louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00104364: A Study of MK0731 in Patients With Advanced Solid Tumors (0731-002)(COMPLETED)
Official title: An Open-label, Dose Escalation Phase I/II Trial of a KSP Inhibitor Given as a Constant 24-Hour Infusion in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study MK0731 in patients with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for whom standard therapy does not exist. Part of the study includes only patients who have taxane-resistant cancers.

Exclusion Criteria:

* Patients who have had treatment with any investigational therapy within the past 30 days.
* Patients who have certain types of blood cancers such as leukemia or lymphoma.
* Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation.
* Patient is pregnant or nursing.

Primary outcomes:
measure: Safety and tolerability of MK0731 administered as a 24-hour CIV Infusion. Dose limiting toxicities. Maximum tolerated dose and recommended Phase II dose of L-001154704 administered as a 24 hour CIV infusion.
Secondary outcomes:
measure: Predose predictive biomarkers of response to MK0731
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Holen K, DiPaola R, Liu G, Tan AR, Wilding G, Hsu K, Agrawal N, Chen C, Xue L, Rosenberg E, Stein M. A phase I trial of MK-0731, a kinesin spindle protein (KSP) inhibitor, in patients with solid tumors. Invest New Drugs. 2012 Jun;30(3):1088-95. doi: 10.1007/s10637-011-9653-1. Epub 2011 Mar 22.
Clinical trial NCT02112864: Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome
Official title: Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Dexamethasone
Thoracic Surgery
Cytokines
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery. Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of this study is that dexamethasone, given pre operatively, would help reduce the incidence of post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response, in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.


Eligibility criteria: Inclusion Criteria:

* elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia
* ASA I-III
* age 18-75 yo

Exclusion Criteria:

* contra-indication to thoracic epidural analgesia
* patient refusal
* patients already taking cortisone or dexamethasone
* patients on chronic opioid medication

Primary outcomes:
measure: cytokine elevation
timeFrame: 24 h after surgery
Secondary outcomes:
measure: incidence of post thoracotomy pain syndrome
timeFrame: 3 months after surgery
measure: incidence of post thoracotomy pain syndrome
timeFrame: 6 months after surgery
measure: incisional and shoulder pain
timeFrame: acute post operative period
measure: Brief pain inventory questionnaire
timeFrame: three months after surgery
measure: Brief pain inventory questionnaire
timeFrame: 6 months after surgery
measure: Leeds Assessment of Neuropathic Signs and Symptoms questionnaire
timeFrame: three and six months after surgery
measure: cytokine elevation
timeFrame: 1h after surgery
measure: cytokine elevation
timeFrame: 48 h after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Veronique Brulotte, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203164: Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients
Official title: A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 254
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
* Patients must be willing and able to give informed consent.

Exclusion Criteria:

* Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
* Premature discontinuation from study TVP 1012/133 for any reason.
* A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).

Primary outcomes:
measure: long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy
timeFrame: until commericially available
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Chicago
country: United States
facility: Rush - Presbyterian St. Luke's Medical Center
state: Illinois
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Phyllis Salzman, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01380964: Research of Biomarkers in Duchenne Muscular Dystrophy Patients
Official title: Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: Duchenne Muscular Dystrophy
biomarkers
transcriptomics
mironics
proteomics
Lead sponsor: Genethon
Sponsor class: OTHER
Collaborators: name: Institute of Myology
First posted: 2011-06-27
Enrollment: 220
Sex: MALE
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Duchenne Muscular Dystrophy controls (healthy or patients with a non-related disease)

Brief summary: The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.


Eligibility criteria: Inclusion Criteria:

* FOR PATIENTS:
* Diagnosis of DMD confirmed by genetic testing
* Age over 3 years
* Weight over 15 kg
* Informed consent signed
* FOR CONTROLS:
* Age over 3 years
* Male gender
* Weight over 15 kg
* Subjects with national health insurance coverage
* Informed consent signed
* Nonacute or chronic muscular, allergic, infectious, endocrine or inflammatory disorder in the 3 weeks preceding inclusion

Exclusion Criteria:

* FOR PATIENTS:
* Concomitant chronic or acute muscular, endocrine, infectious, allergic or inflammatory disorder in the three weeks preceding the blood test
* Intake of medicines other than angiotensin-converting enzyme inhibitors, beta blockers, dietary supplements, vitamins, alendronate and methylphenidate. Steroids (and medicines prescribed with them such as calcium supplements and proton pump inhibitors) will be discussed
* Mental retardation or autism
* Vaccination or treatment with immunoglobulins within the three months preceding inclusion
* FOR CONTROLS:
* Concomitant chronic or acute muscular, neurological (including mental retardation and autism), infectious or inflammatory disorder in the three weeks preceding the blood test
* Vaccination or treatment with immunoglobulins within the three months preceding inclusion

Primary outcomes:
measure: IBiSD aims to identify and validate new and disease-specific biomarkers.
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institute of Myology
Study officials:
affiliation: Myology Institute
name: Laurent SERVAIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04562064: Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.
Official title: Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included

Brief summary: keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases.

Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.


Eligibility criteria: Inclusion Criteria:

* Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
* Contact lens intolerance.
* Thinnest location is more than 400 um.
* Maximum keratometry (Kmax) between 48 and 64 D.
* Clear cornea with no Vogt's striae.

Exclusion Criteria:

* Previous corneal surgery.
* Grade IV with corneal scarring.
* Concurrent corneal disease in addition to KC.
* Autoimmune or systemic connective tissue diseases.

Primary outcomes:
measure: The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT01183364: A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors
Official title: A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor Malignancies
Keywords: solid tumor malignancies
tumor
cancer
STA-9090
ganetespib
HSP90 inhibitor
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 27
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: This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression
* If subject has been treated with docetaxel, must have evidence of persistent or progressive disease
* Measurable disease per RECIST
* CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose
* ECOG status less than or equal to 2
* Life expectancy greater than 3 months
* Adequate hematological, hepatic and renal function as defined by protocol
* Willingness and ability to comply with study requirements
* Female subjects of childbearing age must have a negative pregnancy test at study entry
* Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol

Exclusion Criteria:

* Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose
* Radiotherapy within 2 weeks of first dose
* Surgery, radiotherapy or ablative procedure to the only area of measurable disease
* Major surgery within 4 weeks of first dose
* Poor venous access that would require an indwelling catheter for study drug administration
* History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients
* Baseline QTc \>470 msec or previous history of QT prolongation while taking other medications
* Peripheral neuropathy \> Grade 1
* Ventricular ejection fraction less than or equal to 55% at baseline
* Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases
* Women who are pregnant or lactating
* Uncontrolled intercurrent illness

Primary outcomes:
measure: Safety of STA-9090 (ganetespib) and docetaxel combination
timeFrame: June 2011
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: June 2011
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
References:
Clinical trial NCT01895764: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Official title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 110
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: The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.


Eligibility criteria: Inclusion Criteria:

* Subject 18 years of age or older
* Able and willing to give written informed consent and to comply with the requirements of the study protocol
* Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria
* Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs

Exclusion Criteria:

* Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy.
* Previous methotrexate treatment, not stopped 3 month before inclusion
* Surgery scheduled during study
* Female subject without method of contraception
* Contraindication to adalimumab or methotrexate

Primary outcomes:
measure: presence or absence of antibodies against adalimumab
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 6 months
measure: Change from baseline of T and B cells concentrations.
timeFrame: 6 months
measure: Change from baseline of "APRIL" and "TNF alpha" concentrations
timeFrame: 6 months
Other outcomes:
Locations:
city: Blois
country: France
facility: Rhumatologie, CH de BLOIS
city: Brest
country: France
facility: Rhumatologie, CHRU de BREST
city: La Roche Sur Yon
country: France
facility: Rhumatologie, CHD LA ROCHE SUR YON
city: Le Mans
country: France
facility: Rhumatologie, CHR du MANS
city: Nantes
country: France
facility: Rhumatologie, CHRU de NANTES
city: Orleans
country: France
facility: Rhumatologie / IPROS, CHR d'ORLEANS
city: Poitiers
country: France
facility: Rhumatologie, CHRU de POITIERS
city: Rennes
country: France
facility: Rhumatologie, CHRU de RENNES
city: Saint Brieuc
country: France
facility: Rhumatologie, CH de SAINT BRIEUC
city: Saint Nazaire
country: France
facility: Médecine polyvalente, CH de SAINT NAZAIRE
city: Tours
country: France
facility: Rhumatologie, CHRU de TOURS
Study officials:
affiliation: CHRU de TOURS
name: Emilie DUCOURAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04836364: Skincare Products and Environmental Health
Official title: Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecomastia
Endocrine System Diseases
Keywords: Prepubertal Gynecomastia
Essential Oils
Lavender
Tea Tree
Endocrine Disruption
Pediatric Environmental Health
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children aged 2 to 15 years old who live in the United States will be recruited for this study. Emphasis is placed on obtaining a diverse sample which all states and territories, in addition to a racially and SES diverse sample.

Brief summary: The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.

Detailed description: After being informed about the study and privacy, parents will give informed consent and complete the APICHS (Aromatic Plant Ingredient \& Child Health Survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products.

Eligibility criteria: Inclusion Criteria:

* Parent of child aged 2-15 living in the United States

Exclusion Criteria:

* none

Primary outcomes:
measure: Lifetime prevalence of prepubertal gynecomastia
timeFrame: Baseline
measure: Lifetime prevalence of precocious puberty
timeFrame: Baseline
measure: Endocrine Disruption - Comparison between exposed and unexposed
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01920464: Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians
Official title: Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis, Atopic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-08-12
Enrollment: 160
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective database extraction

Brief summary: this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway.

this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. 2/Description of the conditions of use of Flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).


Eligibility criteria: Inclusion Criteria:

Analysis of changes in share of prescriptions:

* Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012.
* Infants aged 3 to 12 months on the day of prescription of topical steroids.

Description of the conditions of use and patient profiles:

* Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012.
* Infants aged 3 to 12 months on the day of prescription of topical steroids.

Exclusion Criteria:

* none

Primary outcomes:
measure: Description of the conditions of use of Flixovate® in infants aged less than 12 months
timeFrame: baseline
measure: - Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012.
timeFrame: baseline, one year, 2 years, 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: