cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk

Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite strong evidence that reducing low-density lipoproteins (LDL) with statins successfully lowers CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment when indicated, and more than 50% of patients stop taking statins within one year of ﬁrst prescription though such therapy typically should be life-long. In this study, we will test the effectiveness of different financial incentives in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The application of conceptual approaches from behavioral economics offers considerable promise in advancing health and health care. We will test these approaches among patients at very high risk of CVD at Harvard Vanguard Medical Associates. Using a 4-arm, cluster-randomized controlled trial, we aim to answer these questions: \[1\] How does the provision of patient incentives compare to no incentives at all? \[2\] Is success with patient incentives improved by increasing the financial amounts? \[3\] Are results sustained after incentives and other interventions are withdrawn?

Study Objectives and Hypothesis

Aim 1: To evaluate the effectiveness of varying patient incentives on improvement in LDL cholesterol relative to usual care during a 3-month intervention among patients at high risk of CVD. H1: Each of the incentives will be more effective than usual care in reducing LDL cholesterol.

Aim 2: To evaluate the relative effectiveness of those intervention arms superior to control in reducing LDL cholesterol. H2: Higher incentive amounts for patients will be more effective than lower incentive amounts.

Aim 3: To evaluate the impact of each effective intervention in sustaining adherence and reduced LDL after the 3-month intervention period.

Aim 4: To conduct a rigorous process evaluation to examine why some incentives were more effective than others and to address other factors relevant to broader implementation.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-80 yrs
* FRS of \> 20% with LDL \> 120, or FRS = 10-20% with LDL \> 140, or a coronary artery disease equivalent (diabetes, peripheral artery disease, ischemic CVD, arteriosclerotic CVD, stroke/TIA, CABG, coronary stenting, or coronary bypass anastomosis) with LDL \> 120.

Exclusion Criteria:

* Patients with a history of side effects to statins. Patients with a history of side effects to statins will be forwarded to the study's medical monitor (a physician aligned with the study) and may still participate in the study if, after the medical monitor reviews the patient's medical record, he/she determines that the patient may safely participate in the study;
* Patients who will not or cannot give consent;
* Patients with terminal illness who are no longer suitable candidates for aggressive lipid management as determined by the patient's primary care physician;
* Patients with ALT values detected at greater than 80 U/L;
* Patients with active or progressive liver disease.
Retention of Complete Denture Using Rapid Prototyping

Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.

For both groups, a preliminary impression will be made \& after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper \& lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. Functional impression will be taken during the try in stage which.

For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.

But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.

For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.

Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 40-70 years.
2. Cooperative patients.
3. male or female patients

Exclusion Criteria:

1. Pathological changes of residual ridges.
2. Patients with any systemic diseases.
3. Patients with xerostomia.
4. Patients with flabby and flat ridges.
5. Patients with allergy to resins.
6. Patient with sever undercuts, or irregular bony exostosis. -
Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

The objective of this project is to assess the effectiveness of a new modality of prescribing the intensity of physical exercise in cardiovascular rehabilitation programs according to physiological criteria (heart rate variability measured every morning) in comparison to a standard non-individualized program.

In coronary artery disease patients, cardiovascular rehabilitation (CR) reduces cardiac mortality by 30% when compared to usual drug therapy without CR. Cardiorespiratory fitness (VO2peak) is the most powerful independent prognostic marker of longevity. An improvement in VO2peak is also associated with better cognitive performance in the elderly.

The effectiveness of CR varies between patients. About 25% of coronary disease patients do not improve their VO2peak after taking part of a CR program. The risk of acute event for those "non-responder" patients, (i.e. not increasing their VO2peak), is high with a mortality rate three times higher compared to "responder" individuals.

It seems that the autonomic nervous system (ANS) is playing an important role in exercise training-induced physiological responses. Based on this, it has been proposed in healthy subjects to prescribe each exercise session according to ANS parameters (via heart rate variability, HRV). It has been suggested that high-intensity exercise when HRV parameters are stable, results in better adaptations to training. Conversely, recovery sessions when HRV is impaired seem necessary.

44 participants with stable coronary artery diseases, and taking part in a CR program will be included in this study. All participants will have signed a written consent form before taking part in the study. Patients will be randomly assigned to one of the 2 following study arms: 1/ standard exercise training ; 2/ Heart Rate Variability-guided exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease patient from the Montreal Heart Institute
* Age\> 18 years old
* Referred to the EPIC center in a cardiovascular rehabilitation program due to stable angina pectoris, acute coronary syndrome (with or without ST segment elevation) or after complete coronary revascularization (primary or elective) by Percutaneous Coronary Intervention.
* Able to perform a maximal cardiopulmonary exercise stress test in accordance with current cardiovascular rehabilitation recommendations.
* Able to read, understand and sign the information and consent form.

Exclusion Criteria:

* Any absolute and relative contraindication to the maximal exercise test and / or physical activity.
* Recent cardiovascular events (cardiac decompensation or treatment with positive inotropic drugs or angioplasty less than 10 days, cardiac surgery less than 1 month, valve disease requiring surgical correction, active myopericarditis, severe ventricular arrhythmias not stabilized under treatment).
* Revascularization by coronary artery bypass grafting
* Atrial fibrillation
* Renal failure
* Heart failure
* Diabetes
Personalized Medicine for Membranous Nephropathy

Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies:

* GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains \> 3.5 g/g and albuminemia \< 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval.
* Personalized treatment:

  * restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO)
  * restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains \> 3.5 g/g and albuminemia \< 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval;
  * Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains \> 3.5 g/g and albuminemia \< 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* Anti-PLA2R1 activity detected by ELISA or Euroimmune Immunofluorescence Assay
* Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis
* eGFR (CKD-EPI) \> 30 ml/min/1,73 m2 at diagnosis
* Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT : Non Immunosuppressive Antiproteinuric Treatment (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)
* Medical insurance
* Signed informed consent
* Having understood and accepted the need for long-term medical follow-up
* Woman of child-bearing age must be using an effective method of contraception

Exclusion Criteria:

* Secondary Membranous Nephropathy: Membranous Nephropathy related to cancer, infectious, systemic lupus erythematosis, drug
* Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
* Pregnancy or breastfeeding
* Immunosuppressive treatment in the 3 last months
* Cancer under treatment
* Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure...)
* Patients with active, severe infections or active hepatitis B
* Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
* Patients in a severely immunocompromised state
* Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
* Patients unable to give an informed consent
Innovations in Personalizing Treatment Study

Eating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of any active eating disorder except ARFID
* Ages 18-65

Exclusion Criteria:

* Active Suicidality
* Active Mania
* Active psychosis
Feasibility Study on LITT for Medical Refractory Epilepsy

Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.

Monteris is sponsoring this multicenter, open-label, prospective feasibility study to characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.

The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. Unlike traditional brain surgery, LITT does not require a large opening in the skull.

Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

Eligibility Criteria:
Relevant Inclusion Criteria are listed below

* Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin
* Averages 1 or more complex partial seizures or secondary generalized seizures compatible with MTLE per month
* On stable antiepileptic medications
* Meets the criteria for a medial temporal lobe resection and is a candidate for LITT
* 18 years or older at the time of consent

Relevant Exclusion Criteria are listed below

* Previous diagnosis of psychogenic/non-epileptic seizures
* Previous diagnosis of primary generalized seizures
* IQ less than 70
* Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated
Trial of Auto Continuous Positive Airway Pressure (CPAP)

Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.

Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night.

Eligibility Criteria:
Inclusion Criteria:

* normal subject
* male and female
* age 18 to 65 years old

Exclusion Criteria:

* obstructive sleep apnea
* unable to sleep with a CPAP device
Role of Left Ventricular Pacing Site

Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.

Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order.

Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed.

Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure

Outcomes. Hemodynamic measures using pressure-volume catheters.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure referred for cardiac resynchronization therapy
* NYHA Class III or IV
* Informed consent form signed

Exclusion Criteria:

* Hypertension not controlled by treatment
* Coronary ischemia not controlled by treatment
Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder

Art therapy support combined with standard care for people with an alcohol use disorder coming to a day hospital for withdrawal could be beneficial compared to standard care alone because it would improve the alexithymia of these patients, helping them to better identify their feelings and / or emotions, and improve their self-confidence, their self-esteem self and their oral communication.

Alexithymia is an inability to identify and describe one's emotions associated with outward thinking. Frequently found in people with an alcohol use disorder, a true mental handicap, alexithymia has been clearly identified as a relapse factor in addictive problems related to alcohol. The ALEXART study intends to study the evolution of alexithymia in people with an alcohol use disorder hosted in an Addictology Day Hospital unit through the use of an approach non-drug that is art therapy. Our hypothesis is that art therapy can help patients with alcohol use disorders to develop a better understanding of their own behaviors, to name their emotions and feelings, and to improve their communication with others and thereby be able to choose to change their behavior.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 or over
* Patient with an alcohol use disorder starting day hospital care in the psychiatry and addiction department of the Angers University Hospital
* Subjects who gave and signed informed consent to participate in the study with alexithymia (Toronto Test greater than or equal to 56)

Exclusion Criteria:

* Non-understanding of the French language
* Non-affiliation to a social security scheme
* Major cognitive impairment
* Motor problems preventing walking
* Protective patients
* Pregnant or lactating women
* Patients under protection of justice or deprived of liberty
* Patients under protective supervision or guardianship
Mode of Ventilation and Bleeding During Transsphenoidal Surgery

The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.

The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.

* group Volume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
* group Pressure-controlled ventilation: initial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
* In both groups, the fraction of inspired oxygen is 50%. A recruitment maneuver is performed if the blood oxygen saturation became less than 92%.

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Patients scheduled for transsphenoidal surgery for pituitary adenomas

Exclusion Criteria:

* Pregnancy
* Obesity (BMI\> 35)
* Known respiratory disease
* Redo surgery
* Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).