louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05834686: HER2 Expression of CTC to Predict Response in HER2-positive Advanced Breast Cancer Patients Treated With ADC
Official title: An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-positive Advanced Breast Cancer Patients Treated With ADC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with HER2-positive breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-positive advanced breast cancer patients treated with ADC


Eligibility criteria: Inclusion Criteria:

* Has pathologically documented breast cancer that:

  1. Is unresectable or metastatic
  2. has confirmed HER2-positive expression defined as IHC 2+/ISH+ or IHC 3+
  3. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
* Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
* Receives anti-HER2 ADC treatment
* Life expectancy \> 3 months
* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
* ECOG ≤2

Exclusion Criteria:

* Has uncontrolled or significant cardiovascular disease
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Primary outcomes:
measure: Progression free survival(PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2years
measure: Overall survival(OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Tao Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT04352686: Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Official title: Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.


Eligibility criteria: Inclusion Criteria:

* HV aged between 18 - 60 years

Exclusion Criteria:

* history of psychiatric disease or a positive first degree psychiatric family history
* pregnancy or lactation
* concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, ...)
* medication affecting esophageal motility
* significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
* prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
* history of gastrointestinal disease

Primary outcomes:
measure: Change in sensitivity to thermal stimulation
timeFrame: After 30 minutes after administration buspirone
Secondary outcomes:
measure: Change in sensitivity to mechanical stimulation
timeFrame: After 45 minutes after administration buspirone
measure: Change in sensitivity to electrical stimulation
timeFrame: After 60 minutes after administration buspirone
measure: Change in sensitivity to chemical stimulation
timeFrame: After 75 minutes after administration buspirone
measure: Change in positive and negative affect score
timeFrame: At the beginning of the study and at the end of the multimodal stimulation
measure: Change in state trait and anxiety score
timeFrame: At the beginning of the study and at the end of the multimodal stimulation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03018886: Diagnosing Adult Growth Hormone Deficiency
Official title: Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Hormone Deficiency
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test

Detailed description: Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat mass, decreased muscle mass, low bone density and adverse effects on quality of life and cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory tests in needed.

The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls used. At moment consensus cut-off criteria are BMI specific, but gender and age may also affect the GH response in the GHRH+arg.

Eligibility criteria: Inclusion Criteria:

for health patients:

1. age 20-60 years,
2. no symptoms indicative of disease.

for patients:

1. age 16-90 years
2. previous pituitary disease
3. suspicion of growth hormone deficiency

Exclusion Criteria:

for healthy controls:

1. pregnancy,
2. a known or suspected disease,
3. any symptoms indicating disease
4. use of medication

Primary outcomes:
measure: Peak serum GH (ug/l) by Immulite 2000 Xpi
timeFrame: one year
Secondary outcomes:
measure: Serum insulin like growth hormone 1 (IGF-1) concentration
timeFrame: one year
measure: Basal serum GH (ug/l) by Immulite 2000 Xpi
timeFrame: one year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Tuula Pekkarinen
Study officials:
affiliation: Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland
name: Esa Hamalainen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03979586: Laser-assisted Hyaluronic Acid Delivery by Fractional CO2 Laser in Facial Skin Remodeling
Official title: Intradermal Delivery of Fractional CO2 Laser-assisted Hyaluronic Acid in Facial Skin Remodeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Skin Remodeling
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.

Detailed description: Fractional CO2 lasers are already used in skin remodeling. They can also create vertical channels to enhance topical drug delivery deep into the dermis. Combining the efficacy of fractional CO2 laser to laser-assisted hyaluronic acid delivery has not yet being studied, the combination of these two techniques could improve facial skin remodeling.

The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the Laser Center for facial skin remodeling,
* aged from 30 to 70 years old,
* with phototype I to IV (Fitzpatrick scale),
* agreeing to participate in this study, signing the informed consent form
* not fitting in any non-inclusion criterion

Exclusion Criteria:

* Pregnancy or breastfeeding,
* active infection, history of oral or genital herpes
* suspected neoplasia,
* active inflammatory or infectious facial dermatitis,
* oral retinoid treatment in the last 6 months,
* phototype V or VI (Fitzpatrick scale)
* age \<30 years or\> 70 years,
* patients under guardianship or curatorship,
* hemostasis disorders, thrombolytic or anticoagulant therapy, c
* ongenital methaemoglobinaemia,
* porphyria,
* known hypersensitivity to hyaluronic acid, local anesthetics of the amide group or to any other component of Anesderm cream Ge 5%

Primary outcomes:
measure: Measurement of the improvment of one of the skin remodeling parameters (cutaneous texture, firmness, fine lines, radiance) using a scale from 0 to 10
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT01522586: Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 74
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male subjects aged 20 to 45 years
2. The subject has Broca's index ≤ 20%
3. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
4. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
2. A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg
3. A subject who shows the following result in clinical laboratory test:

   AST,ALT\>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min
4. Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).

Primary outcomes:
measure: Safety&tolerability
timeFrame: -1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit)
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University College of Medicine Busan Paik Hospital
state: Busanjin-gu
Study officials:
affiliation: BUSAN PAIK HOSPITAL
name: Jae-Gook Shin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04634786: Association Between CRSA and OSA
Official title: The Association Between Central Serous Chorioretinopathy and the Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chorioretinopathy
Obstructive Sleep Apnea
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The central serous chorioretinopathy is defined by RSD (retinal serous detachment) located to the macula, it must be diagnosed since 6 months.

Patients with central serous chorioretinopathy will undergo a Berlin Questions to assess the risks to have an obstructive sleep apnea.

More over, we measure the choroid's thickness by using EDI OCT(Enhanced depth imaging optical coherence tomography) The survey and the measure of the choroid's thickness will be performed during an ophthalmology routing consultation.

Brief summary: This goal of this study is to know the association between the central serous chorioretinopathy and the obstructive sleep apnea. Many studies have been done in order to assess the association between the central serous chorioretinopathy and obstructive sleep apnea and the results are always controverses actually.


Eligibility criteria: Inclusion Criteria:

* Central serous chorioretinopathy since 6 months at least
* Patients beyond 18 years old

Exclusion Criteria:

- All retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy

Primary outcomes:
measure: Association between central serous chorioretinopathy and the obstructive sleep apnea.
timeFrame: During 3 months we will collect the results of Berlin survey.
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT06626386: Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap)
Official title: Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate specific Antigen
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 200
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients between the ages of 40 and 70 who receive a PSA test as part of their routine examination

Brief summary: The aim of the PSA-Cap study is to test the comparability of measurements of total PSA in serum from venipuncture and in serum from capillary blood using anonymized diagnostic blood samples from patients. Furthermore, a stability test of the samples is carried out after storage at room temperature for 24, 72/96 and 168 hours. Particular attention is paid to the comparability of the measurement results and the influence of the transportation time.

Detailed description: Interventions that are conducted with the PSA-Cap trial are the collection of capillary blood (6 droplets) from the fingertip during regular PSA testing in venous blood. PSA is measured in the serum fraction of both samples (capillary and venous) using the established routine procedure, either immediately or after simulation of common transport conditions (intermediate storage for 24; 72/96 h and 168 h at 22 °C). Control measurements include parameters of cell lysis (LDH, HIL check) and general protein stability (albumin). The patient samples used are anonymized at the source by means of a consecutive series of numbers. The anonymized result groups are compared.

Eligibility criteria: Inclusion Criteria:

* Men aged from 45 to 70 years
* Informed consent for PSA measurement for prostate cancer screening

Exclusion Criteria:

* Patients unable to give consent

Primary outcomes:
measure: Accuracy of PSA measurement in capillary blood vs. venous blood
timeFrame: After 0 h, 1 d, 3/4 d and 7 d
Secondary outcomes:
measure: PSA stability in serum fraction of both samples (capillary and venous)
timeFrame: After 0 h, 1 d, 3/4 d and 7 d
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Klinik für Urologie, Universitätsklinikum Düsseldorf
state: North Rhine-Westphalia
Study officials:
References:
Clinical trial NCT02273986: Drug-Drug Interaction Study in Health Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of digoxin in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 24 hours
Secondary outcomes:
measure: Area under concentration curve (AUC)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Stuart Campbell
role: STUDY_DIRECTOR
References:
Clinical trial NCT02340286: Pilot Study for Determination of Total Energy Expenditure and Fat Oxidation in Children
Official title: Pilot Study for Determination of Total Energy Expenditure and Fat Oxidation in Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 toddlers born from mothers of the Glowing study (NCT01131117)

Brief summary: The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old children.


Eligibility criteria: Inclusion Criteria:

* 1.5-2.5 years of age
* Mother is a participant in the Glowing study (protocol NCT01131117)
* Healthy without taking medication that can affect study outcomes, as determined by the PI.

Exclusion Criteria:

* None listed

Primary outcomes:
measure: To determine total energy expenditure in 2 year old children
timeFrame: 15 days
measure: To determine fat oxidation in children
timeFrame: 2-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
Clinical trial NCT00760786: Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque
Official title: Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: IVUS-VH
Plaque characterization
Omega3-fatty acid
Atorvastatin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.


Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome within 48 hours of symptom onset
* Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation

Exclusion Criteria:

* Cardiogenic shock
* ST segment elevation myocardial infarction within 1 week
* Hematologic disorder: neutropenia (neutrophil\<3000/mm3), thrombocytopenia (platelet\<100,000/mm3)
* Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* Impaired renal function with serum creatinine \> 2mg/dL
* Bleeding diathesis or history of coagulopathy
* Pregnancy
* Hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish

Primary outcomes:
measure: Plaque stabilization using serial virtual histology intravascular ultrasound analysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiac and Vascular Center; Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joo-Yong Han, Professor
role: PRINCIPAL_INVESTIGATOR
References: