cyrilzakka/clinical-trials huggingface dataset:
Cost-effectiveness Analysis on Remote Monitoring for CIEDs in Japan by Using Systematic Review Methodology

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

Eligibility Criteria:
Inclusion Criteria:

* Studies that involves CIEDs Remote Monitoring, such as Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, and Pacemaker
* Follow-up periods more than or equal to 12 months
* Prospective studies
* QALYs available to make ICER analysis possible
* Published after Year of 1971

Exclusion Criteria:

* Studies that are not related with CIEDs
* Follow-up periods less than 12 months
* Not prospective studies
* QALYs unavailable
* Published before Year or 1971
Immunologic Biomarker Profile of Cerebrospinal Fluid

The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients


Eligibility Criteria:
Inclusion Criteria:

* patients who have had neuromyelitis ptica with anti-AQP4 antibodies, or anti- Myelin Oligodendrocyte Glycoprotein antibodies, or double seronegative antibodies.
* Neuromyelitis Optica patients have been prospectively included in the OFSEP collection
* Multiple sclerosis patients, isolated myelitis or optic neuritis patients, and symptomatic controls whose samples will come from the "NEURO" collection of the Hospital Biological Collections Center,
* Patients have given their free consent for use of their samples in research
Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.

Study participants will be randomized assigned to drink either placebo (a drink that looks and tastes like cranberry juice, but does not contain cranberry juice) or a double strength Ocean Spray light cranberry juice cocktail for four months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over the age of 18 years old with known or suspected cardiovascular disease including documented CAD by cardiac catheterization, and multiple cardiovascular risk factors will be included, regardless of severity of endothelial dysfunction or previous history of cardiovascular events.
* Subjects with no known history of cardiac disease will also be eligible to participate.
* Subjects must demonstrate endothelial dysfunction via the RH-PAT test (an RH-PAT score of less than 2.0) to continue participating in this study.

Exclusion Criteria:

* Patients will be excluded if they have confounding factors including, but not limited to, history of renal or liver failure, or relevant food allergies (cranberries, etc.).
Cutibacterium Acnes in Bone and Joint Infections

Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis, prostatitis and specifically in PJIs. C. acnes is able to escape the immune system. This phenomenon could reflect two bacterial behavior: the bacterial internalization by host cells and the biofilm formation.

The aim of the study is to evaluate specific pathogenicity factors (ability to internalize bone cells and ability to form a biofilm) of bacteria derived from clinical strains of C. acnes isolated from bone infections on orthopedic material.

Eligibility Criteria:
Inclusion Criteria:

* bone infection with C. acnes,
* isolation of the strain,
* presence of a single species,
* conservation of a viable strain,
* patients over 18 years
A Trial to Determine the Feasibility and Effectiveness of Early Multisensory Stimulation Intervention in Patients in the Trauma-Neurosurgical Intensive Care Unit (TNICU) Following Severe Acquired Brain Injury

St. Michael's Hospital (SMH) provides service to individuals with some of the most severe brain injuries and intensive care needs in Canada. These patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care requirements. Many hospitals face resource limitations, specifically involving the health disciplines and their ability to provide frequent intervention.

It has been proposed that multisensory stimulation (i.e. exposing the patient to various sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in improved responsiveness/cognitive function.

Previous research has indicated a potential benefit for early multisensory stimulation intervention for patients with severe brain injury. However there is still not enough conclusive evidence to confirm whether the intervention is truly effective. The investigators are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to determine the feasibility and examine the effectiveness of early multisensory stimulation with patients following severe brain injury who remain in a coma, vegetative state, or minimally conscious state. Eligible patients will be randomized to a control group (standard care + family/caregiver education) or an intervention group (standard care + family/caregiver education + early sensory intervention). Data regarding number of patients enrolled, amount of intervention completed, percentage of outcome data collected, patient's level of responsiveness and cognitive function will be collected before and after the intervention period, using several outcome measures. The investigators hope to determine the feasibility of conducting this type of study within this clinical setting and the effectiveness of multisensory stimulation with this patient population.


Eligibility Criteria:
Inclusion Criteria:

* At least 2 weeks post injury, no more than 8 weeks post injury
* Glasgow Coma Scale score of less than or equal to 9, or motor component score of 5 or less if patient intubated
* No previous brain injury
* No chronic/progressive neurological illness
* No intracranial pressure monitor
* No more than1 pre-existing sensory impairment (e.g. deafness, blindness)
* Functional level of English for patient and Substitute Decision Maker (i.e. conversational English, work/education in English, completion of English as a Second Language course, etc.)
* Deemed medically appropriate as per Nurse Practitioner/MD (e.g. no active seizures, no sedation, haemodynamically stable, etc.)

Exclusion Criteria: Patients who do not meet inclusion criteria above.
Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Chronic atrial fibrillation

Exclusion Criteria:

* Left atrial diameter \>55 mm
* Left ventricular ejection fraction \<0.30
* Contraindication to amiodarone therapy or anticoagulation with warfarin
* Presence of a mechanical prosthetic valve
* History of a cerebrovascular accident
* Presence of left atrial thrombus on TEE
* Prior attempt at catheter or surgical ablation for atrial fibrillation
Quality of Life Assessment Before and After Essure Removal

To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.

Tubal sterilization is a widely used method of contraception. The hysteroscopic sterilization method (Essure®; Bayer, Germany) was approved in 2007 in France. Increasing patients reports of complications, such as bleeding pain, allergies, fatigue or articular pain have raised concerns about the safety device. Women suffering of alleged complications of the Essure® device ask for surgical removal. But, only few studies have assessed Essure® removal in terms of quality of life. This observational study contains two parts will be conducted at two academic tertiary care center (Montpellier - Marseille):

* a prospective part having received a favorable opinion from a Committee for the Protection of Persons,
* and a retrospective part having received a favorable opinion from the Institutional Review Board (IRB), local ethics committee

Patients: Women requesting surgical management for removal of Essure® for alleged adverse effects.

Assessment tools :

Quality of life with the Short Form 36 (SF-36) Health Survey questionnaire (pre-operatively and at 1 and 3 months) Hospital Anxiety and Depression (HAD) scale (pre-operatively and 3 months)

Preoperative imaging, procedure characteristics, including the Essure® removal method, operative findings, perioperative complications, histopathologic report, and length of hospital stay will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients carrying Essure®
* Patients requesting surgical removal of Essure®
* Patients with adverse effect
* Being affiliated or benefiting from a French social security system

Exclusion Criteria:

- Patients with guardianship or curators
Teeth Decrowding With and Without Fixed Appliances

In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.

In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.

Eligibility Criteria:
Inclusion Criteria:

- Patients with permanent dentition between age group of 13 - 30 years.

* Maxillary or mandibular crowding \>4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
* Fully erupted teeth from 1st molar to the 1st molar.
* Patients with periodontally sound dentition.
* Patients with good general health. No previous history of extraction or orthodontic tooth movement.

Exclusion Criteria:

* Cases requiring orthognathic surgery.

  * History of systemic and medical illness.
  * Contraindication of extraction.
  * Previous history of orthodontic treatment.
  * Poor oral hygiene.
  * Nickel allergy.
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male and/or females, 19 to 60 years of age, inclusive.
2. Medically healthy with no clinically significant screening results as deemed by the PI.

Exclusion Criteria:

1. History of presence of clinically significant medical condition or disease in the opinion of the PI.
2. Alcoholism or drug abuse.
3. Liver disease.
4. Female subjects who are pregnant or lactating.
5. Known history or evidence of active hepatitis A, B, or C or HIV.
6. Clinically significant cardiovascular disease.
7. Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.
Tirofiban for Patients Treated With Alteplase

After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.
* 6≤ NIHSS ≤20 before IV tPA, or NIHSS \>20 but decrease ≥ 8 after IV rt-PA.
* ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage
* Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form

Exclusion Criteria:

* Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.
* Patients had used antiplatelet therapy in the past 5 days before the stroke.
* Patients had used anticoagulant therapy in the past 5 days before the stroke.
* Scheduled for surgery or interventional treatment requiring study drug cessation.
* CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.
* Any evidence of clinically significant bleeding ,or known coagulopathy.
* Renal insufficiency (creatinine clearance rate \<30ml/min)
* Hepatic dysfunction (ALT \>2 folds of Upper limit of normal value or AST\>2 folds of Upper limit of normal value).
* Pre-existing disability with ≥ mRS 2.
* Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.
* Severe non-cerebrovascular disease with life expectancy \<3 months
Cardiac RadiothErapy for VEntricular Tachycardia II

Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion
* Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria:

* Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy \< 6 months in the absence of VT
* Any condition that is deemed a contraindication in the judgment of the investigators
Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials

This study is aimed at patients who have been admitted to the respiratory care center of this hospital who meet the PMV conditions (defined as continuous use of the ventilator for at least ten days) who are about to receive the ventilator out of training. After obtaining the explanatory consent, they will undergo continuous complete Before and after spontaneous breathing training, collect various relevant physiological data of lung volume and ventilation perfusion distribution, and analyze and predict the correlation of ventilator detachment.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 20 years old, have undergone tracheotomy, have been using a ventilator for at least 10 days, and have stable vital signs.

Exclusion Criteria:

* Age \<20 years
* The oxygen concentration (FiO2) provided by the respirator exceeds 60%
* pregnant
* Blood pressure-systolic blood pressure below 70 mmHg
* Heartbeat is lower than 50/min or higher than 160/min
* Respiration rate is higher than 50/min
* Lack of voluntary breathing
The Effect of Combined Dulaglutide and Dapagliflozin Treatment vs DPP-4 Inhibitors in Endothelial and Vascular Function in Patients With Type 2 Diabetes Mellitus and Albuminuria

Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness, UACR, endothelial glycocalyx and global longitudinal strain will be assesed at baseline, 4 and 12 months.

Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness via pulse wave velocity (PWV), UACR, endothelial glycocalyx via Microscan camera, and global longitudinal strain via echocardiography will be assesed at baseline, 4 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR\&gt; 60 ml/min

Exclusion Criteria:

* Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years old.
* Patient must be diagnosed with depression and have had previous episodes of depression.
* Patient must sign informed consent.

Exclusion Criteria:

* Female and pregnant or breastfeeding.
* History of bipolar disorder, schizophrenia, or other psychotic disorders.
* Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
* Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
* Have taken an antidepressant called fluoxetine within 30 days of the start of the study.
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery

The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.
* Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery.
* Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.

Exclusion Criteria:

* Surgery performed under general anaesthesia, or sedation.
* Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.
* Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.
* Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.
* Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.
* Hepatic or renal impairment.
* Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension.
* Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.
* Patients under chronic treatment with topical or systemic analgesics/NSAIDs.
* Patients under treatment with any medication that may affect the treatment efficacy evaluation.
* Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries

During coronary artery bypass surgery, myocardial protection, especially of the right ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the antegrade delivery of cold cardioplegia

Asymetric myocardial cooling has been reported to yield postoperative right ventricular dysfunction, which may contribute to postoperative morbidity and mortality. Retrograde coronary sinus perfusion was introduced in 1956 to facilitate surgery involving the aortic valve. This technique was introduced as a means of myocardial protection for coronary artery bypass surgery in 1967 and has recently received renewed interest. An innovative method of delivering retrograde cardioplegia through the right atrium was recently developed by Fabiani and associates. This technique has obviated the need to directly cannulate the coronary sinus and thus has eliminated concerns regarding coronary sinus rupture due to cannulation, and concerns of inadequate right ventricular perfusion. In contrast to antegrade delivery, retrograde delivery of cardioplegia through the right atrium is not subject to the problem of limited distribution in the presence of coronary artery occlusive disease and thus allows more uniform cooling of the left ventricle,so the study will compare the results of combined antegrade and retrograde versurs antegrade cardioplegia in complex coronary artery bypass surgeries

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* LV ejection fraction between 30 and 50%
* left main stem CAD
* mitral or aortic valve disease associated with ischemic heart disease

Exclusion Criteria:

* Double valve disease or other valve disease
* mitral or aortic valve disease associated with congenital heart disease
* patients subjected to prior heart surgery
* emergency operation
* poorly controlled diabetes mellitus