cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Habit-based Work-up to Support Medication Adherence

The goal of this clinical trial is to test the impact of a medication-taking habit worksheet and discussion with a pharmacist in patients who are prescribed a new chronic medication for cardiovascular disease or depression. The main questions it aims to answer are:

* What is the feasibility and acceptability of the workup from the perspective of the patients and the clinic?
* What is the impact of the intervention on the formation of medication-taking habits compared to a comparison group who receive standard pharmacist counseling?
* What is the difference in medication adherence beliefs and behaviors for the group receiving the habit workup compared to those receiving standard counseling?

The purpose of this study is to evaluate a habit adherence workup delivered by pharmacy in primary care. The study population will include patients taking new medications for chronic conditions like high blood pressure, high cholesterol, diabetes, and depression.

This study uses a sequential design which involves first evaluating 16 patients without the added habit worksheet, and then the second phase evaluates 16 patients with the habit worksheet. All participants meet with the pharmacist and are provided standard counseling on the new medications. All participants complete the pre and post survey.

The pharmacist will be trained on the medication habit workup worksheet which has the patient choose cues they will use to develop their medication-taking habit. These will include associating the new habit with hygiene habits like toothbrushing, other habits like making coffee or eating breakfast, or visual cues like setting medications out where they will be easily noticed when doing other habits like getting dressed. Patients will take their sheet with them as a reminder of their plan. Patients also will receive medication counseling. The encounters will occur in a private clinic room.

All participants will complete baseline and follow-up surveys, which will include space for open-ended comments.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be fluent to speak and write in English,
* must be prescribed a new chronic medication

Exclusion Criteria:

* Does not manage their own medications independently
Study of Depression-Ketamine-Brain Function

Targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.Ketamine has been proposed as a novel approach to induce rapid antidepressant response. In this pilot project the investigators aim to introduce this novel and promising approach into clinical practice. Besides the assessment of clinical efficacy, the investigators will put a special emphasis on the assessment of ketamine-associated effects on brain function using fMRI and cognitive testing.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 65 years with a diagnosis of major depressive disorder without psychotic features.
* Drug-resistant depressed patients (defined as non-response to two sufficiently long (at least 6 weeks) drug trials at the maximal authorized or tolerated dose)
* Score 25 or higher on the Montgomery-Asberg Depression Rating Scale
* Stable psychotropic medication (antidepressants, antipsychotics, mood stabilizers) during the last 6 weeks prior to inclusion.
* Legally competent subjects agreeing to comply with the requirements of the study and authorizing the transmission of relevant information to competent physicians in the case of a clinically relevant previously unknown finding during an MRI examination.

Exclusion Criteria:

* Subjects with co-morbid substance abuse or dependence during the 3 months prior to inclusion, except nicotine consumption.
* Patients judged to be at serious suicide risk (score ≥ 4 at item 10 of the MADRS).
* Patients with any other DSM-IV axis one diagnosis including bipolar disorder except for anxiety disorder which are not dominating the clinical presentation.
* History of antidepressant or substance-induced hypomania or mania.
* History of psychotic symptoms.
* Patients with any contra-indication to the administration of ketamine, especially present diagnosis or antecedents of clinically relevant cardiovascular disorders (clinically significant or not adequately treated hypertension, present or previous diagnosis of cardiovascular disorder such as stroke or heart attack etc).
* Any MRI contraindication, especially metallic implants, pacemaker, etc.
* Pregnant women, breast-feeding women, women of childbearing age without effective means of contraception.
* Treatment during the last 2 weeks with thyroid hormones and sympathicomimetic drug.
* Present or past diagnosis of eclampsia or preeclampsia.
* Untreated or insufficiently treated hyperthyroidism.
* Known hypersensitivity to ketamine or to the excipient (benzethonium chloride).
* Present or past diagnosis of glaucoma, intracranial hypertension.
Prospective Electronic Polygenic Risk Study

This study will investigate the role of polygenic risk scores (PRS) in preventive health.

This study will investigate the role of polygenic risk scores (PRS) in preventive health. Specifically, the purpose of this study is to determine whether knowledge of the degree of coronary artery disease (CAD) genetic risk, as measured and conveyed by a PRS, influences patient and physician decision-making during short-term (6 month) and long-term (2 year) follow-up. The initial findings of this study will be used to plan an expanded second phase study with the purpose of prospectively validating that these decision-making changes lead to improvements in clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 45 ≥ Age \< 65
* ASCVD Risk Score \> 7.5% as defined by the standard pooled cohort equation
* Access to and ability to use a smartphone

Exclusion Criteria:

* Prior diagnosis of coronary disease as defined by prior myocardial infarction (STEMI or NSTEMI), or revascularization (stent or coronary artery bypass grafting)
* Cerebrovascular disease with history of ischemic stroke, TIA, carotid endarterectomy, carotid artery stenting
* Peripheral arterial disease with history of claudication, revascularization (stents or bypass)
* Current and active high-intensity statin prescription (rosuvastatin 20 mg, rosuvastatin 40 mg, atorvastatin 40 mg and atorvastatin 80 mg)
* Anti-PCSK9 therapy
* Lipid apheresis therapy
* Currently enrolled in a clinical trial for lipid lowering therapy
* Known statin intolerance to 2 or more statins in the past
Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)

The aim of this study was to compare the response to cardiac resynchronization therapy when the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to response when it was optimized following QRS width criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.

Exclusion Criteria:

-
Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?

The purpose of this study is to determine if resveratrol supplementation preserves beta cell function and insulin sensitivity in post-partum women following a first diagnosis of gestational diabetes. We hypothesize that daily supplementation with resveratrol will preserve beta cell function and insulin sensitivity.

Our primary aim is to perform a randomized controlled trial of resveratrol for the improvement of insulin sensitivity and the preservation of beta cell function in post-partum women following a first diagnosis of gestational diabetes. Our long-term goal is to test resveratrol for the secondary prevention of gestational diabetes and type 2 diabetes. We have developed six conditions that should be satisfied by the study to justify project expansion. Therefore, we will be testing hypotheses and computing estimates for the following six outcomes: (1) recruitment numbers, (2) adherence to study treatment, (3) adherence to study visits, (4) insulin sensitivity measured at 12 months post-partum, (5) beta cell function measured at 12 months post-partum, and (6) adverse events.

The study is a single-site, parallel, double-blind, randomized, placebo-controlled trial. The study population consists of women recruited during pregnancy who had a confirmed first diagnosis of gestational diabetes, who do not have either diabetes or pre-diabetes when re-tested 3 months post-partum, and who have stopped breastfeeding by 9 months post-partum. They study intervention is resveratrol (or identical placebo) twice daily for a total of 12 weeks from 9 months to 12 months post-partum. Our planned sample size is 112 women based on the hypothesis testing and estimation considerations for the six above-mentioned outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (18 years of age or older) 3 months post-partum with a recent history of first diagnosis of gestational diabetes.
* Willingness to provide informed consent 3 months post-partum.

Exclusion Criteria:

* Abnormal glucose tolerance or type 2 diabetes recorded at 3 months post-partum.
* Breastfeeding beyond 9 months post-partum.
* Intention to consume resveratrol open label.
* Intention to drink red wine (more than 4 glasses per week) or eat foods high in resveratrol (grapes, grape juice, peanuts, peanut products).
* Unwillingness to use two approved types of contraception until one year post-partum and unwillingness to undergo pregnancy test at randomization.
* Twin pregnancy.
* Consuming medications with a risk of interaction with resveratrol.
* Liver disease.
* Unlikely to be able to comply with study follow-up as judged by social (e.g. transient, not permanent residents, etc.) or geographical considerations.
Investigation of the Effect of 4 in 1 Block Application on Postoperative Analgesia in Knee Surgeries.

to investigate the effects of ultrasonography-guided 4in1 block application on postoperative analgesia in patients undergoing knee surgery. After knee surgeries performed with spinal anesthesia, 4in1 block will be applied in one group and medical analgesics will be applied in the service in the other group.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* 18-60 ages
* who were informed about the study and accepted,
* who underwent knee surgery

Exclusion Criteria:

* ASA III-IV
* who are under general anesthesia
* who do not agree to participate in the study
* who are urgently operated
Optimization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging

This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize the image quality for easier clinical interpretation, and lead to radiopharmaceutical saving in the context of myocardial perfusion Imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patient underwent stress-test 99 mTc-Sestamibi SPECT/CT myocardial perfusion Imaging on a Siemens Intevo Bold Anger camera with the cardiofocal SmartZoom® collimator

Exclusion Criteria:

* None
Parental Involvement in Enteral Nutrition in Neonatal Units

* Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump.
* Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.

* Nutrition is the cornerstone of neonatology. Adequate nutrition is necessary for a healthy brain growth and a physiological development. When oral feeding skills are not acquired, enteral feeding is used via a nasogastric tube by an electric syringe pump. The birth a premature child jeopardizes parent-infant bonding and hinders parental feeding skills. Family-centered care has shown to be beneficial for the child and his parents by promoting early interactions, which lay the foundations for the child's psychological development. As such, pushed bolus enteral feeding by the parents with a syringe has been a common practice in Sweden since the 1980s to involve the parents in enteral feeding practices. In France, this practice has been used in neonatal intensive care units (NICU). Two French studies on this subject have been published. One focused on using parental pushed bolus enteral feeding in a hospitalization at home setting, whereas the other study investigated the impact of parental observation on pushed bolus enteral feeding. To our knowledge, there is no study proving the superiority of bolus feeding with a syringe under parents' visual control over enteral feeding with a syringe pump.
* This study is an open-label, randomized, comparative interventional study with an intention-to-treat analysis. We compared a control group (enteral nutrition with an electric syringe pump while the neonate is lying in a cocoon or carried by their parent) to an intervention group (pushed bolus enteral nutrition under parents' visual control)
* In the control group, enteral feeding used an electric syringe pump.
* In the intervention group, the first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents only if they can or will grow. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 30 and 34 WA (weeks of amenorrhea)
* Patient affiliated to a social security scheme
* Hospitalized in neonatal intensive care unit (NICU)
* 3 days of life or more

Exclusion Criteria:

Corrected age\> 34WA and 4 days

* Mechanical ventilation or non-invasive ventilation with FIO2\> 35%
* Serious congenital malformation
* Planned transfer to another hospital
* Enteral nutrition \<40ml / kg / day
* Immediate post-operative care
* Multiple pregnancy
* Poor understanding of french

  • Secondary exclusion criteria
* Digestive rest greater than 5 days
* Death
* No enteral nutrition pushed by parents
Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is able and willing to comply with the schedule and protocol.

For implantation of DRG stimulator;

* Subject has been diagnosed with complex regional pain syndrome (CRPS I or II).
* Subject has had chronic, intractable pain of the groin or lower limbs for at least 6 months.
* Subject is indicated for implantation of an Abbott DRG stimulation system.
* Subject will be undergoing trial implantation of an Abbott DRG stimulation system.

For implantation of SCS;

* Subject has been diagnosed with chronic, intractable pain of the trunk and/or limbs.
* Subject is indicated for implantation of a SCS system.
* Subject will be undergoing implantation of an Abbott lead.
* Subject has had stable neurologic function in the past 30 days.
* Subject is able to provide informed consent.

Exclusion Criteria:

* Subject will be implanted with 3 or more DRG leads.
* Subject is currently participating in a clinical investigation that includes an active treatment arm.
* Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by physician examination.
* Subject currently has an active implantable device including an ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump.
* Subject is a prisoner.
* Female subject is pregnant.
Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.

The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.

Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.

Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction for at least 6 months
* In relationships
* Patient accept not to use any other therapy against erectile dysfunction

Exclusion Criteria:

* Prostatectomy
* Radiotherapy in pelvis
* Hormonal therapy against prostate cancer
* Anatomical penis disorder
* Penile prosthesis
* Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
* Psychiatric disorder
* Hypogonadism
* IIEF score higher than 25
* Pregnant partner og delivered within last 12 months
* Critical health disease
* Neurological disorders
The Evicel Post-Authorization Surveillance Study

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
* EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
* Subjects must be willing to and capable of participating in the study, and provide written informed consent

Exclusion Criteria:

* Subjects with known intolerance to blood products
* Subjects unwilling to receive blood products
* Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
* Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
Service Dog Training Program for Military Veterans With PTSD

Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.

Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and end of the program (after 8 sessions). Participants also wear a monitor to record heart rate variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same times.

Eligibility Criteria:
Inclusion Criteria

1. Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:

   1. military veteran;
   2. diagnosis of PTSD;
   3. able to give informed consent; and
   4. able to understand English; And
2. Military Veteran

Exclusion Criteria:

Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:

1. fear of dogs;
2. allergy to pet dander;
3. active substance abuse;
4. active psychosis, or
5. history of animal abuse
6. Excluded by the WCC from participation in their Service Dog Training Program because they have:

fear of dogs; allergy to pet dander; active substance abuse; active psychosis, history of animal abuse or physically unable to complete tasks required to train dogs

.
Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

This study will evaluate the effectiveness of an individualized approach to diagnosing and/or treating atherosclerosis. This will be done by combining genetic information, lifestyle information, participant education, and imaging tests to track diagnoses, therapies, and treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to standard of care) and 2) Individualized Management Group (standard of care plus genetic testing and coronary artery calcium scans).

The purpose of this proposal is to create a large, community-based demonstration project to evaluate the value of a highly individualized approach to atherosclerosis risk reduction. In this project we set out to compare the delivery of appropriate therapies and resource utilization using current national guidelines for the management of atherosclerosis and will compare this to using a highly individualized approach for atherosclerosis risk reduction, based on the evaluation of specific features in individuals and tailoring management based on this evaluation. We plan to show that utilizing the iCARE Program, more patients will receive appropriate diagnoses and subsequent therapies in a more efficient manner.

Eligibility Criteria:
Inclusion Criteria:

* No known coronary artery disease

  * no prior coronary disease by cardiac catheterization (≤39% in any major epicardial vessel)
  * no prior myocardial infarction
  * no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
  * no prior non-ST-elevation myocardial infarction (CK-MB \> 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
  * no prior coronary revascularization procedure
* Intermediate or high Framingham Risk Score (10-year risk 10% or greater)
* Ability and willingness to provide consent and Authorization for use of PHI

Exclusion Criteria:

* Presence of known cardiomyopathy
* Presence of permanent pacemaker, defibrillator, or CRT device
* Presence of clinically significant, uncontrolled arrhythmia (chronic or paroxysmal atrial fibrillation is NOT an exclusion. Arrhythmias treated successfully with ablation are not an exclusion.
* Presence of a known genetic abnormality of cholesterol metabolism (e.g. familial hypercholesterolemia)
* Inability or unwillingness to adhere to follow up schedule
* Inability or unwillingness to provide informed consent and Authorization for use of PHI