cyrilzakka/clinical-trials huggingface dataset:
Physician-Nurse Dyad Rounding: A Collaborative Approach to Improve Unit-Level Metrics

The project will be implemented on one unit at a time until the co-rounding process has been implemented on each Medical-Surgical unit. This study will involve the geo-localized hospitalist on the designated unit and the nursing staff involved in clinical patient care

Patient experience top box scores as well as doctor and nurse domains will be evaluated retrospectively prior to project implementation and this evaluation will continue to be evaluated six months after IRB approval and project initiation. Baseline patient experience scores are routinely captured as a part of routine data collection practices via Press Ganey survey administration.

LOS and discharge times are also routinely collected as a part of routine data collection practices. LOS and average discharge times will be reviewed on an ongoing basis after project implementation to monitor for improvements.

Eligibility Criteria:
Inclusion Criteria:

* Patient Experience, LOS, and Discharge Times: Private hospitalist patients at MDMC
* LOS: Patients with a LOS ≤20 days

Exclusion Criteria:

* Patient Experience: Patients other than private hospitalist patients excluded from this measure.
* LOS: Patients with LOS \>20 days are considered an outlier and will be excluded from the study
Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.

Loss of bone mass is a common complication in patients with end-stage-renal failure, both before and particularly after transplantation. In addition to standard underlying therapy with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate) versus placebo on bone mineral density as well as incidence of fracture rates after kidney transplantation.We also wish to study whether any prevented bone loss will also lead to reduced cardiovascular disease. Patients will be followed for 12 months after transplantation, and the ibandronate treatment is one injection every 3 months.

Demographic, medical history, previous and current medication, as well as baseline measurements of Bone Mineral Density (BMD), laboratory efficacy and safety variables as well as Quality-of-Life scores will be undertaken in the period from 1 week prior to transplantation until 1 week after transplantation. In this period, any existing fractures will be determined using traditional x-ray of the thoraco-lumbar columna. Renal graft functioning as well as transplantation complications will be followed tightly, and calcium supplementation as well as active vitamin D (calcitriol) will be administered together with the standard immunosuppressive regimen.

As soon as patients have recovered from transplantation, and renal functioning is considered sufficiently stable, and no later than 28 days after the transplantation, qualified patients will be randomised to receive either ibandronate or placebo, stratified by gender. Bone mineral density and most of the clinical data and laboratory tests will then be followed until 12 months after transplantation as described in the attached flowchart (section 11.1), with hospital visits for administration of study drugs and follow-up of at 13, 26, 39 and 52 weeks after transplantation. Furthermore, all the patients will be followed prospectively from the time of transplantation and for ten years with regard to cardiovascular events. Data concerning cardiovascular events will be collected from the Norwegian renal registry for the whole study population in the follow up period of about 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients
* Adults, ≥ 18 years of age
* Either gender
* Signed informed consent

Exclusion Criteria:

* Persisting s-Ca \> 2.55 mmol/L (through the first two weeks after transplantation)
* Impaired graft functioning (estimated GFR \<30 ml/min)
* Previous (within the last 12 months) treatment with bisphosphonates, sodium fluoride, calcitonin, strontium, PTH, SERM, growth hormone or anabolic steroids at any time before transplantation.
* Known adynamic bone disease
* Previous parathyroidectomy
* Pregnant or lactating females or females of childbearing potential who do not use an approved method of contraception (oral contraceptives or IUD); positive urine pregnancy test, where applicable.
* Use of any investigational drug (s) and/or device(s)
* Previous participation in this trial
* History of hypersensitivity to bisphosphonates
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

The Sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper™ surgery in patients with refractory FI.

Patients with FI, who met the inclusion criteria were enrolled to our study and received Sphinkeeper™ implantation. Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery. In the routine check-up patients received endoanal ultrasound and anorectal manometry.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
* Ability and willingness to understand and comply with study interventions and restrictions.
* Voluntarily signed informed consent after full explanation of the study to the participant.

Exclusion Criteria:

* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
* Inability to communicate well with the investigator due to language problems or reduced mental development
* Inability or unwillingness to give written informed consent
The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.

The purpose of this study is to investigate the changes in adult peripheral blood immune cell subpopulations, subpopulations, and cell functional status before and after intervention with Nicotinamide Mononucleotide (Vital NAD ) as NAD+ supplement for a certain period of time。To Explore and validate the biological functions of Nicotinamide Mononucleotide (Vital NAD ) of rejuvenation of the Peripheral blood immune cells of Adults.

This study focuses on the effects of Nicotinamide mononucleotide (Vital NAD) as NAD+ supplement on the subtypes and biological functions of immune cells of Adults, especially the types and subsets of immune cells, immune cell differentiation, and immune cell status indicators. Therefore, this study plans to enroll approximately 20 adult subjects in a daily dose of 600mg/day and receive 30 days of Nicotinamide Mononucleotide (Vital NAD) intervention. The study will evaluate the improvement effect of NMN intervention on human immune cell research indicators before and after intervention. The study will also study the impact of NMN on Hematology and blood biochemical indicators, and evaluate the changes of human Hematology biological age after NMN intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Male/females of 18 to 80 years of age.
2. Able to provide written Informed Consent.
3. BMI 25.0-44.9 kg/m².
4. Able to follow verbal and written study directions.
5. Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
6. Able to maintain consistent diet and lifestyle habits according to the study.

Exclusion Criteria:

* 1. Diabetes.

  2.Premenopausal or menopause \<1 year.

  3.Persons who have received hormone replacement therapy within the past 6 months.

  4.Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.

  5.Unstable weight (\>3% change during the last 2 months before entering the study).

  6.Significant organ system dysfunction or disease.

  7.Present cancer or history of cancer that has been in remission for \<5 years.

  8.Polycystic ovary syndrome.

  9.Major psychiatric illness.

  10.Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study.

  11.Metal implants.

  12.Persons who consume \>14 units of alcohol per week.

  13.Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)

Silicosis is well-known occupational disease caused by free crystalline silica (silicon dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative evidences that exposure to Caesar stone (quartz surface products that manufactured from up to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers.

Goals: To examine marble workers exposed to Caesar Stone in order to propose a working plan of surveillance and prevention by biological monitoring.

Study participants would be recruited during two years of the study. They will be asked to come to a single visit at Pulmonary Laboratory of Tel Aviv Medical Center. During the meeting, participants will be given a precise explanation about the tests they will perform and after signing the informed consent will perform following tests:

1. Induced sputum (IS) - will be done after pretreatment with short acting beta-2 agonist and 3% saline will be administrated by an ultrasonic nebulizer for up to 20 min. Differential cell count, particle size distribution test of the particulate matter (with a Eyetech Analyzer (Ankersmid, Yokneam, Israel)will be done from IS samples and evaluation the activity of Heme oxygenase 1 (HO-1) protein from IS supernatants.
2. EBC-Exhaled Breath Condensate-will be done by condensation expiratory air and particulate matter and markers of oxidation will be measured.
3. Participants will be asked to complete occupational questionnaire.
4. Pulmonary function tests (PFTs): The measurement will be performed using standard protocols according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Including Lung diffusion testing.

Laboratory tests of induced sputum and EBC will be done within a week of a participant visit. Analysis of data will be done after the completion of data collection and laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

1. male
2. 18-70 years old
3. At least six months of professional exposure to Caesar stone

Exclusion Criteria:

1. Other occupational exposure (welding of any kind)
2. Chronic Obstructive Pulmonary Disease (COPD), tuberculosis, asthma, autoimmune disease in healthy exposed workers
3. Interstitial lung disease in exposed workers with clinically approved silicosis
Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery

The purpose of this study is to evaluate the conjunctival flora prior to cataract or vitrectomy surgery comparing mupirocin ointment applied to the conjunctiva along with standard ocular sterilization vs. standard ocular sterilization alone.

Bacterial endophthalmitis is a rare but devastating complication of intraocular surgery. Given the devastating ocular sequelae of endophthalmitis, one cannot underestimate the need to develop a sterilization strategy which most effectively prevents intraocular infection. The most common organisms causing bacterial postoperative endophthalmitis are gram-positive cocci, particularly coagulase-negative staphylococci and Staphylococcus Aureus. It is thought that the most common sources of bacterial contamination predisposing to endophthalmitis are the eyelids and conjunctiva (Ariyasu).

The two main techniques used to reduce the bacterial flora on the ocular surface include treatment of the ocular surface with topical antibiotics prior to surgery and the instillation of 5% povidone-iodine during the prep immediately prior to beginning the surgical procedure (Speaker). Mupirocin ointment is a logical choice for surgical prophylaxis as it has been reported that mupirocin treatment applied to the nose resulted in elimination rates (of S. Aureus from the nares) of 91% directly after therapy (Doebbeling). Use of mupirocin ointment applied to the nares prior to eye surgery resulted in a significant decrease in the bacterial load on the conjunctiva at the time of surgery (Alexandrou, in press). Using mupirocin ointment directly to the conjunctiva, in addition to standard ocular sterilization techniques, may result in an even greater decrease in conjunctival flora prior to eye surgery.

Eligibility Criteria:
Inclusion Criteria:

* Included in the study will be any patient eligible for cataract or vitrectomy surgery. No populations will be excluded on the basis of demographics.

Exclusion Criteria:

* Excluded will be those patients who have known sensitivity or allergy to mupirocin ointment, or patients using topical ocular or systemic antibiotics during a two week period prior to entry into the study. Additionally, patient's using topical corticosteroids will be excluded as well
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.


Eligibility Criteria:
Inclusion Criteria:

* At least 22 years of age at time of consent
* Clinically-indicated for an ambulatory Event Recorder or Holter monitor
* Able to follow the protocol
* Provision of written-informed consent

Exclusion Criteria:

* Known allergy to any component of the Event Recorder
* Known allergy to any component of the Holter monitor
* Known allergy to any component of the HeartWatch
* Dextrocardia
Evaluation of Pilot Online Binge Eating Disorder Group (BEG) in Under 18s.

The National Institute for Clinical Excellence recommends a cognitive behavioural therapy (CBT) group intervention for binge eating disorder in under-18s. However, there is limited current research in this population. The present study sought to evaluate a CBT group intervention for binge eating disorder in under-18s.

Background and study aims: The National Institute for Clinical Excellence recommends a cognitive behavioural therapy (CBT) group intervention for binge eating disorder in under-18s. However, there is limited current research in this population. The present study sought to evaluate a CBT group intervention for binge eating disorder in under-18s.

Who can participate? Participants were recruited from the Coventry Warwickshire Partnership Trust's Children and Young People Eating Disorders Team (n=2).

What does the study involve: Participating in a group intervention and completing questionnaires (Eating Disorder Examination - Questionnaire (EDE-Q), Revised Children's Anxiety and Depression Scale (RCADS) Child and RCADS Parent) before the group, at the end of the group and a follow-up appointment, as well as a feedback form at the end of the group intervention.

What are the possible benefits and risks of participating:

* Benefits: Working towards recovering from binge eating disorder
* Risks: As with all therapy, there is a risk of distress due to the topics discussed. There is no more risk than any other group online therapy.

Where is the study run from: Online intervention for participants who are eligible and who are under the care of the RISE Eating Disorders Team within Coventry and Warwickshire NHS Partnership Trust.

When is the study starting and how long is it expected to run for: The study commenced on on 23rd May 2023. The group intervention ran from 20th June 2023 to 26th September 2023.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Binge Eating Disorder
* Under 18 prior to the group commencing
* Spoke English fluently

Exclusion Criteria:

* If they were underweight. This was measured by percentage median body mass index (%mBMI) as recommended by the Medical Emergencies in Eating Disorders guidelines (Royal College of Psychiatrists, 2022) for under 18s. As such, individuals were excluded if %mBMI was less than 95%
* If they had any physical illness serious enough to prevent the participant from engaging fully in the group and completing the in-between session work
* If they were pregnant
* If they had an eating disorder-induced physical health state requiring regular medical intervention by the nursing team
* If they presented a mental health state requiring stabilisation prior to participating in the group intervention according the assessment team
* If they regularly used alcohol and/or drugs
* If they repeatedly self-harmed to the point of requiring additional interventions
* If they had a living situation not conducive to the start of an intervention (ongoing or upcoming changes).
EC95 of Remifentanil for Preventing Cough

The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol anesthesia.

At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for laryngomicrosurgery

Exclusion Criteria:

* Anticipated difficult airway
* COPD, Asthma
* Recent URI (\< 2 weeks)
* Severe cardiac, hepatic renal disease
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.


Eligibility Criteria:
Main inclusion Criteria:

* Clinical and laboratory diagnosis of HAE
* Plasma level of functional C1INH of less than 50% of normal
* Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.

Main exclusion Criteria:

* Acquired angioedema
* Pregnancy or breastfeeding
* Participation in another clinical study within prior 3 months
Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease

This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.

This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 90 days after the last treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years to ≤ 75 years.
* One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
* Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
* Provides written informed consent
* Understands and accepts the study requirements

Exclusion Criteria:

* Age less than 18 years of age or over 75 years of age
* Diagnosis of radiolucent stones
* Diagnosis of stones in the lower pole of kidney
* History of cystinuria
* Urine pH below 5.5
* Current untreated urinary tract infection
* Pregnancy
* Coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician.
* Mobility issues - unable to comfortably lie still for up to 30 minutes or unable to roll from back to side
* Known hypersensitivity to conductivity gel
* Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
* Body mass index greater than 35
* American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia risk level
* Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anaesthetics, topical anaesthetics, and opioid analgesics.
* Enrollment in another research study or previous participation within 30 days of enrollment.
A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.

Eligibility Criteria:
Inclusion Criteria:

* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision procedures where other treatment or devices have failed
* 18 years of age or older
* Subjects willing to return for follow-up evaluations

Exclusion Criteria:

* Infection, sepsis and osteomyelitis
* Subjects unable to cooperate with and complete the study
* Neurological conditions affecting movement
* Pregnancy