louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03416933: Therapeutic Drug Monitoring of BRAF-mutated Advanced Melanoma
Official title: Therapeutic Drug Monitoring of Kinase Inhibitors and Study of Circulating Tumor DNA in Patients With Mutated BRAF Metastatic Cutaneous Melanoma and Treated With Anti-BRAF and Anti-MEK Kinase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma (Skin)
Keywords: ctDNA
MAPK inhibition
BRAF(V600) mutated
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 35
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: BRAF V600-mutant metastatic melanoma are commonly treated using a combination of anti-BRAF and anti-MEK tyrosine kinase inhibitors (TKIs). The OPTIMEL trial aims to study the interest of therapeutic drug monitoring (TDM) of TKIs and circulating tumor DNA (ctDNA) detected in plasma of patients with metastatic melanoma for disease monitoring. 35 patients with metastatic melanoma and treated with dabrafenib and trametinib will be enrolled in this trial. Blood samples will be collected for the determination of TKIs concentration and ctDNA detection.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years of age and older
* Histologic proven advanced skin melanoma (Stage IV or stage IIIc inoperable) with BRAF V600 mutation
* Patient who will treated with combined kinase inhibitors (dabrafenib + trametinib).
* Patient able to stand a blood collection of 20 mL
* Ability to provide an informed written consent form
* Patient must be affiliated to a social security system
* Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Patient with mucosal melanoma
* Patient with non-metastatic skin melanoma (All stages except stage IV and stage III C inoperable)
* Patient with another synchronous cancer, or within 3 years
* Patient with a contraindication to blood collection of 20 mL
* Patient deprived of liberty or under supervision
* Patient unable to receive kinase inhibitor therapy
* Patient treated with another combined kinase inhibitors than dabrafenib and trametinib
* Pregnant or breastfeeding women
* Patient (man or woman) of childbearing age who does not agree to use of contraceptive methods validated during the study

Primary outcomes:
measure: Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc (CGFL)
city: Thionville
country: France
facility: Hôpital de Mercy
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine (ICL)
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Geoffrois Lionnel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04408833: Palmitate Study: A Method Study of Dietary Lipid Oxidation in Toddlers
Official title: Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 10
Sex: ALL
Minimum age (years): 23
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 toddlers approximately two years of age from ongoing studies or as a new participant from the community

Brief summary: The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.

Detailed description: The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Male or female
* Toilet trained or not

Exclusion Criteria:

* Diagnosed metabolic disease

Primary outcomes:
measure: How toddlers burn fat
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Institute
name: Elisabet Borsheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03900533: Emotion Regulation Group Skills Training for Adolescents and Parents
Official title: Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Symptoms
Emotional Instability
Keywords: child psychiatry
emotion regulation skills training
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 119
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.


Eligibility criteria: Inclusion criteria:

* Being enrolled as a patient at the child- and adolescent psychiatric clinic in Linköping
* Having an adult participant joining the skills training
* Being between the ages of 14-17 years
* Having sufficient knowledge of the Swedish language

Exclusion criteria:

* Clinical diagnosis of schizophrenia
* Clinical diagnosis of psychosis
* Clinical diagnosis of severe anorexia nervosa
* Clinical diagnosis of severe autism spectrum disorder
* Having a cognitive disability
* Having an ongoing drug or alcohol abuse
* Clinical diagnosis of bipolar disorder
* Insufficient knowledge of the Swedish language

Primary outcomes:
measure: Difficulties with Emotion Regulation Scale (DERS)
timeFrame: Change from baseline at 7 weeks and at 3 months
Secondary outcomes:
measure: Beck's Anxiety Inventory (BAI)
timeFrame: Change from baseline at 7 weeks and at 3 months
measure: Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
timeFrame: Change from baseline at 7 weeks and at 3 months
measure: Global Assessment Scale for Children (C-GAS)
timeFrame: Change from baseline at 7 weeks and at 3 months
measure: Brunnsviken Brief Quality of Life (BBQ)
timeFrame: Change from baseline at 7 weeks and at 3 months
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: Change from baseline at 7 weeks and at 3 months
measure: Levels of Emotional Awareness (LEAS-C)
timeFrame: Change from baseline at 7 weeks and at 3 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Region Östergötland BUP-kliniken
Study officials:
affiliation: Region Ostergotland/Linköping universitet
name: Maria A Zetterqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05901454: Yellow Fever Human Infection Model With YF-17D
Official title: Yellow Fever Human Infection Model With YF-17D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Yellow Fever
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: The International Society of Travel Medicine
First posted: 2023-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
Primary purpose: OTHER

Brief summary: No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

Detailed description: No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

Eligibility criteria: Inclusion Criteria:

* age 18-50 years

Exclusion Criteria:

* contraindication to receive YF-17D (immune deficiency, thymus illness)
* previous YF vaccination
* pregnancy
* chicken egg allergy
* hypersensitivity to any other substance in the YF-17D vaccine
* interval of \< 4 weeks of another live attenuated vaccine

Primary outcomes:
measure: yellow fever 17D in urine
timeFrame: within 30 days of the vaccination
Secondary outcomes:
measure: peak of YF 17D viruria after vaccination
timeFrame: within 30 days of the vaccination
measure: YF-17D viremia (in plasma) after vaccination
timeFrame: within 14 days of the vaccination
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Anna HE Roukens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04997954: EMERALD TRIAL Open Label Extension Study
Official title: EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Amyotrophic Lateral Sclerosis
Cannabis
CBD
Motor Neuron Disease
Lead sponsor: Gold Coast Hospital and Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Bod Australia
First posted: 2021-08-10
Enrollment: 7
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: EMERALD OLE trial is an open-label extension of the EMERALD trial. Long term tolerability and safety of the MediCabilis CBD oil has not been extensively studied. EMERALD OLE aims to establish data on the prolonged used of the study drug product.

All participants who completed the EMERALD trial will be offered to enter EMERALD OLE. Participants will be taking the active drug MediCabilis CBD oil for 6 months.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ALS/MND, either definite or probable according to the El Escorial revised criteria
* Can provide written informed consent
* Able and willing to comply with all study requirement
* Male or female, 25-80 years old
* Randomised into the EMERALD trial

Exclusion Criteria:

* Participants who are bedridden
* History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
* Heavy consumption of alcohol or use of illicit drug
* Hypersensitivity to cannabinoids or any of the excipients
* Any of the following: eGFR \<30 mL/min/1.73m2, ejection fraction \<35%, or AST and ALT \>5 X ULN
* Unwillingness of a female participant of child-bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
* Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
* Received any investigational drug or medical device within 30 days prior randomisation except MediCabilis CBD Oil
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
* Inability to cooperate with the study procedures
* Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
* Close affiliation with the study team, e.g. close relative of the investigator

Primary outcomes:
measure: Incidence of treatment related adverse events [safety and tolerability].
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the long-term effects of MediCabilis CBD Oil on the functional status of MND patients using Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
timeFrame: 6 months
Other outcomes:
Locations:
city: Gold Coast
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
Study officials:
References:
Clinical trial NCT01832454: Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years
Official title: Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cerebral Palsy
Keywords: cerebral palsy stem cells [MNCS]
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Detailed description: This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern

Eligibility criteria: Inclusion Criteria:

* Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
* Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
* Able to Comprehend and give written informed consent form for the study
* willing to come to the hospital for follow up visits as per the protocol requirements

Exclusion Criteria:

* History of meningitis,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
* Hemodynamically unstable patients
* history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
* peripheral Muscular dystropy

Primary outcomes:
measure: Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.
timeFrame: 6 months
Secondary outcomes:
measure: -Improvement in IQ by using Benit Kamat scale.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitnany Hospital
state: Maharashtra
Study officials:
affiliation: chaitanya stem cell centre
name: Anant E Bagul, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858554: The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg
Official title: The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laparoscopy
Keywords: Laparoscopy
coelioscopie
Veress Needle Technique
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022.

Brief summary: Veress techniques and open laparoscopy are the techniques most used by gynecological surgeons to date. Advantages of the direct introduction unknown because technique still little used.

The research hypothesis is that very few major complications are expected showing the safety of direct introduction.

A look back at the practice of direct introduction into laparoscopy from 2012 to 2022 at the CMCO (Medical-Surgical and Obstetrical Center of Strasbourg)


Eligibility criteria: Inclusion criteria:

* Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022.
* Subject, having not expressed their opposition to the reuse of data of their data for the purposes of scientific research.

Exclusion criteria:

- Subject having expressed its opposition to the reuse of its data for scientific res

Primary outcomes:
measure: Study of intraoperative complications of direct introduction in open laparoscopy
timeFrame: Files analysed retrospectively from from January 01, 2010 to December 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05919654: Clinical Evaluation of MyoCare in Europe (CEME)
Official title: Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Keywords: myopia
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Cooperativa de Ensino Superior, Politécnico e Universitário
name: Novovision
name: Instituto de Cirugia Ocular
name: Miranza Virgen de Lujan
name: ICQO Instituto Quirúrgico de Oftalmología
name: CPO Clinica Privada de Oftalmologia, S.A.
name: Carl Zeiss Vision International GmbH
First posted: 2023-06-26
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism \< 1.50D, and anisometropia \< 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.


Eligibility criteria: Inclusion Criteria:

* Age 6-13 years
* Caucasian ethnicity
* Monocular/binocular decimal visual acuity with correction ≥ 1.00
* Spherical equivalent between -0.75D and -5.00D
* Astigmatism \< 1.50D
* Anisometropia \< 1.00D
* Evolution of at least -0.50D in one year

Exclusion Criteria:

* Presence of ocular pathology or a history of ocular and systemic abnormalities
* Strabismus or binocular vision problems
* History of eye surgery
* Having previously used some method to control myopia.
* Having contraindications for the application of drugs for cycloplegia/corneal anesthesia

Primary outcomes:
measure: Objective refraction
timeFrame: 2 years
Secondary outcomes:
measure: Axial length
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References:
Clinical trial NCT02196454: Video to Promote HPV Vaccination
Official title: Educating Pre/Teens and Their Parents on the Importance of HPV Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Acceptance
Social Acceptance
Acceptance Processes
Health Behavior
Human Papillomavirus
Keywords: HPV vaccine
vaccination
immunization
video
health education
communication
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Noble Medical, LLC
First posted: 2014-07-22
Enrollment: 110
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds.

Detailed description: Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential to cause cancer. The vaccine is recommended because it prevents the HPV infections that most commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive the complete, three-vaccine series and have time to develop an immune response before being exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.

Results from this study will help us learn why participants do or do not get the HPV vaccination and whether video-based education can help improve vaccination rates

Eligibility criteria: Inclusion Criteria:

* Parent-child dyads in which the child is a male or female age 11 to 17 years who has not received the HPV vaccine

Exclusion Criteria:

* Parent-child dyads in which the child has received the HPV vaccine
* Parent-child dyads in which the child is older than 18 at the time of enrollment
* Non-English speakers

Primary outcomes:
measure: HPV Vaccination Series Initiation
timeFrame: 90 days
measure: HPV Vaccine Series Initiation
timeFrame: 0 days
Secondary outcomes:
measure: HPV Vaccine Series Initiation (depending on male versus female narrator)
timeFrame: 0 days
measure: HPV Vaccine Series Initiation (depending on male versus female narrator)
timeFrame: 90 days
Other outcomes:
measure: HPV Vaccine Awareness
timeFrame: 0 days
Locations:
city: Flourtown
country: United States
facility: Primary Care, Flourtown, Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Nicholas and Athena Karabots Pediatric Care Center
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadephia
name: Kristen A. Feemster, MD MPH MSHP
role: PRINCIPAL_INVESTIGATOR
References: