louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00799149: Etoricoxib Versus Gabapentin for Knee Arthroscopy
Official title: Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for Ambulatory Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthroscopy
Keywords: Post-operative pain
Knee arthroscopy
Gabapentin
Etoricoxib
Elective ambulatory knee arthroscopy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 75
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: To determine that when administered as part of a multimodal analgesic regimen, use of the new COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).

Detailed description: Background: Post-discharge pain remains a significant problem after many ambulatory surgery procedures. Both etoricoxib and gabapentin have been used to prevent postoperative pain; however their relative efficacy in the post-discharge period is not known. We hypothesized that daily use of etoricoxib would offer advantages over gabapentin as part of a multimodal analgesic regimen in the perioperative period due to its pharmacokinetic profile.

Methods: Seventy-five healthy outpatients undergoing elective ambulatory knee arthroscopy were randomly assigned to receive identical-appearing capsules containing either a placebo, gabapentin (1.2g, or etoricoxib 120 mg, 30-90 min before skin incision and at 08H00 on the first, second, and third postoperative days. Post-discharge pain was treated with "rescue" dipyrone syrup (500 mg). Pain intensity (as assessed using a 100 visual analog scale), dipyrone usage, and the incidence of nausea and vomiting, sedation and anxiety were recorded at specific time intervals in the postoperative period. The recovery of functional activity was assessed at 96 h after surgery using a validated questionnaire.

Eligibility criteria: Inclusion Criteria:

* Elective ambulatory knee arthroscopy

Exclusion Criteria:

* History of clinically-significant cardiovascular,pulmonary,hepatic,renal, neurologic, psychiatric or metabolic disease
* Patients chronically receiving pain killers

Primary outcomes:
measure: 1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage
timeFrame: 96 hours post-operation
Secondary outcomes:
measure: The recovery of functional activity
timeFrame: 96 hours
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT01052649: Gene Expression Monitoring of Mononuclear Cells (MNC) Subpopulations and Immunological Status and Metabolome Defining of Healthy Population
Official title: Gene Expression Monitoring of Peripheral Blood Mononuclear Cells Subpopulations (CD4+ Cells, CD56+ Cells and CD4+CD25+ Cells) and Immunological Status and Metabolome Defining of Healthy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gene Expression
Metabolomics
Immunological Status
Keywords: MNC subpopulations
Gene Expression
Metabolomics
Immunological Status
Lead sponsor: Blood Transfusion Centre of Slovenia
Sponsor class: OTHER_GOV
First posted: 2010-01-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy population

Brief summary: Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+ cells)and should provide a reference for comparison with transcriptomic data of any disease state.Furthermore, metabolome and immunological status are defined on same samples.


Eligibility criteria: Inclusion Criteria:

* age: 20-70 years
* healthy

Exclusion Criteria:

* acute or chronic diseases
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Blood Transfusion Centre of Slovenia
Study officials:
References:
Clinical trial NCT05697549: Effects of Cognitive Behavior Language Therapy for Patients With Post Stroke Aphasia
Official title: Effects of Cognitive Behavior Language Therapy for Patients With Post Stroke Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is clinical trial based and the target population in this study is patients with post-stroke aphasia. Cognitive linguistic quick test (CLQT) and Speech Language unhelpful thoughts and belief scale (SLUTBS) will apply as an assessment. Inclusive criteria include diagnosed male and female post-stroke severe aphasia patients above 30 years of age. These participants must have high instance of unhelpful speech language thoughts and belief. Participants in inclusive criteria must not be participated in any other psychotherapy/ speech language intervention program. Participants must sign an informed consent form. Participants having a caregiver who is willing to be present during the period of intervention. Exclusive criteria include individuals below 30 years of age and patients with aphasia caused by non-stroke etiology.

The aim of the study is to check the effects of cognitive behavior language therapy on patients with post-stroke aphasia. So, it will help speech language pathologists to adopt the principles of CBLT intervention to treat aphasia that occurs as a result of aphasia.


Eligibility criteria: Inclusion Criteria:

* Both male and female.
* Over 30 years of age.
* All types of diagnosed aphasia.
* Severe aphasia following stroke.
* High instance of unhelpful speech language thoughts and belief.
* Participants who are not participating in any other psychotherapy / speech language intervention program will be included.
* Participants who are willing to sign an informed consent form.
* Participants having a caregiver who is willing to be present during the period of intervention.

Exclusion Criteria:

* Below 30 years of age.
* Patients with aphasia caused by a non-stroke etiology.

Primary outcomes:
measure: Cognitive linguistic quick test
timeFrame: 4 week
measure: Speech language and helpful thoughts and belief scale
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rahim yar khan
country: Pakistan
facility: Sheikh Zaid
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aleena Irum, MSLP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04128449: Modifications in the Anaerob Threshold in Cyclists by Consuming Docosahexaenoic Acid (DHA)
Official title: Modifications in the Anaerob Threshold in Cyclists (DHA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance
Keywords: performance
cyclists
docosahexaenoic acid
anaerobic threshold
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a double-blind, parallel randomized clinical trial with 38 cyclists in whom the performance improvement was determined after the consumption of docosahexaenoic acid for one month.


Eligibility criteria: Inclusion Criteria:

* Male between 18 and 75 years old.
* Cyclists who train three or four times a week.

Exclusion Criteria:

* Suffering some type of chronic disease.
* Consume habitually pharmacological treatments that could influence the physiological or biochemical responses to be analyzed in the present work.
* Consumption in the month prior to the start of the study, or during the performance of the same, functional food enriched with omega-3 fatty acids.
* To present during the performance of the stress tests, any of the absolute or relative contraindications dictated by the American College of Sports Medicine (ACSM, 1999) 15 would be duly informed and excluded from the present study.

Primary outcomes:
measure: ergospirometry variable: heart rate
timeFrame: The change was evaluated after one month of product consumption.
measure: ergospirometry variable: absolute oxygen consumption
timeFrame: The change was evaluated after one month of consumption of the product
Secondary outcomes:
measure: ergospirometry variable:respiratory ratio
timeFrame: The change was evaluated after one month of consumption of the product
measure: ergospirometry variable: oxygen equivalent
timeFrame: The change was evaluated after one month of consumption of the product
measure: blood variables: Natremia, potassium, chloremia, calcemia, , bicarbononatemia, ph, lactacidemia.
timeFrame: The change was evaluated after one month of product consumption.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
Clinical trial NCT00394849: Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Official title: Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Pain
Keywords: Tonsillectomy
Suturing of tonsillar pillars
pain
postoperative hemorrhage, bleeding
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-11-01
Enrollment: 763
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.

Detailed description: After induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual Otolaryngologist performing the procedure. Next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. The side chosen was determined by a computer generated schedule. Routine postoperative care was given.

Eligibility criteria: Inclusion Criteria:

* Any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol.

Exclusion Criteria:

* Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess

Primary outcomes:
measure: which side was more painful on or about postoperative day 14
timeFrame: 14 days
Secondary outcomes:
measure: Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
timeFrame: 40 days
measure: any other adverse events (complications)
timeFrame: 40 days
measure: which side was more painful on or about postoperative day 21
timeFrame: 21 days
measure: overall assessment at the postoperative clinic visit (on or about day 28)
timeFrame: 28 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Childrens' Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Bruce H. Matt, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matt BH, Krol BJ, Ding Y, Juliar BE. Effect of tonsillar fossa closure on postoperative pain and bleeding risk after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1799-805. doi: 10.1016/j.ijporl.2012.09.004. Epub 2012 Sep 25.
Clinical trial NCT00518349: Colonoscope Passive Bending Function
Official title: Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis
Adenoma
Carcinoma
Functional Colonic Disease
Lead sponsor: Norwegian Department of Health and Social Affairs
Sponsor class: OTHER_GOV
Collaborators: name: Sykehuset Telemark
First posted: 2007-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Detailed description: Results from the first prototype evaluation has been published.Modifications are presently evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

* Pregnant women
* Age below 18 years

Primary outcomes:
measure: Patient Assessment of Pain Experienced During Colonoscopy
timeFrame: Pain experienced during colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Gastroenterology section, Dept. of Medicine, Telemark Hospital
Study officials:
affiliation: Head of Research, Telemark Hospital
name: Geir Hoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoff G, Moritz V, Bretthauer M, Ludolph T, Huppertz-Hauss G, Paulsen J, Seip B, Sauar J, Kjellevold O, Chengarov L. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study. Scand J Gastroenterol. 2011 Jan;46(1):104-8. doi: 10.3109/00365521.2010.521891. Epub 2010 Oct 6.
citation: Hoff G, Bretthauer M, Huppertz-Hauss G, Sauar J, Paulsen J, Dahler S, Kjellevold O. Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study. Endoscopy. 2005 Nov;37(11):1123-6. doi: 10.1055/s-2005-870444.
Clinical trial NCT04394806: The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
Official title: The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Keywords: Triglycerides
Glucose
Adiposity
Air displacement plethysmography
Continuous glucose monitoring
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 140
Sex: ALL
Minimum age (years): 0
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese pregnant women between the ages of 20-39 years old, who are receiving care at a University of Colorado Health Facility.

Brief summary: This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.


Eligibility criteria: Inclusion Criteria:

* Pregnant women less than 16 weeks gestational age
* Between the ages of 21-39 years
* Pre-pregnancy BMI 28-39 kg/m2

Exclusion Criteria

* Pre-gestational diabetes or prediabetes
* History of gestational diabetes
* History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks
* Tobacco or illicit substance use
* Chronic steroid use

Primary outcomes:
measure: Newborn Fat Mass
timeFrame: 7-14 days after birth
Secondary outcomes:
measure: Newborn Intrahepatic Fat
timeFrame: 7-14 days after birth
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado/Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Linda A Barbour, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Teri L Hernandez, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.
Clinical trial NCT06360406: Real-World Treatment Study of Koselugo (Selumetinib)
Official title: Real-World Treatment Study of Koselugo (Selumetinib)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurofibromatosis 1
Neurofibroma, Plexiform
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with Koselugo (Selumetinib) under the approved label in South Korea.

Brief summary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.

This study will provide information on the Korean patient population that is treated with the study drug.


Eligibility criteria: Inclusion Criteria:

1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Primary outcomes:
measure: Adverse events (AEs) rate
timeFrame: 1 year
measure: Physeal dysplasia occurance rate
timeFrame: 1 year
Secondary outcomes:
measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable
timeFrame: 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jeonnam
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Wonju-si
country: Korea, Republic of
facility: Research Site
city: Yangsan-si
country: Korea, Republic of
facility: Research Site
Study officials:
References:
Clinical trial NCT01827306: Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance
Official title: Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. The purpose of this study is to evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just prior to initiating the in-office exercise program. Values of pain (NPRS) and disability (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by repeated measures ANOVAs within and between group, time, and interaction main effects. Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the associated disability. The ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. In turn, patients will correct the underlying condition of their shoulder pain at a faster rate.


Eligibility criteria: Inclusion Criteria:

* 18-64 years old
* mechanical shoulder pain
* candidates for conservative care

Exclusion Criteria:

* pregnancy
* radicular symptoms
* not a candidate for conservative care
* history of recent shoulder surgery

Primary outcomes:
measure: Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks
timeFrame: 2 weeks
measure: Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks
timeFrame: 2 weeks
measure: Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks
timeFrame: 4 weeks
measure: Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport & Spine Rehab
state: Maryland
Study officials:
affiliation: Sport and Spine Rehab Clinical Research Foundation
name: Jay Greenstein, DC
role: PRINCIPAL_INVESTIGATOR
References: