louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00738348: Effect of Perioperative Sivelstat Administration for Liver Resection
Official title: Effect of Perioperative Sivelstat Administration for Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: surgery
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.

Detailed description: Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.

Eligibility criteria: Inclusion Criteria:

* liver disease which surgical management was indicated

Exclusion Criteria:

* weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease

Primary outcomes:
measure: The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1.
timeFrame: during hospitalization
Secondary outcomes:
measure: The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Kohasu-Okocho, Nankoku
country: Japan
facility: Kochi Medical School
Study officials:
affiliation: Kochi Medical School
name: Takehiro Okabayashi, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00517348: Study Evaluating IMA-026 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026 administered subcutaneously (SC) or intravenously (IV) in healthy adults.


Eligibility criteria: * Healthy men and women ages 18 - 50
* Body weight greater than or equal to 50 kilograms
* Nonsmoker or fewer than 10 cigarettes per day
* No serious infection, i.e., requiring hospitalization or IV antibiotics, or an upper respiratory infection within 1 month before dosing

Primary outcomes:
measure: Pharmacokinetic (PK) analysis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04449848: The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Official title: The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sudden Hearing Loss
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-29
Enrollment: 20
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: During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear

Exclusion Criteria:

* Patients with abnormal sense of taste
* Middle or inner ear anomaly
* Eustachian tube dysfunction

Primary outcomes:
measure: Bitter taste
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02408848: The Value of Three Dimensional Echocardiography in Congenital Cardiac Surgery
Official title: Three Dimensional Echocardiography in Congenital Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 9
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing congenital cardiac surgery with or without cardiopulmonary bypass

Brief summary: There are few studies evaluating the value of 3D echocardiography in children undergoing congenital cardiac surgery. The aim of this observational study is to describe common and uncommon congenital malformations with the help of 3D echo and compare the findings and the measurements with those obtained with conventional 2D echo.


Eligibility criteria: Inclusion Criteria:

* All children requiring general anesthesia for congenital heart surgery and in whom informed parental consent has been obtained

Exclusion Criteria:

* Children with congenital heart disease who do not require heart surgery

Primary outcomes:
measure: correlate three dimensional measurements with two dimensional measurements
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
References:
Clinical trial NCT05851248: Free Mucogingival Graft for Isolated Root Coverage
Official title: Free Mucogingival Graft for Isolated Root Coverage and Correct Unfavorable Mucogingival Conditions in Lower Incisors: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Free Mucogingival Grafts
Gingival Recession
Root Coverage
Periodontal Plastic Surgery
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 24
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 goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.


Eligibility criteria: Inclusion Criteria:

* Healthy patients with deep GR associated with lower incisor MCD.
* Full mouth plaque and bleeding scores were \<20%.

Exclusion Criteria:

Patient characteristics:

* Smoking ≥10 cigarettes a day.
* Medications or systemic contraindications for oral surgery.
* Pregnancy.

Defects:

* Thin scalloped biotype (AND/OR)
* Underlying bone dehiscence (AND /OR)
* Generalized GR affecting most sextants.

Primary outcomes:
measure: buccal Recession (bREC)
timeFrame: 12 months
Secondary outcomes:
measure: buccal Clinical Attachment Level (bCAL)
timeFrame: 12 months
measure: interproximal Clinical Attachment Level (iCAL)
timeFrame: 12 months
measure: Interproximal papilla tip location (PT)
timeFrame: 12 months
measure: keratinized tissue width (KT)
timeFrame: 12 months
measure: vestibule depth (VD)
timeFrame: 12 months
measure: Soft tissue attached to alveolar bone (STAB)
timeFrame: 12 months
Other outcomes:
measure: Root Coverage (RC percentage)
timeFrame: 12 months
measure: Complete root coverage (CRC)
timeFrame: 12 months
Locations:
city: Murcia
country: Spain
facility: Centro Odontologico Del Sureste Slp
Study officials:
References:
Clinical trial NCT00539526: Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 106
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 will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

* Known contraindication to latanoprost, bimatoprost or travoprost
* Uncontrolled systemic disease
* Active ocular disease other than glaucoma or ocular hypertension
* Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control

Primary outcomes:
measure: Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change From Baseline in Corneal Staining With Fluorescein at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010 Jun;26(3):287-92. doi: 10.1089/jop.2009.0134.
Clinical trial NCT04899557: Retrospective/Prospective Study of Pediatric Surgical Patients
Official title: Retrospective/Prospective Study of Pediatric Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Robotic Surgery
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patient with splenomegaly

Brief summary: UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.


Eligibility criteria: Inclusion Criteria:

* Pediatric patient with splenomegaly

Exclusion Criteria:

* NOn pediatric patients

Primary outcomes:
measure: Mortality
timeFrame: 30 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Office for the Protection of Research Subjects
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Greg Klazura
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01935557: Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Official title: Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coagulation; Intravascular
Keywords: Continuous heparin infusion
Intermittent heparin infusion
during catheter ablation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important.

Randomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation.

Detailed description: Intravenous heparin was used during the procedure to prevent catheter-induced thrombosis.

heparin is administered during the procedure to achieve recommended activation clotting times (ACT) values, typically \>300 seconds to prevent thromboemboli during the procedure.

Most of the practitioners was that ACT level should be checked at 30- to 60-minute intervals and then have injected intermittently.

intermittent heparin infusion, concentration is great changed because the heparin has 30minutes half-period.

researchers postulate that a constant therapeutic concentrations would be beneficial to continuous infusion than intermittent infusion.

Eligibility criteria: Inclusion Criteria:

* Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria:

* Clinical trial denied

Primary outcomes:
measure: therapeutic ACT retention rate during procedure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul st. mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong Seog Oh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim TS, Kim SH, Kim BK, Kim JY, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Randomized Comparison of Continuous Versus Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2016 Jun;2(3):319-326. doi: 10.1016/j.jacep.2015.11.004. Epub 2015 Dec 9.
Clinical trial NCT00933257: Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
Official title: Study Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DESILSTY_FR.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd PHDESILSTYFR.


Eligibility criteria: Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Concomitant use of photosensitivity drugs
* History of sensitivity or photosensitivity with topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Measure of the photo irritation test and the photosensitivity byusing UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
timeFrame: From the treatment start to the end of the study (treatment period 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00645957: A Comparison of Redrubber Versus Penrose Drains
Official title: A Comparison of Redrubber Versus Penrose Drains in the Management of Odontogenic (Dental) Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Odontogenic Infection
Keywords: drainage
irrigation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients presenting to Grady Memorial Hospital with an odontogenic (dental) infection that requires admission to the hospital and incision and drainage will be eligible for inclusion in this pilot study. The surgical method used for incision and drainage will be determined by the attending surgeon who will operate on the patient. The surgical procedure is a simple and universally standardized involving one or more small incisions in the mouth or in the upper neck and the placement of a drain(s) within the infected area to facilitate continued drainage of pus. Subjects will be randomized to either a red rubber or penrose drain(s). The drains are placed through the mouth or upper neck depending on the location of the infection and typically remain in place until the drainage has stopped (several days). All drains are secured with a single stitch through the gum or skin. The drain(s) will be removed bedside by removing a single suture and gently withdrawing the drain. The timing of this is determined by the clinical picture although this typically occurs within the first week. This is not a painful procedure. Currently some surgeons place red rubber drains which, after placement, allow the infection not only to drain but also be irrigated with saline both during the surgery and in the immediate post-operative period. Other surgeons place penrose drains, which, after placement, continue to allow the infection to drain but cannot be irrigated. Red rubber drains require daily irrigation and as such are labor intensive. Furthermore, drains that are irrigated may continue to drain the saline irrigant in the many hours after irrigation that upon clinical inspection may be difficult to distinguish from sero-sanguinous (pus) drainage. It is daily inspection of the drainage (or lack thereof) which determines the appropriate time to remove the drain(s). This in turn may influence time to discharge and ultimately hospital costs


Eligibility criteria: Inclusion Criteria:

* age 16 and older

Exclusion Criteria:

* none

Primary outcomes:
measure: Resolution of infection
timeFrame: several days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
References:
Clinical trial NCT03073057: Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Official title: Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained
* Body mass index \> 19 and \< 30kg/m2, weight at least 50 kg
* Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
* Known hypersensitivity to the active substance(s) or the excipient of the drug
* Pregnant and lactating females

Primary outcomes:
measure: Cmax of plasma budesonide and formoterol
timeFrame: within 24 hours
measure: AUCt of plasma budesonide and formoterol
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma, Clinical Pharmacology Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Iissa Kivisto
role: STUDY_DIRECTOR
affiliation: Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland
name: Leena Mattila, MD
role: PRINCIPAL_INVESTIGATOR
References: