cyrilzakka/clinical-trials huggingface dataset:
Mid-Urethral Sling Tensioning Trial

Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Women who have elected for surgical management of symptomatic urinary incontinence
* Ability to read \& write in English
* Other prolapse surgery at time of sling placement is allowed
* Must consent to participation in trial

Exclusion Criteria:

* Women with a prior incontinence procedure
* Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)
* Declines participation in trial
* Women with existing urinary retention or significant overactive bladder (requiring medication)
A Pragmatic Cluster Randomized Controlled Trial to Standardize Attending Morning Rounds in Medicine

Attending morning rounds take place at teaching hospitals every day. They are the primary mechanism for patient care delivery, supervision and education of trainees, and communication with patients, families, and staff. However, they are done with little standardization or widely recognized best practices.

The objective of this quality improvement (QI) initiative is to evaluate the adherence to and impact of implementing standardized attending morning rounds on medicine teams at our institution. A standardized rounding intervention has been developed which includes specific guidance on completing the following activities during morning rounds: (1) Pre-rounds discretion; (2) Pre-rounds huddle; (3) Bedside registered nurse (RN) integration; (4) Patient-centered rounding; (5) Real-time order writing.

This trial will randomize half of the investigators' medicine teams at University of California San Francisco to this rounding intervention whilst the other half will be randomized to continue with usual unstandardized rounding practices.

The investigators will compare medicine teams randomized to undertake standardized rounding to those teams undertaking usual practice. Outcomes assessed will relate to the patient (e.g. satisfaction), providers (e.g. satisfaction), efficiency (e.g. total morning round time) as well as adherence to the intervention .

The investigators' study hypotheses are that patient satisfaction scores will be higher for those patients receiving standardized bedside rounds compared to the usual care group. The investigators also hypothesize that total attending morning rounds time and interns length of workday will be shorter and that the number of consultations ordered before noon will increase for those teams undertaking standardized bedside. Further, the investigator hypothesize higher levels of nurse participation, physician and medical student satisfaction with standardized bedside rounding.


Eligibility Criteria:
Inclusion Criteria:

* All attending physicians, residents, interns and medical students of Medicine teams A through H
* All patients admitted to Medicine teams A through H
* All nurses on the Medicine floors

Exclusion Criteria:

* None
Sexual Harassment Within and Outside Sports

This study examines sexual harassment and abuse in and outside sports among adolescent elite athlete boys and girls, adolescent control students, trainers and leaders at elite sport high schools and regular high schools in Norway.

The purpose of the study is to examine the prevalence and outcome of sexual harassment within and outside sports, including who the perpetrators are, the association between experienced sexual harassment and psychological health, knowledge of report mechanisms and emergency plans, and the participants suggestions for preventive strategies. The knowledge from this study will be a good basis to establish and implement prevention strategies and educational programs in the future.

Students, trainers (with more than 20 % employment status) and leaders at elite sport high schools and regular high schools in Norway will answer a questionnaire at two measurement points. Additionally, a sample of randomly selected students who report experiences with sexual harassment, and a random sample of trainers and leaders, will be invited to participate in an individual in-depth interview. Students scoring above cut-off on the questionnaire measuring symptoms of eating disorders (EDE-q) will be invited to a separate diagnostic interview (EDE).

A group of students will also participate in a test-retest examination of the reliability of the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Over 16 years of age
* Students in 2nd grade elite sport high schools in Norway
* Students in 2nd grade at regular high schools (no specialization) in Viken and Oslo in Norway
* Trainers with more than 20 percent employment status at elite sport highs schools
* Leaders/principles at the attending elite sport- and regular high schools

Exclusion Criteria:

* Students under 16 years of age
* Trainers with less than 20 percent employment status
* Students/trainers not understanding written Norwegian language
Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene: Three Steps and 15 Seconds

This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.

The WHO guideline recommends 30 seconds for application of hand rub, however, mean bacterial reduction after 15 seconds of hand rubbing has been recently shown to be non-inferior and shortening application time to 15 seconds has been suggested to improve the frequency of hand hygiene actions in a neonatal care unit. This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.

Eligibility Criteria:
Inclusion Criteria:

* Medical students are eligible for participation
* Signed informed consent

Exclusion Criteria:

* No signed informed consent
Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

The purpose of the study is to evaluate the effectiveness of a nurse led intervention for high risk patients with diabetic foot ulceration and/or amputation.

The effectiveness is defined in two ways 1) as a reduction in complication rates (time till ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in hospital readmissions for foot-related complication (one year survival probability: failure = readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).

Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased peripheral circulation impaired sensation leading to the development of foot ulcers that lead to amputations of toes, feet and limbs. These complications not only have devastating effects on the individual in terms of loss of functionality but also impact the patient's ability to carry out and enjoy occupational, recreational and family functioning activities. Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and loss of productivity. All of these have personal as well as societal economical implications.

This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional patient education program to current management of foot care in patients with DM.

The study aims to test an alternative to current standard of care for patients with foot ulcers. A RCT is the preferred method to establish efficacy for this alternative nurse managed intervention; and if found to be effective, the current study will also allow an evaluation of the cost effectiveness of this intervention and the potential economic reduction in cost to the health care system.

The potential implications are major in terms of quality of life, reduction in morbidity in disability days, and cost savings. It is anticipated that this intervention is at least as effective as hospital stay, and being surrounded by their own loved ones without the threats that a hospital setting presents. The findings will be important to consider whether clinical practice can be changed to benefit patients. If the study results show that the subjects in the IG have better skills in monitoring and treating their diabetic foot ulcerations and eventually avoid developing further complications the intervention can be applied to future patients.

Eligibility Criteria:
Inclusion Criteria:

* patients age 18 or older
* in current treatment for ulceration and/or amputation of a lower limb
* are able to understand German oral and in writing
* are able to give written informed consent

Exclusion Criteria:

* severe psychiatric diagnoses
* subjects living in dependent living facilities (nursing home or rehabilitation)
* subjects lacking supporting family members and incapable of selfmonitoring their feet due to impairment (vision or physical movement)
Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant

Liver transplantation has been a lifesaving treatment for individuals with end stage liver disease and acute liver failure. However, initial poor function of a liver allograft after liver transplantation, termed early graft dysfunction (EGD), has been associated with increased allograft loss or mortality after transplantation. EGD in LDLT is multifactorial. Factors affecting EGD are GRWR, ischemia reperfusion injury, recipient metabolic demand, graft quality, graft inflow and outflow. Studies shows that the incidence of EGD is 15-38%. It is associated with increased allograft loss \&amp; mortality. Rifaximin is an antibiotic that reduces EGD by 50% as shown by 2 studies but this study was done in DDLT setting and rifaximin was given in the pretransplant group.

In this investigators will study the effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.

Methodology:

* Study population: All patients undergoing adult living donor liver transplant recipients
* Study design: Open label Randomized control Study
* Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025
* Sample size: n=100

  * Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
  * Monitoring and assessment: Not valid
  * Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea
  * Stopping rule Not valid (b) Expected outcome of the project: Perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) Ethical issues in the study and plans to address these issues: None expected

Eligibility Criteria:
Inclusion Criteria:

* All recipients (adults) undergoing living donor liver transplant in ILBS.

Exclusion Criteria:

* Negative consent

  * Hypersensitivity to Rifaximin
  * Patients undergoing retransplant
  * ALF, ACLF
  * Pediatrics patients
  * Patients on rifaximin
Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

The purpose of this research is to determine if restorative eye treatment (RET) and Inhance with trihex technology used before and after blepharoplasty can lead to better skin quality before undergoing blepharoplasty, and if these products will lead to less visible scarring and faster healing after blepharoplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women who are about to have blepharoplasty at the Bascom Palmer Eye Institute by Dr. Wendy Lee.
2. Men and women with no known medical conditions that, in the investigator's opinion, may affect wound healing and interfere with study participation (e.g. diabetes, skin disorder etc.).
3. Participants willing to provide consent for photographic release.
4. Participants must not be using any new skincare products, other than the study products provided, on the treatment area for the duration of the study.
5. Participants willing to avoid extended periods of sun exposure and all use of tanning beds for the duration of the study.
6. Participants must be willing to refrain from any other treatments or procedures to the treatment area during the duration of the study.
7. 18 years old or older.

Exclusion Criteria:

1. Any dermatological disorder or poor health, which in the investigator's opinion, may interfere with the accurate evaluation of the participants' skin characteristics or inhibit wound healing.
2. Participants who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
3. Participants that have been using topical products around their upper or lower eyes within 30 days.
4. Participants who are, in the opinion of the investigator, unwilling or unable to comply with the requirements of the protocol.
5. Pregnant or lactating participants will be excluded, as well as participants planning on becoming pregnant during the study duration.
6. Participants with recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing).
7. A participant with a history of keloids or hypertrophic scars.
8. Participants known to harbour a blood borne disease (e.g. Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV ), HIV)
9. Special populations: Prisoners, Pregnant women, Adults unable to consent, Individuals who are not yet adults.
10. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)

The aim is to evaluate a novel treatment routine where contact through a smart phone/computer is used for online support for patients suffering from chronic widespread pain (CWP). The outline is that patients are encouraged to perform physical activity during a period of 12 months with online support from a physical therapist.

The intervention follows principles from the theories of person-centered care and self-efficacy. The examinations performed at baseline and after six months were conducted by blinded examiners at a visit at the primary health care centers. All participants developed a person-centered health plan for physical activity together with a physiotherapist. The intervention group was supported with a digital platform for six months.

Eligibility Criteria:
Inclusion Criteria:

* fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
* access to a smart phone or computer

Exclusion Criteria:

* other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
* unable to speak or read Swedish
Reducing Risk of Dementia Through Deprescribing

A cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.

The R2D2 study will test whether the adverse cognitive effects of anticholinergic medications are reversible by implementing a pharmacist-based deprescribing intervention for older adults within primary care practices. Two groups will be recruited: providers (physicians and advanced practice providers including nurse practitioners), and patients. Primary care providers of those prescribed eligible anticholinergic medications will be recruited for participation in the study, and their patients who also meet eligible criteria will be subsequently approached and recruited. Participants will be randomized to one of two groups: the deprescribing intervention group or usual care; the intervention group will receive a pharmacist-based deprescribing intervention, while the usual care group will receive care as usually provided by their primary and/or specialty care providers. The intervention and follow-up data collection will occur over 24 months in order to test the long-term impact of the intervention on the planned clinical outcomes. Study outcomes include cognition (primary) and safety (secondary) through validated self-reported scales.

Eligibility Criteria:
Inclusion Criteria for Participants:

* Age 65 and older;
* At least one office visit to their primary care physician within the previous 12 months;
* Use of a target anticholinergic medication within the last two weeks OR medical record evidence of exposure to target anticholinergic medications at or above a cognitive risk threshold in the prior 12 months
* Able to communicate in English;
* Access to a telephone

Exclusion Criteria for Participants:

* Permanent resident of an extended care facility (nursing home)
* Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by International Classification of Diseases (ICD) version 9/10 codes
* Diagnosis of Alzheimer's Disease or Related Dementia as determined by (a), (b), or (c) below:

  1. ICD-9/10 codes, or
  2. Current use of a medication for Alzheimer's Disease or a Related Dementia, or
  3. A pattern of responses to the Functional Activities Questionnaire (FAQ) that indicate dementia (i.e., ≥ 3 FAQ items are scored at "requires assistance," or if ≥ 1 FAQ item is scored at "dependent").
Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia

The investigators are doing this research for two reasons. The first is to see how the retina (back of your eye) changes when your blood sugar is treated with medication for the first time. This will help us better understand the progression of a condition known as Diabetic Retinopathy. The second reason is to provide diabetic blood samples, which will possibly help identify biomarkers for diabetic retinopathy. Biomarkers are things that indicate the presence of a specific condition, and indicate a higher likelihood of developing that condition.

The goal of this research is to conduct a study that investigates (1) how diabetic retinopathy progresses when poorly controlled Type 2 diabetic patients initiate intensive blood sugar control and (2) to determine if there are biomarkers that predict progression of diabetic retinopathy. Typically, the retina is thought to undergo rapid progression of diabetic retinopathy, although this has been poorly characterized in a formal study.

The first goal will be quantified by taking initial photos of the retina with the Pictor Plus hand-held fundus camera, as well as monthly photos (when the patient is scheduled for their endocrinology appointments, throughout a 90 day period). The second goal will be accomplished by testing the patient's blood. There will be an initial blood withdraw, as well as blood withdraws at monthly intervals throughout the same 90 day period as the fundus photos.

This study will help us to understand the pathogenesis of diabetic retinopathy, as well as potentially lead to an improved understanding of progression of diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the endocrinology clinic with a hemoglobin A1c of greater than 12.

Exclusion Criteria:

* Patients with other ocular or systemic conditions, including macular degeneration, uveitis, glaucoma, and autoimmune conditions (Rheumatoid Arthritis, Lupus, and other similar conditions).
Electronic Compliance Monitoring in Opioid Substitution Treatment

The purpose of this study is to improve unsupervised dosing of opioid substitution medications. The aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. We would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds.


Eligibility Criteria:
Inclusion Criteria:

* opiate dependence F11.22 according to ICD-10
* Suboxone treatment
* the duration of substitution treatment before study at least one month
* stable medication dose

Exclusion Criteria:

* unstable situation in life according to treatment staff's opinions
Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery

Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.

As short term endpoints: postoperative complications and resumption of bowel function.

Long term endpoints include: 1 and 3 year recurrence and mortality.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of pancreatic cancer
* American Society of Anesthesiologists (ASA) risk I - III

Exclusion Criteria:

* chronic pain
* chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
* contraindications for any of the study medications
* significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)
* Convulsive disorders requiring medication during the last 2 years
* liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III or IV/ decompensated diabetes
* Corticoid dependent asthma
* Autoimmune disorders
* Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
* Refusal for study participation