cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Biomarkers in Human Synovial Fluid

Osteoarthritis is a condition that causes joints in the human body to deteriorate over time. This condition affects more than 250 million people around the globe. Currently, the goal of treating osteoarthritis involves reducing the severity and pain that results from the disease. The ultimate goal of this study is to identify patients with pre-arthritic joints (before symptoms or disease characteristics appear) in an effort to find and use treatments that stop or slow the disease. Joints are filled with a naturally occurring liquid known as synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These samples have the potential to improve diagnosis, classification, and treatment, possibly changing the natural history of this debilitating disease. The purpose of this study is to develop a collection of synovial fluid samples from the shoulder, hip and knee for the analysis of biomarkers and cellular and genetic components therein to better understand the pre-arthritic joint, progression to disease, and response to interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ( \> 18 years old)
2. Patient is eligible for general anesthesia and either arthroscopy or arthroplasty.
3. Patient needs standard of care arthroscopy or arthroplasty of either shoulder, hip or knee joint for osteoarthritis or prearthritic conditions.
4. Patient must have signed an IRB approved informed consent document for the arthrocentesis procedure which will be performed during the arthroscopic or arthroplastic procedure.

Exclusion Criteria:

1. Active Joint Infection within last 6 months.
2. Previous arthroplasty in the joint undergoing arthroplasty
3. History of auto-immune arthropathies.
4. History of HIV or Hepatitis C
Drug Interaction With Metformin

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria:

* Unwilling to use acceptable method of birth control
* current or recent (within 1 month) smoker
* abnormal liver function tests
* presence of edema
* history of diabetes mellitus
* history of heart failure or renal insufficiency
* history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
* history of Hepatitis C
Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units

Resuscitation patients are monitored for various physiological parameters. When these parameters exceed abnormal thresholds, an audible alarm is triggered. Given the complexity of physiological situations and the number of monitored parameters, the number of alarms within an intensive care unit is significant. In the literature, the number ranges from 100 to 350 alarms per patient per day. Among these alarms, 74 to 99% are deemed irrelevant as they provide false or insignificant information. This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

The large volume of unnecessary alarms has multiple negative repercussions. Firstly, the excessively loud sound environment present in most resuscitation services causes stress and discomfort for both patients and caregivers. Additionally, nurses become desensitised and less responsive when the number of alarms is high, particularly if many of them are ultimately pointless. Finally, multiple interruptions of tasks associated with alarms that require responses are sources of errors in the execution of care and medication preparation.

These interruptions contribute to a phenomenon known as "alarm fatigue", which many authorsand health authorities consider a threat to patient safety.The intensive care unit of the Saint-Etienne University Hospital has had a long-standing interest in this topic, and has a computerized data collection tool that permits exhaustive analysis of all alarm signals originating from each resuscitation bed.

This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Patient admitted to the intensive care unit of the ST-ETIENNE University Hospital
* Patient affiliated or entitled to a social security system
* Patient having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study or, for patients who are unable to consent due to health condition, a trusted person/family member who has been informed about the study and has who has co-signed, with the investigator, a consent to participate

Exclusion Criteria:

* Pregnant and nursing women
* Persons of legal age under guardianship
Quadrilateral Surface Plate (QSP) Focused Registry

The absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.

This registry includes six visits at which data is collected form the patinet (pre-op, post-op, 6 weeks FU, 3 months FU, 6 months FU and 12 months FU). Patients can be inlucded prospectively or retrospectively. If properatively recruited patients complete two questionnaires (EQ5D and Merle d'Aubigné) at their preoperative visits. These questionnaires are repeated after 6 and 12 months. Surgeons report about the success of the surgical procedure in a specifically designed questionnaire.

During the whole study period, adverse events related to the implant or surgery are collected as well as x-rays and CT (as per standard of care).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of acetabular fracture requiring surgical fixation
* Ability to understand the content of the patient information / informed consent form
* Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria:

* Any not medically managed severe systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Prisoner
* Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry

Intraoperative exclusion criteria:

* Intraoperative decision to use implants other than the device under investigation
SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study

Prospective trials performed on type 2 diabetes patients without established cardiovascular disease has shown that SGLT2 inhibitors reduce cardiovascular risk. No studies have yet examined the occurrence of cardiovascular disease in patients with acute myocardial infarction.

The investigators designed the current study to evaluate the most ideal oral hypoglycemic agent in type 2 diabetes patients undergoing percutaneous coronary intervention for acute myocardial infarction. The investigators hypothesize that the use of SGLT-2 inhibitors will reduce cardiovascular events and modify left ventricular remodeling after myocardial infarctions.

8 hospitals of the Catholic University of Korea with high-volume percutaneous coronary intervention of following hospitals are participating in the current study.

Seoul St. Mary's Hospital, Seoul, South Korea

Yeoido St. Mary's Hospital, Seoul, South Korea

Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea

Eunpyeong St. Mary's Hospital, Seoul, South Korea

Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea

Incheon St. Mary's Hospital, Incheon, South Korea

St. Vincent Hospital, Gyeonggi-do, South Korea

Daejeon St. Mary's Hospital, Daejeon, South Korea

After recruitment of all patients, the control group will be selected from a previous prospective cohort (COREA-AMI, NCT02385682) using identical inclusion / exclusion criteria except for use of SGLT2 inhibitors. The control cohort of 3,000 patients will be selected using 1:3 propensity matching.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction who were treated with percutaneous coronary intervention
* Type 2 diabetes mellitus
* Started SGLT2 inhibitors \<1 month before/after PCI

Exclusion Criteria:

* Type 1 diabetes mellitus
* Insulin / GLP-1 analogue users
* Previous users of SGLT2 inhibitors
* Pregnancy
Effectiveness of Passive and Active ROM Exercises Following TKA

The purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.

The major objectives of rehabilitation after TKA are the early regain of range of motion (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as part of the postoperative care regime following TKA with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. Conflicting research findings have generated an ongoing debate on its usage. As the greatest loss of function occurs in the first month following TKA, it is surprising that the ROM therapy during hospital stay is still carried out passively. A passive mobilization of the knee joint with CPM does not encourage the patients to actively participate in their rehabilitation. Research on the effectiveness of active ROM exercises added to standard physiotherapy during the short in-hospital period is lacking so far.The objective of this study is to compare the passive clinical standard therapy (CPM) with different active training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies are more effective in improving physical function than the CPM therapy.

Eligibility Criteria:
Inclusion Criteria:

* patients with knee osteoarthritis and scheduled for primary TKA
* age: 50-80

Exclusion Criteria:

* BMI \> 40
* musculoskeletal and neurological disorders that limit physical function
* any planned further joint surgery within 6 months
* substantial pain or functional limitation which make the patients unable to perform study procedures
Vascular Access in Hematological Patients - PICC Versus CVC

The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (CICCs).

The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism. These complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. Evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs is unknown. An understanding of this risk in the context of growing PICC use is an important cost and patients safety questions. Up to now, no systematic review has been done to investigate these questions.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 yrs
* Newly diagnosed AML
* Suspected survival \> 4 weeks
* Need of central venous access \>4 weeks

Exclusion Criteria:

* Ongoing uncontrolled systemic infection
* Presence of significant thrombosis/stenosis in arm or central veins
* Diagnosis of another cancer within 12 months before AML onset
* any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy
* Unability to communicate and/or to sign informed consent
A Study of RG1662 in Individuals With Down Syndrome

This multi-center, randomized double-blind, placebo-controlled study will assess the safety and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated time on study treatment is 38 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult individuals, 18 to 30 years of age, with diagnosis of Down Syndrome (confirmed by karyotype)
* Males and non-pregnant non-lactating females
* Parent or legal guardian/representative and caregiver willing to give written informed consent
* Subject willing and assenting or consenting to participate

Exclusion Criteria:

* Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor
* Subjects meeting clinical diagnostic criteria for autistic spectrum disorder, attention deficit or hyperactivity disorder unlikely to cooperate and take part successfully in the study assessments
* Subjects with other primary psychiatric diagnosis
* Subjects with evidence or meeting clinical diagnosis of dementia
* Subjects with personal history of cardiac abnormalities; patients that have previously undergone congenital heart surgery can be enrolled provided they have no residual complication requiring intervention (e.g. pace maker)
* Subjects with clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)
* Subjects with thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks
* Subjects with sustained elevated supine blood pressure (SBP/DBP) at rest exceeding 140/90 mmHg or notable resting tachycardia (mean HR \> 60 bpm) or blood pressure below 90/40 mmHg
* Subjects who have taken any other investigational medications within 3 months
* Body mass index (BMI) \> 40 kg/m2
Assessing Dextenza Insert After SMILE Procedure

This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.

4.1.1 Inclusion Criteria

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* Age 18 years and older
* Scheduled for bilateral SMILE surgery
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

4.1.2 Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Scheduled for bilateral SMILE surgery
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status

The goal of this cross-over study is to evaluate the physiological response to exercise and body composition according to training status in participants with a wide spectrum of fitness states. The main questions it aims to answer are:

* Which are the physiological differences across participants with different training status?
* Which are the body composition differences across participants with different training status?

To satisfy the objective of the project, participants will perform an incremental test until volitional exhaustion. During this test, respiratory gases will be measured via a gas analyser as well as the cardiac response via an electrocardiogram. The same participants will have their body composition measured by dual X-ray densitometry (DXA).

Eligibility Criteria:
Inclusion Criteria:

* Be in enough physical fitness to perform the incremental test to volitional exhaustion.

Exclusion Criteria:

* Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.
Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia

Recovery of neurological deficits after stroke results from a reorganization of cortical activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of neuroplasticity. Its use to improve function after stroke, particularly of the upper limb, was validated. The investigators propose to evaluate in a prospective pilot against placebo, the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and medium term, especially on walking function and spasticity in patients with sequelae of cerebral infarction in the MCA territory with gait disturbance and motor weakness of the upper limb.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years of two sexes
* Cerebral infarction older than 12 months
* NIH score \> 4
* Patient able to walk with or without technical assistance, Rankin score greater than or equal to 3
* No changes can interfere with treatment of spasticity in the 3 months preceding the study (benzodiazepines, baclofen, dantrolene, botulinum toxin ...)
* No history of generalized epilepsy unbalanced
* Free and informed consent signed by the patient
* MRI with ancient anatomical sequence confirming the accident sylvian

Exclusion Criteria:

* Stroke with motor sequelae of cerebral infarction prior to qualifying
* Alteration of the course prior to stroke
* Generalized epilepsy unbalanced
* Arrhythmias untreated
* Injection of botulinum toxin in the previous 4 months of randomization and 2 months after randomization
* Severe aphasia or cognitive impairment that interferes with the understanding of the tasks
* Presence of ferromagnetic material intracranial
* Pacemaker
Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians

The purpose of this prospective randomized controlled trial (RCT) is to evaluate the feasibility and usability of a commercial pedometer and web application in a case-managed home-based Cardiovascular disease prevention and rehabilitation program for French-speaking Canadians.

A cardiovascular disease (CVD) prevention and rehabilitation program is an evidence-based, standard of care for those who have coronary artery disease or other cardiac conditions; the aim of CVD prevention and rehabilitation program is to minimize disease progression and prevent future cardiovascular events. Behaviour change interventions targeting exercise are effective for improving physical activity levels, but can be intensive and costly. Activity monitors with accompanying web applications may provide a practical compliment to behaviour change interventions as an affordable way to promote and sustain increased physical activity levels, as measured by steps and physical activity levels. To date, no studies have examined the role of a pedometer with accompanying web application on steps and physical activity levels in French-speaking Canadians attending the FrancoForme® cardiac prevention and rehabilitation program at the University of Ottawa Heart Institute. It is also unknown the average daily steps of Canadian Francophone patients. Identifying successful interventions that promote physical activity among CVD prevention and rehabilitation program patients will help to improve their health as well as decrease the risk of first or subsequent cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Francophone (i.e., French-speaking);
* ≥18 years;
* Existing atherosclerotic vascular disease or ≥1 risk factor for CVD (e.g., family history of premature CVD, age \[sex dependent\], smoking, sedentary lifestyle, diabetes, hypertension, hypercholesterolemia, overweight/obesity);
* Live in the Champlain Region and attending the onsite FrancoForme® intake;
* Have a family physician or nurse practitioner (to order blood tests and titrate medications);
* Patient agrees to sign informed consent.

Exclusion Criteria:

* Unwilling to wear activity monitors;
* Unable to engage in physical activity;
* Does not have access to the internet;
* Unable to attend follow-up visits;
* Unable to provide written, informed consent.