louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02362230: Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy
Official title: Sun Yat-sen University Cancer Center
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.

Detailed description: This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* ECOG 0 or 1
* Primary or metastatic tumor onfirmed as triple negative
* Measurable disease per RECIST version 1.1
* normal organ function, including bone marrow function, renal function, liver function, and cardiac function
* Two or more prior chemotherapy
* signed and dated an informed consent form
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Pregnant or breast feeding
* ECOG score ≧2
* Uncontrolled medical problems
* Hepatic, renal, or bone marrow dysfunction as detailed above
* Concurrent malignancy or history of other malignancy within the last five years except as noted above
* Patients were unable or unwilling to comply with program requirements

Primary outcomes:
measure: Progression Free Survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-Yu Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279330: Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?
Official title: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Screening
General Practitioner
Fecal Occult Blood Tests
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: Adeca 75
name: Société de Formation Thérapeutique du Généraliste
name: Hotel Dieu Hospital
First posted: 2011-01-19
Enrollment: 1569
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).


Eligibility criteria: Inclusion Criteria:

* Age : 50 to 74 years.
* Not having answered the first two solicitations of ADECA75 to participate in screening for colorectal cancer

Exclusion Criteria:

* Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).

Primary outcomes:
measure: Completion of Fecal Occult Blod Test
timeFrame: 7 months
Secondary outcomes:
measure: Delays from receipt of the letter and the completion of the test.
timeFrame: 7 months
measure: Proportion of uninterpretable test.
timeFrame: 7 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Université Paris Descartes
state: Ile de France
Study officials:
References:
Clinical trial NCT02650830: Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Prediabetes
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Keywords: type 2 diabetes
prediabetes
bile acids profile
GLP-1
FGF-19
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 362
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.

Brief summary: "The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Through confirmation of different profile of BAs in T2DM, investigator will suggest modulation of specific bile acids as a new possible treatment target in patients with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before hyperglycemia.

In addition, investigator will evaluate the association between each BA species and serum total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration in serum. Investigatr also evaluates the correlation between each BA species and metabolic profiles and oxidative stress marker to find possible roles of each BA component in glucose metabolism.


Eligibility criteria: Inclusion Criteria:

1. pre-diabetes 1. defined according to the ADA guideline (prediabetes definition) FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) or 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) or A1C 5.7-6.4% (39-46 mmol/mol)
2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) FPG ≥126 mg/dL (7.0 mmol/L) or 2-h PG ≥200 mg/dL (11.1 mmol/L) in the 75-g OGTT or A1C ≥6.5% (48 mmol/mol) or In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L) or 2. taking any anti-diabetic medications
3. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI \<25kg/m2

Exclusion Criteria:

1. subjects who refused to agree with informed consents
2. subjects with organ-transplantation
3. pregnant women
4. type 1 diabetes -

Primary outcomes:
measure: bile acid profile
timeFrame: 8h fasting blood sample
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06307730: Application of the Recommendations of the SPLIF (French Society of Infectious Pathology) in a Geriatric Population on the Duration of Treatment for Bacterial Pneumonia
Official title: Duration of Antibiotic Treatment for Infectious Pneumonia in Eldery Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Bacterial
Pneumopathy
Keywords: pneumopathy
Bacterial
nosocomial
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the geriatric short-stay unit at the Casanova's hospital in Seine-saint-Denis for pneumopathy, between January 2, 2023 and April 30, 2023.

Brief summary: Pneumopathy is the leading cause of death from infectious disease in the elderly. Prior to 2021, the recommended duration of antibiotic therapy for pneumonia, in adults, was 7 days.

Two theses have shown that these recommendations were poorly applied in geriatric services. Indeed, the duration of treatment exceeded 7 days, and less than 30% of antibiotic antibiotic treatments were re-evaluated at 72 hours.

In 2021, the SPLIF ( published new recommendations reducing this duration to 5 days in the event of clinical improvement observed on the 3rd day of treatment. These new recommendations are based on studies, in which the average age of participants was 65 years. However, the average age of patients in geriatric short-stay departments is 84.7 years.

In addition, the geriatric population is characterized by immunosenescence, pulmonary vulnerability and undernutrition, raising questions about the validity of these recommendations in the geriatric population.

The investigators offer a monocentric, retrospective, observational study of the geriatric hospital Casanova to assess the application of SPLIF recommendations in the geriatric population.


Eligibility criteria: Inclusion Criteria:

* All patient treated for bacterial/community/nosocomial pneumonia who stayed in the geriatric short-stay at Casanova's Hospital between January 2, 2023 and April 30, 2023

Exclusion Criteria:

* HIV Positif
* Immunosupressed patient
* Complicated pneumonia (abcess, pleuropneumonia)

Primary outcomes:
measure: Sex
timeFrame: Day 1
measure: Age
timeFrame: Day 1
measure: Weight
timeFrame: Day 1
measure: Phone Number
timeFrame: Day 1
measure: Origins
timeFrame: Day 1
measure: Autonomy in daily life's score before hospitalisation
timeFrame: Day 1
measure: Charlson's morbidity score
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hopitalier de Saint-Denis
state: Seine Saint Denis
Study officials:
affiliation: Hôpital Delafontaine
name: Louise BORIES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256930: Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers
Official title: A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Maruho North America Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition.

Detailed description: During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.

Eligibility criteria: Inclusion Criteria:

* Health male or female subjects are age 18 years or older
* Signed and dated Informed Consent Form obtained prior to any study related activities
* Subjects are free of any systemic or dermatologic disorder
* For female, females of non childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test
* Subjects must be able to communicate with the investigator and understand and comply with the requirement of the study and visit schedule

Exclusion Criteria:

* Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
* Have damaged skin in or around the test sites
* Have a history of sensitivity to adhesive tape
* Have a known sensitivity to constituents present in the material being evaluated
* Have a history of, or are currently being treated for skin cancer
* Have used any study drug and/or participate in any clinical study within 60 days prior to randomization
* To engage in any type of strenuous exercise
* Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
* Are deemed to be ineligible by the investigator

Primary outcomes:
measure: inflammatory skin response score
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL research
state: New Jersey
Study officials:
References:
Clinical trial NCT01374230: Long-Term Multicenter Evaluation of the E1® Tibial Bearing
Official title: Long-Term Multicenter Evaluation of the E1® Tibial Bearing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of the Knee
Traumatic Arthritis of the Knee
Keywords: clinical outcomes
radiographic outcomes
total knee arthroplasty
survivorship
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Aalborg University Hospital
name: Göteborg University
name: Hospital Universitario La Paz
name: Hvidovre University Hospital
name: Seoul National University Hospital
name: Ulsan University Hospital
name: Sydney Private Hospital, Australia
name: Kennedy Center at Ascension Mercy Hospital
name: Southern Joint Replacement Institute
First posted: 2011-06-15
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* 20 to 75 years of age
* Subjects requiring total knee replacement
* Subjects with the diagnosis of osteoarthritis, or traumatic arthritis
* Subjects who demonstrate the ability to return to Massachusetts General Hospital for follow-up for the next 10 years

Exclusion Criteria:

* Subjects with osteoporosis, osteomalacia, or neuromuscular disease
* Incomplete or insufficient soft tissue around the knee
* Subjects with a limited life span
* Subjects who have difficulty comprehending the study protocol for any reason
* Subjects with disorders which may impair bone formation
* Subjects whose bony structure deviates substantially from the general norm
* Female subjects that are, or may become, pregnant while participating in this study

Primary outcomes:
measure: Survivorship, as determined by the implant remaining within the patient.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Charles Bragdon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076630: Air Pollution and Health of COPD Patients
Official title: Effect of Air Pollution on Prognosis of Patients With Chronic Obstructive Pulmonary Disease and Its Underlying Biological Mechanism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Air pollution
chronic obstructive pulmonary disease
cardiopulmonary health
biological mechanism
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable COPD patients aged 40-80 in Beijing, China

Brief summary: This panel study aims to evaluate the effects of air pollutants on cardiopulmonary health of patients with chronic obstructive pulmonary disease (COPD) and explore the potential biological mechanisms.

Detailed description: This panel study was conducted in a group of stable patients with COPD in Beijing, China. The health measurements including lung function, blood pressure and airway inflammation were conducted, and morning urine, exhaled breath condensate, saliva and venous blood were collected at the time of enrollment and at 3, 6 and 9 months after enrollment. Individual exposures to fine particulate matter (PM2.5), black carbon (BC), ozone (O3) and nitrogen dioxide (NO2) were performed for 24 hours at each follow-up. And the daily concentrations of air pollutants were collected from the Beijing Air Quality Real-time Publishing Platform and meteorological data were collected from the National Meteorological Information Center. The linear mixed effects model was used to analyze the association between air pollution and cardiopulmonary health in patients with COPD.

Eligibility criteria: Inclusion Criteria:

* doctor-diagnosed stable COPD patients
* aged 40 to 80 years
* lived in Beijing for over one year before being recruited
* Agree to participate and sign the informed consent form.

Exclusion Criteria:

* Patients with a history of acute exacerbation in the last 1 month
* Patients with other respiratory diseases such as bronchiectasis and asthma.

Primary outcomes:
measure: Lung function
timeFrame: Nine months
Secondary outcomes:
measure: COPD Assessment Test scores
timeFrame: Nine months
measure: Modified British Medical Research Council (mMRC) Questionnaire score
timeFrame: Nine months
measure: ST. George's Respiratory Questionnaire scores
timeFrame: Nine months
measure: Blood pressure
timeFrame: Nine months
measure: Respiratory inflammation
timeFrame: Nine months
measure: Airway and systemic oxidative stress levels
timeFrame: Nine months
measure: Systemic inflammation
timeFrame: Nine months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
Study officials:
affiliation: Peking University
name: Furong Deng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02858830: Familial Partial Lipodystrophy Study
Official title: Genetic and Metabolic Basis of Familial Partial Lipodystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipodystrophy, Familial Partial
Keywords: FPL
adipose tissue
diabetes
dyslipidemia
metabolic
hyperinsulinemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Studying patients with rare adipose tissue disorders may help the investigators to better understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and thus have an enormous impact on public health.

Detailed description: A systematic study of body fat distribution is necessary to better define the phenotypic spectrum of FPL, and to better recognize FPL in patients with Metabolic Syndrome. Similarly, genetic studies in these patients will not only help better characterize the genotype-phenotype relationship, but is also likely to help identify other genes involved in regulation of lipid homeostasis, as some patients may not have any of the known mutations.

The Investigators will systematically study mitochondrial protein quality and function under fasting and fed state in relation to intramyocellular and circulating plasma lipid levels, and compare with age, sex and BMI-matched individuals. The Investigators will also study the rate of de-novo protein synthesis to determine if hyperinsulinemia affects both muscle protein anabolism and catabolism.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of lipodystrophy (decreased subcutaneous fat)
2. Family history of lipodystrophy
3. Normal control subject

Exclusion Criteria:

1. Inability to provide informed consent
2. Hemoglobin \< 10g%

Primary outcomes:
measure: Upper body muscle strength measured by chest press dynamometry
timeFrame: Before consumption of a high fat mixed meal
measure: Change in fractional mitochondrial protein synthesis rates
timeFrame: Before and after consumption of a high fat mixed meal (approximately 4 hours after the meal)
measure: Lower body muscle strength measured by knee extension
timeFrame: Before consumption of a high fat mixed meal
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vinaya Simha, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01129830: The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
Official title: The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Infertility
Keywords: ovarian reserve
FSH
anti-mullerian hormone
estradiol
oocyte
IVF
embryo transfer
Lead sponsor: Virginia Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.

Detailed description: Ovarian reserve markers, such as FSH, estradiol, AMH, ovarian volume and antral follicle counts will be monitored on DHEA supplementation in a prospective fashion.

Eligibility criteria: Inclusion Criteria:

* infertile women with diminished ovarian reserve

Exclusion Criteria:

* women \> 45

Primary outcomes:
measure: live birth rate
timeFrame: 3 years
Secondary outcomes:
measure: number of oocytes
timeFrame: 3 years
Other outcomes:
Locations:
city: Reston
country: United States
facility: Virginia Center for Reproductive Medicine
state: Virginia
Study officials:
affiliation: Virginia Center for Reproductive Medicine
name: Fady I Sharara, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.