cyrilzakka/clinical-trials huggingface dataset:
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery

The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between the ages of 21-90 years old
* Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
* Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
* Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
* Patient is willing to sign a Lucid Lane Client Agreement.
* Patient is willing to sign an informed consent form

Exclusion Criteria:

* Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
* Active suicidal ideations
* Patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain)
* Patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer)
* Patients who are in palliative care
* Unable to use English to participate in the consent process, the intervention or study assessments.
* Unable to provide informed consent to participate
Multicenter Retrospective International Survey to Evaluate the Rate of AXIOS-related AEs in Endoscopic Transmural Drainage of Pancreatic Fluid Collections

This is a retrospective study. Electronic chart review at respective centers will be the only database used. No patient contact or additional procedures will be conducted.

The main objectives are:

A) To evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC) in terms of clinical success and technical success.

B) To assess the rates, management, need for re-intervention, need for surgery, etiology and characteristics of Pancreatic fluid collections (PFC) on the occurrence of AXIOS- related related adverse events(AE).

This is a retrospective study. Electronic chart review at respective centers will be the only database used. No patient contact or additional procedures will be conducted.

Data that will be recorded on review of electronic medical record database include:

I. Demographics (age, gender) II. Indication for procedure III. Diagnosis and findings including radiologic findings IV. Prior endoscopy treatments V. Type and number of stents used VI. Pancreatic fluid collection location and measurements VII. Procedure time VIII. Technical success IX. Clinical success X. Adverse events XI. Management of adverse events XII. Recurrence of pancreatic fluid collections XIII. Follow-up time

The above data will be collected and recorded in an excel sheet. The data collection will be completely de-identified and password protected. The file will be emailed using an institution email and encrypted. The password will be given in a separate email or by phone call.

Inclusion:

All patients undergoing endoscopic management of pancreatic fluid collections between January 2011 to June 2017

Exclusion:

Age under 18

We will enroll 100 record between January 2011 to June 2017.

Time for collecting data:

1 month for data collection and 3 weeks for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing endoscopic management of pancreatic fluid collections between January 2011 to June 2017

Exclusion Criteria:

* Age under 18
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

The purpose of this study is to determine if women with chest pain and "clean" heart blood vessels have impaired blood flow to the heart due to problems with the small blood vessels that provide blood and oxygen to the heart. Impairment in the small blood vessels will be tested using ultrasound pictures of the heart, called myocardial contrast echocardiography. Since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of the heart vessels using a dye containing iodine injected in the heart vessels, the problem may remain undiagnosed in women until the heart muscle becomes severely damaged.

A second purpose is to identify if there is a common trait in the population of women with this tiny blood vessel dysfunction, which will be investigated by checking blood levels of certain chemical and hormones related to heart disease. Finally, we would like to investigate the relationship between depression and stress, and heart disease. We will do this by measuring cortisol (a hormone that serves as a measure of stress) and administering questionnaires that help to identify depression and stress.


Eligibility Criteria:
Inclusion Criteria:

* Women 45 to 75 years of age

Exclusion Criteria:

* Pregnancy
* Allergy to any component of the drugs: Definity®. Dipyridamole Aminophyllin or Iodine.
* Known coronary heart disease, significant valvular disease (valvular stenosis or insufficiency greater than moderate) left ventricular systolic dysfunction, congenital heart disease or cardiac shunt, pulmonary hypertension, moderate or severe asthma.
* Inability to reach the patient by mail, fax, e-mail or phone
* Active infection
* Malignancy
* Uncontrolled hypertension
* Smoking
* Severe asthma
* Kidney disease
Chest Compression and Sustained Inflation

Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.


Eligibility Criteria:
Inclusion Criteria:

Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria:

-
Eye Tracking and Simulated Postpartum Hemorrhage

Eye tracking is the process of measuring an individual's eye movements in order to reflect their attentional behavior by using a device called an eye- tracker.

This study uses eye-tracking methodology to observe the gaze patterns of participants to a high fidelity simulation scenario of postpartum hemorrhage acting in the role of leader to evaluate the relationship between eye-tracking patterns and leadership and team behavioral and technical skills.

This study will include 5 groups of anesthesia trainees consisting of 5 participants each. Each group will practice a standardized high-fidelity scenario on postpartum hemorrhage (PPH) which will be repeated for four times. All the scenarios will be video recorded.

All groups will receive a technical briefing on the PPH guidelines before the scenario, and after having assigned to each participant a role (leader anesthesiologist, junior anesthesiologist, obstetrician, and midwife) they will practice a standardized 15 minutes scenario with a high fidelity manikin. A debriefing with an expert debriefer will be performed after each scenario.

The participant acting as the leader will practice the scenario while wearing a pair of eye-tracking glasses (Tobii Pro Glasses 50 Hz wearable wireless eye-tracker). All the eye-tracking video-recordings will be stored and analyzed by using a Tobii Pro Lab Software. Specific areas of interest (AOI), to define regions of a displayed stimulus, and to extract metrics specifically for those regions will be selected. Number and duration of fixations, visit counts and their duration for each area of interest and for each scenario will be examined. Eye-tracking metrics will be mapped as gaze plots and heat maps. Two independent observers will review the scenario video recordings and will assing a score to the leader and team behavioral and technical skills. These scores will be correlated to eye tracking metrics.

Eligibility Criteria:
Inclusion Criteria:

* anesthesia trainee

Exclusion Criteria:

* severe vision defects
Resting Full-cycle Ratio in Side Branch

The goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (RFR) in side branch lesion.

We aims to evaluate whether the diagnostic performance of RFR in the side branch lesion is non-inferior compared to that in the main vessel lesion RFR and FFR measurements will be performed to define functional significance in patients with side branch lesion with or without main vessel lesion

The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Pressure-based functional assessment has been recommended to assess the presence of myocardial ischemia due to low accuracy of image-based assessment in intermediate coronary artery disease. Selective revascularization for only ischemia-producing lesion with fractinal flow reserve(FFR) guidance proved to decrease adverse cardiac events and avoid unnecessary coronary stenting, compared to angiography-guided revascularization. Therefore, Current guidelines strongly recommend FFR measurement for the assessment of the functional severity of moderate stenosis of a culprit lesion in stable coronary artery disease, and non-culprit lesion in acute coronary syndrome. However, it's clinical adaption in a real world was still very low, because of the need of pressure wire and hyperemic agent. Instantaneous flow ratio (iFR), which the ratio of distal coronary artery pressure to aortic pressure during wave-free period at rest, had a high diagnostic accuracy to define functional significance without need of adenosine. According to two large randomized trials, iFR-guided coronary revascularization proved to be non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Recently, new adenosine-free index, called as a resting full-cycle ratio (RFR), which is completely independent of the ECG and irrespective of systole or diastole has been validated to detect myocardial ischemia. RFR is not limited by sensitive land marking of components of the pressure waveform unlike iFR, and is diagnostically equivalent to iFR.

This novel physiologic index without need of adenosine have a potential to widely spread of functional assessment for coronary artery stenosis in daily clinical practice, and simplify procedure in complex coronary artery disease. Therefore, we sought to investigate diagnostic performance of this novel physiologic index to define myocardial ischemia in coronary bifurcation lesion, which is one of complex lesion subset.

Eligibility Criteria:
Inclusion Criteria:

* Patients with side branch lesion, who need functional evaluation

Exclusion Criteria:

* Severe LV systolic dysfunction (LVEF \<30%)
* Culprit vessel in acute coronary syndrome
* Donor vessel to supply chronic total occlusion lesion of non-target vessel
* Symptomatic valvular heart disease or cardiomyopathy
* Too much overlapping or severe tortuosity to disrupt quantitative coronary analysis
* Previous bypass surgery
Serum Ferritin and Prognosis of DKA

the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.

Ferritin studies and correlation to acute events like stroke or Mi was done before, however some studies have found a correlation with the degree and prognosis of these diseases and others not. However no study was tried on DKA patients before so we are trying to find if Ferritin would have a relation with patients of Dka and could be used as a prognostic tool (for example we found in this study when level is less than "200" patients mostly has good prognosis) this is just an example or (serrum ferritin turned out to be irrelevant to DKA prognosis as patients would have good prognosis despite number value) and this will be in selected patients according to criteria to exclude any chronic condition in our hospital care units.

Eligibility Criteria:
Inclusion Criteria:

-

All patients with DKA :

1. Adult Aged 18 years old or older .
2. Type 1 DM , type 2 DM
3. Diagnosis of DKA based on the American Diabetes Association criteria: blood glucose \>250 mg/dL, arterial pH \<7.3, serum bicarbonate \<18 mEq/L,

Exclusion Criteria:

1. Patients age less than 18 years old
2. Iron deficiency anemia and iron overload
3. Chronic Inflammatory Diseases: Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease
4. Acute and chronic infections, including bacterial, viral, and fungal infections
5. Pt presented with other acute complication (MI,stroke)
6. CKD patients
7. Patients with chronic liver diseases
8. Patients with malignancy
9. Pregnant women.
The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills

This study was planned to evaluate the effect of individual education given to adult patients with End Stage Renal Disease receiving hemodialysis treatment, using the Roy Adaptation Model-Based Teach Back Method under the guidance of nurses, on their ability to cope with fluid, diet and medication compliance and their adaptation skills.

The study is a randomized, controlled, two-group intervention trial with pretest-posttest design at three centers. The study will enroll adult End Stage Renal Disease patients receiving hemodialysis treatment who meet the inclusion criteria at the three centers where the study is being conducted. Data for the study will be collected using face-to-face interviews, a patient information form, a hemodialysis treatment information form, the End-Stage Renal Disease Adherence Questionnaire, a Coping and Adaptation Processing Scale, and a "Teach Back Method" questionnaire. Patients participating in the study will receive an educational booklet that will be completed after obtaining expert opinion based on the literature from the researcher. Patients in the intervention group will be trained by the researcher using the "Teach Back Method" in three sessions. Each session will last 45-60 minutes. From the 2nd week of the study, patients' questions will be answered and a 15-minute retraining session will be made in every two weeks. Patients in the control group will undergo a pretest and a posttest, and their routine care and treatment will continue. At the end of the study, patients in the control group will take training booklets.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis treatment for 4 hours, three times a week for at least 3 months with a diagnosis of end-stage renal failure,
* Individuals between the ages of 18 and 65 years,
* Having no speech, vision or hearing problems,
* Be able to speak, read and write in Turkish,
* Patients who have voluntarily to participate and informed consent form in the study.

Exclusion Criteria:

* Those who do not participate or agree to participate in training,
* The general situation is not suitable for questioning,
* Those diagnosed with a cognitive disease such as dementia.
Serial BNP Testing for Heart Failure Management

The scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in conjunction with clinical assessment, in the outpatient setting can guide the management of therapy in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mixed dyslipidemia
* Qualifying cIMT thickness

Exclusion Criteria:

* Patients with certain chronic or unstable medical conditions.
* Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications
* Pregnant or lactating women or women intending to become pregnant
* Patients with diabetes mellitus that is poorly controlled
Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.

The Artisential laparoscopic instrument is a novel device that allows multi-directional articulation during laparoscopic surgery. There are currently no studies evaluating the efficacy or safety of this device in minimally invasive gynecologic surgery. The investigators aim to compare the efficacy and safety of the Artisential instrument with conventional laparoscopic or robotic instruments.

Patients who are scheduled for a laparoscopic or robotic hysterectomy and/or laparoscopic or robotic sacrocolpopexy will be invited to participate in this study. During the suturing portion of the surgery (either vaginal cuff closure during a hysterectomy, or mesh attachment during a sacrocolpopexy), operating times and safety outcomes will be measured. The approach for vaginal cuff closure will be randomly selected. The approach for mesh attachment suturing will be based on the primary surgical approach (conventional laparoscopy or robotic) and compared to suturing with the Artisential and an internally controlled environment. Therefore, half of the knots placed during a case will be with the Artisential laparoscopic device, and the other half will be placed either with robotic instruments or conventional laparoscopic instruments.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for robotic or laparoscopic total hysterectomy
* Patient scheduled for robotic or laparoscopic sacrocolpopexy

Exclusion Criteria:

* Not a candidate for the above surgical procedures
Intraoperative Gamma Probe Localization of the Ureter

This study is being done to find a different way to identify the ureters during an abdominal operation.

During some operations, the operating physician must identify where the ureters are to prevent injury to them. Typically, the surgeon calls the urologist to thread a small scope with a camera into the urethra (where the urine comes out) to place a wire into each of the two ureters to locate them. Instead of this procedure, we will inject a small amount of a radioactive chemical dye (TC99-DTPA)through a vein in your arm. The ureters can then be detected by a hand held probe called the 'gamma probe.' The TC99-DTPA dye passes through the body and is excreted through the urine. The goal of this study is that this probe will alert the physician when it placed directly over the ureters since the TC99-DTPA dye will highlight the ureters as the flow of urine goes through them.

The patient population includes those that are undergoing an elective, open, abdominal surgery.

The patient will receive, on average, 4.5mCi of Technetium labeled diethylene-triamine-penta acetate (DTPA) prior to the time of ureteral localization. The Neoprobe 2000 gamma probe will be placed on the field in sterile fashion in a manner similar to that which is performed during a minimally invasive parathyroidectomy or sentinel lymph node biopsy. The surgery will continue until the surgical team feels the time is appropriate for each ureter to be identified. At this point, the surgical team will use the gamma probe to localize the ureter and the attending physician will note either, "yes" or, "no" to their feeling is that they have correctly identified or did not identify each ureter. The surgical team will know that the ureter has been correctly identified when gentle manipulation of the tissue with forceps produces a "vermicular contraction" of the tubular structure suspected to be the ureter. No other tissue and/or structure produces this classic type of contraction. Background gamma counts, gamma counts over the ureter, and time between Tc-DTPA injection and ureteral localization will be recorded for each ureter sought. If the ureter cannot be localized with this technique, and the surgical team feels that it is imperative that the ureters be identified, then the attending surgeon may request a urologist to place stents in the standard, usual fashion.

Eligibility Criteria:
Inclusion Criteria:

* Agrees to informed consent.
* Patients undergoing elective, open, abdominal surgery
* 18 years or older
* Normal renal function defined by a serum creatinine less than 1.5mg/dL

Exclusion Criteria:

* Pregnant or lactating females
Biomechanics Responses to Power and Strength Combined Training

Anterior cruciate ligament (ACL) is the most frequently injured knee ligament during performance of recreational activities and sports. In the United States, the annual incidence is 68.6 per 100,000 people per year and in Brazil, the estimation of ACL reconstruction increases 64%. There are different biomechanical profiles of risk factors for an ACL injury variable, the ligament dominance, the quadriceps dominance, the trunk dominance, and the leg dominance. Thus, the purpose of this study is to investigate the biomechanics adaptations after power and strength combined training protocol in healthy individuals. A second aim is to determine the effect of the training on knee injury risk factors.

This is a parallel randomized clinical trial comparing the effect of combined training with power and strength exercises on lower extremity biomechanics in healthy individuals.

The sample size was calculated with G\*Power software using the ANOVA: Repeated measures, within-between interaction, 90% power, alpha 0.05, and 30% drop-out. Data from the tuck jump test (knee flexion range) by Makaruk (2014) were considered for this calculation with effect size 0.46. Thus, a total of 32 individuals (16 per group) is required for this study. To ensure the proper simple size, after collecting the first five participants per group, the sample size will be checked again.

The participants will be randomized in experimental and no intervention groups inside each risk profile group. Randomization ratio will be 1:1 and interventions will last 10 weeks, with two weekly sessions for the exercise arms.

The outcomes will include functional clinical tests, kinematic and kinetic variables during landing tasks, and strength of knee and hip muscles.

The data analysis will be performed by intention to treat and per protocol. Generalized estimating equations will be used to identify interaction effects of groups and time followed by Bonferroni post-hoc. When effect are found, effect size will be estimated. Missing data will be estimate by statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male sex;
* Age between 18 and 30 years old;
* Who practice physical activity (except: strength and jump training) between 80 and 150 minute per week;
* No previous muscle lower extremity injury at least 6 months prior to recruitment;
* No previous ligament and tendon lower extremity injury or surgery;
* No auditory, vestibular, visual or musculoskeletal injuries or disease that impairment the execution of assessments or training protocol;
* No hypertension, cardiovascular or respiratory disease.

Exclusion Criteria:

* Body mass index greater than 35 kg/m².