louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03217721: Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit
Official title: Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit : New Recommendations do They Change Our Clinical Practice ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia, Febrile
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pilot, exploratory, monocentric, retrospective, observational study

Brief summary: Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than \<1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.

Detailed description: We evaluate the adequacy antibiotics prescriptions in febrile neutropenia with suspected infection and evaluate factors influencing adequacy therapy and mortality consequence.

Eligibility criteria: Inclusion Criteria:

* Sepsis or septic shock at admission or during the stay

Exclusion Criteria:

* Minor
* Pregnancy
* Opposition

Primary outcomes:
measure: Proportion of adequate antibiotic prescription
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Mortality of all causes
timeFrame: ICU, hospital and 28-day mortality
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
citation: Schnell D, Azoulay E, Benoit D, Clouzeau B, Demaret P, Ducassou S, Frange P, Lafaurie M, Legrand M, Meert AP, Mokart D, Naudin J, Pene F, Rabbat A, Raffoux E, Ribaud P, Richard JC, Vincent F, Zahar JR, Darmon M. Management of neutropenic patients in the intensive care unit (NEWBORNS EXCLUDED) recommendations from an expert panel from the French Intensive Care Society (SRLF) with the French Group for Pediatric Intensive Care Emergencies (GFRUP), the French Society of Anesthesia and Intensive Care (SFAR), the French Society of Hematology (SFH), the French Society for Hospital Hygiene (SF2H), and the French Infectious Diseases Society (SPILF). Ann Intensive Care. 2016 Dec;6(1):90. doi: 10.1186/s13613-016-0189-6. Epub 2016 Sep 15.
Clinical trial NCT04101864: Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty
Official title: Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: navigation
hip arthroplasty
surgical time
landmark
Lead sponsor: Valdoltra Orthopedic Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sample size will be calculated. The Consolidated Standards of Reporting Trials statement guidelines will be followed to perform this prospective, randomized, controlled, trial and to present the results. Included patients will be randomly allocated in a 1:1 ratio into the study and the control group. Randomization will be conducted using computer-generated numbers.
Primary purpose: TREATMENT

Brief summary: A prospective randomized study comparing accuracy and precision of acetabular component placement in total hip arthroplasty with use of novel electromagnetic navigation system versus freehand technique.

Detailed description: Patients with hip arthritis, who are to be treated with total hip arthroplasty will be randomized in two groups. Patents allocated to study group will get their acetabular components implanted with the help of electromagnetic navigation system. Patients allocated to the control group will get their acetabular components implanted with freehand technique. Accuracy and precision of implanted acetabular components will be assessed on images obtained by postoperative computed tomography. Postoperative inclination and anteversion angles of acetabular components will be measured by the independent technician. Results will be statistically analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* age above 18 years
* unilateral surgery
* osteoarthritis of the hip
* no previous surgery on the affected hip
* implantation of the same acetabular component through the same approach
* signed informed consent

Exclusion Criteria:

* age under 18 years
* unwilling to participate
* prior surgery on affected hip

Primary outcomes:
measure: Acetabular component position
timeFrame: Up to 48 hours after surgery
Secondary outcomes:
measure: Surgical time
timeFrame: Immediately after surgical procedure
measure: Clinical result
timeFrame: 8-10 weeks postoperatively
Other outcomes:
Locations:
city: Ankaran
country: Slovenia
facility: Valdoltra Orthopedic Hospital
Study officials:
affiliation: Valdoltra Orthopedic Hospital
name: Rene Mihalič, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valdoltra Orthopedic Hospital
name: Rihard Trebše, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05841264: Growth Chart Parameters, Risk Factors
Official title: Comparison Between Children Growth Chart Parameters and Their Abnormality Associated Risk Factors in Assiut Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Growth Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children living in different areas have low incomes, high fertility, and provide poor care form their parents different socioeconomic state, different type of food

Brief summary: comparison between growth chart parameters and different risk factors which can cause abnormal growth chart parameter

Detailed description: Infant growth is defined as a positive change in body size over a period of time, and it is a sensitive predictor of an individuals' health. An inappropriate growth pattern indicates nutritional disorders, chronic and infectious diseases in infants. Early growth rate is related to adulthood health, such that it is important to develop the concept of appropriate growth for parents, in other to detect children with abnormal growth rates, as soon as possible .Weight and height of preschool children are the most common anthropometric measurements, to investigate a child's growth rate. Weight is the simplest and most reliable anthropometric measurement, and may be used as an indicator of childhood infection. On the other hand, height summarizes various measures of nutritional conditions in the first two decades of a human's life. Many children younger than 5 years in developing countries are exposed to multiple risks, including poverty, malnutrition, poor health, and unstimulating home environments, which detrimentally affect their cognitive, motor, and social-emotional development.

Eligibility criteria: Inclusion Criteria:

* All children attending primary health care units in Assiut governorate aged from one year to five year

Exclusion Criteria:

* 1. congenital anomalies 2. chronic diseases (D.M , thyroid dysfunction)

Primary outcomes:
measure: comparison of growth and development of children in different areas in Assiut governorate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: factors affecting growth and development of children in different areas in Assiut governorate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02591264: Periprocedural Myocardial Infarction: the Role of Human Neutrophil Peptide-1 to 3
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Thrombosis
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Troponin negative patients assigned for stent implantation in our medical institution.

Brief summary: The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Troponin negative patients
* Stable angina
* Unstable angina
* Positive screening tests

Exclusion Criteria:

* Troponin positive
* Technical failure of procedure
* Hemodynamic unstability

Primary outcomes:
measure: Human Neutrophil Peptide Level
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00808964: Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery
Official title: Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Disease
Keywords: CABG
anticoagulant
Off-Pump CABG
Lead sponsor: ARCA Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be conducted in up to 30 subjects. The study will evaluate subjects undergoing primary, elective, off-pump CABG surgery with median sternotomy.


Eligibility criteria: Inclusion Criteria:

* Must give written informed consent prior to initiation of any study related procedures
* Male or female subjects at least 18 years of age
* Subject is accepted for primary, elective off-pump CABG surgery with planned sternotomy without other planned concomitant cardiac surgical procedures
* New York Heart Association (NYHA) Class III or less heart failure
* Available for follow-up assessments

Exclusion Criteria:

* Prior surgery with median sternotomy
* Prior CABG surgery
* Women of childbearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives,barrier methods, or other contraception deemed adequate by the investigator); women who are pregnant or lactating
* Stroke within the previous 6 months
* History of stroke with residual neurological deficit
* Intracranial neoplasm, arteriovenous malformation or aneurysm
* Any prior exposure to NU172
* Contraindication to unfractionated heparin
* Refusal to undergo blood transfusion, should it be necessary
* Symptomatic gout
* Serum uric acid \>11mg/dL at screening
* Known bleeding diathesis
* Known thrombotic diathesis
* Participation in any study of an investigational device, drug or biologic within 30 days prior to planned surgery
* Any other disease or condition that, in the judgment of the investigator would interfere with the subject's ability to comply with study procedures and requirements

Primary outcomes:
measure: Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery
timeFrame: 30 day follow-up visit
Secondary outcomes:
measure: Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Nicholas Smedira, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02804464: The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
Official title: The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Marrow Transplant Infection
Lead sponsor: Karius, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2016-06-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are being evaluated for a stem-cell transplant at the University of California, San Francisco Hospital will be eligible for this study.

Brief summary: Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients who plan on undergoing an allogeneic stem cell transplant and are admitted to UCSF Medical Center.

Exclusion Criteria:

* Inability to provide informed consent and comply with study-related procedures

Primary outcomes:
measure: Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Peter Chin-Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693364: Acceptability of 3D Printed Breast Models as Surgical Decision Aids for Breast Cancer Treatment
Official title: 3D Printed Breast Models: Acceptability of Personalized Models in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer who are candidates for surgical management and agreed to have a 3D model created

Brief summary: This study is to find out the acceptability of a 3D printed breast model by patients as they consider their surgical treatment options. Researchers also want to learn the possible impact of the 3D printed breast model in the patient's decision making process.

Detailed description: PRIMARY OBJECTIVE:

I. To determine feasibility and explore the acceptability of 3 dimensional (3D) printed breast models as a decision aid in breast cancer treatment decision making.

OUTLINE:

Patients complete questionnaire over 5 minutes about difficulties in making decision about breast cancer treatment, then participate in a consultation with regular care doctor and study doctor/study staff using the 3D breast model. Patients then complete questionnaires over 5-10 minutes about their opinions on the breast model and different breast surgical treatment options available.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Women diagnosed with breast cancer
* Patient is a candidate for surgical management
* Patient has a surgeon at MD Anderson Cancer Center (MDACC) (main campus and/or regional care centers) who has agreed to have the 3D model created
* Patients with a breast magnetic resonance imaging (MRI) performed at the MD Anderson (at the West Houston location as well as main campus)
* Patient able to speak, read or write English
* PHYSICIAN ELIGIBILITY: Breast surgeon

Exclusion Criteria:

* Pregnant and breast feeding patients

Primary outcomes:
measure: Change in patient decisional conflict
timeFrame: 45 minutes - up to 12 months
measure: Acceptability of the 3D model
timeFrame: 45 minutes - up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Elsa Arribas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223664: Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis
Official title: The Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis Resulting From Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Cirrhosis
Keywords: ABMSC
Allogenic bone marrow mesenchymal stem cells
Liver cirrhosis
Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.


Eligibility criteria: Inclusion Criteria:

* Aged 16\~65 years.
* Serum HBsAg positive for over six months.
* Ultrasonographic evidences of cirrhosis

Exclusion Criteria:

* History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
* Prothrombin time is over 30s.
* Cirrhosis caused by other reasons except HBV infection.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Liver tumor on ultrasonography, CT or MRI examination.
* Pregnant or lactating women.
* Imaging evidences of vascular thromboses.

Primary outcomes:
measure: Liver Function
timeFrame: 12 months
Secondary outcomes:
measure: Immunity
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: SunYat-sen University
name: Lin B Liang, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733564: Evaluation of Different Anesthesia for Uterine Curettage
Official title: Evaluation of the Anesthetic Efficacy of Propofol,Sevoflurane and Paracervical Block for Uterine Curettage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Curettage
Abortion, Induced
Keywords: Local anesthetic
Propofol
Sevoflurane
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.


Eligibility criteria: Inclusion Criteria:

* ASA status I-II
* Performing abortion operation (medical- or surgical)
* Requiring painless abortion

Exclusion Criteria:

* \< 19 yrs, and \>=45 yrs
* History of central active drugs administration
* Drug abuse
* Hypertension
* Diabetes
* Any other chronic diseases
* Allergy to the study drugs
* Habit of over-volume alcohol drinking
* Records of history of centrally active drug use and psychiatry
* Any organic disorder

Primary outcomes:
measure: Bispectral Index (BIS) value
timeFrame: 0, 5, 10, 20, 30min after anesthesia
Secondary outcomes:
measure: Intraoperative awareness
timeFrame: 0, 5, 10, 20, 30min after anesthesia
measure: Vital signs
timeFrame: 0, 5, 10, 15, 20, 25, 30min after anesthesia
measure: Arterial blood gas analysis
timeFrame: 5min before operation; 1min and 5min after beginning of the operation
measure: Pain intensity
timeFrame: 0, 5, 10, 20, 30min after surgical procedures
measure: Cortisol level
timeFrame: 30min before operation; 1 and 5min during operation
measure: Side effects
timeFrame: 30min after operation
measure: Uterine bleeding
timeFrame: 0min after completion of the operation; 1 hour after the operation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: