louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02410928: Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
Official title: Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy, videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy, duration and hemodynamic responses during the procedure.

Detailed description: The vocal cord will be visualised after the extubation with one of the following methods:

direct laringoscopy videolaringoscopy fiberoptic laringoscopy ultrasonography The of efficacy of the method (0= not able to visualize the vocal cords, 1= the vocal cords were visualized) duration of the procedure and hemodynamic responses (heart rate, mean arterial pressure) during the procedure will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

* Benign or malignant thyroid pathology

Exclusion Criteria:

* anticipated difficult intubation

Primary outcomes:
measure: visualisation of the vocal cords
timeFrame: 1 min after extubation
measure: duration of the procedure
timeFrame: 10 min after extubation
measure: mean arterial pressure
timeFrame: 10 min after extubation
measure: heart rate
timeFrame: 10 min after extubation
measure: peripheal oxygen saturation
timeFrame: 10 min after extubation
Secondary outcomes:
measure: hypertention
timeFrame: 5 minutes after the extubation
measure: tachycardia
timeFrame: 5 minutes after the extubation
measure: laceration
timeFrame: 5 minutes after the extubation
measure: teeht damage
timeFrame: 5 minutes after the extubation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Teaching and Research Hospital
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: Dilek yazicioglu, Dr
role: STUDY_DIRECTOR
References:
citation: Jeannon JP, Orabi AA, Bruch GA, Abdalsalam HA, Simo R. Diagnosis of recurrent laryngeal nerve palsy after thyroidectomy: a systematic review. Int J Clin Pract. 2009 Apr;63(4):624-9. doi: 10.1111/j.1742-1241.2008.01875.x.
citation: Higgins TS, Gupta R, Ketcham AS, Sataloff RT, Wadsworth JT, Sinacori JT. Recurrent laryngeal nerve monitoring versus identification alone on post-thyroidectomy true vocal fold palsy: a meta-analysis. Laryngoscope. 2011 May;121(5):1009-17. doi: 10.1002/lary.21578.
citation: Kristensen MS. Ultrasonography in the management of the airway. Acta Anaesthesiol Scand. 2011 Nov;55(10):1155-73. doi: 10.1111/j.1399-6576.2011.02518.x. Epub 2011 Sep 7.
Clinical trial NCT03384628: An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Official title: An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lens
The Young Theory
Lead sponsor: Visioncare Research Ltd.
Sponsor class: OTHER
Collaborators: name: Visioncare Research Ltd.
First posted: 2017-12-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will wear the three contact lens types bilaterally in random succession
Primary purpose: TREATMENT

Brief summary: This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.

Detailed description: This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years.
* Able to read, comprehend and sign an informed consent.
* Willing to comply with the wear and study assessment schedule.
* Spherical distance prescription between -0.50 and -6.00 (inc.).
* Astigmatism, if present,≤1.50DC in both eyes.
* Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:

A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).

Exclusion Criteria:

* Previous anterior ocular surgery
* Any active corneal infection, injury or inflammation

  . •Large pinguecula likely to affect soft lens fit
* Systemic or ocular disease or medication which might interfere with CL wear
* Pregnancy or breastfeeding
* Participation in any concurrent trial

Primary outcomes:
measure: Lens fit (position on the eye) in mm
timeFrame: 25 minutes
measure: Lens edge tightness fit grade 0-4
timeFrame: 5 minutes
measure: Lens tightness fit graded as %
timeFrame: 5 minutes
measure: Lens overall fit grade 0-5
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
facility: Visioncare research
state: Surrey
city: Birmingham
country: United Kingdom
facility: Aston University Optometry Clinic
state: West Midlands
Study officials:
affiliation: Managing director
name: Graeme Young, PhD MPhil
role: STUDY_DIRECTOR
References:
Clinical trial NCT01452828: A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
Official title: A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal Impairment
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.

Detailed description: To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function

Eligibility criteria: Inclusion Criteria:

* BMI between 18.0 and 40.0 kg/m2 inclusive
* Male or female subjects between 18 and 75 years of age
* Stable dosage of medication for 30 days
* for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months

Exclusion Criteria:

* Functioning transplanted solid organ
* High tyramine diet
* Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects

Primary outcomes:
measure: Composite (or Profile) of Pharmacokinetics
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Trius Investigator Site 001
state: Florida
city: Minneapolis
country: United States
facility: Trius Investigator Site 002
state: Minnesota
Study officials:
affiliation: Trius Therapeutics
name: Philippe Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.
Clinical trial NCT01957228: Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
Official title: Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthetic Joint Infections
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic.

Primary:

Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.

Hypothesis:

Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.


Eligibility criteria: Inclusion Criteria:

* Patient is more than 18 years old.
* Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection
* Patient who do not declined to have his medical records reviewed for research
* Patient with health insurance

Exclusion Criteria:

* Patient minor (\<18 years).
* Pregnant or lactating woman.
* Major under guardianship Patient.
* Patient deprived of liberty or under court order

Primary outcomes:
measure: Bone biopsies multisite
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT02283528: A Comparison of Stryker Hybrid Arch Bars
Official title: A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture Mandible
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 50
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: Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).

The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing


Eligibility criteria: Inclusion Criteria:

1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
2. Age 18 years - 90 years
3. Ability to give informed consent
4. Minimum 6 weeks follow-up
5. Pre and post-operative panoramic xrays

Exclusion Criteria:

1. Comminuted fractures
2. Infected fractures
3. Previously treated fractures
4. Complete edentulism
5. Gun shot wounds
6. Pregnancy or breast feeding

Primary outcomes:
measure: Time to Place Archbars
timeFrame: During initial admission and surgery
Secondary outcomes:
measure: Number of Participants With Fracture Healing at 6 Weeks
timeFrame: 6 weeks
measure: Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures
timeFrame: up to 6 weeks post operatively
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
References:
Clinical trial NCT02187328: Effects of Fruit Juices on Hormone Metabolism
Official title: Effect of Grapefruit Juice and Exercise on Cortisol Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cortisol
Lead sponsor: Benedictine University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether grapefruit juice alters the metabolism of cortisol following intense exercise.


Eligibility criteria: Inclusion Criteria:

* Young men and women, not taking medications known to alter glucocorticoid metabolism

Exclusion Criteria:

* Diabetes, uncontrolled hypertension, obesity, any medication known to interact with grapefruit juice

Primary outcomes:
measure: Plasma cortisol change from baseline at 45 minutes
timeFrame: Baseline, 45 minutes
Secondary outcomes:
measure: Change in plasma cortisol from 15 minutes to baseline
timeFrame: baseline, 15 minutes
Other outcomes:
Locations:
city: Lisle
country: United States
facility: Benedictine University
state: Illinois
Study officials:
affiliation: Benedictine University
name: Pedro Del Corral, PhD-MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05880628: Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts
Official title: Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Cysts
Keywords: Bone Cysts
Aneurysmal Bone Cysts
simple Bone Cysts
Discogel
Effectiveness
Safety
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel will be included.

Brief summary: There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

Detailed description: The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.

Eligibility criteria: Inclusion Criteria:

* Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel

Exclusion Criteria:

* Refusal

Primary outcomes:
measure: Feasibility of the technique
timeFrame: Year: 2
Secondary outcomes:
measure: Safety of the technique by number of adverse event
timeFrame: Year: 2
measure: Number of discogel® injections by sclerose of the lesion
timeFrame: Year: 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain Grange, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00065728: Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
Official title: An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: AMD
age-related macular degeneration
Anecortave
Acetate
Wet form of age-related macular degeneration
CNV
Anecortave Acetate
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-08-01
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percent of patients who maintained stable vision
timeFrame: Month 24
measure: Mean change in best-corrected visual acuity at Month 24 from baseline
timeFrame: Baseline, Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Central Contact Ft. Worth
country: United States
facility: Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
state: Texas
Study officials:
affiliation: Alcon Research
name: Terry Wiernas, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05770128: Subserosal Laparoscopic Cholecystectomy
Official title: Subserosal Laparoscopic Cholecystectomy for Safe Gall Bladder Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholecystitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any patient admitted to surgical department wth age above 18 years old suffering \& diagnosed of chronic cholecystitis , symptomatic cholelithiasis

Brief summary: The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .


Eligibility criteria: Inclusion Criteria:

* Adult with age of or above 18 years.
* Diagnosis of chronic cholecystitis , symptomatic cholelithiasis

Exclusion Criteria:

* Previous operation or adhesion
* severe Acute Calculus pancreatitis
* gall bladder cancer
* Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
* Recurrent cases

Primary outcomes:
measure: Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01888328: Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
Official title: An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fed conditions

Detailed description: An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fed conditions

Eligibility criteria: Inclusion Criteria:

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
7. Regular tobacco use in the 3 months prior to study dosing.

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: Pre-dose (0) and 0.5, 1,1.5,2,2.5,3,4,5,6,7,8,11,14,18, 24,36,48,72 and 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Quadrangle Drive, Chapel Hill,
country: United States
facility: AAI
state: North Carolina
Study officials:
affiliation: AAI
name: Dr. Ralph Scallion, MD
role: PRINCIPAL_INVESTIGATOR
References: