louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01509196: A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet
Official title: Open-label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics of Fenofibric Acid Between Lipidilsupra Tablet and HIP0901 Capsule in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fenofibric acid
HIP0901
Lipidilsupra
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HIP0901 capsules and Lipidilsupra tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* Weight\>50kg, BMI of \>18kg/m2 and \<27kg/m2 subject

Exclusion Criteria:

* Acute disease within 28 days prior to start of study drug administration
* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Has a severe medical history of hypersensitivity to fibric acid derivative
* Participation in another clinical study within 30 days prior to start of study drug administration

Primary outcomes:
measure: AUC of Fenofibric acid
timeFrame: 0-96 hrs
measure: Cmax of Fenofibric acid
timeFrame: 0-96 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji-Young Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05955196: Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
Official title: Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of the Colon
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 115
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: The population studied concerns patients over the age of 18, suffering from colon cancer, undergoing immediate surgery or after chemotherapy.

Brief summary: Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .

In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient who has signed a consent to participate;
* Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
* Patient affiliated to a social security scheme, or beneficiary of such a scheme

Exclusion Criteria:

* Patient who had emergency colon cancer surgery
* Person in an emergency situation or unable to express their consent.
* Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
* Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons

Primary outcomes:
measure: Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample
timeFrame: 18 months from study launch
Secondary outcomes:
measure: Establishment of a validated cryobank of patient derived organoids (minimum n=30)
timeFrame: 18 months from study launch
measure: Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form
timeFrame: 48 month
measure: To assess the effect of immunotherapy on the antitumor activity of autologous T cells from peripheral blood samples using tumor viability measurements (cell titer glo, FACS)
timeFrame: 48 month
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Paoli Calmettes Institute
name: Cécile de CHAISEMARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01488396: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Official title: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stevens-Johnson Syndrome
Keywords: Cyclosporin
Stevens-Johnson syndrome
Dry eye
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_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 of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs.

Detailed description: Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology

Eligibility criteria: Inclusion Criteria:

* Males or females, of legal age of consent
* Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms
* Dry eye symptoms are defined as

  1. has dry eye symptom everyday for more than 3 months
  2. has foreign body sensation frequently
  3. use tear substitutes more than 3 times per day
* Tear test shaw abnormalities at least 1 of 2 of following:

  1. Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes
  2. Fluorescein clearance test at first 10 minutes is not more than 3 millimeters and has at least 1 of 3 of the following:

2.1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression cytology is consistent to dry eye

* Patent punctum

Exclusion Criteria:

* Age \< 18 years old
* Patients with Steven Johnson syndrome without dry eye
* Patients used oral cyclosporine or anticholinergic drug within past 2 months
* Patients with HIV or immunocompromise status
* Patients with active ocular infections and patients with a history of herpes keratitis
* Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
* Female patients are pregnant or nursing

Primary outcomes:
measure: dry eyes symptoms : dryness, gritty, photophobia, burning and pain
timeFrame: 0, 2, 4, 6 months
Secondary outcomes:
measure: Schirmer I test
timeFrame: 0, 6 months
measure: Fluorescein clearance test (FCT)
timeFrame: 0, 6 month
measure: Corneal staining
timeFrame: 0, 2, 4, 6 months
measure: Fluorescein tear break up time
timeFrame: 0, 2. 4. 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol university
Study officials:
affiliation: Mahidol University
name: Pinnita Prabhasawat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931796: Enhanced vs Conventional Recovery After Breast Surgery
Official title: Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Mahmoud Saeed Ebaid
First posted: 2023-07-05
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: the investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased.

Detailed description: Group A NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care. Group B ERAS pathway

Eligibility criteria: Inclusion Criteria:

* • Age: 20-60 years.

  * Adequate cognitive state (able to understand and collaborate)
  * American society of anesthesia (ASA) I, II

Exclusion Criteria:

* Patients who are:

  * Uncooperative.
  * Having allergy to any of the study drugs.
  * Known abuse of alcohol or medication.
  * Having Local infection at the site of injection or systemic infection.
  * Pregnancy.
  * With coagulation disorders.
  * Any complicated patients

Primary outcomes:
measure: This study aims to explore the effectiveness and safety of the enhanced recovery after surgery (ERAS) protocol vs. traditional perioperative care programs for modified radical mastectomy.
timeFrame: 48 hours
Secondary outcomes:
measure: Time of first ambulation
timeFrame: 48 hours
Other outcomes:
measure: Anesthesia recovery time
timeFrame: hour
measure: Time to regular diet.
timeFrame: 24 hours
measure: Postoperative opioid use.
timeFrame: 48h
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: Mahmoud Saeed Ebaid
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05566496: The Findings of Magnetic Resonance Imaging in Subtypes of Tics-related Disorders
Official title: The Findings of Resting-state Functional Magnetic Resonance Imaging, Diffusion Spectrum Imaging, and Wideband Magnetic Resonance Imaging in Subtypes of Tics-related Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tourette Syndrome in Children
Keywords: MRI
pediatric neurology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enrolled treatment-naive Tourette syndrome or chronic tic disorder pediatric patients for Tourette group and healthy age- and gender-matched participants for healthy control

Brief summary: The findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders


Eligibility criteria: Inclusion Criteria:

* Age less than 18 years old
* Diagnosed as Tourette syndrome or chronic tic disorders

Exclusion Criteria:

* History of neuropsychiatric disorders
* Already receive treatment for Tourette syndrome/chronic tics disorder
* Have some device not allowed for MRI scan

Primary outcomes:
measure: Difference between healthy and Tourette group
timeFrame: 2 years after enrollment for primary evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Children Hospital Pediatric Neurology Department
Study officials:
affiliation: National Taiwan University Children Hospital Pediatric neurology department
name: Wang-Tso Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814996: Social Functioning in Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: schizophrenia

Brief summary: There are two research purposes of this study. One is to explore which psychosocial issue or biological issue would affect the social function among people with schizophrenia. The other one is to explore which social function would affect the job tenure among people with schizophrenia. There are 60 participants diagnosed with schizophrenia and divided into two groups, employment and unemployment. we will use several social function tests to collect social function, PANSS to evaluate their psychotic symptoms. And then we will compare and analysis the data through statistic software. Finally, we will have he answer about how social skills affect the social function and which social skill would affect the job tenure among people with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* schizophrenia

Exclusion Criteria:

* substance abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01628796: Ultrasound Examination and Guided Injection Into the Acromio-clavicular Joint
Official title: Ultrasound Measurement of the Acromio-clavicular Joint and Injection of Standard Contrast Material Into the Joint Under Ultrasonic Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of Acromioclavicular Joint
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2012-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound?


Eligibility criteria: Inclusion Criteria:

* adults over 18 years with AC joint degenerative changes

Primary outcomes:
measure: ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray
timeFrame: outcome assessed at the time of the injection (1 day)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01619696: Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
Official title: Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rectal Adenocarcinoma
Keywords: chemotherapy
rectal adenocarcinoma
proctectomy
Fmiso TEP
MRI
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-06-14
Enrollment: 3
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: DIAGNOSTIC

Brief summary: The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

Detailed description: The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.

Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.

Eligibility criteria: Inclusion Criteria:

* locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.

Exclusion Criteria:

* synchonous metastatis
* previous malignant tumour
* previous radiotherapy/ chemotherapy
* performance status WHO\>2
* contraindication to 5 FU

Primary outcomes:
measure: acceptation rate of the entire sequence by eligible patients
timeFrame: 13 weeks
Secondary outcomes:
measure: radiological changes while on chimiotherapy, to tumour regression, and prognosis
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Guillaume Portier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131296: Lung Bacteriobiota and Influenza Mortality
Official title: Association of Lung Bacteriobiota With Intensive Care Unit Mortality in ARDS Patients: MicroFlu Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza
Critical Illness
Keywords: influenza
microbiota
intensive care unit
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Influenza patients admitted to ICU

Brief summary: Influenza is a potentially lethal disease still responsible for thousands excess deaths both in Europe and the United States. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. Lung microbiota has been shown to be involved in the immunity against influenza and is correlated with lung inflammation in numerous chronic respiratory diseases. We therefore aim to analyse the correlation between lung bacteriobiota and influenza ICU mortality

Detailed description: Influenza is a viral disease which is still responsible for thousands of excess deaths par year both in Europe and in the US. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. As lung microbiota is correlated with lung inflammation in numerous chronic respiratory diseases, we hypothesize that lung microbiota would be correlated with influenza outcomes. In a pilot study, we found that lung bacteriobiota but not mycobiota is associated with influenza ICU mortality. We therefore aim to confirm this correlation between lung bacteriobiota and influenza mortality.

Eligibility criteria: Inclusion Criteria:

* Patient above 18 year-old admitted to intensive care unit
* Influenza diagnosis by PCR or rapid diagnostic test

Exclusion Criteria:

* Guardianship or curatorship
* Prisoners
* No health insurance
* No legal representative

Primary outcomes:
measure: Lung bacteriobiota and ICU mortality
timeFrame: at admission
Secondary outcomes:
measure: Lung bacteriobiota and ICU mortality
timeFrame: at admission
measure: Lung bacteriobiota and 7-day mortality
timeFrame: at admission
measure: Bacteria and ICU mortality
timeFrame: at admission
measure: Bacteria and 7-day mortality
timeFrame: at admission
measure: ICU mortality based on Shannon index
timeFrame: at admission
measure: Lung bacteriobiota and 7-day mortality
timeFrame: at admission
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Medical intensive care unit, Pellegrin hospital
state: Nouvelle-Aquitaine
city: Libourne
country: France
facility: Intensive care unit, CH Robert Boulin
city: Pau
country: France
facility: Intensive care unit, CH Francois Mitterrand
Study officials:
References:
Clinical trial NCT03976596: Measurement of in Vivo Mitochondrial Capacity in Infants
Official title: Measurement of in Vivo Mitochondrial Capacity in Infants: a 31P-MRS Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy Infants
Keywords: neonates
mitochondria
MRI
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 2
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional study will enroll up to 18 infants. Infants will complete 2 study visits over a 1-10 day period for outcome measures.

Brief summary: The overarching aim of this project is to determine the test re-test reliability of 31P-magnetic resonance spectroscopy measurements in infants. Primary endpoints include two separate measures of in vivo mitochondrial capacity (ATPmax) over a 1-10 day period to assess feasibility and reliability.


Eligibility criteria: Inclusion Criteria:

* healthy, full-term infant
* aged 14-28 days at Visit 1
* willingness of parents to be notified of incidental findings from study procedures

Exclusion Criteria:

* born preterm
* implanted metal or electronic objects that render MRI unsafe
* unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center

Primary outcomes:
measure: In vivo mitochondrial capacity (ATPmax)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, PhD
role: PRINCIPAL_INVESTIGATOR
References: