cyrilzakka/clinical-trials huggingface dataset:
Echocardiography in Nursing Home

The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.

Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.

Thirty nursing homes and 1050 residents will be included overall

Eligibility Criteria:
Inclusion Criteria :

Nursing homes residents with a life-expectancy estimated \> 1 year, and able to participate to the study, giving an oral consent

Exclusion Criteria :

* no accessible to echocardiography
* closed unit (severe Alzheimer disease...)
* recent contagious disease such Covid (\<15 days)
* no consent to participate
* no social security number
Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

Perform a cost-utility analysis in patients with chronic low back pain through electroanalgesia treatment and exercises administered by telemedicine program versus face-to-face program

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the cost- effectiveness of a face-to- face rehabilitation program vs a telemedicine program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain ≥ 3 months.
* Age between 30 and 67 years old.
* Not being receiving physical therapy.

Exclusion Criteria:

* Presence of lumbar stenosis.
* Diagnosis of spondylolisthesis.
* Diagnosis of fibromyalgia.
* Treatment with corticosteroids or oral medication in recent weeks.
* History of spine surgery.
* Contraindication of analgesic electrical therapy.
* Have previously received a treatment of electrical analgesia or exercise.
* Central or peripheral nervous system disease.
The Study Of CT Scans and Echo Parameters in Patients With PAH

Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive and non-invasive tests. The goal of the study is to correlate data from CT scans, echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The ultimate goal is to determine patterns of the PAH disease processes.

The goal of our study is to correlate data from various non-invasive tests such as commuted tomography (CT) imaging, echocardiogram, Pulmonary Function Tests, and other laboratory tests along with hemodynamic measurements from Right Heart Catheterizations in these ILD patients with Pulmonary Hypertension, as well as all other pulmonary hypertension. The ultimate goal is to determine patterns of the PAH disease processes, as well as define optimal diagnostic modalities including in-hospital verses outpatient studies.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Hypertension;
* ILD with Pulmonary Hypertension

Exclusion Criteria:

* NON-PH
Assessing Effects of a Denture Gel on Gum Abrasions

This is a parallel design study. Up to 40 subjects with a full mandibular and full maxillary dentures will be enrolled into the study. Subjects will use their current denture care +/- a treatment gel for 4 weeks. Subjects will have an Oral Soft Tissue exam, a Mucosa Condition Assessment, and a Pre-Gum Abrasion Evaluation followed by a peanut challenge and then have a Post-Gum Abrasion Evaluation at designated timepoints.

This is a single center, two-treatment, parallel design study. Up to 40 subjects will be enrolled with a full mandibular and full maxillary denture with a history of food related abrasions.

At each visit, an Oral Soft Tissue exam, a Mucosa Condition Assessment and a Gum Abrasion Evaluation will be performed. At Baseline, the subjects will be randomized to a treatment group. At Baseline, Week 2, and Week 4 subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts (subjects will be permitted to take breaks if needed and drink small sips of water). Following the peanut challenge, a licensed dental professional will re-evaluate the number and size of abrasions. Subjects will receive a consumer questionnaire to complete as well prior to the Baseline, Week 2, and Week 4 assessments.

Eligibility Criteria:
Inclusion Criteria:

In order to be included in the study, each subject must:

* Be 18 years of age;
* Read, sign, and receive a copy of the Informed Consent prior to initiation of study procedures;
* Have a full maxillary and mandibular denture and wear on a daily basis;
* Have a history of food particles getting under their full denture and causing gum irritation;
* Are willing to abstain from eating at least four hours prior to the visits;
* Are willing to eat 4 X 20 grams of peanuts three times (Baseline, Week 2 and Week 4) without denture adhesive;
* Clean their dentures on a daily basis;
* Agree not to change their regular denture cleaning routine;
* Agree to abstain from using denture adhesive during the study;
* Agree to not participate in any other oral/dental product studies during the study.

Exclusion Criteria:

* Exhibit evidence of obvious oral pathology, as determined by the Study Dentist, as a result of a mandatory OST examination on the first day of the study;
* Are allergic to any of the ingredients contained in the study product gel;
* Are allergic to peanuts;
* Wear dentures overnight;
* Are insulin-dependent and/or have any health condition(s) which would prevent compliance with study procedures;
* Are routinely using denture adhesive;
* Present with any disease or conditions that could be expected to increase their susceptibility to gum abrasion (like diabetes or xerostomia); or
* Present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study
Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?

This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).

Periprosthetic joint infection (PJI) is a major burden for healthcare systems. The European Bone and Joint Infection Society (EBJIS) proposed a new set of criteria introducing a three level 'traffic light' distinction: Infection Unlikely, Infection Confirmed but also an intermediate group called Infection Likely (but nor confirmed). This retrospective multi-center, multi-national cohort study is to validate the EBJIS Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).

Eligibility Criteria:
Inclusion Criteria:

* THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018

Exclusion Criteria:

* less than two years follow up
* less than four intraoperative microbiology samples (synovial fluid, tissue samples, implant sonication)
* no preoperative/intraoperative synovial fluid differential leukocyte count
Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease

This study evaluated the safety and efficacy of 10 cm\^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm\^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age
* Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria
* MMSE (Mini-Mental State Examination) score of \> 10 and \< 26
* Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)
* Patients who failed to benefit from previous cholinesterase inhibitor treatment

Exclusion Criteria:

* Patients not treated according to the product monograph for rivastigmine capsules
* patients involved in a clinical trial
* Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)

Other protocol-defined exclusion criteria applied to the study.
Management of Anemia in Patients with EndocaRditis Infectious Candidates for Cardiac Surgery: the AMERICA Study

Infective endocarditis (EI) is an extremely serious disease requiring prolonged hospitalisation, complex management by multidisciplinary teams and high healthcare costs. Anemia is also emerging as a virtually constant condition associated with endocarditis, as evidenced by its inclusion in the variables used to calculate risk scores.Anemia associated with infective endocarditis (EI) has a remarkably complex and multifactorial pathogenesis.It is essential to treat anaemia in patients with EI as an integral part of their overall therapy, in what is now called patient blood management. Blood transfusion is not the only approach available to treat this condition. It is essential to correct any deficiencies, whether iron or vitamins. In addition, some patients may benefit from the administration of erythropoiesis-stimulating agents.


Eligibility Criteria:
Inclusion Criteria: Patients with endocarditis who are candidates for elective surgery; Male and female patients aged \> 18 years; Patients who have given written consent to participate in the study and to have their clinical data processed for the purposes of the study.

Exclusion Criteria: Age \< 18 years; Patients with hypersensitivity (bronchial asthma, urticaria, allergic phenomena) to preparations of intravenous iron, folic acid, vitamin B12, erythropoietin; Patients who have not given written consent to participate in the study and who have specifically refused the use of their clinical data for the purposes of the study; Patients participating in other investigational trials; Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for the study
Use of Donepezil for Treatment of Cocaine Dependence

The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.

This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.

Eligibility Criteria:
Inclusion Criteria:

* Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or intravenous injection within the four weeks prior to screening, and must supply a cocaine-positive urine obtained within four weeks of entry into the study.

Exclusion Criteria:

* Shows signs of psychostimulant toxicity, or has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
* Has a current psychiatric disorder other than drug abuse or dependence or dementia.
* Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
* Has received opiate-substitution therapy (methadone or buprenorphine) within two months prior to enrollment.
* Has current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, or family history of seizure disorder.
* Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral beta-adrenergic agonist.
* Has had head trauma that resulted in neurological sequelae.
* Has an unstable medical condition, which, in the judgement of investigators, would make participation hazardous.
A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue

This randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible and acceptable to breast cancer survivors with minimal side effects and that the Yoga intervention will be effective in improving fatigue and physical performance.

Fatigue is the most common and distressing side effect of cancer treatment and persists beyond successful treatment completion in approximately 30% of breast cancer survivors, causing serious disruption in quality of life. Behavioral interventions incorporating physical activity or relaxation/stress management have demonstrated beneficial effects on cancer-related fatigue, although research in cancer survivors is limited. Mind-body interventions such as yoga are extremely popular among cancer patients and offer a promising alternative to traditional treatments. Research is needed to establish the feasibility and efficacy of these interventions in cancer populations, particularly those who are experiencing problems with fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with early, resectable breast cancer (Stage I or II)
* Completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously
* No other cancer in last 5 years, including breast cancer recurrence
* Postmenopausal women
* Age 40 - 65
* Reporting persistent cancer-related fatigue

Exclusion Criteria:

* Evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit \< 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)
* Evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)
* Physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)
* Regular use of medications and/or behavioral therapies that would confound evaluation of IY, including regular participation in yoga classes
* Presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)
* Use of medications that might confound immune evaluation (e.g., regular use of corticosteroids, narcotics, opiates)
* Unable to commit to intervention schedule
* Body mass index greater than 30 kg/m2
* Regular tobacco (defined as daily or near daily) or alcohol use (defined as \> 2 drinks/day)
Pediatric and Adolescent Patellar Instability

This is a multi-center, randomized controlled clinical trial, the purpose of which is to determine if patients age 25 and younger who undergo medial patellofemoral ligament (MPFL) reconstruction have lower rates of recurrent instability compared to those treated non-operatively. The MPFL is a ligament that stabilizes the kneecap, and maintains its proper position in the groove on the femur (thighbone). Instability refers to a situation in which the kneecap moves out of place, or dislocates. When instability is recurrent, it occurs more than once in the same knee.

A total of 240 patients will be enrolled across participating sites around the country. These sites currently include: The Hospital for Special Surgery, Oregon Health and Science University, Inova Sports Medicine, and Mayo Clinic. Patients are randomly assigned to one of two treatment groups. Patients assigned to the "stabilization" group will undergo surgery to reconstruct the MPFL using either a hamstring tendon that is your own or one obtained from a donor. Patients assigned to the "conservative" group will be treated with physical therapy, and possibly a simple knee arthroscopy if you are found to have a loose fragment on x-ray or MRI. All patients will be required to return for follow-up visits, which will continue over the course of 5 years. During these visits, patients will be examined, asked to answer questions about their surgery and general health, and have imaging (x-ray and MRI) performed on the knee. All patients enrolled in this study will undergo a standardized, intensive rehabilitation protocol. The investigators anticipate that all patients may benefit from extensive rehabilitation, including strengthening and return to sport training. The knowledge gained from this study may benefit others in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be age 25 or younger
* Patients must be first-time dislocators, meaning have had only one episode of patellar instability, during which they dislocated their patella (kneecap)

Exclusion Criteria:

* Patients with more than one episode of patellofemoral instability
* Patients who have had prior patellofemoral surgery on the knee of interest
* Patients with large cartilage tears in the knee. These patients will undergo stabilization of the patellofemoral joint (MPFL reconstruction) as per standard of care, and will not be included in the study.
Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy

To the best of Investigator knowledge, no studies to this date have compared the safety and efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing trabeculectomy. Given that filtration surgery is usually less successful in patients with developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb morphology.

Standard combined trabeculectomy with trabeculotomy (CTT) All CTT surgeries will be performed under general anesthesia.Under aseptic surgical technique, a superior rectus suture will be placed using 4'0 silk and a limbal-based conjunctival flap to be performed. Sub-Tenon dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular scleralflap will to be dissected up to clear cornea, and radial incision will be placed at the location of the schemes canal, Harms trabepculotome will be used to pass into the schemes canal and rotated into the anterior chamber to open app 60 degree on either sides, A 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl continuous suture.

The same procedure will be done for the CTT with ologen® except, before closing the conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex of the triangular scleral flap

ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 month to 3 years (inclusive)
* Any case diagnosed as congenital glaucoma (with enlarged corneal diameter more than 11 mm, including corneal edema or Haab'sstria with or without optic disc cupping, IOP\>12 mm Hg)
* Parents of the patientis willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

* Patients withany other types of secondary glaucoma
* Patients with any other ocular disease