louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00708513: Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.
Official title: Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticoduodenectomy
Pancreatectomy
Esophagectomy
Gastrectomy
Hepatectomy
Keywords: Cell Saver
Liver Tumors
Liver Cancer
Surgical Oncology
Whipple
Blood Transfusion
Blood salvage
cancer surgery
blood loss
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 98
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: Surgical Oncology Clinic

Brief summary: The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.

Detailed description: Homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. Recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal.

This research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. The blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells.

This study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.

Eligibility criteria: Inclusion Criteria:

1. Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
2. Subject is ≥ 18 years of age.
3. Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.

Exclusion Criteria:

1. Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
2. Subject is \< 18 years of age.
3. Subject or Subject's LAR did not sign IRB-approved informed consent form.

Primary outcomes:
measure: Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration
timeFrame: Hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert CG Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03095313: 18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Official title: 18-F Sodium Fluoride (18F-NaF) Positron Emission Tomography (PET) for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aortic Stenosis
Keywords: Transcatheter Aortic Valve Replacement (TAVR).
Surgical bioprosthetic aortic valve replacement
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters.

Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.

Detailed description: This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Techniques that can identify specific increases in calcification activity are therefore likely to provide important insights into predicting the longevity of TAVR valves and guidance towards subsequent interventions.

Twenty patients whom have undergone either TAVR or surgical bioprosthetic aortic valve replacement will be invited to participate in an 18F-NaF PET scan (baseline) and CT scan imaging (baseline and Year 2). Baseline, Year 1 and 2 will also include clinical assessment, labs and echocardiograms. Telephone contact at Years 3, 4, and 5 will provide follow up for major cardiovascular adverse events.

Eligibility criteria: Inclusion Criteria:

* Aged ≥60 years
* Patients between 1 month and 5 years following transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement

Exclusion Criteria:

* Inability to provide informed consent
* Creatinine \>1.5 mg/dL
* History of severe allergy to iodine contrast agents
* Active atrial fibrillation
* Paget's disease
* Metastatic malignancy

Primary outcomes:
measure: Presence of calcification activity within the replacement valve by 18F-NaF PET-CT
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Daniel S. Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06567613: Validation of a Swiss German Language Test for Children
Official title: Validation of a Swiss German Language Test for Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: University Hospital, Zürich
name: Luzerner Kantonsspital
First posted: 2024-08-23
Enrollment: 180
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children without hearing loss

Brief summary: The aim of this study is to validate a Swiss German children's language test. Standard values for the speech intelligibility of Swiss German monosyllables and disyllables for children with normal hearing aged 4-6 years are recorded.


Eligibility criteria: Inclusion Criteria:

* Native Swiss German speakers
* Hearing threshold better than 20dB HL at 0.5, 1, 2 and 4kHz
* Written informed consent by the parents

Exclusion Criteria:

* Hearing loss
* Cognitive impairment

Primary outcomes:
measure: Speech reception threshold for monosyllabic words
timeFrame: Single visit at baseline
measure: Speech reception threshold for bisyllabic words
timeFrame: Single visit at baseline
Secondary outcomes:
measure: Speech reception threshold in noise for monosyllabic words
timeFrame: Single visit at baseline
measure: Speech reception threshold in noise for bisyllabic words
timeFrame: Single visit at baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Inselspital Bern, Berne University Hospital
name: Christoph Schmid
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01887613: Specified Drug Use-Results Survey of Regnite
Official title: Specified Drug Use-Results Survey of Regnite
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Keywords: Gabapentin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 1597
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe idiopathic restless legs syndrome

Brief summary: This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.

Detailed description: Sleeping condition and severity of restless legs syndrome (RLS) were recorded at the start and during the treatment. The treatment period is scheduled to last 52 weeks in principle. For patients completing or discontinuing the use of Regnite® within 52 weeks, follow up on the withdrawal and rebound syndrome will be conducted up to 4 weeks of completion or discontinuation.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe idiopathic restless legs syndrome

Exclusion Criteria:

* Patients with a history of hypersensitivity to any ingredients in Regnite or gabapentin
* Patients with severely impaired renal function (creatinine clearance of less than 30 mL/min)

Primary outcomes:
measure: Safety such as occurrence of adverse drug reactions and lab-tests
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Restless Leg Syndrome score
timeFrame: Baseline and at 52 weeks
measure: Clinical Global Impression
timeFrame: Baseline and at 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05978713: A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
Official title: A Study to Evaluate Tirzepatide Concentrations in Breastmilk Following Administration of Single Dose of Tirzepatide by Subcutaneous Injection in Healthy Lactating Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy females as determined by medical evaluation
* Female participants who delivered normal-term infant (at least 37 weeks gestation) and are at least 6 weeks postpartum at the time of screening
* Body mass index (BMI) between 18.5 and 40.0 kilograms per meter squared (kg/m²), inclusive
* Female participants who has well-established lactation and is breastfeeding her infant. Note: Breastfeeding must be discontinued prior to the administration of tirzepatide on Day 1 and not resumed for the remaining duration of the study until a follow-up visit (or for total of 29 days after tirzepatide dosing for participants who discontinue early).

Exclusion Criteria:

* Have a history of inadequate lactation (for multiparous females who have previously breastfed)
* Have confirmed type 1 or type 2 diabetes mellitus
* Regularly use known drugs of abuse or show positive findings on drug screen

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])
timeFrame: Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Las Vegas Clinical Research Unit - PPD
state: Nevada
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05090813: A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens
Official title: A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Eyhance™ Intraocular Lens Model ICB00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All subjects will be followed for 12 months postoperatively.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients at least 22 years of age
2. Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens
3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
4. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion Criteria:

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
2. Planned monovision correction (one eye designated for near correction).
3. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Primary outcomes:
measure: mean monocular postoperative DCIVA
timeFrame: 6 months
measure: percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6
state: Hainan
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05785013: The Impact of Preoperative Supplementation of Zinc
Official title: The Impact of Preoperative Supplementation of Zinc on Post-operative Outcomes in Children Undergoing Elective Surgery for Hirsch Sprung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Nutrition Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Pre operative anthropometric assessment including : weight in kg, height/length and BMI
2. Pre operative Zinc supplementation (dose according to the age) for 7 days preoperatively for cases
3. Postoperative data collection

Detailed description: Postoperative data collection :

* Length of hospital stay
* Complication and sorting of them
* Lab withdrawal of inflammatory markers on 2-3 day postoperatively

Eligibility criteria: Inclusion Criteria:

1. All children patients with Hirschsprung disease admitted for surgical intervention with different ( age , sex )
2. Type of surgery : transanal pull through
3. Whose parents or caregivers approve for the participation in the study

Exclusion Criteria:

1. Patients with emergency situations
2. Whose parents or caregivers will not apply for the participation in the study

Primary outcomes:
measure: The effect of preoerative Zinc supplementation on the hospital length stay in children operated for Hirschsprung's disease
timeFrame: zinc supplemenation for one week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hoda Atef Abdelsattar Ibrahim
Study officials:
References:
Clinical trial NCT00763113: A Prospective Randomized Study on Vanguard Cruciate Retaining Versus Vanguard High Flex Posterior Stabilized Total Knee System in the Early Range of Motion
Official title: A Prospective Randomized Study on Vanguard Cruciate Retaining Versus Vanguard High Flex Posterior Stabilized Total Knee System in the Early Range of Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Main Objectives are: Test Difference in terms of early ROM between Vanguard FB CR and Vanguard FB PS. Knees; Demonstrate the comparable ROM of high flex PS to CR.


Eligibility criteria: Patients need total knee replacement

Primary outcomes:
measure: Knee Society Score
timeFrame: 6weeks, 6months, 1 year
Secondary outcomes:
measure: WOMAC
timeFrame: 6weeks, 6months, 1 year
measure: Oxford Knee
timeFrame: 6weeks, 6months, 1 year
measure: Complication
timeFrame: Anytime
Other outcomes:
Locations:
city: Ontario
country: Canada
facility: St. Catharines Hospital
Study officials:
affiliation: St. Catharines Hospital
name: David Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04387513: Impact of Early Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Retrospective Study
Official title: Impact of Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Multicentric,Retrospective, Propensity-score Matching Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocarditis
Neurologic Complication
Lead sponsor: Gros, Alexandre, M.D.
Sponsor class: INDIV
First posted: 2020-05-14
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients in intensive care unit. They all have an indication of surgery, but they are not all operated (neurological or others contre-indications).

Brief summary: Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.

Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.

Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.

Primary endpoint:

1) Mortality at 1 year

Secondary endpoints:

1. Analyze the factors associated with neurological degradation
2. Evaluate the neurological tolerance of cardiac surgery.

Detailed description: Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.

Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.

Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.

Primary endpoint:

1) Mortality at 1 year

Secondary endpoints:

1. Analyze the factors associated with neurological degradation
2. Evaluate the neurological tolerance of cardiac surgery.

Methods Multicentric study (7 French university hospitals). Retrospective study: from august 2010 to december 2017. Propensity score matching study. 192 patients are included.

Eligibility criteria: Inclusion Criteria:

* Left endocarditis
* With indication of cardiac surgery
* Severe endocaditis (SOFA score \> or = 3/16)
* With pre operative neurological complications

Exclusion Criteria:

* Age \< 18
* Right endocarditis without left endocarditis
* No severe endocarditis (SOFA score \< 3)
* Ne pre operative neurological complications
* Endocarditis without indication of cardiac surgery

Primary outcomes:
measure: Mortality
timeFrame: at 1 year after the diagnosis of endocarditis
Secondary outcomes:
measure: Neurogical tolerance
timeFrame: At 6 months
Other outcomes:
Locations:
Study officials:
References: