louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00728624: Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns
Official title: Expert Group On Antibiotic Susceptibility Testing [EGAST] 2008: A Non-Interventional, Multicenter In-Vitro Study To Evaluate The Prevalence Of Beta-Lactamase Producing Strains Among Clinical Isolates Obtained From Hospital In-Patients And Comparison Of Antimicrobial Susceptibility Using Disc-Diffusion Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Antibiotic susceptibility; beta lactamase; ESBLs
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 2039
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Isolates from hospitalised patients

Brief summary: EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites).

Objectives:

* Comparison of antimicrobial susceptibility using disc-diffusion method
* Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients

Detailed description: n/a n/a

Eligibility criteria: Inclusion Criteria:

Isolates (as specified in the observational plan) from hospitalised patients

Exclusion Criteria:

Isolates obtained from outpatients will not be included for the study. Isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded.

Isolates identified as commensals or contaminants will be excluded

Primary outcomes:
measure: Comparison of antimicrobial susceptibility using disc-diffusion method
timeFrame: duration of trial
Secondary outcomes:
measure: Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients
timeFrame: duration of trial
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Manipal
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chandigarh
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Porur, Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
city: Chennai
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00781924: Interventional Sonography Guided by Image Fusion
Official title: Interventional Sonography Guided by Image Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Liver Lesions
Focal Lesions in the Abdomen
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-10-29
Enrollment: 60
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: patients with focal liver lesions where biopsy is needed or the lesion has to be verified by sonography

Brief summary: The purpose of this study is to register the precision of image fusion between live sonography and CT, MRI or PET/CT of liver lesions and other focal lesions in the abdomen. To test whether it will be possible to biopsy guided by image fusion.


Eligibility criteria: Inclusion Criteria:

* Focal liver lesion seen on CT, MRI or PET/CT

Primary outcomes:
measure: Verification of the tumor by sonography
timeFrame: baseline only
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
References:
citation: Ewertsen C, Henriksen BM, Hansen CP, Knigge U. Synchronous gastric neuroendocrine carcinoma and hepatocellular carcinoma: a case report. BMJ Case Rep. 2009;2009:bcr03.2009.1667. doi: 10.1136/bcr.03.2009.1667. Epub 2009 Sep 15.
Clinical trial NCT06735924: Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis
Official title: Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: oxalate synthesis
oxalate metabolism
MASLD
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-12-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Detailed description: Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use a low-oxalate controlled diet, repeat fasted urine collections and 24-hr urine collections on a low-oxalate diet, to determine the daily rate of endogenous oxalate synthesis in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* History of MASLD, with liver fat content \> 5%
* Normal kidney function
* Stable medication for at least 1 month for diabetes mellitus if any
* Willingess to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits

Exclusion Criteria:

* Age \< 18 years
* Inaccurate 24-hour urine collections
* Liver fat content \<5%
* Liver cirrhosis
* Evidence of other chronic liver disease, viral hepatitis
* history of alcoholism within 2 years of enrollment
* Contra-indication to Magnetic Resonance Imaging
* Chronic kidney disease with estimated Glomerular Filtration rate \< 60 ml/min/1.73m2
* Type 1 Diabetes Mellitus or treatment with insulin
* Uncontrolled diabetes
* Pregnancy, lactation or intention to be
* Uncontrolled hypertension
* Use of weight loss medication, SGLT2 inhibitors, GLP-1 receptor agonists, osteoporosis medication, chronic NSAID
* History of gastric or intestinal surgery or resection that could potentially alter oxalate absorption
* Chronic fat malabsorption
* Use of immunosuppressive medications
* Known immuno-compromised status
* Active malignancy or treatment for malignanacy within the last 12 months

Primary outcomes:
measure: estimated endogenous oxalate synthesis rate
timeFrame: 1 day
Secondary outcomes:
measure: Urinary Oxalate excretion
timeFrame: 2 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kyle D Wood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210924: Chinese Network of Pediatric Antiretroviral Therapy
Official title: Chinese Study of Pediatric Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Keywords: children
Acquired Immunodeficiency Syndrome
antiretroviral therapy
China
Mortality
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
First posted: 2010-09-29
Enrollment: 400
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric HIV-infected patients receiving triple antiretroviral drugs

Brief summary: This is an observational cohort in pediatric HIV patients in China. Children who receive antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1. To establish simpler and smarter pediatric antiretroviral therapy in China including both first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms of immunoreconstitution in HIV-infected children using the data and samples from the pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical research network based on the pediatric antiretroviral cohort.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of HIV infection
* receiving triple antiretroviral drugs

Exclusion Criteria:

* clinical status not stable

Primary outcomes:
measure: The immunology and virologic outcomes
timeFrame: 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for AIDS/STD Control and Prevention, China Center for Disease Control and Prevention
Study officials:
affiliation: National Center for AIDS/STD control and prevention
name: Fujie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903524: Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer
Official title: The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients


Eligibility criteria: Inclusion Criteria:

* Female patients with age between 18 and 70 years.
* Newly diagnosed breast cancer, stages IIb-IIIc.
* KPS performance status≥70.
* Measurable disease according to RECIST version 1.1.
* Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
* Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
* Adequate hepatic and renal function.
* AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
* Serum creatinine≥44 µmol/L and ≤133 µmol/L.
* Written informed consent are acquired.
* Not in pregnancy or the pregnancy tests of females is negative.

Exclusion Criteria:

* Severe heart failure (NYHA grade II or higher).
* Active and uncontrolled severe infection.
* Have accepted any other anti-tumor drug within 30 days before the first dose or
* received radiation treatment.
* Other situations that investigators consider as contra-indication for this study.

Primary outcomes:
measure: pathological complete response
timeFrame: until the completion of 4 cycles (each cycle is 21 days) of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Shi Jiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT00458224: Prevention of Permanent Obesity in Children
Official title: Prevention of Permanent Obesity in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Child
Keywords: overweight
obesity
child
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2007-04-10
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In the county of Oppland, Norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. Particularly growth, physical activity and diet is addressed.

Families who have children with a BMI \>18.9, which corresponds to BMI\>30, and living in selected municipalities in the county are invited to participate in a 5 year intervention program in order to avoid future overweight conditions in children. Similarly overweight children from the rest of the county serve as controls.

Detailed description: Background: Intervention programs to limit or reduce weight in severely obese adults and adolescents are rarely successful. In the present study intervention is aimed at moderately overweight children of 6 years.

Families in 7 municipalities who have children with BMI \>18.9 are invited to a group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training. The families are invited to meet in groups times the first year, two times the second and one time the third year. According to personal interest the families are also invited to meet with the nurse between each of the the above gatherings.

The children are examined by a pediatrician before entry and after 1, 2, 3 and 5 years with specific focus on height and weight. No blood studies are routinely done.

BMI development will be related to BMIs in the family, mother's weight increase in pregnancy, socioeconomic background, general health, psychological factors scored through the Strengths And Difficulties Questionnaire, and compliance with the program. Furthermore, the results are compared to similarly overweight children from the counties who are not invited to participate in the intervention program. The results are obtained through the routine health follow-up programs in school.

Eligibility criteria: Inclusion Criteria:

* BMI \> 18.9
* Age 5-7 years
* Residing in Oppland county

Exclusion criteria:

* chronic disease

Primary outcomes:
measure: Effect of BMI from a specific family oriented program
timeFrame: 1, 3 and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Sykehuset innlandet HF, Department of Pediatrics
Study officials:
affiliation: Sykehuset Innlandet HF
name: Trond Markestad, Md. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218124: Optimal Remifentanil Concentration and Thyroidectomy
Official title: Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Thyroidectomy
Remifentanil
Extubation
Cough
Target controlled infusion
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational study. Decreasing/increasing remifentanil effect site concentrations (Dixon's up and down model) to obtain cough-free extubation after thyroidectomy
Primary purpose: OTHER

Brief summary: The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose.

Possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.


Eligibility criteria: Inclusion Criteria:

* 18\<age\<67
* 6 hrs fasting
* American society of anesthesiology (ASA) Physical Status I o II
* Informed consent

Exclusion Criteria:

* Absence of inclusion criteria
* Use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery
* Arhythmia, pacemaker or unstable cardiovascular disease
* Hepatic or renal failure
* Anticipated difficulty in airways management
* Chronic obstructive pulmonary disease (COPD), Asthma, increased risk for inhalation, airway infection in the previous 4 weeks;
* Smoker
* Obesity (BMI \>35)
* Pregnancy
* Hypersensitivity to drugs administered for the study

Primary outcomes:
measure: Cough
timeFrame: 15 minutes after surgery
Secondary outcomes:
measure: Hemodynamics 1
timeFrame: 15 minutes after surgery
measure: Hemodynamics 2
timeFrame: 15 minutes after surgery
measure: Respiratory outcome 1
timeFrame: 15 minutes after surgery
measure: Respiratory outcome 2
timeFrame: 15 minutes after surgery
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: Policlinico Duilio Casula
state: Cagliari
Study officials:
affiliation: Cagliari University
name: Gabriele Finco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877824: Study of Fast-track Surgery in Hernia Repair and Laparoscopic Cholecystectomy
Official title: Consequences of Fast-track Training in Surgery in Denmark in Selected Operative Skills.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Training
Keywords: Surgery
Training
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: Aalborg University Hospital
name: TRYG Foundation
First posted: 2013-06-14
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: All Danish trainees in surgery in a two-year period asked for participation when enrolled in the formal five-year training program for specialty in surgery. The participants are randomized for either educational intervention or control (without intervention). The intervention group receive a skills-lab course in hernia repair followed by an opportunity to perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance will be video recorded three times during the intervention and as follow-up at end of the first year of training. After termination of the hernia training program a similar program for laparoscopic cholecystectomies are made. Each participant receive both intervention. The control group are video recorded at start of their first year and at end. All videos are blindly assessed with a validated rating scale of operative performance. The purpose is to assess if a fast-track program improves technical skills and if a change is sustained. Furthermore we want to compare outcome in similar training programs in open and laparoscopic skills.


Eligibility criteria: Inclusion Criteria:

* Medical doctors accepted for formal surgical training in Denmark in 2010-11.

Exclusion Criteria:

* Current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures.
* Employed at a non-participating hospital.

Primary outcomes:
measure: Technical skills in performed surgical procedures
timeFrame: Three years
Secondary outcomes:
measure: Operative time
timeFrame: Three years
measure: Satisfaction
timeFrame: Three years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Centre of Medical Education
Study officials:
affiliation: University of Aarhus
name: Peder Charles, MD, DMSci
role: STUDY_CHAIR
References:
citation: Carlsen CG, Lindorff-Larsen K, Funch-Jensen P, Lund L, Konge L, Charles P. Module based training improves and sustains surgical skills: a randomised controlled trial. Hernia. 2015 Oct;19(5):755-63. doi: 10.1007/s10029-015-1357-6. Epub 2015 Mar 3.
Clinical trial NCT05719324: Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study
Official title: Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunotherapy
Keywords: Immunotherapy
Checkpoint inhibitor
Solid tumor
Predictor
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable solid tumors confirmed by histopathology or cytology, and continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.

Brief summary: This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.

Detailed description: The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old and gender is not limited.
* Patients with unresectable solid tumors confirmed by pathology or histology.
* Patients received checkpoint inhibitor therapy for 2 cycles or more.

Exclusion Criteria:

* Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
* Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment.
* Pregnant or breastfeeding women.
* Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
* The investigator judges that other conditions are not suitable for inclusion in the study.

Primary outcomes:
measure: Progression-free survival (PFS）
timeFrame: Up to 24 months.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 24 months.
Other outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 24 months.
measure: Disease Control Rate (DCR)
timeFrame: Up to 24 months.
measure: Adverse events (AE)
timeFrame: Up to 24 months.
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Lingxiang Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: