louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02137031: Continuous Glucose Monitoring and Metabolic Control in Children With Type 1 Diabetes
Official title: Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment.

With increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c levels.

Research on the effectiveness of continuous glucose monitoring on metabolic control in children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.


Eligibility criteria: Inclusion Criteria:

* Children aged 6-18 years
* T1D for greater than one year;
* Willing to perform at least three self-monitoring blood glucose tests per day;
* Has been using continuous subcutaneous insulin infusion for more than one month
* English speaking

Exclusion Criteria:

* Presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control)
* Use of corticosteroids that have systemic effects and affect glucose levels
* Currently using continuous glucose monitoring
* Cognitively unable to self-manage, based on parent's and/or care provider's opinion

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Fear of Hypoglycemia
timeFrame: 3 months
measure: Frequency of Hypoglycemia
timeFrame: 3 months
measure: Frequency of Hyperglycemia
timeFrame: 3 months
measure: Frequency of Diabetic Ketoacidosis
timeFrame: 3 months
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Whitby
country: Canada
facility: Charles H. Best Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Krystie A Robinson-Vincent, PhD c
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04374331: Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair
Official title: The Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Repair
Keywords: Rotator cuff repair
video-assisted training
upper extremity problems
upper extremity functions
complication
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR.

Detailed description: Methods: Forty-eight elective RCR patients were randomly assigned to VAT and control groups. VAT group (n=24) received VAT including early post-operative care for RCR, activities of daily living (ADL) and gradual exercise program while control group (n=24) received routine care. Primary outcomes were upper extremity problems and functions, assessed using Disabilities of the Arm, Shoulder and Hand (DASH) and Modified Constant-Murley (MCM) scores. Secondary outcomes were complications within three months. Outcomes were collected at baseline, after six weeks and three months.

Eligibility criteria: Inclusion Criteria: Patients who

* underwent elective RCR for the first time;
* whose arm was suspended and fixed for up to three weeks after RCR;
* had an SMMT score of ≥23 points;

Exclusion Criteria: Patients who

* had been diagnosed with a psychiatric illness;
* have any history of an upper extremity fracture or a rheumatologic disease;

Primary outcomes:
measure: Change upper extremity problems
timeFrame: Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months
measure: Change upper extremity functions
timeFrame: Change from baseline the Modified Constant-Murley score at 3 months
Secondary outcomes:
measure: Change of complications
timeFrame: 1st and 3rd months
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenisehir
Study officials:
affiliation: Mersin University
name: Gulay Altun Ugras, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05874531: End-expiratory Occlusion Test and Prediction of Preload Dependence
Official title: End-expiratory Occlusion Test and Prediction of Preload Dependence: Echocardiographic and Hemodynamic Study in the ICU.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Units
Ultrasonography
Blood Volume
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty patients were included. The main causes of admission in intensive care were traumatic causes, post operative care or medical causes. 35 were responders avec 25 non responders to fluid load.

Brief summary: Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. Patients were considered responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. SPSS was used for statistic study. A p \< 0.05 was considered significant. The investigators performed univariate and then multivariate analysis.

Detailed description: The patients included were in the supine position in a prone position at 30°. They had continuous monitoring by: electrocardioscopy; pulse oximetry and invasive blood pressure. Diuresis was monitored hourly.

A venous access to the superior vena cava territory (central venous catheter) was set up.

The patients were sedated with a Ramsay score \> 4 and ventilated in controlled assisted mode.

The sub-aortic TVI (in cm) was measured in an apical 5-chamber section by pulsed Doppler using a 1-5 MHz ultrasound probe (M-Turbo sonosite). Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. At each point, the investigators noted the hemodynamic, ultrasound and biological parameters.

Eligibility criteria: Inclusion Criteria:

* Patients under mechanical ventilation and sedation in the intensive care units
* patients for whom the decision of 250 mL saline administration was taken for : hypotension (systolic pression under 90 mmHg or diatolic pression under 40 mmHg or tachycardia more than 90 pulse per minute or oliguria or the increase in cathecholamin needs.

Exclusion Criteria:

* Pulmonary Edema
* arrythmia
* dialysis
* Prone position

Primary outcomes:
measure: an increase in sub-aortic VTI of more than 10%
timeFrame: before and 10 minutes after 250 mL saline administration
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim hospital
Study officials:
affiliation: Mongi Slim Hospital
name: Mhamed Sami MS Mebazaa, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06060431: Effectiveness of a Pain Science Education Programme in Adolescent Students.
Official title: Effectiveness of a Specific Pain Science Education Programme in Adolescent Students. Randomised Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Pain
Pediatric ALL
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 293
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education.

Detailed description: Design:

Randomized controlled clinical trial. The primary endpoint of the study was pain conceptualization recorded by a questionnaire.

Setting:

The participants were school-age children attending a different high school in the province of Barcelona.

Participants:

Of the 450 potential school participants, 306 agreed to participate. 13 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 293

Eligibility criteria: Inclusion Criteria:

* to be schooled at the El Cim school
* to be between 10 and 16 years old (both included)
* to have or have had pain in the last month; to be able to read and write in Catalan and/or Spanish.

Exclusion Criteria:

* had an intellectual disability and/or cognitive impairment that interfered with their participation
* had not submitted the informed consent form duly completed and signed by their legal guardians

Primary outcomes:
measure: Conceptualization of Pain Questionnaire (COPAQ)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vilanova i la Geltrú
country: Spain
facility: Laura Menés Fernández
state: Barcelona
Study officials:
References:
citation: Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
citation: Mankelow J, Ravindran D, Graham A, Suri S, Pate JW, Ryan CG, Martin D. An evaluation of a one-day pain science education event in a high school setting targeting pain related beliefs, knowledge, and behavioural intentions. Musculoskelet Sci Pract. 2023 Aug;66:102818. doi: 10.1016/j.msksp.2023.102818. Epub 2023 Jun 27.
citation: Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
Clinical trial NCT04625231: Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans
Official title: Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Surgery
Keywords: orthopedics
hand surgery
opioid use
counseling
education
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.


Eligibility criteria: * 1. Inclusion Criteria:
* a. 18-89 years of age
* b. Patient at the Orthopedic Department at the Veterans Health Administration
* c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision
* 2. Exclusion Criteria:
* a. History of opioid use disorder
* b. Had any recent surgery within four weeks of upper extremity procedure
* c. Taking opioids prior to surgery
* d. Returning to an institutionalized setting
* e. Pregnancy
* f. Unable to communicate in the English language
* g. Allergy to any medication recommended for post-operative analgesia

Primary outcomes:
measure: Number of Opioid Pills Dispensed
timeFrame: 1 day (Once after surgery)
measure: Number of Opioid Pills Consumed
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Pain Interference Score
timeFrame: Once a week for 4 weeks after surgery
measure: Patient-Reported Outcomes Measurement Information System Pain Intensity Score
timeFrame: Once a week for 4 weeks after surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center
name: Rajshri Bolson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757731: FMS European Long-Term Study
Official title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia Syndrome
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Eligibility criteria: Inclusion Criteria:

* patient who completed the 3-month F02207 GE 302 study
* patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

Exclusion Criteria:

* known hypersensitivity to milnacipran
* major depressive episode
* significant risk of suicide
* generalised anxiety disorder
* substance abuse
* clinically significant cardiac disease
* pulmonary dysfunction
* active liver disease
* renal impairment
* autoimmune disease
* current systemic infection
* epileptic
* active cancer
* severe sleep apnoea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* (for men) prostatic enlargement or other genito-urinary disorders
* (for women) pregnancy or breastfeeding

Primary outcomes:
measure: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily
timeFrame: 12 months
Secondary outcomes:
measure: To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily
timeFrame: 12 months
Other outcomes:
Locations:
city: Pardubice
country: Czech Republic
facility: Rheumatology Ambulance
city: Kuopio
country: Finland
facility: Kuopion Oma Laakari Oy
city: Paris
country: France
facility: Hopital Hotel Dieu
city: Koln
country: Germany
facility: KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Lillehamer
country: Norway
facility: Center For Clinical Studies
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz
city: Bucharest
country: Romania
facility: Dr I CANTACUZINO CLINICAL HOSPITAL
city: Barcelona
country: Spain
facility: Hospital de La Esperanza
city: Molndal
country: Sweden
facility: Gottfriesclinic Ab
Study officials:
affiliation: HOSPITAL EGAS MONIZ, Lisboa, Portugal
name: Jaime C BRANCO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.
Clinical trial NCT05325931: 1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia
Official title: 1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2022-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.


Eligibility criteria: Inclusion Criteria:

* Be 40 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Have no active ocular disease or allergic conjunctivitis.
* Not be using any topical ocular medications.
* Be willing and able to follow instructions.
* Have signed a statement of informed consent.

Exclusion Criteria:

* Participating in a conflicting study.
* Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Visual Acuity
timeFrame: One week
measure: Near Visual Acuity
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch site 1
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen
role: STUDY_DIRECTOR
References:
Clinical trial NCT06562231: Development of Isthmocele Symptom Severity and Quality of Life Scale
Official title: Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Keywords: isthmocele
quality of life
questionnaire
abnormal uterine bleeding
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section.

Brief summary: Isthmocele, also known as cesarean scar defect (CSD), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain.

There is currently no quality of life scale that assesses isthmocele symptoms. A scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

Detailed description: Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps. Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Eligibility criteria: Inclusion Criteria:

* Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.

Exclusion Criteria:

* The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps.
* Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Primary outcomes:
measure: Development of isthmocele symptom severity and quality of life scale
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University School of Medicine
Study officials:
affiliation: Sakarya University School of Medicine
name: Hilal Uslu Yuvacı
role: PRINCIPAL_INVESTIGATOR
References: