louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02875652: Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)
Official title: Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choroidal Melanoma
Keywords: circulation tumor DNA
choroidal melanoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma

Detailed description: This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.

The patient will have a blood sample at the following times :

* T0: before treatment of the primary tumor.
* T1: 1 months after the end of the local treatment.
* T2: at 7 months.
* Tn: every 6 months up to 3 years.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years old or more.
* Patient with a recent choroidal melanoma before the start of the specific treatment.
* Patient able to stand a blood collection.
* Work-up for extension (CT).
* Patient explanation given and consent information signed or by legal representative

Exclusion Criteria:

* Patient without social protection / insurance.
* Person deprived of liberty or under guardianship.
* Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological

Primary outcomes:
measure: Assesment of the change of the circulating tumor DNA from baseline at 3 years
timeFrame: T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
Secondary outcomes:
measure: Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.
timeFrame: 3 years
measure: Comparison of the circulating tumor DNA rate to hepatic imaging if available.
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Laurence Desjardins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05625152: Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures
Official title: Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures in Children
Keywords: Femur Fracture
FRACTURES IN CHILDREN
Pediatric population
Bony Callus
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020

Brief summary: Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.


Eligibility criteria: Inclusion criteria:

* Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
* Fracture of the femur resulting from orthopedic treatment instituted during a period of hospitalization
* Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

Exclusion criteria:

* Patient or legal representative who expressed their opposition to participating in the study
* Fracture of the femur having benefited from a surgical intervention
* Weakening metabolic or bone pathology
* Fracture on pathological focal lesion
* Fractures of the epiphysis or affecting the growth cartilage
* Impossibility of giving informed information to the subject

Primary outcomes:
measure: Define retrospectively the chronology of the appearance of periosteal callus, secondary callus and remodeling phenomena from the study of radiographs of the femur
timeFrame: Files analysed retrospectively from January 01, 2007 to December 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01333852: Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer
Official title: Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Squamous Cell Carcinoma
Keywords: head and neck cancer
paclitaxel
metformin
squamous cell carcinoma
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: University of Campinas, Brazil
First posted: 2011-04-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial

Detailed description: METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.

Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin or placebo until disease progression or unacceptable toxicity. The primary end-point is disease control (complete response, partial response or stable disease, according to RECIST 1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular markers in samples collected before and under treatment will be tested for correlation with clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Biopsy-proven head and neck squamous cell carcinoma
* Ineligibility for curative intent therapy, e.g., surgery or radiation therapy
* recurrent or stage IV disease
* previous failure to platinum-based chemotherapy
* measurable disease according to RECIST v1.1
* PS ECOG 0-2

Exclusion Criteria:

* known hypersensitivity to metformin or paclitaxel
* SNC metastasis
* Acute or chronic infection

Primary outcomes:
measure: Disease control at week 12
timeFrame: 12th week
Secondary outcomes:
measure: Progression-free survival
timeFrame: 6mo after the last patient recruited
measure: Overall Survival (subjects without death (any cause))
timeFrame: 6mo after the last enrolled patient
measure: Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE
timeFrame: 6 mo after the last enrolled patients
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: SP
Study officials:
affiliation: HCB
name: Lucas V dos Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas, Brazil
name: Jose BC Carvalheira, MD, PhD
role: STUDY_CHAIR
affiliation: HCB
name: Andre L. Carvalho, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06349252: Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer
Official title: Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 1263
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with pathological N2 non-small cell lung cancer based on the eighth TNM staging system in Fudan University Shanghai Cancer Center.

Brief summary: The International Association for the Study of Lung Cancer Staging Committee recently unveiled the ninth edition of TNM staging system for lung cancer. This study aims to explore survival outcomes, stage grouping, and gene mutations in N descriptors of this new classification system.


Eligibility criteria: Inclusion Criteria:

Pathological N2.

Exclusion Criteria:

Patients undergoing neoadjuvant chemotherapy

Primary outcomes:
measure: Overall Survival
timeFrame: Five year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT06901752: Effectiveness of Kinesiotaping in Adolescent Idiopathic Scoliosis
Official title: Effectiveness of Kinesiotaping in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scoliosis Idiopathic Adolescent
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 54
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effectiveness of kinesiotaping application in addition to exercise in Adolescent Idiopathic Scoliosis will be compared on the pain level with the numerical rating scale, the Cobb angle and scoliometer measurements, the quality of life with the Scoliosis Research Association-22 quality of life scale, and the patient's visual perception level with the Walter Reed visual assessment scale. Research Group: In addition to the regular exercise program, kinesio taping will be applied to patients diagnosed with Adolescent Idiopathic Scoliosis. Kinesio taping will be applied for 5 days on and 2 days off for 4 weeks. Control Group: Patients diagnosed with Adolescent Idiopathic Scoliosis will continue their regular exercise program. No intervention will be applied. Patients will be evaluated before and 3 months after treatment in terms of pain level with numerical rating scale, Cobb angle measurement and Scoliometer measurement, quality of life with Scoliosis Research Association-22 quality of life scale and Walter Reed visual assessment scale.


Eligibility criteria: Inclusion Criteria:

* Being under follow-up with the diagnosis of Adolescent Idiopathic Scoliosis
* Having a Cobb angle between 10-25 degrees
* Being willing to participate in the study
* Having thoracic C scoliosis

Exclusion Criteria:

* Having a spinal curvature of more than 25 degrees
* Presence of cardiopulmonary disease and musculoskeletal deformity that will prevent exercise
* Having an open wound in the area where kinesio taping will be applied or being allergic to the tape application
* Presence of S scoliosis

Primary outcomes:
measure: Cobb Angle Measurement
timeFrame: 3 months
measure: Scoliometer Measurement
timeFrame: 3 months
Secondary outcomes:
measure: Scoliosis Research Society-22 Test
timeFrame: 3 months
measure: walter reed visual assessment scale
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01346852: Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
Official title: Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: pediatrics
Medicaid
asthma
outcomes
asthma medication ratio
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 101437
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study intends to identify subjects at least 4 years of age with asthma and using asthma medications

Brief summary: The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.


Eligibility criteria: Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 4 years of age
* use of at least 1 controller or at least 5 albuterol prescriptions in 12 months

Exclusion Criteria:

* Subjects with COPD or treatment for COPD

Primary outcomes:
measure: Mean Ratio of Controller Medication to Total Asthma Medication
timeFrame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
Secondary outcomes:
measure: Mean Number of Short-acting Beta-agonist (SABA) Canisters Used
timeFrame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05296252: Attention and Achievement: A Mind Wandering Investigation
Official title: Attention and Achievement (A Subproject Affiliated With the Texas Center for Learning Disabilities or TCLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Disturbances
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 53
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The factors are study condition order (reading, math), proactive and reactive mind-wandering manipulation (yes, no), and lesson target (reading, math, both, neither)
Primary purpose: TREATMENT

Brief summary: This study assesses the impact of mind-wandering on reading and math.

Detailed description: This study assesses the impact of mind-wandering on reading and math. Specifically 120 middle school student participants will receive descriptive measures (of achievement, attention and related factors including mind-wandering), and will receive a brief (\~30 min) lesson in reading and math (order counterbalanced). Participants will receive a brief pre-test, the lesson, and then a post-test on the reading and math outcomes. 75% of the participants will receive a brief manipulation that sets up the influence of mind-wandering, as well as redirects when probe-caught mind-wandering occurs. The remaining participants will receive only redirects, and only randomly. Among participants to receive the mind-wandering manipulation, an equal number will receive this only for reading, only for math, and for both reading and math.

Eligibility criteria: Inclusion Criteria:

* enrollment in schools where we have permission to conduct the study

Exclusion Criteria:

* students known to be enrolled in separate curricula (e.g., life-skills classes)

Primary outcomes:
measure: Investigator Developed Items Derived From Reading Content Being Taught
timeFrame: administered one time immediately following the single reading learning session on day 1
measure: Investigator Developed Items Derived From Math Content Being Taught
timeFrame: adminstered one time immediately following the single math learning session on day 1
Secondary outcomes:
measure: Investigator Developed Probe-Caught Mind-Wandering
timeFrame: On 12 occasions interspersed during each of the math and reading learning sessions, on day 1 only.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Paul T. Cirino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668252: Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects
Official title: Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: endothelial progenitor cells
estrogen
menopause
cardiovascular risk
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2008-04-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The purpose of this study is to determine whether the number of circulating EPC is different between healthy women and men.

Detailed description: Study design: Open pilot study in health volunteers in the Hospital Saint-ANTOINE's Clinical Investigation Centre (CIC).

Recruitment and course of the study: The subjects will be recruited among the CIC's pool of healthy volunteers. Volunteer people will then have biological and clinical baseline examinations. If they match the inclusion criteria, an appointment will be taken for the blood sample intend for the characterization of the EPC and hormonal plasma levels evaluation. The participation will not exceed 2 months. Young women will have to come between the 9th and the 11th day after the beginning of menses). A total of 150 ml of peripheral blood will be collected. The study will last 18 months.

Eligibility criteria: Inclusion Criteria:

* BMI between 19 and 25 kg/m²
* non menopausal women :
* age 18 to 40 years,
* regular menstrual cycles
* no hormone therapy as contraceptives
* postmenopausal women :
* age above 55 years old
* amenorrhoea since 5 years at least
* no hormone therapy since at least 3 month

Exclusion Criteria:

* no medical insurance
* inclusion in another study
* smoking, Statins treatment, uncontrolled diabetes or hypertension and personal history of cardiovascular disease.

Primary outcomes:
measure: Number of endothelial progenitor cells by cytometry
timeFrame: Baseline
Secondary outcomes:
measure: To compare the number of EPC in young women to older men and menopausal women. To evaluate the correlation between the number of EPC and 17 b-estradiol plasma level.
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris - Hopital Saint Antoine
Study officials:
affiliation: Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6
name: Tabassome Simon, MD - PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004652: Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Keywords: Tourette syndrome
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Rochester
First posted: 2000-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.

II. Determine whether tic severity, medication side effects, academic performance and psychosocial functioning are better in the short term pimozide therapy or longer term pimozide therapy.

Detailed description: PROTOCOL OUTLINE: This is a combined open label and double blind randomized study.

Patients receive pimozide (open label) orally until a stable level of tic control is achieved and remains unchanged for at least 1 month.

Then, patients are randomized to one of two possible double blind treatments. In the short term pimozide group, patients receive pimozide over 2 weeks. Then, pimozide is gradually replaced by an inactive placebo within the following 10 weeks.

Patients in the long term pimozide group receive pimozide. Patients continue treatment for 12 months or until a worsening of tics or behavioral symptoms are present for which an increased dosage is required.

Patients who do not experience an exacerbation of tics requiring an increase in dosage are followed for 1 year from the date of entry.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- DSM-III-R criteria for Tourette syndrome Chronic motor tic disorder with tics sufficiently severe to require neuroleptic therapy --Prior/Concurrent Therapy-- No clonidine for at least 2 weeks or any neuroleptic (e.g., haloperidol, pimozide) within 3 months prior to study Stable dosage of other medications (e.g., antiobsessional, stimulant) for at least 3 months prior to and during study required

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Roger Kurlan
role: STUDY_CHAIR
References:
citation: Short-term versus longer term pimozide therapy in Tourette's syndrome: a preliminary study. Neurology. 1999 Mar 10;52(4):874-7. doi: 10.1212/wnl.52.4.874.