louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01261468: Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Official title: Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Electric Stimulation Therapy
Neurologic Examination
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST).

Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.

After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.

The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.


Eligibility criteria: Inclusion Criteria:

* minimum age 18
* able to understand participant information and cooperate at the neurological examination
* uncomplicated treatment with spinal cord stimulation for at least 3 months
* pain in only one extremity
* treatment effect in only one extremity

Exclusion Criteria:

-

Primary outcomes:
measure: Change in sensory parameters
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Danish Pain Research Center
Study officials:
affiliation: Danish Pain Research Center
name: Troels S Jensen, prof.
role: STUDY_DIRECTOR
affiliation: Danish Pain Research Center
name: Kaare Meier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemler MA, Reulen JP, Barendse GA, van Kleef M, de Vet HC, van den Wildenberg FA. Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. Anesthesiology. 2001 Jul;95(1):72-80. doi: 10.1097/00000542-200107000-00016.
Clinical trial NCT00563368: A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Official title: A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2007-11-26
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.


Eligibility criteria: Inclusion Criteria:

* 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
* Informed Consent
* Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

* Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* Glaucoma or elevated intraocular pressure
* Pregnancy or breastfeeding
* Drug or Alcohol abuse
* Smoking cessation within previous 3 months or plans to quit smoking during study
* Eating disorders within past year
* Cholelithiasis within past 6 months
* Type 2 diabetes
* Previous bariatric surgery
* Bipolar disorder or psychosis
* Steroid hormone therapy not stable for 3 months
* Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg

Primary outcomes:
measure: Percent Weight Loss From Baseline to Week 28
timeFrame: baseline to 28 weeks
measure: Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
timeFrame: baseline to 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: VIVUS LLC
name: Craig Peterson
role: STUDY_DIRECTOR
affiliation: Duke University
name: Kishore Gadde, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05314868: Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
Official title: Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Cardiac Anomaly
Keywords: bovine pericardium patch
cardiac repair
cardiac reconstruction
Lead sponsor: Artivion Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch.

Brief summary: The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical repair or reconstruction procedure. PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques.

Detailed description: This study will include a review of approximately 300 charts spanning the implant period of January 1, 2018 through June 30, 2019. Those that meet the inclusion and exclusion criteria will undergo full review and data extraction to be captured in the electronic database. Given the retrospective nature of the study design, a Waiver of Consent will be requested from the Institutional Review Board (IRB). Potential subjects this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. Targeted cardiac procedures include intracardiac repair (including annulus and septal repair), great vessel repair (including superior vena cava, inferior vena cava, pulmonary arteries, pulmonary veins, and ascending aorta), and suture line buttressing and pericardial closure. Follow-up data will be abstracted from the subject's medical record. Study specific testing, including imaging and laboratory testing, will not be required.

Eligibility criteria: Inclusion Criteria:

* Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium

Exclusion Criteria:

* Subject required valve leaflet repair using PhotoFix

Primary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: All-cause reoperation
timeFrame: Up to 5 years
measure: Device-related reoperation
timeFrame: Up to 5 years
measure: Explant
timeFrame: Up to 5 years
measure: Morbidity
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christopher Baird, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06332768: NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients
Official title: Comparison of High Flow Oxygenation, Noninvasive Ventilation and Standard Oxygen Therapy in the Early Post-extubation Period in Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Weaning Failure
Acute Respiratory Distress Syndrome
High-flow Oxygenation
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.

Detailed description: HFNO (high-flow nasal oxygenation and NIV (non invasive ventilation) are to be randomly compared in the ARDS postextubation period.

Eligibility criteria: Inclusion Criteria:

ARDS

Exclusion Criteria:

Severe ICU-aquired weakness Severe COPD

Primary outcomes:
measure: Weaning failure
timeFrame: 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: City hospital # 1
state: Arkhangelsk Region
Study officials:
References:
Clinical trial NCT01387568: Lidocaine Infusion for Major Abdominal Pediatric Surgery
Official title: The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Elective Major Abdominal Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.

Detailed description: The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.

Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.

Eligibility criteria: Inclusion Criteria:

* Pediatric
* Abdominal surgery
* ASA class I and II

Exclusion Criteria:

* history of hepatic diseases
* history of cardiac diseases
* history of renal diseases
* allergy to local anesthetics
* epilepsy

Primary outcomes:
measure: Blood pressure
timeFrame: for 2hrs after infusion
Secondary outcomes:
measure: Plasma Cortisol
timeFrame: for 24 hrs after infusion
measure: Serum lidocaine
timeFrame: 6 hrs after infusion
measure: Heart rate (HR)
timeFrame: for 6 hrs after infusion
measure: Pain scales
timeFrame: 24 hrs postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Anesthesia Dept, Mansoura University
state: DK
Study officials:
affiliation: alaaeldeep9@hotmail.com
name: Alaa El Deep, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01868568: Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
Official title: A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.


Eligibility criteria: Inclusion Criteria:

* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
* Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator
* A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
* A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing

Primary outcomes:
measure: Area under the insulin aspart concentration curve
timeFrame: 0-2 hours after dosing
Secondary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: 0-26 hours after dosing
measure: Area under the serum insulin 454 concentration curve
timeFrame: 0-120 hours after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04625868: Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
Official title: Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Hand Injuries and Disorders
Surgery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Society for Surgery of the Hand
First posted: 2020-11-12
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.

Detailed description: This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery. Patients undergoing elective hand surgery are randomized to either watch a preoperative educational video or not. Patients are asked to record their pain medication usage postoperatively, as well as their daily pain levels and satisfaction with their pain control after surgery.

Eligibility criteria: Inclusion Criteria:

* undergoing elective hand surgery
* surgeon is planning to prescribe opioids for postoperative pain control

Exclusion Criteria:

* emergent surgery
* surgeon not planning to prescribe opioids for postoperative pain control

Primary outcomes:
measure: Morphine milliequivalents consumed in 2 weeks postoperatively
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 2 weeks after surgery
measure: Patient satisfaction
timeFrame: 7-10 days after surgery
measure: Proper disposal
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: David M. Kalainov, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200668: Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.

Detailed description: First whole body FDG-PET scan and MRI before the start of the treatment. Second whole body FDG-PET scan and MRI after the end of the treatment. On a basis of patient, comparison between PET and MRI will be done tumoral site by site. Sensitivity, Specificity will be estimated for both techniques. In case of discrepancy, another imaging method or biopsy (if easy to perform) will be serve as standard of reference. Kappa coefficients and Mc Nemar test will be performed to compare the two methods. FDG = fluorodeoxyglucose FLUCIS® (Schering-CisBio® international)

Eligibility criteria: Inclusion Criteria:

* Patients from 18 to 65 years old.
* De novo histologically proven multiple myeloma.

Exclusion Criteria:

* No history of another cancer or of HIV
* No history of renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Olivier Couturier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01470768: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
Official title: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cow's Milk Allergy
Intolerance to Extensively Hydrolyzed Formulas
Intolerance to Breast Milk
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.


Eligibility criteria: Inclusion Criteria:

* 0 to 6 months of age inclusive
* Born at ≥ 37 weeks gestation
* Birth weight of 2500 g (5 lb 8 oz) or more
* Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
* Infants with symptoms suggestive of cow's milk allergy
* Signed Informed Consent

Exclusion Criteria:

* Infants who for whatever reasons were not discharged home as per routine
* Infants with metabolic illness requiring a special formula
* Infants fed with nasogastric tube

Primary outcomes:
measure: Level of fatty acids in whole blood of infants
timeFrame: 4 months
Secondary outcomes:
measure: body weight
timeFrame: 4 months
measure: Occurrence of allergic manifestations
timeFrame: 4 months
measure: Occurrence of adverse events
timeFrame: 4 months
measure: Incidence of gas
timeFrame: 4 months
measure: Incidence of fussiness
timeFrame: 4 months
measure: Stool characteristics
timeFrame: 4 months
measure: Body length
timeFrame: 4 months
measure: Head Circumference
timeFrame: 4 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormand Street Hospital and Institute of Child Health
state: United Kingdon
Study officials:
affiliation: UCL Institute of Child Health and Great Ormond Street Hospital
name: Nikhil Thapar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Clinical trial NCT00308568: RCT of Mailed Brochure to Boost Adherence to Screening Colonoscopy
Official title: Randomized Controlled Trial of a Mailed Brochure to Increase Adherence to Referrals for Screening Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Mass Screening
Keywords: screening colonoscopy
adherence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The Henry J. Kaiser Family Foundation
First posted: 2006-03-29
Enrollment: 628
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of a mailed educational brochure on adherence to referral for screening colonoscopy. The comparison (or control) group receives no mailer, which is usual care.


Eligibility criteria: Inclusion Criteria:

Referrals for screening colonoscopy; Asymptomatic; age\>=50

Exclusion Criteria:

Referrals for diagnostic colonoscopy

Primary outcomes:
measure: Rate of adherence to screening colonoscopy referral within at least three months of receipt of referral.
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Thomas D. Denberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: