louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00265499: The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison
Official title: Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Bypass
Skeletonization
Internal Thoracic Artery
Flow
Length
Pain
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2005-12-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether skeletonization of the internal thoracic artery leads to improved flow, increased length, improved sternal perfusion, and decreased pain and dysesthesia in patients undergoing coronary artery bypass surgery

Detailed description: Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Although the benefits of ITA use are well established, there are certain limitations to its routine use. Recent studies, primarily observational, have suggested that skeletonization of the ITA (i.e. harvesting of the ITA alone) may overcome some of these limitations by improving conduit flow, increasing length, and reducing the risk of deep sternal infection in high risk patients. Furthermore, skeletonization of the ITA can potentially preserve intercostal nerves and reduce post-operative pain and dysesthesias associated with ITA harvesting. In order to assess the effects of ITA skeletonization, this is a prospective, randomized, within-patient study design in patients undergoing coronary artery bypass grafting.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing bilateral internal thoracic artery harvest for coronary artery bypass surgery

Exclusion Criteria:

* Inability to speak English or French
* Inability to complete follow-up visits

Primary outcomes:
measure: Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses
Secondary outcomes:
measure: - Internal Thoracic Artery length
measure: - Sternal Perfusion (SPECT imaging)
measure: - Post-operative pain and dysesthesia
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Institute, Division of Cardiac Surgery
name: Fraser D. Rubens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04168099: Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
Official title: Comparative Study Between the Efficacy of Oral Gemifloxacin and Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Detailed description: Comparative Study between the Efficacy of oral Gemifloxacin and intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Eligibility criteria: Inclusion Criteria:

* Patients with spontaneous bacterial peritonitis

Exclusion Criteria:

* secondary peritonitis

Primary outcomes:
measure: Number of patients with resolution of infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: Hala Shaaban El Gendy, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Tropical Medicine Dept.-Tanta University - Faculty of Medicine
name: Osama El Sayed Negm, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tropical Medicine Dept.-Tanta University - Faculty of Medicine
name: Sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05248399: Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19
Official title: Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Latino Day Laborers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to adapt and pilot test the feasibility of implementing a corner-based risk reduction program that aims to assist Latino day laborers (LDL) in their efforts to adhere to COVID-19 mitigation practices, including receiving the COVID-19 vaccine, using personal protective equipment (PPE), and practicing social distancing.


Eligibility criteria: Inclusion Criteria:

* Self-identify as Hispanic or Latino
* Be present at the corner for the purposes of looking for work

Exclusion Criteria:

* Have not been previously hired to work at a corner
* Symptoms of COVID-19 in the previous 48 hours

Primary outcomes:
measure: Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey
timeFrame: Baseline, 4 weeks post intervention
Secondary outcomes:
measure: Change in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a Survey
timeFrame: Baseline, 4 weeks post intervention
measure: Change in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a Survey
timeFrame: Baseline, 4 weeks post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez-Esquer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02634099: A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery
Official title: Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Keywords: major pediatric surgery
hemoglobin measurement
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

Detailed description: The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

Eligibility criteria: Inclusion Criteria:

Paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia Arterial catheter necessary in the anesthetic protocol. BMI\<30 No opposition holders of parental authority and children.

Exclusion Criteria:

Hemoglobin disease Pretreatment with erytropoietin or iron

Primary outcomes:
measure: comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision
timeFrame: within the day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Chru Nancy
Study officials:
affiliation: CHRU NANCY
name: Claude MEISTELMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888599: Knowledge and Attitudes Towards Human Papillomavirus Infections and HPV Vaccination
Official title: Knowledge and Attitudes Towards Human Papillomavirus Infections and HPV Vaccination Among Undergraduate Health Students From Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV-Related Cervical Carcinoma
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women above the age of 18 years, currently attending the School of Health Sciences of three selected Swiss towns to obtain a nurse or midwife degree

Brief summary: A better understanding of the target audiences about HPV infection and HPV vaccination would surely allow for a better spread of this vaccination in Switzerland. In order to know if the target audiences are properly informed, we have decided to carry out a study evaluating their level of knowledge on a particular audience that are the men and women undergraduate nurse.


Eligibility criteria: Inclusion Criteria:

* Eligible women and men aged between 18-36 years
* Understands study procedures and accepts voluntarily to participle of the study

Exclusion Criteria:

.Don't understand french language

Primary outcomes:
measure: Questionnaire about basic knowledge HPV infection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Jeannot
Study officials:
References:
Clinical trial NCT01110499: Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Primary Open-Angle Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.


Eligibility criteria: Inclusion Criteria:

- Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

* Any active ocular disease
* Anticipated wearing of contact lenses during study
* Anticipated use of artificial tears during study
* Contraindication to pupil dilatation

Primary outcomes:
measure: Part 1: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, Day 7
measure: Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
timeFrame: Baseline, Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05919199: PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia
Official title: The Efficiency of 18F-FDG PET Probe Signal in Bone Marrow for Predicting Acute Myeloid Leukemia Patients' Response to Induction Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Bone marrow micro-environment
18F-fluorodeoxyglucose
cancer metabolism
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AML patients in First Affiliated Hospital of Jinan University

Brief summary: The purpose of this study is to evaluate the predictive value of 18F-FDG PET probe signal in de novo diagnosed or refractory/relapsed patients with acute myeloid leukemia. It is hypothesized that the intensity of 18F-FDG signal, an indicator of glucose uptake capacity, in various cell subsets of bone marrow will improve the predictive effect of clinical standard prognostic work-up.

Detailed description: Rationale:

FDG is incorporated by leukemia cells and other cell subsets in bone marrow micro-environment of various degree. The heterogeneous FDG uptake is a promising marker for predicting response to treatment. The investigators will collect bone marrow under standard clinical work-up after 18F-FDG PET/CT scan and correlate the FDG signal intensity with clinical and genomics features of the patients to explore its prognostic significance.

Objective:

The primary objective of this research project is to investigate the intensity of FDG PET probe based glucose uptake signal in predicting induction treatment response of AML. As secondary objectives, this analysis will be applied to calculate the overall predictive specificity and sensitivity of FDG probe avidity in predicting PFS and OS.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Acute myeloid leukemia, non APL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients voluntarily participated in this study and signed the informed consent

Exclusion Criteria:

* Pregnant
* Uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)

Primary outcomes:
measure: Composite complete remission rate (CRc)
timeFrame: At the end of Cycle 2 (each cycle is about 28 days)
Secondary outcomes:
measure: Progress-free survival (PFS )
timeFrame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
affiliation: First Affiliated Hopital of Jinan University
name: Hui Zeng
role: STUDY_CHAIR
References:
Clinical trial NCT01510899: A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
Official title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.


Eligibility criteria: Inclusion Criteria:

General criteria

* Body mass index (BMI) between 18 and 32 kg/m2

Criteria applying to renal impaired subjects

* Adult subjects, 18-65 years of age
* Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
* Part 2: Subjects with severe, moderate or mild renal impairment
* Stable renal function

Criteria applying to healthy subjects

* Adult subjects, 18-70 years of age

Exclusion Criteria:

General criteria

* Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
* Any condition which could relapse during or immediately after the study
* History of alcohol or drug abuse

Criteria applying to renal impaired subjects

* Evidence of unstable clinically significant disease other than renal impairment
* Clinically significant liver disease
* Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start

Criteria applying to healthy subjects

* History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)

Primary outcomes:
measure: Pharmacokinetics: Area under concentration time curve of RO4917838
timeFrame: Days 1-16
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Rennes
country: France
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00481299: Insulin Resistance in Women With Prolactinoma
Official title: Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolactinoma
Insulin Resistance
Hyperlipidemia
Keywords: Insulin
glucose
lipids
prolactinoma
hyperprolactinemia
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 2004
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma.

The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.

Detailed description: A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.

Eligibility criteria: Inclusion Criteria:

* Prolactinoma
* Female gender
* Premenopausal

Exclusion Criteria:

* Obesity (BMI ≥ 30 kg/m²)
* Diabetes mellitus
* Hypertension
* GH deficiency
* Hypothyroidism
* Primary hypogonadism
* Adrenal insufficiency
* Pituitary surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clementino Fraga Filho University Hospital
state: RJ
Study officials:
affiliation: Federal University of Rio de Janeiro - Brazil
name: Erika CO Naliato, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02268799: High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter
Official title: High Sensitivity Troponin T Levels Following Elective External Direct Current Cardioversion for Atrial Fibrillation / Atrial Flutter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Cardioversion
High Sensitivity Troponin T (Hs-Trop T)
Brain Natriuretic Peptide (BNP)
Neutrophil Gelatinase-associated Lipocalin (NGAL)
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 101
Sex: ALL
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: Patients with atrial fibrillation/flutter who attend the Coronary Care Unit of the University Hospital Limerick for a pre-organised appointment for direct current external cardioversion will be requested to participate in the study

Brief summary: The purpose of this study is to determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. This will help us determine if direct current cardioversion results in damage to the heart muscles in a sufficient amount to cause a rise in high sensitivity troponin T.

Detailed description: High sensitivity Troponin T is a relatively new biomarker that is highly sensitive and specific for myocardial injury. Its widespread use has helped in the determination and investigation for myocardial ischemia in patients. Previous studies have shown a rise in creatine kinase (CK) and the more specific creatine kinase-MB isoenzyme (CKMB) after DC cardioversion. Studies on the earlier generation troponin T found that the levels don't rise or rise only minimally after DC cardioversion. The high sensitivity troponin T has never been studied in the setting of DC cardioversion.

Eligibility criteria: Inclusion Criteria:

* Patients with atrial fibrillation / atrial flutter attending for direct current external cardioversion
* Age 18 or older

Exclusion Criteria:

* Myocardial infarction within the last 6 weeks
* Coronary artery bypass grafting, percutaneous coronary intervention or any other invasive cardiac procedure within the last 6 weeks

Primary outcomes:
measure: High Sensitivity Troponin T levels pre and 6 hours post cardioversion
timeFrame: 1 year
Secondary outcomes:
measure: Creatine Kinase levels pre and 6 hours post cardioversion
timeFrame: 1 year
measure: B-type Natriuretic Peptide (BNP) levels pre and 6 hours post cardioversion
timeFrame: 1 year
measure: Neutrophil Gelatinase-associated Lipocalin (NGAL) levels pre and 6 hours post cardioversion
timeFrame: 1 year
Other outcomes:
Locations:
city: Dooradoyle
country: Ireland
facility: University Hospital Limerick
state: Limerick
Study officials:
affiliation: University of Limerick
name: Thomas J Kiernan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02156999: Changes of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment
Official title: Changes of Bone Turnover Markers and Bone Mineral Density After Treatment in Osteoporotic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients


Eligibility criteria: Inclusion Criteria:

* Osteoporosis

Exclusion Criteria:

* Kidney, parathyroid, congenital bone metabolic disease

Primary outcomes:
measure: Changes of bone mineral density
timeFrame: every 4-6 months
Secondary outcomes:
measure: Improvement of bone turnover markers
timeFrame: Every 3-6 months
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
state: Nagano
Study officials:
References: