cyrilzakka/clinical-trials huggingface dataset:
Enhancing the Detection and Management of Adverse Drug Events in Nursing Homes

Adverse drug events (ADEs) are the most clinically significant and costly medication-related problems in nursing homes (NH) and are associated with an estimated 93,000 deaths a year and as much as $4 billion of excess healthcare expenditures. Current ADE detection and management strategies that rely on pharmacist retrospective chart reviews (i.e., usual care) are inadequate. Active medication monitoring systems are recommended by many safety organizations as an alternative to detect and manage ADEs. These systems have been shown to be less expensive, faster, and identify ADEs not normally detected by clinicians in the hospital setting. The investigators developed and pilot-tested an active medication monitoring system for use in a single NH, where it was shown to detect ADEs with a high degree of accuracy and at a rate of nearly 2.5 times that of usual care. The long-term objective of our proposed research is to improve patient safety with respect to medications in NHs. The short-term objectives or specific aims of our proposed research are to determine if NH patients managed by physicians who receive active medication monitoring alerts have more ADEs detected, have a faster ADE management response time, and can result in more cost-savings from a societal perspective compared to usual care.

To accomplish the aims outlined in our brief summary above, the investigators will conduct a cluster randomized controlled trial among up to 86 NH physicians working in one of 4 UPMC Health System nursing homes (NHs) in Southwestern Pennsylvania for a period of 12 months. Our hypotheses are that NH patients managed by physicians who receive active medication monitoring alerts will have more ADEs detected, will have a faster ADE management response time, and will result in cost-savings from a societal perspective compared to usual care. This application by an early stage investigator is responsive to PA-09-070 AHRQ Health Services Research Projects and several of its research portfolio priority areas (health information technology, patient safety, and value) by addressing how medication management systems can be used to improve the quality and safety of medication management, as well as improve healthcare decision making. This study represents the first large, well-controlled, comprehensive examination of an active medication monitoring system in the NH.

Eligibility Criteria:
Inclusion Criteria:

All physicians participating in the study must be a credentialed attending physician at at least one of four UPMC Nursing Homes: UPMC Canterbury Place, UPMC Cranberry Place, UPMC Heritage Place, and/or UPMC Seneca Place.

Exclusion Criteria:

Physicians not credentialed as an attending physician at at least one of four UPMC Nursing Homes: UPMC Canterbury Place, UPMC Cranberry Place, UPMC Heritage Place, and/or UPMC Seneca Place.
Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care

The purpose of this research is to look at how educational videos provided by doctors might affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs surgery care. Patients will be randomized to either: 1) a group that receives educational videos in addition to standard-of-care written and verbal instructions or 2) a group that receives only standard-of-care written and verbal instructions.

The Primary Objective of this study is to determine if video discharge instructions, when added to standard of care written and verbal instructions, lead to a decrease in unnecessary phone calls from patients in a Mohs dermatology clinic.

The Secondary Objectives of this study are to determine if video discharge instructions, when added to standard of care written and verbal instructions, help to improve patients' satisfaction with education materials provided by the clinic, improve patients' knowledge of post-operative management, improve patients' confidence in taking care of their suture site post-operatively, and reduce post-operative anxiety about their suture site.

This study will be a randomized controlled trial in which the impact of video discharge instructions on patient calls, anxiety, and confidence will be evaluated. Patients will be randomized using a permuted block model generated through SAS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a linear closure on the face at UH Mohs clinic
* Fluent English speakers

Exclusion Criteria:

● Non-fluent English speakers
VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.

This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.

Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.

Eligibility Criteria:
Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):

* Eligible for either the VentrAssist or an FDA-approved DT LVAD
* LVEF \<=25%
* Stage D heart failure
* Ineligible for cardiac transplantation
* Treated with standard heart failure therapy

Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):

* Contraindication to LVAD implantation
* Contraindication to anticoagulant or anti-platelet agents.
* Pre-existing mechanical circulatory support other than intra-aortic balloon pump
* Therapy with an investigational intervention at the time of screening
* A condition, other than heart failure, which would limit survival to less than 2 years
Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer

This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above
* For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS
* For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study.
* Active patients of MSK and participating institutions

Exclusion Criteria:

* Patients who have been diagnosed with a tumor greater than 2 cm
* Patients with clinically suspicious lymphadenopathy in the neck
* Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor
Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia

Cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. To date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. However, there isn't any standard guidelines indicating what would be the best chronological order, or sequence, when performing those procedures. This randomised, double-arm, open-label study aims at investigating whether the sequence "cataract surgery then vitrectomy" or "vitrectomy then cataract surgery" can have an impact on iris hernia occurence.

Cataracts and vitreo-retinal conditions are frequently associated, such as epimacular membranes, vitreomacular tractions, macular holes, or even macular edema. Cataract is also a frequent complication of posterior vitrectomy. Surgical treatment for pre- or post-vitrectomy cataract is corneal phacoemulsification with intraocular lens implantation.

Many patients undergoing vitrectomy alone consult five to ten years later, without useful vision due to a dense cataract that might be more complicated to treat at a late stage. Indeed, if the phacoemulsification on a previously vitrectomized eye is not an issue in the first years, the intervention can be complicated ten years later, due to nuclear hardness and zonular weakness.

To date, there are no recommendations regarding the surgical sequence for the combination of cataract surgery and vitrectomy. The most-used sequence is to start with cataract surgery and then to perform the vitrectomy most often in 25 gauges (retinal surgery). When we start with cataract surgery under locoregional anesthesia, we often have (in about 15% of cases) iris hernia, which causes intraoperative discomfort (need to put stitches on the cornea), intraoperative miosis, pigments release, which can interfere with visualization during vitrectomy and which require dilating agents use.

The hypothesis of this study is that reversing the order of interventions and starting with vitrectomy could in particular reduce the incidence of intraoperative and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 years old or more
* Patient with macular disease requiring vitrectomy
* Patient with cataract requiring surgery
* Patient suitable for local-regional anesthesia
* Patient suitable for undergoing both surgical procedures consecutively and in any order
* Patient that have given informed consent before performing any study-related procedure
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pseudophakic patients
* Contra-indications to local-regional anesthesia
* Pregnant or breastfeeding patients
* Patients under legal protection
Comparative Effects of Strain-counterstrain and Muscle Energy Techniques on Neck Pain and Functional Disability in Patients with Cervicogenic Headache

The primary objective of this study is to compare effects of SCS and METs on reduction of neck pain intensity and improvement in functional disability in individuals with CGH. The secondary objective is to assess the impact of both techniques on ROM in cervical spine


Eligibility Criteria:
Inclusion Criteria:

* participants who fulfill the criteria of international headache society.

Exclusion Criteria:

* participants who have cervicogenic headache after cervical injury or head surgery.
Acceptance and Commitment Therapy and Compassion-Based Virtual Group Therapy to Improve Psychological Wellbeing in Patients with Cancer

This clinical trial tests how well acceptance and commitment therapy and compassion based virtual group therapy works to improve psychological wellbeing, such as compassion, understanding, and flexibility, in patients with cancer. Receiving a cancer diagnosis, undergoing cancer treatment, and living with cancer- or treatment-related symptoms have often been found to be associated with elevated distress and decreased quality of life for individuals, even when the disease is stable or in remission. Acceptance and Commitment Therapy (ACT) has demonstrated considerable benefits on individuals' quality of life, psychological flexibility, and amelioration of psychological distress following a cancer diagnosis and in the face of uncertainty, loss, and challenges associated with cancer.

PRIMARY OBJECTIVES:

I. To assess if participants perceive compassion and understanding by the provider who facilitates the virtual group intervention.

II. To assess if participation in the ACT-based group intervention is associated with increases in patients' self-reported psychological flexibility as well as amelioration in psychological and physical distress.

SECONDARY OBJECTIVE:

I. To assess if participation in the ACT-based group intervention is associated with increases in patients' self-reported mindfulness, self-compassion, meaning and purpose, and posttraumatic growth.

OUTLINE:

Patients attend acceptance and commitment virtual group therapy sessions over 1.5 hours each, once a week for 6 weeks.

After completion of study treatment, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Being an adult (18 years or older)
* Being a patient of Mayo Clinic Arizona
* Having a cancer diagnosis, having treatment planning in progress, undergoing cancer-related treatment, or having completed cancer within the past 2 years (in recent survivorship
* Experiencing stress or challenges related to cancer and having treatment goals that align with the purpose of the group
* Having self reported proficiency to read/write/speak English
* Expressing interest and commitment to attend all six virtual group sessions

Exclusion Criteria:

* Patients' inability to take part in and benefit from the virtual group therapy based on clinical judgment of the psychosocial oncology team member who completes the psychosocial evaluation, which may include having active suicidal or homicidal intent, experiencing uncontrolled psychotic symptoms, having untreated personality disorder/characteristics that are likely disturbing in a group setting, and/or having moderate to severe cognitive impairments
Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department

The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.


Eligibility Criteria:
Inclusion Criteria:

- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied

Exclusion Criteria:

* \< 18 years
* pregnancy
* burns
* amikacin treatment in the previous 2 weeks
* known allergy to aminoglycosides
* Do Not Reanimate Code ≥ 2
* Hospitalized patients with a prolonged deep venous or arterial catheder
* Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy

To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.

The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.

Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP

Secondary objectives:

* Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast ventricular tachycardia (FVT)
* Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow ventricular tachycardia (slow VT)
* Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular tachycardia (slow VT)
* Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF

Eligibility Criteria:
Inclusion Criteria:

* CRT + ICD indications (Class I-IIA) according to the guidelines
* Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP
* Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD

Exclusion Criteria:

* Patient's life expectancy less than 1 year due to a non cardiac chronic disease
* Patient on heart transplant list which is expected in \< 1 year
* Patient's age less than 18 years
* Replacements and upgrades
* Epicardial lead
* Mechanical tricuspid valve
* Ventricular Tachyarrhythmias associated with reversible causes
* Unwillingness or inability to provide written informed consent
* Enrollment in, or intention to participate in, another clinical study during the course of this study
* Inaccessibility for follow-up at the study center
Interactive Decision Aid for Men Diagnosed With Prostate Cancer

Prostate cancer is the second leading cause of cancer related deaths in the western world (National Cancer Institute, 2011). Prostate cancer diagnosis relates to significant psychological distress (Roesch et al, 2005; Hervouet et al, 2005). The management options available for men with localized prostate cancer typically offer similar survival rate and one treatment has not been determined more effective than other. Variance in severity, duration and frequency of side effects between treatments is considerable (National Cancer Institute, 2011). This can make the choice between management options challenging and distressing. Researches show that patients that are actively involved and provided with sufficient information have better health outcomes (Stewart, 1995).

The study involves implementing interactive, web-based decision-aid to assist men with localized prostate cancer with their decision regarding their prostate cancer management options. Participants will be randomized to standard-care (SC) and SC + interactive decision-aid (IDA). The SC group will meet with their urologist and receive and information brochure. In addition the IDA group will receive a website that includes a wealth of information (e.g., overview about prostate cancer, overview of different treatment options, pros and cons of different treatment options and a value clarification exercise that is designed to assist participants to weigh the risks and benefits of each prostate cancer management option).

The effectiveness of the intervention will be evaluated with questionnaires administered prior to randomization (baseline) and then again two weeks, one, three and six months after the randomization.

Aim 1. Evaluate the relative impact of SC versus SC + IDA on medical decision making. It is hypothesized that participants randomized to the SC + IDA arms will have improved decision making (e.g., reduced decisional conflict) and psychosocial outcomes (e.g., distress), compared to those randomized to SC only.

Aim 2. Identify mechanisms by which the interventions impact patient outcomes. It is hypothesized that: 1) improved decision making and psychosocial outcomes for the IDA arms will be mediated by increased knowledge; 2) participants who are undecided about the treatment decision and those that have information-seeking decision styles will benefit most from the decision-aid interventions.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with localized prostate cancer.

Exclusion Criteria:

* Reads and understands Icelandic
* Can give informed consent
Provider and Peer Delivered Youth Smoking Intervention

The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.

The majority of adolescent smokers are interested in quitting and have attempted to stop with limited success. A recent review of cessation trials for adolescents has concluded that there are no proven programs to help teens stop smoking, but suggested interventions based on cognitive behavioral therapy and sensitive to stages of change appear promising. The American Academy of Pediatrics suggests that pediatricians are well-positioned to intervene with adolescent smokers, as well as with nonsmokers to prevent initiation. A comprehensive, practice-based smoking prevention and cessation intervention for adolescents delivered by pediatric providers and peer counselors in the context of routine care has the potential for assisting nonsmoking adolescents in remaining smoke-free and smoking adolescents to quit.

Eligibility Criteria:
Inclusion Criteria:

* Aged 13 to 17, regardless of smoking status
* Scheduled for routine or acute care office visit
* Parental consent and youth assent

Exclusion Criteria:

* Unable to complete study requirements
Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?

Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.


Eligibility Criteria:
Inclusion Criteria:

* infertility
* at least one abnormal sperm quality parameter
* female age \< 35
* normal ovarian reserve

Exclusion Criteria:

* known allergy to one of the food additives planned for treatment
Outcomes in the Palm of Your Hand: Improving the Quality and Continuity of Patient Care

This study evaluates the usability of personal digital assistants (PDAs) by nurses for collecting, utilizing and communicating patient health information, and the feasibility of using PDAs to increase nurses' access to and utilization of best-practice guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Nurses are eligible to participate if they work on a participating unit, 20 or more hours/week
* Patients are eligible if they are being cared for on a participating unit, are able to provide informed consent in English, and are able to answer questions about their daily activities and symptoms (pain, nausea, dyspnea, fatigue.)

Exclusion Criteria:

* none
Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects

Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older
* Diagnosis of gastroparesis and/or functional dyspepsia
* Being prescribed a prokinetic agent or symptom modulator for their clinical care
* Able to undergo BSGM recording both before and during treatment
* Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment

Exclusion Criteria:

* Under 18 years of age
* Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)
* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
* Pregnant women
* No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved