louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06455371: Patient-centered Dosage of Levothyroxine
Official title: Patient-centered Decision Support Tool for Levothyroxine Dosage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypothyroidism
Thyroid Cancer
Thyroid
Keywords: Decision support tool
Patient-centered dosage
thyroidectomy
levothyroxine
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: SINTEF Health Research
name: Helseapps
name: Norinnova
name: Helse Nord
First posted: 2024-06-12
Enrollment: 240
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: Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.


Eligibility criteria: Inclusion Criteria:

* Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals

Exclusion Criteria:

* Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy

Primary outcomes:
measure: Number of patients at biochemical target
timeFrame: Outcome is measured at 8 weeks, 6 months and 12 months post surgery
Secondary outcomes:
measure: Time to biochemical target
timeFrame: Measured at 18 months after surgery
measure: Distance from biochemical target
timeFrame: Measured at 8 weeks post surgery
measure: Patient reported outcome - ThyPRO39 questionnaire
timeFrame: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
measure: Patient reported outcome - RAND-36 questionnaire
timeFrame: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
measure: Abscence from work
timeFrame: Measured at18 months after surgery
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
References:
citation: Brun VH, Eriksen AH, Selseth R, Johansson K, Vik R, Davidsen B, Kaut M, Hellemo L. Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy. Thyroid. 2021 Sep;31(9):1297-1304. doi: 10.1089/thy.2021.0125. Epub 2021 Jun 22.
Clinical trial NCT05499871: Effect of a Gait Retraining Intervention and a Minimalist Footwear Transition on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.
Official title: Comparison Between Gait Retraining Intervention With a Transitioning Toward Minimalist Footwear on the Foot-ankle Strength, Running Economy and Injury Incidence in Endurance Runners: a One-year Follow up Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Running
Wounds and Injuries
Oxygen Consumption
Keywords: Gait retraining
Performance
Injuries
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main aim is to determine whether a gait retraining intervention will improve the strength of the foot-ankle muscle, the running economy and reduce the injury incidence in a one-year follow-up study. The secondary aim is to seek whether a minimal foot-ankle strength is necessary to reduce the risk to sustain to a running-related-injury to transit toward a forefoot strike pattern or toward a minimalist footwear for an endurance runner.

Participants will be assessed at baseline, at 2 month follow-up, at 6 month follow-up and at 12 month follow-up. Assessment will be composed by questionnaires, a foot screening, maximal voluntary isometric strength of foot-ankle muscle with hand held dynamometer. Then, participants will run on a treadmill at self-paced and at 10 km/h with to measure their running economy and their footstrike pattern. In function of their distribution, participants will receive either nothing (control group) or minimalist footwear or a training to modify their footstrike pattern toward a more forefoot strike.


Eligibility criteria: Inclusion Criteria:

* Run 15 km per week since minimum 6 month

Exclusion Criteria:

* No running related injuries in the last 3 month before the participation.
* Have never worn minimalist footwear (minimalist index superior to 70%)
* Have never modified their footstrike pattern

Primary outcomes:
measure: Change in foot-ankle strength
timeFrame: Change from Baseline foot-ankle strength at 2 month follow-up, Change from Baseline foot-ankle strength at 6 month follow-up, Change from Baseline foot-ankle strength at 12 month follow-up
measure: Change in running economy
timeFrame: Change from Baseline running-economy at 2 month follow-up, Change from Baseline running economy at 6 month follow-up, Change from Baseline running economy at 12 month follow-up
measure: Running-related-injuries
timeFrame: At any time during the 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Guillaume Abran
Study officials:
References:
Clinical trial NCT00451971: Objective Study in Rheumatoid Arthritis
Official title: Objective Study in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-26
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objectives

1. To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range.
2. To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care.

Secondary Objectives

1. To establish the relationship between achieving a given STO or combination of STOs and damage progression.
2. To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
* Active disease: ≥6/28 swollen joints or
* Erythrocyte sedimantation or C-Reactive Protein \> normal
* Disease duration ≤ 15 yrs
* Any therapy
* Females of child-bearing potential must be adequate contraception

Exclusion Criteria:

* Frailty, limiting co-morbidity
* Obesity limiting ability to have MRI
* Geographical difficulty preventing follow-up and visits
* Women at risk of becoming pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
measure: The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
measure: C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
Secondary outcomes:
measure: Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: J Edmonds
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poh MQ, Lassere M, Bird P, Edmonds J. Reliability and longitudinal validity of computer-assisted methods for measuring joint damage progression in subjects with rheumatoid arthritis. J Rheumatol. 2013 Jan;40(1):23-9. doi: 10.3899/jrheum.120549. Epub 2012 Nov 1.
Clinical trial NCT04398771: To Evaluate Safety and Effectiveness of RovatitanTab.
Official title: A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Hyperlipidemias
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have hypertension and hyperlipidemia

Brief summary: To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia

Detailed description: * Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
* Safety: we will collect safety data

Eligibility criteria: Inclusion Criteria:

* Patients who have hypertension and hyperlipidemia and older than 19 years
* Patients who undertstand purpose and method of study, agree with study

Exclusion Criteria:

* Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs
* Uncontrolled hypertension (SBP\>=180mmHg or DBP\>=110mmHg)
* Patients who participated another clinical study or observational study 3 months ago.

Primary outcomes:
measure: The ratio of patients who reach the target BP
timeFrame: 12weeks
measure: The ratio of patients who reach the target LDLcholesterol
timeFrame: 12weeks
Secondary outcomes:
measure: The ratio of patients who reach the target BP and LDL-c
timeFrame: 12weeks
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Kang seokmin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03922971: Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
Official title: Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: colonoscopy
EGD
endoscopy
ASC
outpatient
infection
Endoscopic procedures
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Medivators Cantel
First posted: 2019-04-22
Enrollment: 303
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will notify centers of center's post-endoscopic infection rates and evaluate the effectiveness of this notification system to decrease infection rates. The investigators aim to notify centers of the number of patients and center's risk-adjusted rates of hospitalizations for infections after colonoscopy and esophagogastroduodenoscopy (EGD) procedures performed between January 2015 and September 2018. The investigators will randomize centers to two notification groups: (1) Ability to view center's rate compared with all other centers (ASCs and outpatient centers notified and compared separately) or (2) Ability to view center's rate compared with the other centers with a similar patient comorbidity profile and in addition to viewing option 1. Facilities will answer questions about center's infection control practices. The investigators hypothesize that centers with high rates of post-procedural infections will (1) be more likely to report that the center took action to investigate the center's infection control practices after the first notification and (2) observe a decrease in infections after the notification. The investigators anticipate that centers with high rates of post-procedural infections that are randomized to group 2 will have greater change. The investigators anticipate no change in rates of infection in the facilities that had zero or very low (n=1) event rates.


Eligibility criteria: Inclusion Criteria:

* Facilities that bill to fee for service Medicare for gastrointestinal endoscopy

Exclusion Criteria:

-

Primary outcomes:
measure: Change in the infection rate among centers with elevated infection rates
timeFrame: Baseline, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Susan Hutfless
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06187571: Mulligan Mobilization With Movement Method in the Treatment of Shoulder Problems
Official title: Comparison of Conventional Therapy and Mulligan Mobilization With Movement Method in the Treatment of Shoulder Problems: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Syndrome
Pain
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 41
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 whether Mulligan mobilization with movement (MWM) and Conservative treatment CT give different results on pain, ROM, and functional activities in participants with shoulder problems.

Detailed description: Shoulder problems are one of the common orthopedic problems. Patients with shoulder problems experience an increase in pain and a decrease in joint movement and functionality. With conventional treatment, patients' symptoms improve. However, the MWM is one of the manual therapy techniques frequently used to reduce pain in musculoskeletal system problems. It is extremely important to evaluate patients' functionality after rehabilitation. Although there are studies comparing the effect of MWM in the literature, studies evaluating patient-specific functionality are also limited.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Having any shoulder problems (impingement, rotator cuff syndrome, glenohumeral joint problems, etc.),
* Having a history of shoulder pain lasting at least 3 months, and volunteering to participate in the study.

Exclusion Criteria:

* Having systemic or degenerative disease, a neurological disease, and
* Having more than one upper extremity pathology.

Primary outcomes:
measure: Shoulder pain
timeFrame: through study completion, an average of 6 month
Secondary outcomes:
measure: ROM
timeFrame: through study completion, an average of 6 month
measure: Patient Specific Functional Scale
timeFrame: through study completion, an average of 6 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
state: Esenboğa
Study officials:
References:
Clinical trial NCT04601571: Confirming Feeding Tube Position Using CORTRAK
Official title: Confirming Feeding Tube Position Using the CORTRAK Enteral Access System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Enteral Nutrition
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A non-inferior cohort study design
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare the accuracy of the CORTRAK enteral access system (CEAS) to x-ray for the determination of feeding tube position within the abdomen.

Detailed description: In the inpatient pediatric care area (PICU, PCCU, PIMU, ACU), when an x-ray is performed for any reason and a patient has a CORTRAK feeding tube, a provider from the research team will re-insert the small, individualized, flexible stylet back into the patient's feeding tube and document the position of the tube on the CORTRAK display monitor. The x-ray will be obtained by current standard of care and the tube location on x-ray will be compared to the tube location on the CORTRAK monitor. The x-ray will only be obtained as part of the routine care decided by the medical team, the patient will not receive any additional x-rays for this study.

Eligibility criteria: Inclusion Criteria:

* CORTRAK feeding tube placed as part of clinical care
* Getting xray for any reason
* CORTRAK Stylet available in the room
* Pediatric patients (Aged 17 or younger)

Exclusion Criteria:

-CORTRAK Stylet has been misplaced

Primary outcomes:
measure: Confirmation of correct placement of the Feeding tube
timeFrame: Baseline to removal of feeding tube (on average 10-14 days)
Secondary outcomes:
measure: Number of Radiographs required for placement
timeFrame: Baseline to removal of feeding tube (on average 10-14 days)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health Systems Hospital
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Andrew Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757471: Brillant Blue Versus Indocyanine Green for Macular Hole Surgery
Official title: Membranepeeling With Brillant Blue Versus Membranepeeling With Indocyanine Green for Patients With Idiopathic Macular Holes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Macular Holes
Keywords: Macular hole surgery
membranepeeling
closure rate
vitreoretinal dyes
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Macular Hole Surgery with two different Dyes


Eligibility criteria: Inclusion Criteria:

* Idiopathic stage 3 and 4 macular holes
* Stage 2 macular holes, followed up for at least 6 months
* Pseudophakic and phakic eyes
* Age over 60 years

Exclusion Criteria:

* Traumatic macular holes
* Secondary macular holes
* Severe ocular diseases

Primary outcomes:
measure: Macular Hole Closure Rate
timeFrame: 12 Months
Secondary outcomes:
measure: Visual Acuity Microperimetry Optical Coherence Tomography
timeFrame: 12 Months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery
Study officials:
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Katharina Kreppler, MD
role: STUDY_CHAIR
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Christiane I Falkner-Radler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270087: The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Official title: The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis, cardiovascular disease, adalimumab
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
name: The Swedish Research Council
name: The Swedish Rheumatism Ass
name: Crafoord Foundation
First posted: 2011-01-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis
* Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis
* Active disease despite treatment with at least one disease modifying anti-rheumatic drug
* Treatment with adalimumab indicated according to the the patient's rheumatologist
* At least six swollen joints in 28-joint index
* CRP \> 8 mg / L within the last three months

Exclusion Criteria:

* Treatment with anti-TNF drugs in the last three months
* Treatment with intravenous corticosteroids within fourteen days
* Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
* Severe bleeding disorder
* Extensive or refractory leg ulcers
* Severe peripheral vascular disease

Primary outcomes:
measure: Endothelial expression of HLA-DQ in muscle biopsies
timeFrame: 3 months
measure: Endothelial expression of interleukin-1 alpha in muscle biopsies
timeFrame: 3 months
measure: Carotid artery intima-media thickness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Rheumatology, Skåne University Hospital
Study officials:
affiliation: Department of Rheumatology, Skåne University Hospital
name: Carl Turesson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191087: Duloxetine in the Treatment of Stress Urinary Incontinence.
Official title: Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 458
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Women with predominant stress urinary incontinence.
* 7 or more incontinence episodes per week.

Exclusion Criteria:

* Use of monoamine inhibitors.

Primary outcomes:
measure: To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence
Secondary outcomes:
measure: To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
state: England
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: