cyrilzakka/clinical-trials huggingface dataset:
The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use

Digital communication tools are becoming ubiquitous in healthcare, though their impact on patient/provider communication, healthcare utilization, and outcomes remains poorly established. M Health Fairview (MHFV) in collaboration with the Center for Learning Health System Sciences (CLHSS) Rapid Eval team will be evaluating one such communication application: OPY, which leverages the Epic-Care Companion functionality to remove barriers in communicating with the patient's care team. This project will evaluate the effectiveness of a digital, post-operative patient engagement tool (Epic-Care Companion made available through MyChart), OPY, which has the goal of preventing patients from becoming addicted to opioids or to suffer from opioid misuse or diversion. In the proposed pragmatic trial, standard care with education available in MyChart and the patient after visit summary will be augmented by OPY. OPY is available to patients starting the same day they go home from surgery with a new opioid prescription. OPY provides a daily interactive experience that collects patient pain and side-effect information, provides advice for pain management, and uses behavioral "nudges" to encourage timely weaning and responsible disposal of opioid medications. The primary goal of this project is to evaluate the effect of two versions of OPY on measures of opiate use relative to the standard of care in a pragmatic randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Surgery at The M Health Fairview Clinics and Surgery Center - Maple Grove (Maple Grove) or M Health Fairview Clinics and Surgery Center - Minneapolis (CSC)

  ▪ Currently, only outpatient surgeries are performed at CSC and Maple Grove
* Active opioid prescription (prescribed between 30 days prior to surgery, until day of surgery)
* Patient class (outpatient or same day surgery)
* Never previously randomized or exposed to OPY

Exclusion Criteria:

* Age \< 18
* Chronic opiate use defined as:

  * Patients aged 18 and older and
  * 3 or more opioid dispensing events, in the last 12 months with at least 1 of these events in the last 6 months.
* Any long acting opioid prescription in the last 6 months
* Interpreter needed - YES selected (EPT840)
* Patient has a Health Proxy (Legal Guardian) designated in Epic
* Patients who have opted out of clinical research
* Patients with an active palliative care referral
Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.


Eligibility Criteria:
Inclusion Criteria:

* Signed ICF (Informed Consent Form) and data protection form
* Patient-reported history of DED in both eyes
* Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1
* Have Meibomian Gland Dysfunction (MGD) at Visit 1.
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning a pregnancy
* Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies
* Wear of contact lenses
* Known allergy or sensitivity to the medical device or its components
* Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1.
* Clinical site employees or immediate family members of the same
Cerebellar Functions in Visuomotor Adaptation

Transcranial focused ultrasound stimulation (tFUS) will be used in this study to functions of the cerebellum in human motor learning. Participants will complete a visuomotor task while receiving stimulation pulses from tFUS. How tFUS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy.

The purpose of this study is to test functions of the cerebellum in human motor learning. The cerebellum has been thought to play critical roles in human motor control and motor learning. Non-invasive brain stimulation studies with transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) provided evidence for the involvement of the cerebellum in human motor learning. However, due to limitations in spatial resolution of tDCS and TMS stimulation, it is still unclear what specific functions the cerebellum may have in motor learning, considering the behavioral and anatomical evidence that the cerebellum also has connections with prefrontal cortex and is associated with cognitive functions. By applying transcranial focused ultrasound stimulation (tFUS), which is a non-invasive brain stimulation technology with great spatial precision, the investigators aim to dissect functions of motor area and non-motor area of the cerebellum in motor learning. Young healthy adults will be recruited and randomly assigned to one of three experimental groups. During learning to adapt to a visual rotation (45 degrees) when reaching for a virtual target, subjects will receive tFUS stimulation over motor area of the cerebellum or non-motor area of the cerebellum depending on the study group. How tFUS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult subjects
* 18 to 35 years of age
* Right-handed
* Provide written informed consent

Exclusion Criteria:

* Presence of a psychiatric or neurologic illness
* History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
* Personal or family history of seizure
* Any history of stroke/transient ischemic attack (TIA) or severe traumatic brain injury
* Taking any medications that may decrease the threshold for seizure
* Pregnancy (self-reported)
* Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI
* Have any type of metal in the body
* Failure to follow laboratory or study procedures
Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes

The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine
* Patient about to start insulin pump therapy at the CHU Sainte-Justine
* Last HbA1c between 7.2 and 9.7%
* Informed and signed consent

Exclusion Criteria:

* Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin \< 0.5U/kg/day
* Home of the patient at more than 50km of the CHU Sainte-Justine
* Refusal to consent
Monitoring Blood Pressure at Home

The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage your blood pressure is feasible. The study will enroll 24 participants at UAB who are seen at the Emergency Department Post-Discharge Clinic. Half of the participants (12 patients) will be asked to measure their blood pressure at home, and half of the participants (12 patients) will continue to receive usual care. Participants who measure their blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 3 months.

For all participants:

1. Participants will receive information on the importance of measuring blood pressure and ways to improve blood pressure.
2. Participants will complete questionnaires describing current socioeconomic position, medical history and healthcare needs.
3. Participants will come in for one research clinic visit to get blood pressure measured 3 months after enrollment in this study.

For participants asked to measure blood pressure at home:

1. Measure blood pressure twice a day at home, following the instructions provided. The study will provide participants with the device and send text message reminders each week day. Participants will return the device at study visit 3 months from now.
2. Following the instructions provided, participants will talk to a pharmacist over the phone weekly to discuss blood pressure and medications. All medication changes will be discussed with a collaborating physician.
3. Participants will complete questionnaires on satisfaction with the program.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen at the Emergency Department Post-Discharge Clinic
* \>=18 years
* Blood pressure \>=130/80 mmHg and \<=160/100 mmHg
* English speakers
* Have a smartphone

Exclusion Criteria:

* Patients with blood pressure \>=160 mmHg
Quadratus Lumborum Block for Percutaneous Nephrostomy

Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.

Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\\analgesia to a minimum.

Eligibility Criteria:
Inclusion Criteria:

1. ASA grade III and IV patients,
2. Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy

Exclusion Criteria:

1. Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3.
2. Untreated urinary tract infection;
3. Pre-operative haemoglobin \<10 gm/dl,
4. Severely co morbid patients
5. Non-dilated renal collecting system
6. Patient refusal to consent for the procedure.
FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.

This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.

The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.

Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose \[MAD\] in the absence of dose limiting toxicities \[DLTs\] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of B-cell lymphoma (BCL) as described below:

  * Histologically documented BCL
  * Previously untreated or no more than one prior systemic therapy for BCL
  * At least one bi-dimensionally measurable lesion
  * Subjects with \>1 measurable lesion agreement to undergo a biopsy
* Capable of giving signed informed consent
* Age ≥ 18 years old
* Stated willingness to comply with study procedures through study duration
* Contraception use for women and men as defined in the protocol
* Negative serum pregnancy test within 7 days of treatment for women

Key Exclusion Criteria:

* Prior anthracycline therapy
* Females who are pregnant or breastfeeding
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
* Evidence of insufficient organ function
* Currently receiving or likely to receive systemic immunosuppressive therapy
* Receipt of allograft organ transplant
* Known active central nervous system (CNS) involvement by malignancy
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Clinically significant cardiovascular disease
* Positive HIV test
* Positive Hepatitis B (HBV) or Hepatitis C (HCV) test
* Live vaccine \<6 weeks prior to start of conditioning
* Allergy to human albumin or dimethyl sulfoxide (DMSO)
An Investigational Scan (MRI) in Imaging Patients With Newly-Diagnosed or Recurrent Thymoma

This trial studies the accuracy of a magnetic resonance imaging (MRI) scan in imaging the inside of the chest in patients with thymoma that is newly diagnosed or has come back. An MRI scan may be able to detect if and how far the tumor has spread more accurately than a standard computed tomography (CT) scan.

PRIMARY OBJECTIVES:

I. To determine whether thymoma staging by MRI is as accurate as staging by CT as compared to surgical staging.

SECONDARY OBJECTIVES:

I. To determine whether evaluation of phrenic nerve paralysis by functional MRI is as accurate as the fluoroscopic "sniff test" as compared to surgical evaluation of phrenic nerve involvement.

II. To determine whether fast novel MRI sequences are as accurate as conventional MRI sequences for staging thymoma, when comparing to surgical staging.

OUTLINE:

Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled to meet with a thoracic surgeon from MD Anderson Cancer Center (ACC) for resection of newly diagnosed thymoma or thymoma recurrence in the chest and scheduled for surgery

Exclusion Criteria:

* Children, defined as individuals younger than 18 years old on the preoperative visit with the thoracic surgeon
* Pregnant patients
* Patients unable to understand the consent form
* Patients with metal within the chest and pacemakers
* Patients with a known allergic reaction to gadolinium, who will have their MRI performed without contrast
* Patients with glomerular filtration rate (GFR) \< 60 ml/min, who will have their MRI performed without contrast
* Patients with an allergy to iodinated contrast material will follow departmental routine policy, that is those with anaphylaxis will have their CT performed without intravenous contrast and others will be prepped as for departmental guidelines for routine chest CT
* Patients with abnormal renal function will have their CT study perform as per DI's iodinated contrast administration guidelines, and no contrast will be administered with GFR lower than 30 ml/min
Study on Bladder and Sexual Function Change After Simple Hysterectomy

To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who is planed to undergo simple hysterectomy due to benign uterine disease

  1. Uterine leiomyoma
  2. Uterine adenomyosis
  3. Endometrial hyperplasia
  4. Cervical intraepithelial neoplasia (including carcinoma in situ, FIGO stage IA1 cancer)
  5. Dysfunctional uterine bleeding
  6. Other benign uterine disease requiring hysterectomy

Exclusion Criteria:

* Patients who are taking medication for overactive bladder
* Patients who underwent incontinence surgery due to urinary incontinence
* Acute or chronic infectious disease of urinary tract
* Neurologic disease causing urinary abnormality
* Previous pelvic radiation therapy
* Patients who are undergoing incontinence surgery with hysterectomy
* Pregnant woman
Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

This study will compare two arms in a randomized clinical trial of cardiovascular risk prevention in women with a history of preeclampsia. The first arm will provide postpartum patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle Recommendations for women with a history of preeclampsia. The second arm will additionally receive access to a customized patient-informed online program with modules on how to achieve the AHA recommendations for diet, activity and weight management.

The study team will work with patients via focus groups to develop a novel internet-based program to provide information and tools for cardiovascular disease (CVD) risk reduction for women who are at increased risk of CVD by virtue of their history of preeclampsia, a common complication of pregnancy. The American Heart Association has recently issued guidelines that physicians should include history of the hypertensive pregnancy disorder, preeclampsia, as a risk factor for CVD. Indeed, research demonstrates that roughly 2 out of 3 women with a history of preeclampsia will die from CVD. This study will work with patients with prior preeclampsia and with the Preeclampsia Foundation, a patient- based organization, to create an online lifestyle modification program ( accessible by computer or smart phone) for women with recent preeclampsia to reduce CVD risk. The study is a randomized controlled trial to test the program's acceptability, use, and impact on diet, postpartum weight retention, physical activity, blood pressure, and patient knowledge and self-efficacy to improve health.

Eligibility Criteria:
Inclusion Criteria:

* Within 5 years of a live birth complicated by preeclampsia as determined by medical chart review
* Age \>=18
* Not pregnant
* Normotensive or prehypertensive
* Access to the internet via computer or mobile device
* Able to communicate in English or Spanish at an 8th grade level.

Exclusion Criteria:

* Type 1 or Type 2 diabetes
* Currently pregnant
* Diagnosis of hypertension BP \>140/90 mm Hg or on medications for treatment of hypertension
A Modified Approach for Morbid Obese With Gynecologic Cancer

Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers.


Eligibility Criteria:
Inclusion Criteria:

1. Resectable (ovarian, endometrial, cervical) cancers.
2. Anaesthetically fit (ASA 1 and 2).
3. Abdominal pannus below symphysis pubis.

Exclusion Criteria:

1. Non resectable gynecologic cancer.
2. Unfit patients.
3. Patients who refuse to share in the trial.
Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Observational feasibility study using Patient Reported Outcomes (PRO) to assess quality of life and 'return to normal life' up to 1 year following emergency laparotomy

Regaining baseline Health Related Quality of Life (HRQoL) and returning to 'normal life' after surgery are of vital importance for patients. Knowledge of the trajectory and degree of long-term functional recovery following emergency laparotomy, including the regaining of optimal HRQoL is limited as most research relating to this field has been done in patients undergoing planned surgery. Furthermore, a comprehensive understanding of the pattern of recovery and restoration of baseline HRQoL is also important to researchers wishing to assess the full impact of interventions in order to improve outcomes following emergency laparotomy. Assessing HRQoL in this surgical population remains a challenge in the absence of a validated instrument. The investigators plan to undertake a feasibility study to assess utilisation of four patient questionnaires, well established within other surgical populations, to describe the quality of early and long-term recovery following emergency laparotomy. The investigators will utilise the QoR-15 to describe short-term (in - hospital) recovery metrics and versions of the WHO-DAS and the WHOQOL-BREF to describe longer term disability free survival and return towards baseline HRQoL. The Post-Operative Morbidity Survey (POMS) will help capture the onset of complications at different points during recovery. The study also aims to test the feasibility of assessing the impact of pre-operative co-morbidities, age, quality of peri-operative and intra-operative care, surgical indication and findings as well as post-operative complications on long-term HRQoL.

Eligibility Criteria:
Inclusion Criteria:

- \>=18 years NELA Inclusion Criteria

Exclusion Criteria:

- Not willing to participate NELA Exclusion criteria
Acupoint Stimulation and Postoperative Sleep in Elderly Patients

Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.


Eligibility Criteria:
Inclusion Criteria:

* Age≥65 years old
* scheduled for abdominal surgery under general anesthesia

Exclusion Criteria:

* anticipated duration of surgery longer than 5 hours or shorter than 1 hour
* American society of anesthesiologists status over stage 3
* Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
* Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3))
* Participants with a history of alcohol or drug abuse
* Participants with severe hepatic or renal insufficiency kidney disease
* Participants with contraindications to the use of acupoint stimulation (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices)