louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01907750: Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT
Official title: Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Living Donor Liver Transplantation
Keywords: biliary fistula
biliary stricture
biliary drainage tube
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.

Detailed description: a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).

A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.

the study is to compare the effectiveness and safety of 2 different placement techniques:

1. the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct
2. a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)

Eligibility criteria: Inclusion Criteria:

* living donor liver transplantation
* single bile duct in the graft

Exclusion Criteria:

* multiple bile ducts

Primary outcomes:
measure: early postoperative biliary fistula
timeFrame: 2 weeks
Secondary outcomes:
measure: biliary stricture
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gastro-enterolgy surgical center, Mansoura University
state: Al-Dakahleia
Study officials:
affiliation: Gastro-enterology surgical center, Mansoura University
name: Ahmad M Sultan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastro-enterolgy surgical center, Mansoura University
name: Mohammed Abdul-Wahab, MD, PhD
role: STUDY_CHAIR
affiliation: Gastro-enterolgy surgical center, Mansoura University
name: Tarek Salah, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00693550: Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
Official title: Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-06-09
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona

Brief summary: RATIONALE: Gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer.

PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.

Detailed description: OBJECTIVES:

* Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma.
* Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations.

OUTLINE: This is a multicenter study.

* Participants undergo metal patch testing using 27 metals\* commonly used in dental repairs that are part of the Mayo metal series. Metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. Relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented.

NOTE: \*Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Newly or previously diagnosed oral squamous cell carcinoma

    * Recruited from the otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
  * Healthy volunteer (control)

    * No history of intraoral squamous cell carcinoma
    * Employed at Mayo Clinic Rochester or Mayo Clinic Arizona

PATIENT CHARACTERISTICS:

* No immunosuppression
* No other conditions that interfere with patch testing

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Relationship between intraoral metal contact allergy and epithelial carcinogenesis
timeFrame: one year
measure: Prevalence of metal contact allergy comparison to study control data
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James A. Yiannias, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01780350: Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Hypotension
Lead sponsor: Advanced Circulatory Systems
Sponsor class: INDUSTRY
First posted: 2013-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.


Eligibility criteria: Inclusion Criteria:

* adults between the ages of 18-120 years
* presenting to EMS with or development of Hypotension during EMS interaction
* treated by EMS with the ITD

Exclusion Criteria:

* pediatric patients
* patients that do not present with or develop hypotension
* patients who the ITD will not form a secure seal due to anatomical abnormalities

Primary outcomes:
measure: Change in Systolic Blood Pressure From Baseline (Before ITD Use)
timeFrame: During device use, up to 1 hour
Secondary outcomes:
measure: Tolerability
timeFrame: Duration of device use, up to 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04220450: T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease
Official title: T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD
Heart Failure
Valvular Disease
Coronary Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging

Brief summary: On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* Referred for Cardiovascular Magnetic Resonance Imaging

Exclusion Criteria:

* Non-compatible Devices

Primary outcomes:
measure: Correlation NAFLD and liver T1mapping
timeFrame: cross-sectional within one year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Mascherbauer K, Dona C, Koschutnik M, Dannenberg V, Nitsche C, Duca F, Heitzinger G, Halavina K, Steinacher E, Kronberger C, Bardach C, Beitzke D, Loewe C, Waldmann E, Trauner M, Barkto P, Goliasch G, Mascherbauer J, Hengstenberg C, Kammerlander A. Hepatic T1-Time Predicts Cardiovascular Risk in All-Comers Referred for Cardiovascular Magnetic Resonance: A Post-Hoc Analysis. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014716. doi: 10.1161/CIRCIMAGING.122.014716. Epub 2022 Oct 18.
Clinical trial NCT02176850: Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension
Official title: Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 19870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice

Brief summary: This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes with essential hypertension and a minimum age of 18 years

Exclusion Criteria: (Not applicable)

Primary outcomes:
measure: Indicence of ulcera
timeFrame: Up to 6 months after start of study
measure: Incidence of gastrointestinal (GI) bleedings
timeFrame: Up to 6 months after start of study
Secondary outcomes:
measure: Incidence of adverse events (GI-complaints inclusive)
timeFrame: Up to 6 months after start of study
measure: Change from baseline in office blood pressure
timeFrame: Up to 6 months after start of study
measure: Response rate
timeFrame: Up to 6 months after start of study
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00711750: Immediate Maintained Cannulation of a Newly Implanted Prosthetic Arteriovenous Access for Acute Hemodialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-Stage Renal Disease
Prosthetic Arteriovenous Access
Keywords: underwent
specific
creation
hospital
November 2003
October 2005
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end-stage renal disease underwent the specific prosthetic arteriovenous access creation in our hospital from November 2003 to October 2005 were retrospectively reviewed.

Brief summary: Objectives: Examine the acute utility of immediate maintained cannulations of a newly implanted prosthetic arteriovenous access. Background: Recurrent failure of central catheterization is not uncommon. An alternative access is necessary for acute hemodialysis after the exhaustion of central veins. Methods: We constructed the access by cannulating two dialysis needle-catheters and securing them on the skin after the implantation of the graft. The access was used immediately and maintained for one week and thereafter used as a long-term access.


Eligibility criteria: Inclusion Criteria:

* end-stage renal disease underwent the specific prosthetic arteriovenous access creation in our hospital from November 2003 to October 2005

Exclusion Criteria:

* patients' poor health as long as they did not have other options and needed an access for acute hemodialysis. Exclusions included shock, active systemic infection, and rejection by the attending nephrologists

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT02607150: Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood
Official title: Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Transfusion Reaction
Keywords: Spinal Fusion
Cerebral Oxygenation
Blood Transfusion
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal surgery patients.

Brief summary: A prospective study designed to evaluate changes in tissue and cerebral oxygenation before and following administration of blood for patients undergoing spinal surgery.

Red blood transfusions (autologous and allogeneic) are indicated to improve oxygen delivery to the tissues and hence tissue oxygenation. Despite the presumed efficacy, there are limited data to demonstrate changes in tissue oxygenation with the administration of blood. Furthermore, the administration of both autologous blood from cell saver and allogeneic blood can be associated with both acute and long-term deleterious physiologic effects which may impact the perioperative course. As such, data are needed to clearly delineate the benefits of transfusion during the perioperative period.

Detailed description: This prospective study will include patients presenting for spinal surgery. There will be no change in the anesthetic or perioperative care of these patients. Per our usual clinical routine, cell saver will be used intraoperatively to limit the need for allogeneic blood. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS). The device is applied non-invasively like pulse oximetry to a muscle bed (usually the deltoid) and the forehead to measure tissue oxygenation. These devices are used routinely in the operating room and the cardiothoracic intensive care unit. Although not used on every major orthopedic procedure, these devices are routinely used in various high risk clinical scenarios. As clinically indicated, cell saver blood (autologous) or allogeneic blood will be administered. During this time, tissue and cerebral oxygenation will be recorded every 5 minutes starting 10 minutes before the transfusion and continued for 30 minutes following the transfusion.

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing spinal surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Cerebral Oxygenation Changes
timeFrame: Intraoperative measure
Secondary outcomes:
measure: Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions
timeFrame: Intraoperative measure
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D. Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567450: Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block
Official title: Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subgluteal Sciatic Block
Keywords: sciatic block
ropivacaine
mepivacaine
locoregional anesthesia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.

This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* surgery of the foot under sciatic block

Exclusion Criteria:

* no indication of locoregional anesthesia
* polyneuropathy or any neurological disease
* know hypersensitivity to local anesthetics
* porphyria
* atrio-ventricular block
* not controlled epilepsia
* hypovolemia
* pregnancy
* anticoagulant treatment

Primary outcomes:
measure: Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve
timeFrame: 4h
Secondary outcomes:
measure: intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects.
timeFrame: 48h
Other outcomes:
Locations:
city: Amiens cedex
country: France
facility: CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet
Study officials:
affiliation: Anesthesiology department
name: Campana Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04667650: Ocular Mysathenia Gravis Generalization
Official title: Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Myasthenia Gravis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-12-16
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database

Brief summary: Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.


Eligibility criteria: Inclusion Criteria:

- Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database

Exclusion Criteria:

- OMG differential diagnoses

Primary outcomes:
measure: Time to myasthenia gravis generalization
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Antoine GUEGUEN
Study officials:
References:
Clinical trial NCT00902850: One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens
Official title: One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 28
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: The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Have no active ocular disease or allergic conjunctivitis.
* Not be using any topical ocular medications.

Exclusion Criteria:

* Participating in a conflicting study.
* Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Clinical Performance
timeFrame: Insertion, 4 hours & End of Day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Research Clinic
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen, OD, MS
role: STUDY_DIRECTOR
References: