cyrilzakka/clinical-trials huggingface dataset:
Telehealth Virtual Reality Exergaming for Spinal Cord Injury

This pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health.

There are three purposes to this study.

The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary.

The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1.

The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test.

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease \[ICD\] codes)
* a caregiver to support the participant if the participant is a child (\<18 years of age)
* access to a Wi-Fi Internet connection in the home

Exclusion Criteria:

* physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
* cannot use the arms for exercise or operate the controller buttons using their fingers
* complete blindness or deafness
* recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension \[BP \>/= 180/110 mmHg\]
* prone to seizures
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

Specific aim:

To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.

All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.

If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial.

Specific aim:

To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.

All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.

If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
* No previous stoma.
* Over the age of 18.
* Informed consent signed by the patient.

Exclusion Criteria:

* Expected lifetime less then 3 years.
* Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
* Previous stoma.
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence

Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.

Stress urinary incontinence (SUI) is defined as involuntary passage of urine with rising intra-abdominal pressure. SUI is a common problem affecting 18-26.4% of women.

Over the last two decades, SUI treatment has shifted to a mid-urethral sling (MUS) or a mesh-based bladder neck procedure. Although the surgery was believed to be relatively safe, there has been a steep rise in the number of reported cases of their erosion into the lower urinary tract. Several options outside of synthetic mid-urethral sling placement exist, such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection. Each has its limitations, whether related to morbidity or efficacy.

The autologous slings most commonly used are the fascia lata and the rectus fascia, and they are placed at the urethra-vesical junction through the 'retropubic' approach. In an attempt to present the benefits of a "transobturator" surgical approach and avoiding risks associated with synthetic sling material, Linder and Elliott, 6performed a novel technique for autologous urethral sling placement via a" trans obturator" approach for managing female SUI.

Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release, and there were no major (Clavien III-V) complications.The aim of this study is to report long-term transobturator sling outcomes using autologous rectus fascia for SUI in women.

Eligibility Criteria:
Inclusion Criteria:

* Women with genuine stress urinary incontinence.
* Mixed urinary incontinence with predominant stress element.
* Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.

Exclusion Criteria:

* Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment.
* Mixed incontinence with predominant Urge urinary incontinence.
* Associated local abnormalities (e.g. cystocele).
* Recent or active urinary tract infection.
* Recent pelvic surgery.
* Neurogenic lower urinary tract dysfunction.
* Previous surgery for stress urinary incontinence.
* Pregnancy
* Less than 12 months post-partum.
* Other gynaecologic pathologies affecting bladder functions ( eg,large fibroids)
* Genito-urinary malignancy.
* Current chemo or radiation therapy.
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

The purpose of this study is to assess the effect on LDL-C of implementation of a systematic LDL-C management care pathway that includes initiation of inclisiran compared to usual care without inclisiran in participants with a recent hospitalization (inpatient/outpatient) for an acute coronary syndrome (ACS) with LDL-cholesterol ≥70 mg/dL despite receiving statin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
* Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
* Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening
* Calculated glomerular filtration rate \>20 mL/min by estimated glomerular filtration rate (eGFR)
* Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose

Exclusion Criteria:

* New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction \<25%.
* Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
* Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.
* Planned use of other investigational products or devices during the course of the study.
* Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
* Recurrent ACS event within 2 weeks prior to randomization.
* Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.
Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease

Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by repeating a normal gait pattern with high intensity. This study is a feasibility study to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson 's disease.

Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.

Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved the recovery of independent gait after stroke compared with conventional rehabilitation therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been reported to improve walking speed and walking endurance compared to conventional physical therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has been reported that in patients with Parkinson's disease with balance impairment, robot-assisted gait training can improve balance disorder compared with physical therapy, and gait freezing has improved in some small-scale patients. However, studies on the effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and the mechanism of the effect has not been elucidated. In particular, the effect on gait automaticity, which is a characteristic of Parkinson 's disease, has not been studied. Therefore, this pilot study is aimed to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed patients with idiopathic Parkinson's disease
* Hoehn \& Yahr stage 2.5 or 3 patients
* Patients with a Mini-Mental Status Examination (MMSE) score of 24 or higher

Exclusion Criteria:

* Patients with severe dyskinesia or on-off fluctuations due to medication
* Patients who need to change drugs during the study period
* Patients with sensory abnormalities of the lower limb
* Patients with vestibular disease or paroxismal vertigo
* Patients with other neurological or orthopedic disease involving legs, or severe cardiovascular diseases
Gastroesophageal Reflux Disease (GERD) Segmentation: Document How Swiss General Practitioners (GPs) Allocate Their GERD Patients to the Three GERD Patient Segments

Document how Swiss GPs allocate their GERD patients to the three GERD patient segments (according to King et al.) and how treated GERD patients are affected by their GERD treatment


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed GERD patients
* on treatment for at least 2 weeks

Exclusion Criteria:

* none
Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta

Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.

Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. Between June 2015 and August 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. Both groups benefitted similar management protocol with the exception of interventional radiology operation. Intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.

Exclusion Criteria:

* Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.
reSET-O RCT (Randomized Controlled Trial)

This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.

This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
* Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
* Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
* Prison inmates are eligible to participate in the study
* Ability to read, write, and comprehend English

Exclusion Criteria:

* Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
* Planning an outpatient detoxification
* Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
* Less than 18 years of age
* Unable to read, write, and comprehend English
Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy

This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.

This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results.

The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Must undergo definitive local therapy with either breast conserving therapy or mastectomy
* Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
* Able to undergo breast MRI

Exclusion Criteria:

* Not pregnant or breastfeeding
* No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
* No prior mantle radiation
* No locally advanced breast cancer
* No diffuse malignant appearing microcalcifications requiring mastectomy
* No known collagen vascular disease
* No previous ipsilateral radiation
* No participants who undergo surgery at an outside institution
* No prior history of breast carcinoma
MyStroke in Chronic Stroke

This is a single-center randomized control trial assessing the impact of a personalized video-based educational platform on patients satisfaction and stroke knowledge in the context of chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. History of ischemic stroke between 1 and 10 years prior to enrollment
2. Receiving outpatient stroke care at the Hospital of the University of Pennsylvania
3. At least 18 years old
4. Access to a smart phone, tablet, or computer
5. Willingness to complete 2 follow-up surveys (7 days and 90 day post-enrollment)

Exclusion Criteria:

1. Unwilling or unable to access the customized app with a smartphone, tablet, or computer
2. Complete dependence on caregiver for all activities of daily living
3. Stroke occurred less than 1 year or greater than 10 years prior to screening/enrollment
4. Patient has severe aphasia (score of greater than or equal to 2 on National Institutes of Health Stroke Scale item 9)
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease

Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the result of chronic transmural inflammation combined with a dysregulated wound-healing process. While inflammatory strictures may respond to anti-inflammatory treatment, fibrotic strictures are usually anti-inflammation resistant, requiring further endoscopic balloon dilation or surgical intervention. Therefore, to determinate the inflammatory or fibrotic nature of intestinal stricture is a key step in the treatment of CD. 18F-FDG is a radiotracer reflecting the glucose metabolism of disease and is usually accumulated in inflammatory disease. 68Ga-FAPI is a novel radiotracer that specifically targets fibroblast activation protein (FAP). FAP is a membrane glycoprotein expressed on activated fibroblasts, which are key cells in the process of fibrotic intestinal stricture of CD. In this study, we hypothesis that the inflammatory or fibrotic nature of intestinal stricture can be non-invasively evaluated by 18F-FDG and 68Ga-FAPI PET/CT in patients with CD.

Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consectutive days. The accumulation of 18F-FDG and 68Ga-FAPI at the site of stricture will be determined by standard uptake value (SUV), molecular volume (MV), and total molecular index (TMI). In patients with a planned surgical resection of one or more stricture (s), the image results will be compared with histological findings.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed
* Crohn's disease patients with proofs of intestine stricture by other modalities, e.g. MRI, CT, ultrasound, and/or endoscopy.

Exclusion Criteria:

* Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI.
* If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake.
* Pregnant or breast-feeding women.
* Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Enhanced Recovery After Surgery (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire

ERAS after cardiac surgery is a well known protocol ,However the investigators study if it is applied at our institute

Enhanced recovery after surgery (ERAS) is a term that include a series of evidence-based perioperative care pathways designed to reduce physiological and psychological stress in surgical patients and to achieve rapid recovery.

In 2016, the first pilot study was published, which analyzed enhanced recovery after cardiac surgery (ERACS). Weaning from mechanical ventilation is considered one of the items that forms the concept of enhanced recovery in cardiac surgery.

Pain is an undesirable consequence of surgery especially cardiac surgery as pain during and following cardiac surgery has been shown to be a risk factor for increased morbidity. Systemic opioids have been the main stay for the management of perioperative pain in cardiac surgery. Lower doses of opioids has been related to early extubation and minimizing opioid-related side effects, such as prolonged ventilation, tolerance, nausea, vomiting, gut dysfunction, and immunosuppression.

On the other hand the investigators find cases of morbidity and mortality not related to the surgical procedure. ERAS protocol discuss the optimum condition that can be used to avoid the morbidity and mortality complications.

the investigators aim to know how well ERAS protocol is known and applied

Eligibility Criteria:
Inclusion Criteria:

* Cardiac anesthesiologists.
* Cardiac intensivists.
* Cardiothoracic surgeons.
* All stuff members from resident to consultant are included inside this study

Exclusion Criteria:

-