have had both CTA and Coronary angiogram.
* 18 years old and older.

Exclusion Criteria:

* Under 18 years of age
* Memory Impairment:

  * Stroke
  * Traumatic brain Injury
  * Dementia

Primary outcomes:
measure: Utility of CT and catheter angiography
timeFrame: Within 6 months of testing with CT and catheter angiography
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: Aine Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: