louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06213181: Mindfulness on Physical and Mental Condition in Older Adults With Chronic Pain
Official title: Effects of an Intervention Based on Mindfulness on the Physical and Mental Condition in People Over 65 Years of Age With Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research corresponds to an experimental study, a randomized controlled clinical trial in people over 65 years of age, distributed into two groups: the experimental group will receive a program that will consist of an eight-week mindfulness-based intervention; and the control group that will only receive general recommendations about the benefits of physical exercise. Measurements will be carried out at the beginning of the intervention and immediately after its completion.


Eligibility criteria: Inclusion Criteria:

* The study participants are men and women over 65 years of age residing in the city of Jaén (Spain).
* People with pain with more than 3 months of evolution.
* Participants must have completed the informed consent.

Exclusion Criteria:

* That they do not voluntarily accept to participate in the study and that they are able to understand the instructions and follow the instructions of the intervention.

Primary outcomes:
measure: SF-12 (reduced version of The Health Survey Short Form-36)
timeFrame: Up to twelve weeks
measure: Numeric Rating Scale (NRS)
timeFrame: Up to twelve weeks
measure: FSS (Fatigue Severity Scale)
timeFrame: Up to twelve weeks
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: Up to twelve weeks
measure: PSS (Perceived Stress Scale)
timeFrame: Up to twelve weeks
measure: Chair stand test
timeFrame: Up to twelve weeks
measure: TUG test (Timed Up and Go test)
timeFrame: Up to twelve weeks
measure: Tinetti scale
timeFrame: Up to twelve weeks
measure: HADS (The Hospital Anxiety And Depression)
timeFrame: Up to twelve weeks
measure: Arm curl test
timeFrame: Up to twelve weeks
measure: Back scratch test
timeFrame: Up to twelve weeks
measure: Chair-sit and reach-test
timeFrame: Up to twelve weeks
measure: Brief Pain Questionnaire (CBD)
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: BMI (Body Mass Index)
timeFrame: Up to twelve weeks
measure: Waist circumference
timeFrame: Up to twelve weeks
measure: Hip circumference
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Municipal social services center "el boulevard"
Study officials:
References:
Clinical trial NCT00616681: Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Epilepsy
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 28
Sex: ALL
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 objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical labratory results duirng screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepne or any other comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MDS Pharma Services
state: Quebec
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663481: A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Official title: A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Keywords: CoFactor
ANX-510
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Males and Females age 18-65 inclusive at screening.
* Subject has to agree to practice abstinence or medically accepted contraception and not to participate in sperm donation or in vitro fertilization.
* Body Mass Index in the range of 18 to 30 kg/m2 and body weight of 45 to 95 kg.
* Subject must be healthy as determined by the investigator on the basis of screening evaluations.
* Subject must be nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the in-clinic stay.

Exclusion Criteria:

* Presence of clinically significant illness within 21 days prior to dosing, viral or bacterial infection, or documented drug allergies that may affect subject's safety during the study.
* Laboratory or clinical evidence suggestive of disease.
* Clinically significant or predisposing disorder that may interfere with the absorption, distribution, metabolism and/or excretion of drugs.
* History of drug abuse within 1 year of dosing and/or admitted alcohol abuse or history of alcohol use that may interfere with the ability to comply.
* Pregnant, lactating, or positive pregnancy test.
* Clinically significant electrocardiogram abnormalities.
* History of positive test for hepatitis B or C, or HIV.
* Positive findings of urine narcotic screen.
* History of drug allergy.

Primary outcomes:
measure: Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
Secondary outcomes:
measure: To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Parexel International - Baltimore CPRU
state: Maryland
Study officials:
affiliation: Parexel International - Baltimore CPRU
name: Ronald Goldwater, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05648981: Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children
Official title: Effectiveness of Photobiomodulation Using Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Inevitable problems were reported following the injection of local anesthesia in pediatric dental procedures, which can last until the elimination of soft tissue anesthesia.

Purpose of the study: To evaluate the effectiveness of diode laser photobiomodulation therapy on the reversal of soft tissue anesthesia (STA) in children following inferior alveolar nerve block anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients in need of operative dental procedures, requiring inferior alveolar nerve (IANB) anesthesia.
* Healthy patients (physical status ASA I).
* Definitely positive or positive patients on the Frankl behavior scale.
* No reported allergies to LA, epinephrine or sulfites.
* Normal lip sensation before administration of LA

Exclusion Criteria:

* Patients requiring surgical procedures (i.e. extractions).
* Patients who will show excessive fear to the Transcutaneous Electric Nerve Stimulator (TENS) device and provide a false-positive response on inactivated electrode (absence of current) using the Venham scale.
* Patients who will not be trainable in the standardized lip tapping procedure (could not learn to distinguish the anesthetized numb side from the non-anesthetized side).
* Patients who will not achieve profound numbness after initial LA administration, requiring additional anesthesia using SEM scale.

Primary outcomes:
measure: Time to recovery of normal lip sensation
timeFrame: For two hours after the procedure
Secondary outcomes:
measure: Assessment of soft tissue injury
timeFrame: 24 hours after the procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04844281: Wear Experience With Daily Toric Contact Lenses Over a Long Day
Official title: Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens
Astigmatism of Both Eyes
Keywords: Toric Contact Lens
Daily Contact Lens
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2021-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.


Eligibility criteria: Inclusion Criteria:

* Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
* Distance visual acuity of 20/25 or better with current lenses.
* Recent eye exam in the last year.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Ability to give informed consent.
* Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
* Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.

Exclusion Criteria:

* Current ocular inflammation or infection as assessed by the study investigator.
* Currently pregnant, lactating, or planning to become pregnant during the course of the study.

Primary outcomes:
measure: Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
timeFrame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
measure: Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
timeFrame: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT00551681: Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
Official title: Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Dysfunction
Heart Failure
Keywords: cardiac resynchronisation therapy
epicardial lead
coronary sinus
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
First posted: 2007-10-31
Enrollment: 52
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 compare a surgical approach of LV lead placement for BIV pacing with the conventional transvenous approach by assessment of differences on the effects on cardiac perfusion and relate this to the clinical cardiac function.


Eligibility criteria: Inclusion Criteria:

* Heart failure NYHA III or IV
* QRS duration \>120msec or, when paced \> 200msec on 12-lead ECG
* LBBB on ecg
* LV ejection fraction 35% or less
* LV dyssynchony on echocardiography

Exclusion Criteria:

* Severe (drug refractory) heart failure with short (\<6 months) life expectancy.
* Permanent or persistent atrial fibrillation
* Other indications for cardiac surgery within 6 months
* Life expectancy less than one year due to other conditions
* Major contra-indication for general anaesthesia
* Participation in another study
* Pregnancy or the desire to become pregnant during the follow up of the study.

Primary outcomes:
measure: Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
timeFrame: 6 months
Secondary outcomes:
measure: Resynchronization of the LV, measured with TDI, 2D- and 3D-echocardiography, in patients with epicardial LV lead placement, compared to transvenous LV lead placement
timeFrame: 6 months
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Lucas VA Boersma, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120910: Pleth Variability Index (PVI) to Predict Fluid Responsiveness
Official title: Validation of PVI as a Parameter to Predict Fluid Responsiveness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).

Detailed description: No subjects were enrolled into the validation portion of this study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
* Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure

Exclusion Criteria:

* Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study
* Patients with cardiac arrhythmias
* Patients with intracardiac shunts

Primary outcomes:
measure: Clinical utility of PVI
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
References:
Clinical trial NCT02925910: Comparison of User Experience With Wheelsoft Wheels Intalled on a Wheelchair Compared With Normal Wheels.
Official title: Assesment of Patient Experience Using a Wheelchair Equipped With Suspension Wheels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Personal Satisfaction
Fatigue
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Two groups of randomised rehabilitation patients will try a softwheels wheelchair and a regular one. One group will start with the softwheelsl and then change to the regular, and the other will start with the regular and then change to the softwheel.

Detailed description: The patients who are received to the rehabilitation ward and are confined to the use of a wheelchair are randomized to two groups. The first are given a wheelchair with wheelsoft wheels and the second group with regular wheels. The wheels of the chair are all covered to look similar to regular wheels (the regular wheels are also covered). All the patients will be taken once a day to a 10 minute trip with the wheelchair. After two days a questionnaire regarding their experience with the chair will be passed. On the third day the groups will change their wheels to the other kind. And again taken to daily trips and a final questionnaire on day four. We will collect additional data from the patients: age, sex, medical record, weight, height, ethnic background, marital status, working status.

Eligibility criteria: Inclusion Criteria:

* wheelchair bound for at least 4 days

Exclusion Criteria:

* not able to answer verbal questions
* over 95 kg of weight (wheel limit)

Primary outcomes:
measure: Satisfaction - first round
timeFrame: 2 days
Secondary outcomes:
measure: Satisfaction - Second round
timeFrame: 2 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: haemek MC
Study officials:
affiliation: haemek medical center
name: uriel giwnewer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004810: Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: gastrointestinal disorders
rare disease
ulcerative colitis
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 2000-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.

Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.

Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Mildly to moderately severe ulcerative colitis
* Patient age: 18 to 80

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: Warren L. Beeken
role: STUDY_CHAIR
References:
citation: Beeken W, Howard D, Bigelow J, Trainer T, Roy M, Thayer W, Wild G. Controlled trial of 4-ASA in ulcerative colitis. Dig Dis Sci. 1997 Feb;42(2):354-8. doi: 10.1023/a:1018874120749.
Clinical trial NCT02218710: Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography
Official title: Bone Geometry, Volumetric Density, Microarchitecture and Estimated Bone Strength Assessed by High Resolution Peripheral Quantitative Computed Tomography in Patients With Adult Onset Growth Hormone Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Onset Growth Hormone Deficiency
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are all seen at the Odense University Hospital at the department of Endocrinology. All patients at the hypophysis clinic were checked and those receiving growth hormone replacement therapy were invited to participate.

Brief summary: The aim of the study is to assess bone geometry, bone compartment specific volumetric densities and micro-architecture as well as to evaluate non-invasive estimates of bone strength in patients with adult onset growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Men and women diagnosed with Adult onset Growth Hormone Deficiency
* Age between 18-80
* Informed consent

Exclusion Criteria:

* Competing bone disease (e.g.. Mb. Paget, myelomatosis, osteogenesis imperfecta, osteoporosis, primary hyperparathyroidism)
* Ongoing medical treatment affecting bone metabolism (eg. osteoporosis medications)
* Ongoing pregnancy or breast feeding

Primary outcomes:
measure: volumetric bone mineral density in grams per cc
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Endocrinological department M, Odense University Hospital
state: Region syddanmark
city: Odense
country: Denmark
facility: Department M
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
References: