cyrilzakka/clinical-trials huggingface dataset:
Trajectory of Recovery in the Elderly

The purpose of this study is to understand how elderly individuals regain their cognitive skills following general anesthesia. The investigators will compare an age stratified group of volunteers who will be evaluated with a series of cognitive tests and a functional MRI. The participants will then be administered general anesthesia for two hours. The investigators will then assess the participants using state of the art tools to determine when participants return to their cognitive baseline.

Elderly patients undergoing anesthesia and surgery frequently suffer from postoperative cognitive dysfunction (POCD) and postoperative delirium (PD). The cause of these entities is unknown. It is unclear what part anesthetics play in the development of POCD and PD. The investigators hypothesize that elderly patient's cognitive capacities recover more slowly after receiving general anesthesia, perhaps because they have more limited cognitive reserve. A more prolonged recovery would confound diagnoses of POCD and PD and potentially puts patients who are discharged on the day of surgery at risk of not understanding postoperative instructions. The trajectory of postoperative cognitive recovery has never been explored and elderly participants have been explicitly not included in any type of emergence research. To explore this vital area the investigators propose to study young and elderly volunteers with a combination of two state of the art neuropsychological tests (Postoperative Quality of Recovery Scale and the NIH Toolbox) and functional magnetic resonance imaging. Starting from baseline, the investigators will determine multiple cognitive domains and resting state networks, treat the participants with general anesthesia for two hours while continuing to examine network activity, and then explore the recovery of the cognitive domains and alterations in functional networks using both the PQRS and the NIH Toolbox Cognitive Measures. Participants will be evaluated at 1 month, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years old
* American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. Individuals with minimal disease burden)
* Capable and willing to consent

Exclusion Criteria:

* Airway assessment as potentially difficult (Mallampati III or greater)
* Allergies or hypersensitivity to drug or class
* Chronic Inflammatory conditions such a lupus or system rheumatoid arthritis (arthritis limited to 1 or 2 joints will be acceptable)
* Patients with diabetes mellitus
* Patients with a recent illness (within the last 2 weeks)
* Patients with severe visual or auditory disorder/handicaps
* English illiteracy
* Pregnancy
* Participants not expected to be able to complete the postoperative tests
* History of malignant hyperthermia
* Nursing mothers
* Body Mass Index \> 30
* Patients with significant metal implants in body
* Current use of cocaine or opiates
* Current smokers
Modified Trabeculectomy With an ESST Versus Conventional SST for Management of Primary Open Angle Glaucoma

* To evaluate prospectively the surgical outcome in terms of intraocular pressure control, potential advantages, disadvantages, success rate, complications and bleb morphology of this modified trabeculectomy with an extended subscleral tunnel (ESST) in comparison to the conventional subscleral trabeculectomy (SST) in management of uncontrolled primary open angle glaucoma.
* This study will recruit 40 eyes of (40) candidate patients with primary open angle glaucoma (POAG) who are indicated for surgery.
* The candidate patients will be recruited into 2 equal comparative groups. In group (A) 20 eyes (20 patients) who will undergo conventional (SST) with intraoperative mitomycin C (MMC) (0.03%) and group (B); 20 eyes of 20 patients will undergo trabeculectomy with an ESST also with intraoperative adjunctive MMC (0.03%).

* Different surgical procedures were developed and the principle behind them was to establish a fistula between the anterior chamber and the subconjunctival space to permit the aqueous humour to exit the eye.
* Subscleral trabeculectomy has remained the most commonly performed glaucoma surgery to which the newer operations are compared.Although this procedure is very effective in reducing intraocular pressure (IOP) immediately, surgical failure has often been observed over time due to fibrosis of the surgical site and resultant non-filtering bleb. -Improvement of the complication profile and the efficacy of glaucoma filtering surgery is still a major concern for glaucoma surgeons.Therefore, several modifications, combinations, and new techniques of subscleral trabeculectomy have been described.
* In the current study, a fornix-based conjunctival flap will be fashioned in an attempt to encourage more posterior drainage. In this modified trabeculectomy technique, an additional small perpendicular strip of sclera is removed extending from the AC to 2 mm beyond the edge of the scleral flap thus creating an extended subscleral trabeculectomy facilitating aqueous passage into the posterior subconjunctival space.

Eligibility Criteria:
Inclusion Criteria:

* Patients with POAG aged from (40- 70) years who are candidate for glaucoma surgery with BCVA ≥ 3/60 to be able to perform visual field testing.
* Non- compliant patients to the medical treatment willing for follow-up visits for at least 6 months post-operatively .

Exclusion Criteria:

* Congenital, traumatic, neovascular, uveitic glaucomas or cases with angle closure glaucoma (ACG) associated with shallow AC.
* Undergoing simultaneous cataract surgery.
* Previous vitreo-retinal surgery including vitrectomy and buckling surgery.
* Other pre-existing ocular cicatrizing diseases.
* Corneal abnormality that precluded reliable applanation tonometry.
Accelerated Prone Position Ventilation of Patients With COVID-19

Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study is to assess whether applying prone position ventilation immediately after intubation reduces the duration of mechanical ventilation compared to prone position ventilation according to standard criteria for prone position.

In patients with COVID-19 the incidence of ARDS is 15% and the all-cause mortality 4%. No treatment has been shown to improve the outcome of these patients.

Mechanical ventilation in the prone position decreases mortality with around 50% when applied to patients with severe respiratory failure. Applying prone position earlier in patients with COVID-19 could have several benefits, but may also carry significant side-effects and an increased workload for the health-care personnel. It is urgently needed to assess whether this potential life-saving intervention is effective.

The aim of the PROVENT-COVID is to determine whether prone position ventilation, initiated immediately after intubation, lead to more days alive without respiratory support compared to prone position initiated according to standard indication in patients with COVID-19 associated respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age.
* Admitted to an intensive care unit.
* Indication for intubation and mechanical ventilation
* No suspicion of significant cardiac failure induced pulmonary edema.
* Suspected COVID-19 or positive SARS-Cov-2 PCR or equivalent diagnostic test.
* Inclusion as soon as possible and maximum 12 hours after intubation.

Exclusion Criteria:

* Contraindication for prone position ventilation: Suspected high intracranial pressure, massive hemoptysis requiring an immediate surgical or interventional radiology procedure, tracheal surgery or sternotomy during the previous 15 days, serious facial trauma or facial surgery during the previous 15 days, cardiac pacemaker inserted in the last 2 days, unstable spine, femur, or pelvic fractures, single anterior chest tube with air leaks, body constitution that is incompatible with prone position ventilation (i.e. high BMI)
* Admitted under duress (psychiatry).
* Pregnant or breastfeeding.
* Mechanical ventilation in prone position prior to inclusion in the trial
A Phase I Study of LY3471851 in Healthy Participants

The purpose of this study is to compare two different formulations (test \& reference) of LY3471851 in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving the study drug that is LY3471851.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical history and physical examination
* Have body weight greater than 45 kilograms (kg) and body mass index within the range 18.0 to 32.0 kilograms per square meter (kg/m²)
* Male and female participants must agree to adhere to contraceptive requirements

Exclusion Criteria:

* Have an abnormality in the 12-lead electrocardiogram (ECG), vital signs, or both
* Have had symptomatic herpes zoster within 3 months prior to screening
* Have a known allergy or hypersensitivity to levocetirizine
* Intend to use prescription or nonprescription medication within 14 days or 5 half-lives prior to dosing
* Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
* Smoke more than 10 cigarettes or other tobacco products per day before study entry
* Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.


Eligibility Criteria:
Inclusion Criteria:

Subjects with suboptimal response to ruxolitinib:

* Treatment with at a stable dose of ruxolitinib prior to study entry
* Subjects ≥ 18 years of age and able to provide informed consent.
* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
* High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)
* Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematological, hepatic, \& renal function.

Exclusion Criteria:

Treatment-naive subjects:

* Prior treatment with any JAKi

Subjects with suboptimal response to ruxolitinib:

* Documented disease progression while on ruxolitinib treatment

All subjects:

* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
* Prior treatment with a BTK or BMX inhibitor
1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus

The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.

Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.

Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
* Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion Criteria:

* Patients with any other known systemic disease
* Patients on systemic statin therapy
* Known or suspected allergy to statin supplementation
* Patients with aggressive periodontitis
* Tobacco use in any form, smokers, alcoholics
* Immunocompromised patients
* Pregnant or lactating females
Effect of Different Size of Patellar Resurfacing on Patellar Crepitus of the One-stage Bilateral Total Knee Arthroplasty.

The goal of this study is to compare the incidence of patella crepitation using different size of patella component in bilateral simultaneously total knee arthroplasty with patella resurfacing. The main question is does size of patella component effect the incidence of patella crepitus? In the control group, anatomically sized patella components were used, whereas the intervention group received 3 mm smaller, reduced-size patella components. Participants were scheduled for follow up examination 2 weeks, 6 weeks, 6 months and 1 year for incidence of the patella crepitation and other outcomes.

For decades, total knee arthroplasty (TKA) has been the treatment of choice for knee osteoarthritis, with posterior-stabilized (PS) systems showing excellent long-term outcomes. However, patellar crepitus is more common with PS TKA systems because the cam and post mechanism can entrap fibrosynovial tissue within the intercondylar box, causing crepitus or clunking. Patellar crepitus (PC) was defined as an audible grinding noise or palpable vibrations in the knee during active and passive range of motion, detected by the examiner's hand on the patient's patella and sometimes can be audible.

This study was designed as a single-center, prospective randomized controlled trial comparing anatomical and reduced size of patella component in patients who underwent sequential bilateral TKA with patella resurfacing under single anesthesia. All participants were blinded to their intervention. A total of 94 knees from 47 patients were randomly assigned to undergo TKA with an anatomically sized patella component in one knee and reduced-size patella component in another knee or vice versa.

Crepitus, as a primary outcome, was assessed at 2, 6, 24 and 48 weeks follow-up using a validated and standardized approach. Crepitus was graded as: 0 (none), 1 (fine palpable), 2 (coarse palpable), and 3 (audible). Secondary outcomes included anterior knee pain (AKP), Feller's patella score (FPS), Kujala score, knee society score (KSS), range of motion (ROM), radiographic findings, and complications. AKP was measured using a 10-cm visual analog scale (VAS) in 1-cm increments. Knee ROM was measured with a goniometer. Radiographic parameters were measured at 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 80 years.
* American Society of Anesthesiologists (ASA) Classification 1 or 2.
* Diagnosed with primary knee osteoarthritis and requires bilateral total knee arthroplasty with patellar resurfacing.
* Participants can understand and consent to participate in the research project

Exclusion Criteria:

* Secondary knee osteoarthritis,
* Previous knee surgery or arthroscopic surgery
* Individuals who cannot undergo surgery due to underlying medical conditions.
* BMI \> 40 kg/m2
* Infection around the knee
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at the time of Informed Consent
* Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom
* Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria:

* Have any clinically significant ocular condition
* Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months
* Meet any other exclusion criteria outlined in the clinical study protocol
Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-up

The efficacy of TVT-O (tension-free vaginal tape obturator) is well established in patients with stress urinary incontinence (SUI). The objective of this study was to evaluate the efficacy, safety and patient satisfaction of TVT-O in patients suffering from primary, mixed (MUI) or recurrent urinary incontinence (UI) in long-term follow-up.

The long-term results after TVT-O have been scarce. At five years no significant differences were seen between TVT (tension-free vaginal tape) and TVT-O for female SUI in a randomized trial. In two studies the patients were followed-up for ten years after the TVT-O procedure. The first randomized study reporting long term outcomes of TVT-O and outside-in TOT (transobturator tape) in women with urodynamic mixed urinary incontinence (MUI) showed that transobturator tension-free vaginal tapes are associated with a good and sustained patient-reported success rate.

The success of the incontinence procedures should be assessed not only with objective measures but also with methods evaluating subjective satisfaction. The aim of this study was to evaluate the efficacy, safety and overall patient satisfaction of the TVT-O technique in a long-term follow-up of patients suffering from primary or recurrent SUI or MUI.

Eligibility Criteria:
Inclusion Criteria:

We included all the patients who underwent the TVT-O operation between August 2004 and October 2011 in our hospital, Turku university hospital Finland.

Exclusion Criteria:

No exclusion criteria were applied.
Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy

This study aims to determine the functional outcomes of patients who underwent internal hemipelvectomy with or without reconstruction or external hemipelvectomy for pelvic tumors. Learning about the outcomes of these patients may help researchers determine the long-term effects of different types of hemipelvectomy procedures and may help improve quality of life.

PRIMARY OBJECTIVE:

I. To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.

SECONDARY OBJECTIVES:

I. To determine factors that influence the functional outcomes of these patients following surgery.

II. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.

III. Determine whether type of surgery influences long-term sexual and urinary function.

OUTLINE:

Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.

Eligibility Criteria:
Inclusion Criteria:

* Patients within the institution who have undergone or will undergo a hemipelvectomy

Exclusion Criteria:

- None
Studies of Human Inference Using On-line Testing

The investigators will record behavioral responses from human participants on crowdsourcing platform Prolific to identify the decision strategies humans apply short-term, long-term, and multi timescale (across both timescales) inference tasks. Participants will perform a Jar Switching Task (described in Research Strategy Aim 1- "Jar Switching Task") in which balls are drawn with replacement from one of two known jars. The current jar in use switches based on an underlying change rate across trials. Subjects must perform three task blocks: 1) report the current jar in use (short-term inference), 2) predict the subsequent jar (long-term inference), and 3) both report and predict the jars (multi-timescale inference). The investigators will record these responses, the number (and sequence) of balls drawn, and the response time (time from the end of trial until the response) for each trial. Subjects will perform all blocks (parameters and number of blocks to be determined by inference model development and testing prior to task development) so that we can compare responses at each timescale. Since participants participate voluntarily for small sums of money (around $10/ hour based on duration of task) and the investigators' previous studies have collected over 200 subjects in a matter of days, they will aim to record behavioral data from 1000 subjects. This number allows them to address the broad range of subject variability expected using Bayesian statistical methods such as Bayes factors.


Eligibility Criteria:
Inclusion Criteria:

* Adult Prolific participants who have a 95% approval rating and achieve a minimum score of 80% on our pre-test,
* Speak fluent English
* Are in the US.

Exclusion Criteria:

* None
The Effects of Virtual Reality and Augmented Reality Training System on Elderly Oral Care Skill for Oral Hygiene and Nursing Students

Virtual reality (VR) has been proposed as a promising technology for education since the combination of immersive and interactive features enables experiential learning. The study aimed to evaluate the effectiveness of VR-based training on oral health care for dependency elderly among oral hygiene students.

A randomized controlled trial was conducted. Overall, the study recruited students from third grade of Department of Oral Hygiene students in Kaohsiung Medical University during 2021. The participants were randomly assigned to virtual-reality experimental (EG; n = 11) and control (CG; n = 12) groups. The students in EG received a 2-hour VR training for elderly oral health care at 2-week (Time 2), 4-week (Time 3) and 6-week (Time 4) follow-ups. Each student collected the data by a self-administrated questionnaire before and immediately after each of the intervention. Linear regression in generalized estimating equations (GEE) compare the differences between both groups.

Eligibility Criteria:
Inclusion Criteria:

* third grade of Department of Oral Hygiene students in Kaohsiung Medical University during the 2021 academic semester
* Participants have to take both the courses of 'Basic Medical Nursing Care' and 'Oral Health Care for Community People and Long-term Care Residents' before intervention.

Exclusion Criteria:

* none
Exercise-training Before Coronary Artery Bypass Graft (CABG)

The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for CABG both with and without heart failure

Exclusion Criteria:

* Unstable angina
* Unable to walk on a treadmill (except those with heart failure who only will serve as a reference group)
* Participation in another study