louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02812576: Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China
Official title: Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Group B Streptococcal Disease
Keywords: Group B streptococcus
Infants
China
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Guangzhou Women and Children's Medical Center
First posted: 2016-06-24
Enrollment: 150
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants \<3 months old born in or treated in a study hospital

Brief summary: Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data. This study as the first national, multicenter study to investigate the epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to appraise the necessity of appropriate interventions.


Eligibility criteria: Inclusion Criteria:

1. Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
2. ≤90 days old at the time of GBS confirmation.
3. Voluntary written informed consent provided.

Exclusion Criteria:

1. None

Primary outcomes:
measure: Incidence of group B streptococcal (GBS) disease
timeFrame: From birth to 3 months of age
measure: Case Fatality Rate of GBS disease
timeFrame: From birth to 3 months of age
measure: GBS serotype distribution
timeFrame: From birth to 3 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Health Science Center of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Haiying Liu, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ji W, Liu H, Jin Z, Wang A, Mu X, Qin X, Wang W, Gao C, Zhu Y, Feng X, Lei J, She S, Jiang L, Liu J, Yang S, Liu Z, Li G, Li Q, Guo D, Aziz MM, Gillani AH, Fang Y. Disease burden and antimicrobial resistance of invasive group B streptococcus among infants in China: a protocol for a national prospective observational study. BMC Infect Dis. 2017 May 31;17(1):377. doi: 10.1186/s12879-017-2475-9.
Clinical trial NCT03894176: Association of Plasma PTX3 Concentration and Outcomes of STEMI
Official title: Association of Plasma Pentraxin 3 Concentration With Angiographic and Clinical Outcomes in STEMI Treated by Primary Angioplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Coronary; Ischemic
Lead sponsor: Indonesian Cardiovascular Research Center
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 335
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with STEMI with symptom onset \<12 h who admiited to the emergency department and planned for primary PCI.

Brief summary: 335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method. The angiographic and clinical outcomes were evaluated according to the PTX3 concentration.

Detailed description: 335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method using human PTX3 kit. Blood was drawn at the emergency department before primary PCI. The angiographic and clinical outcomes were evaluated and analyzed according to the PTX3 concentration. The angiographic outcome were thrombus grade on initial angiogram and final TIMI flow. The clinical outcome were ECG resolution after primary PCI and all-cause death at 30 days. The plasma PTX3 concentration was then compared based on the outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with acute STEMI with symptom onset \<12 h undergoing primary PCI

Exclusion Criteria:

* Acute STEMI patients who received fibrinolytic therapy

Primary outcomes:
measure: The proportion of thrombus grade 4&5 and final TIMI flow <3
timeFrame: Intraprocedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Indonesian Cardiovascular Research Center
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT06678776: Endoscopic Anatomy of the Breast Fascia System
Official title: Endoscopic Anatomy of the Breast Fascia System: A Reverse Development Theory
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Disease
Anatomy
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 184
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University.

Brief summary: This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory. The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions. However, an intriguing phenomenon contradicting this developmental process was discovered through endoscopic mastectomy, which has not been previously discussed. Based on the aforementioned theoretical analysis, this study includes patients who underwent endoscopic and reduction mammaplasty in the Department of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University. The investigators proposed the following research framework: firstly, comprehensively understanding the structure of the breast fascia and the sequence of breast development through endoscope and existing research; secondly, exploring the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty; lastly, proposing a reverse development theory for breast fascia based on these theories in order to provide standardized and procedural guidance for breast surgeons.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.

Exclusion Criteria:

* breast conserving surgery

Primary outcomes:
measure: Identification of ligaments
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02362776: Metabolic Changes as a Diagnostic Indicator for Cancer
Official title: Metabolic Changes as a Diagnostic Indicator for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lung Cancer
Keywords: NMR spectroscopy
metabolic changes
blood plasma
biomarker
cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Algemeen Ziekenhuis Vesalius
name: Ziekenhuis Maas en Kempen
name: Mariaziekenhuis Noord-Limburg
First posted: 2015-02-13
Enrollment: 426
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of breast or lung cancer

Brief summary: This study aims to determine whether metabolic changes occur in blood plasma of cancer patients, and whether these changes can be used as a biomarker to detect cancer. These analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast or lung cancer (new lesion)

Exclusion Criteria:

* Not fasted for at least 6 hours
* Plasma glucose concentration ≥ 200 mg/dl
* Intake of medication at the day of investigation
* History/treatment of cancer in the previous 5 years

Primary outcomes:
measure: Metabolic phenotype of cancer
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Michiel Thomeer, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Kurt Baeten, dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Louis E, Adriaensens P, Guedens W, Vanhove K, Vandeurzen K, Darquennes K, Vansteenkiste J, Dooms C, de Jonge E, Thomeer M, Mesotten L. Metabolic phenotyping of human blood plasma: a powerful tool to discriminate between cancer types? Ann Oncol. 2016 Jan;27(1):178-84. doi: 10.1093/annonc/mdv499. Epub 2015 Oct 20.
Clinical trial NCT01695876: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-09-28
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Adult subjects between 25 and 55 years old
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
* Additional inclusion criteria apply

Exclusion Criteria:

* Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety.
* Additional exclusion criteria apply

Primary outcomes:
measure: Safety and Tolerability
timeFrame: up to 35 days
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: up to 35 days
measure: Effect of Food on AMG 357
timeFrame: up to 11 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Research Site
city: Christchurch
country: New Zealand
city: Grafton, Auckland
country: New Zealand
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05887076: Postoperative Delirium After Kidney Transplantation
Official title: Postoperative Delirium After Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-operative Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients 18 years and older who underwent kidney transplantation

Brief summary: This project is a retrospective evaluation of the routine data of patients who underwent a kidney transplant at the Charité Campus Mitte between January 2015 and December 2019 (until the corona pandemic).

Detailed description: Post-anesthetic complications such as delirium can occur in patients after kidney transplantation. We would therefore like to characterize pathophysiological changes after transplantation of the kidneys and, if necessary, gain diagnostic and therapeutic knowledge. The purpose is to study postoperative delirium after kidney transplantation.

Eligibility criteria: Inclusion Criteria:

* All patients 18 years and older who underwent kidney transplantation and who were admitted to Post-intensive care unit or to an Intensive care unit at the Campus Charité Mitte

Exclusion Criteria:

* Incomplete data records of the parameters to be determined
* Underage Patients

Primary outcomes:
measure: Incidence of delirium
timeFrame: 2015 - 2019
Secondary outcomes:
measure: Duration of delirium
timeFrame: 2015 - 2019
measure: Severity of delirium
timeFrame: 2015 - 2019
measure: Intraoperative parameter
timeFrame: 2015 - 2019
measure: Anesthesia
timeFrame: 2015 - 2019
measure: Anesthesiological parameters
timeFrame: 2015 - 2019
measure: Immunosupressive therapy
timeFrame: 2015 - 2019
measure: Delirium treatment
timeFrame: 2015 - 2019
measure: Pain teatment
timeFrame: 2015 - 2019
measure: Intensive care unit stay
timeFrame: 2015 - 2019
measure: Hospital stay
timeFrame: 2015 - 2019
measure: Mortality
timeFrame: 2015 - 2019
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin
city: Berlin
country: Germany
facility: Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01421576: Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions
Official title: A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.

Detailed description: The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.

Eligibility criteria: Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Primary outcomes:
measure: Composite of Pharmacokinetics(Cmax, AUClast)
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam
Study officials:
affiliation: Samsung Medical Center
name: Jae Wook Ko, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00732576: Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
Official title: Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Cardiovascular
Calcification
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 57
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular calcification. In this study we investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of K2 vitamins.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects - BMI \< 30
* written informed consent

Exclusion Criteria:

* Use of oral anticoagulants
* Coagulation disorders
* Use of multivitamin supplements
* Use of corticosteroids, anticonceptives
* hypertriglyceridemia, hypercholesterolemia

Primary outcomes:
measure: Endogenous Thrombin Potential (ETP)
timeFrame: 12 weeks
Secondary outcomes:
measure: Osteocalcin carboxylation
timeFrame: 12 weeks
measure: Matrix Gla-protein carboxylation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: VitaK - Maastricht University
Study officials:
affiliation: Department of Biochemistry, Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02962076: Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia
Official title: Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Ventricular Tachycardia
Lead sponsor: Mercy Research
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
name: Washington University School of Medicine
First posted: 2016-11-11
Enrollment: 11
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: Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.


Eligibility criteria: Inclusion Criteria:

* Clinical indication for ventricular tachycardia (VT) ablation (at least one clinical episode of sustained VT) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one
* Ischemic or nonischemic cardiomyopathy
* Sustained monomorphic VT

Exclusion Criteria:

* Right ventricular VT
* Polymorphic VT or ventricular fibrillation (VF) being the sole detected clinical arrhythmia
* Patient is unable to sign informed consent
* Recent myocardial infarction less than 30 days
* Recent ablation for ventricular tachycardia less than 30 days
* Patient is unwilling or unable to cooperate with the study
* Prosthetic mitral or aortic valve
* General contraindications to VT ablation, e.g., major contraindication to anticoagulation therapy, known presence of left ventricular thrombus, reversible causes of VT or VF
* General contraindications to PET imaging, e.g., pregnancy or lactation
* General contraindication to magnetic resonance imaging or to the administration of gadolinium.
* Contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access

Primary outcomes:
measure: Correlation Between PET Data and Electroanatomic Data
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
Study officials:
References:
Clinical trial NCT00974376: Gabapentin Treatment of Cannabis Dependence
Official title: Gabapentin Treatment of Cannabis Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Dependence
Cannabis Withdrawal
Cognitive Deficits
Keywords: Cannabis Treatment
Cannabis Use
Cannabis Dependence
Executive Functioning
Cognitive Deficits
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-09-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

Detailed description: This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.

Eligibility criteria: Inclusion Criteria:

* Males or females from 18-65 years of age
* Meets DSM IV criteria for current cannabis dependence
* Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
* Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
* At least a 2-year history of regular MJ use

Exclusion Criteria:

* Abstinent from cannabis more than 2 days at the time of randomization
* Active suicidal ideation
* Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
* Significant medical disorders that will increase potential risk or interfere with study participation,
* Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
* Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
* Inability to understand and/or comply with the provisions of the protocol and consent form
* Treatment with an investigational drug during the previous month
* Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
* Ongoing treatment with medications that may affect study outcomes

Primary outcomes:
measure: Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: