louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05926622: Clinical and Radiological Outcomes of Medacta Shoulder System FR
Official title: Clinical and Radiological Outcomes of Medacta Shoulder System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Osteoarthritis
Secondary Osteoarthritis
Rotator Cuff Tear Arthropathy
Rheumatoid Arthritis Shoulder
Avascular Necrosis
Fracture
Revision of Shoulder Arthroplasty
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 200
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: Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

Brief summary: This is a post-marketing surveillance on Medacta Shoulder System


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patient with one of the following diagnosis:

Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (\<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty

Exclusion Criteria:

* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspect infections (at the time of surgery)
* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)

Primary outcomes:
measure: Survival Rate
timeFrame: 10 years
Secondary outcomes:
measure: Clinical outcome evaluating Constant & Murley Score
timeFrame: 1, 2, 5 and 10 years
measure: Functional outcome evaluating Oxford Shoulder Score
timeFrame: 1, 2, 5 and 10 years
measure: Radiographic performance of the implants evaluating presence of radiolucencies
timeFrame: 3 months, 1, 2, 5 and 10 years
measure: Patient evaluation quality of life
timeFrame: 1, 2, 5 and 10 years
measure: Adverse events
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Annecy
country: France
facility: Clinique Générale Annecy
Study officials:
affiliation: Clinique Générale Annecy
name: Bruno Toussaint
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02692222: Measurement of Pulse Pressure Variation and Cardiac Output by a New Application for Android™ (Captesia™)
Official title: Measurement of Pulse Pressure Variation (PPV) and Cardiac Output (CO) by a New Application for Android™ (Captesia™) : Comparison With PPV and CO Obtained by a Method of Transpulmonary Thermodilution.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Bypass
Keywords: pulse pressure variation monitoring
Captesia
cardiac output monitoring
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for coronary artery bypass

Brief summary: This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV and CO calculated by thermodilution.

Detailed description: Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for coronary artery bypass

Exclusion Criteria:

* patients with arrhythmias like atrial fibrillation
* patients with valvular insufficiency

Primary outcomes:
measure: PPV
timeFrame: at time of surgery
Secondary outcomes:
measure: CO
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme Hospital Bruxelles
name: Céline F Boudart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme Hospital Bruxelles
name: Alexandre Joosten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang X, Du B. Does pulse pressure variation predict fluid responsiveness in critically ill patients? A systematic review and meta-analysis. Crit Care. 2014 Nov 27;18(6):650. doi: 10.1186/s13054-014-0650-6.
citation: Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
Clinical trial NCT01240122: Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Staining
Keywords: Corneal staining and comfort evaluation in normal, habitual contact lens wearers.
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.


Eligibility criteria: Inclusion Criteria:

* were at least 18 years old;
* were experienced contact lens wearers;
* were correctable to at least 20/40 or better in both eyes with contact lenses;
* were in good general health, with healthy eyes (other than requiring vision correction);
* had not worn lenses for at least 12 hours before each baseline visit;
* had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
* had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

* had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
* required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
* had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
* were currently participating in any other clinical study;
* had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Primary outcomes:
measure: Corneal Staining by Wear Time
timeFrame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4
Secondary outcomes:
measure: Subjective Solution Preference
timeFrame: Day 4
measure: Overall Ocular Comfort
timeFrame: Day 4
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Abbott Medical Optics Inc
state: California
Study officials:
affiliation: AMO
name: Eugenia Y Kao, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143622: Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients
Official title: A Phase Ib/II, Multicenter Study of LJM716 in Combination With Cetuximab in Patients With Platinum-pretreated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Most recent regimen contains both platinum and cetuximab (Phase II, group B).
* ECOG Performance Status (PS) ≤ 2.
* Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
* Measurable disease as determined by RECIST v1.1.

Exclusion Criteria:

* Previous anti-HER3 antibody treatment.
* Symptomatic brain metastasis.
* Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
* Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
* Inadequate end organ function.
* Ongoing diarrhea CTCAE Grade ≥ 2. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1
timeFrame: 6 months
measure: Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
timeFrame: 35 days
measure: Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1
timeFrame: 6 months
Secondary outcomes:
measure: Safety and tolerability of the LJM716- cetuximab combination
timeFrame: 6 months
measure: blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration
timeFrame: 6 months
measure: Best overall response (BOR), per RECIST 1.1
timeFrame: 6 months
measure: Duration of response (DOR) per RECIST 1.1
timeFrame: 6 months
measure: Overall survival (OS) per RECIST 1.1
timeFrame: 12 months
measure: Progression free survival (PFS) per RECIST 1.1
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02446522: Compare Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting
Official title: Comparative Results of Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting: a Prospective Randomized Parallel-group Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autovenous Conduit for Coronary Artery Bypass Grafting
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-05-18
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Detailed description: The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility \[1\] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.

Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.

The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.

Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Eligibility criteria: Inclusion Criteria:

* subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.

Exclusion Criteria:

* urgent coronary artery bypass surgery with unstable haemodynamics;
* previous coronary artery bypass surgery;
* chronic venous insufficiency С4-С6 under СЕAR classification;
* previous limb surgeries.

Primary outcomes:
measure: postoperative wound complications
timeFrame: during 30 day after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01550822: HEALS (Healthy Eating And Lifestyle After Stroke)
Official title: HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke, lifestyle habits
Lead sponsor: Los Amigos Research and Education Institute
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: University of California, Los Angeles
name: University of Southern California
First posted: 2012-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise, and smoking cessation) among stroke survivors and result in a reduction in measures of general and abdominal obesity.

Detailed description: Study data collection will consist of a baseline and outcome study visit. Each visit will consist of a survey and physical exam to collect height, weight and body measurements.

Outcome measures include:

1. Physical Activity: Collected via survey using a version of the International Physical Activity Questionnaire
2. Diet: Collected via survey using the Brief Dietary Assessment Tools for Hispanics
3. Body Mass Index (BMI): Collected via physical exam following the Alaska State Department of Health and Social Services BMI Guidelines
4. Abdominal Obesity: Collected via physical exam following the NIH Standard Circumference methods.

Eligibility criteria: Inclusion Criteria:

* Phase I: Completed 12 month SUSTAIN trial (SUSTAIN criteria: age ≥ 40 years, acute TIA or ischemic stroke within the prior one month and systolic blood pressure (SBP) \>120 mm Hg).
* Phase II: Stroke or TIA \> 3 months prior to screening date, age \> 20 years, blood pressure (SBP) \> 120 mm Hg.

Exclusion Criteria:

* Phase I and Phase II: Same as SUSTAIN criteria: medical condition limiting participation in follow up assessments, severe cognitive impairment (MMSE ≤24), and severe global disability (modified Rankin ≥3).

Primary outcomes:
measure: Physical activity
timeFrame: 6 months
measure: Diet
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
Secondary outcomes:
measure: Abdominal obesity
timeFrame: 6 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
Study officials:
References:
citation: Towfighi A, Cheng EM, Hill VA, Barry F, Lee M, Valle NP, Mittman B, Ayala-Rivera M, Moreno L, Espinosa A, Dombish H, Wang D, Ochoa D, Chu A, Atkins M, Vickrey BG. Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke. J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105323. doi: 10.1016/j.jstrokecerebrovasdis.2020.105323. Epub 2020 Sep 28.
Clinical trial NCT01414322: Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Bronchiolitis
Lead sponsor: KarmelSonix Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hadassah Medical Organization
First posted: 2011-08-11
Enrollment: 45
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital

Brief summary: Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.


Eligibility criteria: Inclusion Criteria:

* patient is admitted to the ER with shortness of breath
* patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:

  * asthma management protocol
  * bronchiolitis management protocol
* ages 0 - 15
* patient's parent/guardian is able to comprehend and give informed consent for participating in the study

Exclusion Criteria:

* patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
* patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
* ventilated patients, while ventilated
* chest skin lesions
* cystic fibrosis
* hemodynamic instability
* patient's parent/guardian objects to the study protocol
* concurrent participation in any other clinical study
* physician objection

Primary outcomes:
measure: increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
timeFrame: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Secondary outcomes:
measure: cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment
timeFrame: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center Mt. Scopus
Study officials:
affiliation: Hadassah Medical Center Mt. Scopus, Jerusalem, Israel
name: Eitan Kerem, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05411822: Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment
Official title: Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.

Detailed description: Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.

Eligibility criteria: Inclusion Criteria:

* mild cognitive impairment
* age matched healthy control
* macular pigment density either \< 0.3 or \> 0.5

Exclusion Criteria:

* extensive brain vascular disease
* Parkinson's disease
* bipolar disorder
* seasonal depression
* diabetes
* high blood pressure
* obstructing cataracts
* macular degeneration
* diabetic retinopathy
* use of melatonin supplements
* use of beta blockers
* use of sleep medications
* use of antidepressant medication

Primary outcomes:
measure: Change in melatonin levels
timeFrame: one sample will be collected every 30 minutes during each 90 minute study session up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menands
country: United States
facility: Light and Health Research Center at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01787422: Comparison of Telemedicine Versus Traditional Practice in a University Health Center
Official title: Comparison of Telemedicine Versus Traditional Practice in a University Health Center
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Health Service Research on Telemedicine
Keywords: Telemedicine
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is to determine if telemedicine visits provide similar quality and patient/physician satisfaction as traditional office visits in a college health population.

Detailed description: This study which is open to students at Arizona State University who require follow-up care after their visit to ASU Health Services. Patients who are seen by a Mayo Clinic physician working at the ASU Health Services are randomized to either be seen for followup at the health center with the same physician or seen at the health center by the same physician at Mayo clinic utilizing telemedicine.

After the visit, patients and the physician will fill out an patient satisfaction survey and the record will be reviewed by an independent investigator for determining quality of care by reviewing the record.

Eligibility criteria: Inclusion Criteria:

* Arizona State University students who require a follow-up care visit.
* ages 18 and above

Exclusion Criteria:

* patients who are medically unstable to be randomized to a telemedicine visit.

Primary outcomes:
measure: Quality of care score between the two groups
timeFrame: At the 24 hour visit
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University Health Services
state: Arizona
Study officials:
affiliation: Arizona State University
name: Allan L Markus, MD
role: PRINCIPAL_INVESTIGATOR
References: