louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03238521: Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device?
Official title: Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Fixation, Internal
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.


Eligibility criteria: Inclusion Criteria:

* Men and women between 18 and 80 years-old;
* Patient with an indication of PPTLO for one or two segments
* Patient in a position to understand protocol information;
* Patient who received information about the protocol and who did not show opposition to participate

Exclusion Criteria:

* History of posterior spinal fusion surgery on the spinal level concerned by the study;
* Morbid obesity (body mass index greater than 35 kg / m²);
* Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.
* Simultaneous participation in another research protocol involving the human person

Primary outcomes:
measure: Dose area product in cGy.cm2 (DAP)
timeFrame: Surgery Day
Secondary outcomes:
measure: Radiation duration in seconds (measured on the fluoroscope);
timeFrame: Surgery Day
measure: Radiation rate
timeFrame: Surgery Day
measure: Path of pedicle screws extracted from fluoroscopic images
timeFrame: Day 2 after surgery
measure: Operating time in minutes.
timeFrame: Surgery Day
Other outcomes:
Locations:
city: Rennes
country: France
facility: Orthopedic surgery division
Study officials:
affiliation: Rennes University Hospital
name: Jonathan LEBHAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04369521: Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease
Official title: Evaluation of the Effects of a Low Free Sugar Diet on Lipid Profile, Glycemic Indices, Liver Enzymes, Inflammatory Factors and Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

1. Age of 18 to 60 years
2. Body Mass Index (BMI) between 25-40
3. Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

1. Alcohol consumption
2. pregnancy or lactation
3. Other liver disease (viral,cirrhosis,...)
4. Use of drugs such as phenytoin,tamoxifen,lithium
5. A history of Cancer, autoimmune disease,Renal disease \& Celiac disease, hypothyroidism or Cushing's syndrome
6. Lack of desire to continue studying
7. Have to use antibiotics with hepatotoxic drugs while studying
8. Non-compliance with diet

Primary outcomes:
measure: ALT
timeFrame: 12 weeks
measure: AST
timeFrame: 12 weeks
measure: GGT
timeFrame: 12 weeks
measure: TG
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: LDL-c
timeFrame: 12 weeks
measure: HDL-c
timeFrame: 12 weeks
measure: FBS
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: hs-CRP
timeFrame: 12 weeks
measure: TNF-a
timeFrame: 12 weeks
measure: NF-kb
timeFrame: 12 weeks
measure: Liver fibrosis
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azita Hekmatdoost
state: Middle East
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT01886521: Use of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.
Official title: Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subarachnoid Hemorrhage.
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 20
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: Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
* In need for CSF drainage based on clinical judgment

Exclusion Criteria:

* intraventricular clots
* intraparenchymal clots causing midline shift
* pregnancy

Primary outcomes:
measure: Accumulated Hb and bilirubin in CSF drainage
timeFrame: From drain placement to removal, in average 10 days.
Secondary outcomes:
measure: placement of a ventriculoperitoneal shunt
timeFrame: participants will be followed for the duration of hospital stay, in average 3 weeks
measure: Lindegaard ratio (TCD) > 3
timeFrame: the participants will be followed for the duration of hospital stay, in average 3 weeks
measure: clinical signs of vasospasms
timeFrame: The participants will be followedd for the duration of hospital stay, in average 3 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Neurosurgery, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Peter Birkeland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860521: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
Official title: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical; Abortion, Fetus
Keywords: Termination of pregnancy
Second trimester
Programmed intermittent epidural bolus
Continuous epidural infusion
Epidural analgesia
Legally Induced Abortion
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 104
Sex: FEMALE
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 included women who underwent voluntary second trimester termination of pregnancy. Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous epidural infusion for pain analgesia. In this randomized, double-blind study, the investigators assess the incidence of motor block (primary outcome), degree of satisfaction of the patients, total levobupivacaine and sufentanil consumption and adverse events (secondary outcomes) between the two study groups.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* pregnancy at second trimester
* willingness of voluntary interrupt the pregnancy
* comprehension of Italian Language
* baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)

Exclusion Criteria:

* contraindication to epidural analgesia and to narcotics
* history of drug abuse or chronic use
* maternal disease (such as severe asthma, cardiac, liver or kidney disease)
* inability to comprehend or comply with the analgesia pain management procedures.

Primary outcomes:
measure: Incidence of Motor Block
timeFrame: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).
Secondary outcomes:
measure: Degree of Satisfaction of the Patients With the Analgesia Procedure
timeFrame: At discharge from the hospital (up to 72 hours from starting of the procedure).
measure: Total Levobupivacaine Consumption
timeFrame: At the moment of fetal expulsion (up to 66 hours from starting of the procedure).
measure: Total Sufentanil Consumption.
timeFrame: During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa
state: Ligury
Study officials:
affiliation: Universita degli Studi di Genova
name: Simone Ferrero, PhD
role: STUDY_DIRECTOR
affiliation: Universita degli Studi di Genova
name: Umberto Leone Roberti Maggiore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05621421: The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
Official title: The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
Collaborators: name: Vilnius University
First posted: 2022-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.

Brief summary: A single center, prospective, observational study to investigate the impact of intravascular ultrasound (IVUS) on the functional percutaneous coronary intervention (PCI) result (assessed with fractional flow reserve (FFR)) and one-year target vessel failure (TVF) rate after percutaneous treatment of long coronary artery lesions


Eligibility criteria: Inclusion Criteria:

* Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation);
* Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation);
* Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention.

Exclusion Criteria:

* Patient's age ≤ 18 years;
* Acute myocardial infarction with ST segment elevation;
* Treatment with dual antiplatelet therapy contraindicated;
* Survival expectancy ≤ 1 year;
* Known allergy to sirolimus, everolimus or zotarolimus.

Primary outcomes:
measure: The proportion of patients with optimal physiology result
timeFrame: 1 day
measure: The proportion of patients with optimal anatomy result
timeFrame: 1 day
measure: The proportion of patients with optimal physiology and anatomy result
timeFrame: 1 day
Secondary outcomes:
measure: The rate of target vessel failure (TVF)
timeFrame: 12 months post PCI follow up
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
Study officials:
affiliation: Vilnius University Hospital Santaros Klinikos
name: Giedrius Davidavicius, PhD, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03631121: Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus
Official title: Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type2 Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with Basalin and one week after changing the insulin into Lantus.

Detailed description: The participants will take continuous glucose monitoring system for 3 days when they change the insulin into Lantus after reach euglycemia control with Basalin treatment for one week.

Eligibility criteria: Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
2. Patients were using Basalin with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 3 month would be recruited into this study;
3. Patients had relatively constant diet and exercise in 2 month before the study.
4. Fasting blood glucose\<6.1mmol/L, and postprandial (or random) blood glucose \<14mmol/L

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
2. Patients with severe infectious diseases;
3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Primary outcomes:
measure: Change of glycemic variation
timeFrame: Day 1-13
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hostital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ma Jianhua
role: STUDY_CHAIR
References:
Clinical trial NCT02668302: The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Official title: The PIO II Study: A Randomized, Controlled, Blinded Trial to Evaluate the Safety and Efficacy of In-office Placement of a Steroid-eluting Sinus Implant Post-ethmoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Sinusitis, Ethmoidal
Keywords: Steroid-eluting sinus implant
Mometasone furoate
Endoscopic sinus surgery
Lead sponsor: Collin County Ear Nose & Throat
Sponsor class: OTHER
Collaborators: name: Intersect ENT
First posted: 2016-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Primary purpose: TREATMENT

Brief summary: Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.

Detailed description: This prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). Patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines, including presence of bilateral ethmoid disease.
* ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of the other paranasal sinuses also permitted.

Exclusion Criteria:

* Known history of intolerance to corticosteroids or an oral steroid-dependent condition.
* Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma

Primary outcomes:
measure: Inflammation Score
timeFrame: Change from baseline to Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Collin County Ear Nose & Throat
state: Texas
Study officials:
affiliation: Collin County Ear Nose & Throat
name: Keith E Matheny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914121: Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)
Official title: A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)


Eligibility criteria: Inclusion Criteria: Men or women of nonchildbearing potential; 18-50 years old; healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.

Primary outcomes:
measure: Corrected QT interval, including QTcN, QTcB, and QTcF
timeFrame: 6 weeks
Secondary outcomes:
measure: Laboratory evaluations, Vital Sign measurements, Adverse Event reports
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01391221: Inflammatory Markers and Cognitive Function in Major Depression
Official title: Inflammatory Markers and Cognitive Function in Major Depression:a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depression
Keywords: Depression
Inflammation
Cognition
Pain
Allostatic load
Lead sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2011-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Major depression is accompanied by cognitive changes as well as alterations in multiple physical functions. The inflammatory system is altered generally toward a pro-inflammatory state. Antidepressants are associated with a decrease in this proinflammatory state. This study aims to generate pilot data concerning a possible link between cognition, inflammation and response to treatment. The cognitive function of subjects with major depression will be tested before and after treatment with duloxetine. Inflammatory markers will be measured at both time points.


Eligibility criteria: Inclusion Criteria:

* Age 20-50 Primary diagnosis of major depression Ability to give informed consent

Exclusion Criteria:

* Neurologic disorders affecting cognition
* Unstable or untreated medical disorders
* Medical disorders associated with pain
* Recent pregnancy or delivery
* Psychiatric disorders other than MD which are the primary focus of treatment
* Treatment with antidepressants in the past 4 weeks

Primary outcomes:
measure: Cognitive function measured by CANTAB
timeFrame: 12 weeks
Secondary outcomes:
measure: pain inhibition
timeFrame: 12 weeks
measure: Allostatic load
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre de Recherche Fernand Seguin
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve Rosemont
state: Quebec
Study officials:
References:
Clinical trial NCT01184521: Masimo CO-Oximeter Study
Official title: Use of the Masimo Rainbow SET Pulse CO-Oximeter in Patients Undergoing Isovolemic Hemodilution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring isovolemic hemodilution during surgery.

Brief summary: This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.


Eligibility criteria: Inclusion Criteria:

* Any subject that is scheduled to have isovolemic hemodilution

Exclusion Criteria:

* Anything that prevents a subject from having isovolemic hemodilution

Primary outcomes:
measure: hemoglobin value
timeFrame: 1 Day (day of surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: