louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05645809: Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery
Official title: A Multicenter, Randomized, Single-blinded, Active Controlled, Non-inferiority, Post Marketing Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Hysterectomy
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 98
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for hysterectomy by laparoscopic surgery

* Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator
* Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)

Exclusion Criteria:

1. Patients with contaminated wounds
2. Diseases that may affect wound healing
3. When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment

Primary outcomes:
measure: Time used for suturing the surgical site during laparoscopic hysterectomy
timeFrame: 0Day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Jinhwa Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171509: Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
Official title: A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplant
Keywords: Liver transplant, adults, once a day administration, Immunosuppressants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.


Eligibility criteria: Inclusion Criteria:

* At least 6 months post-transplant
* At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
* Receiving stable doses of cyclosporine microemulsion for the past 3 months

Exclusion Criteria:

* - Severe rejection within the past 3 months
* Severe kidney dysfunction
* Transplanted for hepatitis C or autoimmune hepatitis

Other protocol-defined exclusion criteria applied

Primary outcomes:
measure: Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
Secondary outcomes:
measure: assess the safety of a once a day administration of cyclosporine microemulsion.
measure: compare for each patient the C2 levels pre- and post-conversion.
measure: characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
measure: the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually)
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03064009: Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures
Official title: Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infection
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Open fracture

Brief summary: To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop


Eligibility criteria: Inclusion Criteria:

Open Fracture treated surgically between distal radius and distal tibia

-

Exclusion Criteria:

* GSW Unable to follow for one year

Primary outcomes:
measure: Infection
timeFrame: One year after injury
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
References:
citation: Sagi HC, Donohue D, Cooper S, Barei DP, Siebler J, Archdeacon MT, Sciadini M, Romeo M, Bergin PF, Higgins T, Mir H; Center for Bone and Joint Infection. Institutional and Seasonal Variations in the Incidence and Causative Organisms for Posttraumatic Infection following Open Fractures. J Orthop Trauma. 2017 Feb;31(2):78-84. doi: 10.1097/BOT.0000000000000730.
Clinical trial NCT01419509: DNA Tests in Detecting Disseminated Disease in Tumor, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma
Official title: DNA Methylation-based Assays for Detecting Disease Spread in Rhabdomyosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: alveolar childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
mixed childhood rhabdomyosarcoma
pleomorphic childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
nonmetastatic childhood soft tissue sarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-18
Enrollment: 170
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with rhabdomyosarcoma

Brief summary: RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the disease has been disseminated.

PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor, blood, and bone marrow samples from patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:

* To establish a panel of hypermethylation assays for minimal disseminated disease analysis in rhabdomyosarcoma (RMS).
* To apply the hypermethylation assays to a series of bone marrow specimens from RMS patients.

OUTLINE: Archived tumor, bone marrow, and peripheral blood samples are analyzed for DNA hypermethylation by PCR-based assays and microarray assays. Results are then compared with each patient's clinical and pathological characteristics, and outcomes. Patterns of locus hypermethylation in tumor and paired bone marrow samples are also compared.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with rhabdomyosarcoma (RMS)
* Tumor, bone marrow, and peripheral blood samples from the Children's Oncology Group D9803 trial of intermediate-risk RMS

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Panel of hypermethylation assays for minimal disseminated RMS
measure: Detection of RMS cells in bone marrow
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Stephen R. Master, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02858609: Improving the Diagnosis of Diarrhoea in Emergency Rooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 354
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of diarrhoea after POC tests.


Eligibility criteria: Inclusion Criteria:

* Patient admitted at hospital for diarrhoea requiring, for the emergency physician, a microbiological examination with a "POC diarrhoea kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult major under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.

Primary outcomes:
measure: Percentage of patients admitted in emergency rooms for diarrhoea with confirmed etiological diagnosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT06522009: Effect of Time Delay and Syringe Surface Area on Blood Gas Samples Analysis
Official title: Effect of Time Delay and Syringe Surface Area on Results of Blood Gas Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: blood gas
oxygen saturation
syringe surface area
Time Delay
Lead sponsor: Helwan University
Sponsor class: OTHER
Collaborators: name: Theodor Bilharz Research Institute
First posted: 2024-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill-patients, and intraoperative patients who aged above 18 years.

Brief summary: To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2), oxyhaemoglobin saturation (SaO2), acidity (pH), and carbon dioxide tension (PaCO2) in both arterial and venous blood gas outcomes.

Detailed description: Arterial blood gas (ABG) analysis and monitoring is a crucial process for the diagnosis and management of the oxygenation status and acid-base balance of high-risk patients during surgery, as well as for the critical care of critically ill patients in the Intensive Care Unit .

Acid-base imbalance anomalies can have major repercussions in a number of medical scenarios, and in a few rare instances, they may even be a risk factor for death.

ABG test explores the arterial blood's pH, oxyhaemoglobin saturation (SaO2), bicarbonate concentration (HCO3), oxygen tension (PaO2), and carbon dioxide tension (PaCO2).

Traditionally, the concept "blood gas testing" has been used to describe measuring the blood's pH, oxygen saturation of haemoglobin (SaO2), and partial pressures of the physiologically active gases (pO2, pCO2). But now available commercial equipment can measure electrolytes (sodium, potassium, chloride, ionized calcium, and magnesium), glucose, lactate, and creatinine, usually all at the same time, in addition to haemoglobin quantification and co-oximetry

Eligibility criteria: Inclusion Criteria:

* Critically ill-patients, and intraoperative patients who aged above 18 years.

Exclusion Criteria:

* Patients with haematological diseases e.g. sickle cell anaemia
* burn patients with risk of carbon monoxide poisoning
* ARDS
* pulmonary oedema
* samples that were clotted

Primary outcomes:
measure: To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2) arterial and venous blood gas outcomes.
timeFrame: 1 hour
Secondary outcomes:
measure: effect of delay on analysis oxyhaemoglobin saturation (SaO2) acidity (pH) carbon dioxide tension (PaCO2)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Helwan University
name: Adel A hassan, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01286909: Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
Official title: Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metabolic Disease
Keywords: Metabolic
Lead sponsor: Omicron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).


Eligibility criteria: Inclusion Criteria:

1. Men and Women with Metabolic Syndrome
2. Elevated Triglycerides (\> 150)
3. Low High-Density Lipoprotein (HDL) (\< 35)
4. Willingness to take study nutritional supplement once a day for 3 months

Exclusion Criteria:

1. Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
2. Known milk, soy or whey allergy

Primary outcomes:
measure: Increase in High-Density Lipoprotein (HDL)
timeFrame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
Secondary outcomes:
measure: changes of liver enzymes
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Rafic Hariri University Hospital
Study officials:
affiliation: Rafic Hariri University Hospital
name: Dr. Akram Echtay, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817309: Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
Official title: Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peritoneal Dialysis Associated Peritonitis
Keywords: renal failure
survival
peritoneal failure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with PD peritonitis. After inform consent, specimens of PD effluent will be collected on the day of initiating antibiotic treatment, every 5 days until the day of completing antibiotic treatment, and then 28 days later for the test of LPS level. All patients will be followed for one year after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.


Eligibility criteria: Inclusion Criteria:

at least two of the followings:

1. abdominal pain or cloudy PD effluent;
2. leukocytosis in PD effluent (WBC \> 100/ml); and
3. positive Gram-stain or culture from PD effluent

Exclusion Criteria:

* mycobacterial peritonitis
* obvious surgical problems and require laparotomy

Primary outcomes:
measure: relapsing peritonitis
timeFrame: 1 month
measure: recurrent peritonitis
timeFrame: 1 month
measure: repeat peritonitis
timeFrame: 6 months
measure: conversion to long-term hemodialysis
timeFrame: 6 months
Secondary outcomes:
measure: peritonitis that requires hospitalization
timeFrame: 6 months
measure: catheter removal
timeFrame: 6 months
measure: death due to peritonitis
timeFrame: 6 months
measure: all cause mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Cheuk Chun Szeto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415009: Prevalence of IL28B Polymorphism in Hepatitis C Patients
Official title: Prevalence of IL28B Polymorphism in Hepatitis C Patients in Singapore and Its Effect on the Outcome of Hepatitis C Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: IL28B gene
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C patients with genotype 1, 2/3

Brief summary: Response to peginterferon and ribavirin treatment in hepatitis C (HCV) depends on viral and host factors. Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV genotype 1 infection, less so in HCV genotype 2/3 infection. CC genotype in rs12979860 and TT genotype at rs8099917 are associated with good treatment outcome. Asian populations have high prevalence of CC genotype in other studies, which can explain relatively good response to peginterferon/ ribavirin in genotype 1 infection in Asians compared with Caucasians.

Detailed description: The prevalence of different genotypes of IL28B polymorphism in the local population will be studied. DNA will be extracted from the whole blood sample of hepatitis C patients with genotype 1, 2 and 3 infection. It will be amplified by real-time PCR and subsequently analysed for the genotypes of IL28B SNPs.

Eligibility criteria: Inclusion Criteria:

* Patients with positive HCV IgG (EIA or RIBA test) and positive HCV RNA test (RT-PCR)
* HCV genotypes 1, 2 or 3 (determined by Versant™ HCV genotype Assay LiPA 2.0)
* with or without HCV treatment (peginterferon/ ribavirin).

Exclusion Criteria:

-Patients with acute hepatitis C infection.

Primary outcomes:
measure: the prevalence of genetic variants for IL28B SNPs (rs 12979860 and rs 8099917) in HCV patients in Singapore.
timeFrame: Baseline
Secondary outcomes:
measure: The distribution of the different SNP variants in different ethnic groups (Chinese, Malay, Indian and others)
timeFrame: Baseline
measure: The association of the genetic variants and the treatment response in patients receiving peg-interferon/ ribavirin therapy.
timeFrame: Baseline
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Poh Yen Loh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824109: Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position
Official title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aneurysmal Disease of the Abdominal Aorta
Occlusive Disease of the Abdominal Aorta
Keywords: Aneurysmal disease of the abdominal aorta
Occlusive disease of the abdominal aorta
Lead sponsor: Datascope Corp.
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.


Eligibility criteria: Inclusion Criteria:

* Is 18 - 85 years of age
* Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft
* Is affiliated with a social welfare organization system
* Is willing to participate in the clinical evaluation after signature of the informed consent
* Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol

Exclusion Criteria:

* Is treated as an emergency
* Is included in another investigation
* Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial
* Has a known allergy to the material device used
* Has previous aorto-iliac bypass or replacement

Primary outcomes:
measure: Graft patency at three years
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: 86021 Poitiers
country: France
facility: CHU La Miletrie, 350 av. Jacques Coeur
Study officials:
affiliation: Vascular Surgery Dept, CHU La Miletrie
name: Jean-Baptiste Ricco, MD
role: PRINCIPAL_INVESTIGATOR
References: