louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02284932: Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease
Official title: Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
atrophy
muscle
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-11-06
Enrollment: 36
Sex: MALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD

Brief summary: Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.

One prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.

Detailed description: The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle atrophy. Moderate to severe COPD patients (FEV1 under 60% of predicted) and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured in the quadriceps.

Eligibility criteria: Inclusion Criteria:

* male
* COPD with an FEV1 of under 60% of predicted
* non-smoker
* between 55 and 75 years old

Exclusion Criteria:

* all inflammatory disease (HIV, cancer, renal and cardiac deficiency)
* hormonal dysregulation
* inferior limb pathology
* neuromuscular pathology
* history of tobacco or alcool abuse
* oxygen dependent
* recent exacerbation (2 months) of the symptoms of COPD

Primary outcomes:
measure: Decrease of protein degradation in muscles of wasted COPD patients
timeFrame: At baseline (COPD in a stable state of the disease)
Secondary outcomes:
measure: Increase of protein synthesis in muscles of wasted COPD patients
timeFrame: At baseline (COPD in a stable state of the disease)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: François Maltais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537132: "New Perspectives of Adaptation to NIV in ALS"
Official title: "New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Non Invasive Ventilation (NIV)
Amyotrophic Lateral sclerosis (ALS)
adaptation
home care
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Fondazione Salvatore Maugeri
First posted: 2015-09-01
Enrollment: 48
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: The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.


Eligibility criteria: Inclusion Criteria:

* ALS diagnosis according to the criteria of El Escorial;
* Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
* No respiratory infection within 3 months
* Severe disability (ALS-FRS \<31);
* Age \> 18 years;
* The voluntary participation to the Study.

Exclusion Criteria:

-- Previous episodes of pneumothorax;

* Comorbid cardiac and / or renal important
* Severe cognitive impairment;
* Refusal of the patient at the time of Informed Consent.

Primary outcomes:
measure: Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)
timeFrame: Baseline + after 2 and 4 months from the recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Michele Vitacca
state: Brescia
city: Milan
country: Italy
facility: Paolo Banfi
Study officials:
References:
Clinical trial NCT02041832: Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
Official title: Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Hypertension
Diabetes Mellitus
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.


Eligibility criteria: Inclusion Criteria:

* age \> 65 years
* arterial hypertension (at least dual treatment)
* diabetes mellitus (oral antidiabetics or insulin)

Exclusion Criteria:

* known atrial fibrillation
* ischaemic heart disease
* Current anticoagulation treatment
* Ejection fraction \<45 %
* significant valvular heart disease
* previous stroke/transient ischemic attack
* peripheral arterial disease
* end stage renal disease
* thyreotoxicosis

Primary outcomes:
measure: First episode of atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between echocardiographic parameters and incidence of atrial fibrillation
timeFrame: 1 year
Other outcomes:
measure: Correlation between biomarkers and incidence of atrial fibrillation
timeFrame: 1 year
Locations:
city: Haderslev
country: Denmark
facility: Haderslev Hospital
Study officials:
affiliation: Odense University Hospital/University of Southern Denmark
name: Axel Brandes, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1557-1564. doi: 10.1016/j.jacep.2017.06.020. Epub 2017 Nov 6.
Clinical trial NCT03150732: Systemic Nalbuphine Versus Intravenous Regional Anesthesia
Official title: Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups
Primary purpose: PREVENTION

Brief summary: Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective unilateral hand surgery.

Exclusion Criteria:

* Patient refusal.
* Allergy to study medications
* Body mass index \> 35 kg/ m2
* Patients with sickle cell or Reynaud diseases
* Patients with a history of psychiatric illness or on chronic opioids

Primary outcomes:
measure: Duration of postoperative Analgesia
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Diclofenac analgesic consumption
timeFrame: Postoperative 24 hours
measure: Cortisol level
timeFrame: Preoperative and at 4 hours after skin incision
measure: Severity of postoperative Pain
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed H Bakri
Study officials:
References:
Clinical trial NCT01961232: Trans-pulmonary Biomarkers in Pulmonary Hypertension
Official title: Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
biomarker
cardiac
circulation
heart disease
lung disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2013-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pulmonary Vascular Clinic

Brief summary: The investigators are testing whether the addition of Pulmonary Hypertension-related biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation for Pulmonary Hypertension will lead to more informed choices of Pulmonary Hypertension therapy and improved patient outcomes.

Detailed description: Eligible participants with known or suspected Pulmonary Hypertension undergoing a clinically indicated right heart catheterization may be enrolled. Clinical data and blood samples will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Undergoing RHC for PH evaluation

Exclusion Criteria:

* Anemia defined as Hgb \< 10 g/dL and HCT \< 30
* Pregnancy at the time of RHC (as assessed by urine or serum pregnancy test on the day of the procedure)
* Left ventricular ejection fraction ≤ 40%
* Atrial fibrillation at the time of RHC (as defined by telemetry monitoring or EKG on the day of the procedure)
* IPF, CTEPH, COPD/OSA as the dominant etiology of PH
* Patient is currently taking PH medication or long-acting nitrates at the time of their RHC.

Primary outcomes:
measure: Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension
timeFrame: At baseline
Secondary outcomes:
measure: Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR)
timeFrame: At baseline
measure: Vasodilator-induced changes in Pulmonary Hypertension biomarkers
timeFrame: At baseline
Other outcomes:
measure: Differences between Pulmonary Hypertension-related biomarkers in pulmonary circulation and peripheral-venous circulation
timeFrame: At baseline
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ken Monahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monahan K, Scott TA, Su YR, Lenneman CG, Zhao DX, Robbins IM, Hemnes AR. Reproducibility of intracardiac and transpulmonary biomarkers in the evaluation of pulmonary hypertension. Pulm Circ. 2013 Apr;3(2):345-9. doi: 10.4103/2045-8932.114762.
Clinical trial NCT02641132: Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
Official title: The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pterygium
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%

Detailed description: To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups.

* The control group: application of MMC after excision of the body of the pterygium without the head
* The study group: application of MMC after excision of the body and the head of the pterygium

Eligibility criteria: Inclusion Criteria:

* Males/females \>18 Years old
* Pterygium with indication to operate
* Subjects that are able to sign an informed consent

Exclusion Criteria:

* Recurrent Pterygium/suspected tumor lesion
* Patients with endothelial cell diseases
* Patients after anterior segment surgery
* Patients with low compliance
* Patients without judgment ability
* Pregnancy
* Patients participated in another survey

Primary outcomes:
measure: Endothelial cell count
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar saba
country: Israel
facility: Meir medical centre
city: Tel aviv
country: Israel
facility: Sackler school of medicine
Study officials:
References:
citation: Avisar R, Avisar I, Bahar I, Weinberger D. Effect of mitomycin C in pterygium surgery on corneal endothelium. Cornea. 2008 Jun;27(5):559-61. doi: 10.1097/ICO.0b013e318165b158.
citation: Bahar I, Kaiserman I, Lange AP, Slomovic A, Levinger E, Sansanayudh W, Slomovic AR. The effect of mitomycin C on corneal endothelium in pterygium surgery. Am J Ophthalmol. 2009 Mar;147(3):447-452.e1. doi: 10.1016/j.ajo.2008.08.035. Epub 2008 Nov 7.
citation: Avisar R, Apel I, Avisar I, Weinberger D. Endothelial cell loss during pterygium surgery: importance of timing of mitomycin C application. Cornea. 2009 Sep;28(8):879-81. doi: 10.1097/ICO.0b013e3181a3900c.
citation: Kheirkhah A, Izadi A, Kiarudi MY, Nazari R, Hashemian H, Behrouz MJ. Effects of mitomycin C on corneal endothelial cell counts in pterygium surgery: role of application location. Am J Ophthalmol. 2011 Mar;151(3):488-93. doi: 10.1016/j.ajo.2010.09.014. Epub 2011 Jan 13.
Clinical trial NCT03690232: Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
Official title: Comparison of the Clinical Efficacy of Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study in the first year is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.
Primary purpose: TREATMENT

Brief summary: The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.

Detailed description: The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment. The HA group was administered intra-articular HA ((Hyruan PlusR, average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. The results were measured with the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. A baseline for each test was measured before treatment and then the effects of the treatments were measured by each test at 6 and 12 weeks after treatment

Eligibility criteria: Inclusion Criteria:

1. people aged 45 years or more;
2. subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
3. subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
4. subjects with tenderness in the medial tibial plateau area

Exclusion Criteria:

1. . subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;
2. . Inflammatory arthritis or subjects with acute knee arthritis
3. . subjects who have received intraarticular injection on the affected knee within the past 3 months.
4. . subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 weeks
Secondary outcomes:
measure: Lequesne index
timeFrame: 0,6,12 weeks
measure: visual analogue scale (VAS)
timeFrame: 0,6,12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Jia chi Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06450132: Changes in Eye Shape With Myopia Management Interventions
Official title: Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:

* do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
* are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?

Participants will:

* have multiple different types of photos taken
* have their prescription for glasses/contacts checked
* have their eye health checked, including the use of dilating eye drops
* be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
* will complete five study visits over the course of 12 months

Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.


Eligibility criteria: Inclusion Criteria:

* best corrected visual acuity of 20/25 or better in each eye
* nearsighted
* current contact lens wearer
* normal binocular vision (to be determined by an examiner at the first study visit)

Exclusion Criteria:

* eye diseases (including lazy eye or eye turn)
* pregnant, nursing, or planning a pregnancy in the next 12 months
* history of refractive surgery (e.g., LASIK)
* history of myopia control treatment
* sensitivity to anesthetics or preservative in eye drops
* difficulty with pupillary dilation

Primary outcomes:
measure: Change in ocular shape
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Axial elongation (or regression)
timeFrame: baseline to 12 months
measure: Change in accommodative response
timeFrame: baseline to 12 months
measure: Change in refractive error
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Donald O Mutti, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799032: The ATLANTA First in Man Study of the Catania Stent
Official title: Assessment of The Latest Non-Thrombogenic Angioplasty Stent (ATLANTA): Prospective, First in Man, Non-Randomized, Single Center for Patients With Documented Myocardial Ischemia Undergoing PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: Coronary Stent
Lead sponsor: CeloNova BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for the treatment of up to two de novo lesions in native coronary arteries.

Detailed description: This is a prospective, non-randomized, first-in-man single center study. The study requires a 55 patients with documented myocardial ischemia undergoing PCI.

Eligibility criteria: Inclusion Criteria:

* Lesion length ≤ 20 mm
* Vessel size ≥ 2.5 ≤ 3.5 mm

Exclusion Criteria:

* Life expectancy \< 1 year
* Left ventricular ejection fraction (LVEF) \<30%
* Anti-thrombotic drug intolerance

Primary outcomes:
measure: Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI
timeFrame: In Hospital
Secondary outcomes:
measure: Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Ferrarotto Hospital
state: Sicily
Study officials:
affiliation: Ferrarotto Hospital, University of Catania
name: Corrado Tamburino, MD
role: PRINCIPAL_INVESTIGATOR
References: