cyrilzakka/clinical-trials huggingface dataset:
Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either:

1. a local cocktail.
2. a local cocktail plus Exparel.
3. marcaine plus Exparel prior to wound closure following knee arthroplasty.

As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control.

Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either:

1. a local cocktail.
2. a local cocktail plus Exparel.
3. marcaine plus Exparel prior to wound closure following knee arthroplasty.

METHODOLOGY

Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals.

Eligibility Criteria:
Inclusion Criteria:

* Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained
* The subject underwent a primary total knee replacement under adductor canal block with general anesthesia

Exclusion Criteria:

* The subject is a minor
* The subject is on chronic narcotics
* The subject has an indwelling pain pump
* The subject is having a knee revision surgery
* The subject is having a partial knee replacement
* The subject has a history of sepsis in a previously replaced joint
* The subject has back pain
* The subject has radicular pain
* The subject suffers from depression
* The subject has fibromyalgia
* The subject is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.


Eligibility Criteria:
1. Must be 18 or older
2. Must have an appointment for Atrial Fibrillation
3. Must not have dementia
4. Must not have severe hearing or vision impairment Patients will be given a written consent Guests that accompany patients will be given an oral consent KER unit PAG members will be given an oral consent
Quality of Life of the Piloted Individuals and a Cost-efficiency Analysis

The increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on Person-Centred Care approaches. This study aims to improve Person-Centred Care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. A descriptive cross-sectional quasi-experimental design was proposed, with 10 participants.

Background: Increasing life expectancy means that the ageing of populations globally is on the rise. It is therefore important to promote changes in long-term gerontological services based on Person-Centred Care approaches, in which meaningful occupation serves as a basis and is supported by appropriate professional support, such as the occupational therapist and the direct care professional.

Objective: The study aims to analyze the needs, quality of life, and coping strategies of terminally ill patients over five months, as well as burnout and dehumanization among caregivers and healthcare staff.

Methods: This study examines factors influencing the quality of life (QOL) of terminally ill patients and the burnout and dehumanization of caregivers and health professionals using a mixed methodology. The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.

Eligibility Criteria:
Inclusion Criteria:

* That the direct care worker has a degree as a nursing assistant, dependency care technician, geroculturist or certificate of professionalism.
* The worker must speak and understand Spanish.
* The residence must offer service during the day, in the morning or afternoon shift.
* Workers must have been with the department for more than 4 months.

Exclusion Criteria:

* Workers who work night shift only.
* Workers on rotating shifts in all departments of the residence.
* Workers absent at the time of the study due to temporary leave, vacations or other causes.
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Age ≥ 18 years and of either sex
* Willing to comply with protocol instructions, including allowing all study assessments
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence
* Arterial supply adequacy confirmed
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
* Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months).
* Acceptable state of health and nutrition

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine
* Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic)
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit
* Refusal of or inability to tolerate compression therapy
* Therapy of the target ulcer with Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit
* Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit
* Current therapy with systemic antibiotics
* Current systemic therapy with cytotoxic drugs
* Current therapy with chronic (\> 10 days) oral corticosteroids
* Current therapy with TNFα inhibitors
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Telerehabilitation in the Post-COVID-19 Patient (TRIALS)

A major issue brought about by the current pandemic concerns the discontinuation of a large proportion of outpatient services provided locally, especially in the rehabilitation field. Added to this situation is the ever-increasing demand for rehabilitation for post-COronaVIrus Disease 19 (COVID-19) patients. Data show that respiratory and motor rehabilitation for people infected with COVID-19 is necessary at all stages of the disease, even in the medium to long term after discharge from acute hospital care. Also to be taken into account are the logistical difficulties imposed by restrictions on the movement of individuals within the territory for both patients and caregivers, which are amplified in remote or poorly served areas, such as many cross-border territories. In this context, telerehabilitation can provide solutions to assist healthcare facilities in managing the demand for rehabilitation in the territory using a 'digital' therapist. The main objective of this project is therefore to identify the appropriate technology to administer the rehabilitation programme to patients and apply to a group of post-COVID-19 patients a customised respiratory and/or motor rehabilitation programme to be carried out directly at the patients' home after hospital discharge in order to evaluate its effects.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to a rehabilitation facility for functional recovery in disabling motor and/or respiratory outcomes of severe acute respiratory syndrome COronaVirus 2 (SARS-CoV2) infection and residing in cross-border regions with a low density of rehabilitation offerings.

Exclusion Criteria:

* Psychiatric disorders/cognitive impairments that do not allow proper use of tablets and breathing training devices.
An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

The purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials: A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.


Eligibility Criteria:
Inclusion Criteria:

* Included were subjects who completed Pfizer study A1481082 or A1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study.
* For subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout.
* Subjects should continue to maintain a stable sexual relationship throughout the study.

Exclusion Criteria:

* Excluded were subjects who experienced either treatment-related serious adverse events or significant treatment-related laboratory abnormalities in the previous study, and subjects who misused study medication and/or failed to adequately account for study medication in the previous study, or who were non-compliant with visits.
* Also excluded were subjects who were currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols).
EndoStyle: Artificial Intelligence Image Transformation Tool for Colonoscopy

The study addresses the limitations of current AI systems in gastrointestinal endoscopy, which are tipically trained with data from a single type of endoscopy processor and have limited expert-annotated images. The investigators aim to develop and validate EndoStyle, an AI system that can generate images in the style of various processors from a single reference image. EndoStyle will be tested by showing endoscopists colonoscopy sequences with different image types to determine if they can distinguish AI-transformed images. Success would enhance AI training for diverse clinical setups.

The use of artificial intelligence (AI) in gastrointestinal endoscopy has become widespread. However, these systems are often only trained with data from a single type of endoscopy processor, which limits their applicability. In addition, the availability of images annotated by experts is limited, which affects data variability and thus the performance of AI systems.

The aim of this study is to develop a new artificial intelligence (AI) based system (EndoStyle) and validate its authenticity by means of a survey among physicians, which is able to generate multiple images in the style of different processor types (including Olympus, Pentax and Storz) from a single endoscopy reference image.

The investigators hypothesis is that the AI system is able to successfully change the image style of video processors, with the differences being imperceptible to the endoscopist's eye.

The methodology consists of showing to multiple endoscopists 28 colonoscopy sequences of 10 seconds duration each. In each one of them 3 images will be shown that can be all the possible combinations of images belonging to positive control, negative control, and Endostyle (intervention group). By performing a statistical comparison of the percentages of selected images for each group the investigators will be able to establish whether the participants are able to distinguish the images transformed by the AI.

If the results corroborate our hypothesis, our system could generate images that would allow a more customized training of AI systems for each clinical setup.

Eligibility Criteria:
Inclusion Criteria:

* Physicians with experience in colonoscopy.
Effects of Hamstring Shortness on Jump Performance in Young Basketball Players Impact

In the realm of sports performance, particularly in disciplines demanding explosive lower-body strength and agility, such as basketball, an athlete's ability to execute powerful and high-reaching jumps plays a pivotal role. Optimal lower-extremity flexibility, particularly in the hamstrings, is crucial for achieving maximum vertical jump height. Hamstring shortness, characterized by limited flexibility and reduced muscle extensibility, is frequently observed among athletes and has been linked to compromised jump performance.

Young basketball players, in their developmental stages, often face the challenge of balancing strength, flexibility, and functional movement. Hamstring tightness is a prevalent issue among this demographic, potentially influencing their ability to generate adequate power during jumps. The impact of hamstring shortness on jump performance is multifaceted, affecting the force production, range of motion, and efficiency of movement crucial for executing explosive jumps

Eligibility Criteria:
Inclusion criteria

* To be between 10-16 years old
* Being a licensed basketball player
* Playing in the Istanbul Local Basketball League run by the Turkish Basketball Federation
* Sit-to-Face test 30 cm and below Goniometric measurement less than 80 degrees in active straight leg raising test, Exclusion criteria
* Having played one match in the 48 hours prior to the evaluation
* Having a lower extremity injury.
* Participants of both genders will be included in the study.
A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)

This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of \[14C\]-Fosgonimeton

This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of \[14C\]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of \[14C\]-Fosgonimeton.

Eligibility Criteria:
Inclusion Criteria:

1. Males, of any race, between 18 and 60 years of age, inclusive.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
3. In good health, determined by the investigator's discretion
4. Subjects and their partners will agree to use contraception during their participation
5. History of a minimum of 1 bowel movement per day.

Exclusion Criteria:

1. Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. Positive hepatitis panel and/or positive human immunodeficiency virus test.
4. Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
5. Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
6. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
7. Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
8. Poor peripheral venous access.
9. Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)
Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?

The purpose of this study is to determine whether a knee arthroscopy is effective in the treatment of middleaged patients with meniscal symptoms also receiving a standardised exercise program.

There are no studies proving a significant positive effect of a knee arthroscopy in middleaged patients with meniscal symptoms in excess of a structured rehabilitation program. In this study consecutive patients aged 45-64 years referred to the orthopaedic department at the University hospital Linköping for a suspected meniscal injury will be randomised to a rehabilitation program or a knee arthroscopy + the same rehabilitation program. Functional tests will be performed by a physiotherapist. There will be patient administrated questionaries sent out after 3 and 12 month.

Eligibility Criteria:
Inclusion Criteria:

* All (consecutive) patients referred to the orthopaedic department in Linköping for a suspected meniscal injury
* Age:45-64 years old
* No gonarthrosis (Ahlbäck=0) on standing radiographs

Exclusion Criteria:

* Rheumatic disease
* Patellofemoral arthrosis
* Fibromyalgia
* A knee or hip replacement
* A neurologic disorder including stroke
* A contraindication for an operation
* Catching or locking for more than 2 seconds more than once a week
* A permanent extension deficit
* Patients who cannot understand instructions in Swedish
Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD

rapid swallow (MRS) can assess the contractile reserve capacity of the oesophageal body and identify and diagnose oesophageal motility disorders, but the impact of preoperative oesophageal reserve capacity on postoperative symptoms and motility in patients with GERD remains unclear. The aim of this study was to assess the effect of pre-operative oesophageal reserve capacity on post-reflux symptoms and motility in patients with GERD by using a high-resolution oesophageal manometry-based provocation test, MRS, to track pre-operative ineffective oesophageal motility (IEM).

Lower oesophageal sphincter relaxation is an important cause of GERD and ineffective oesophageal motility may be associated with GERD, but the mechanism of oesophageal corporal motility disorders is unclear. High-resolution manometry (HRM) has shown to be more accurate than conventional manometry in assessing oesophageal motility, and can provide guidance for GERD surgery. The aim was to conduct a cohort study to investigate the yu'h of patients with preoperative esophageal motility disorders with or without esophageal reserve, based on the assessment of esophageal motility by high-resolution esophageal manometry to follow up changes in esophageal motility and symptoms in patients after anti-reflux surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Patients to be treated surgically for gastroesophageal reflux disease
* Ineffective esophageal motility diagnosed by high resolution esophageal manometry according to Chicago Classification version 4.0
* Obtaining Informed Consent

Exclusion Criteria:

* Previous other upper gastrointestinal surgery
* Pregnant women and other people with contraindications to surgery and tests
* Other specifically defined esophageal motility disorders, such as nutcracker esophagus
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients

A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. medical history of diabetes
2. diagnosed with proliferative diabetic retinopathy
3. diagnosed with dry eye
4. not involvement in other drug experiment in the past 2 weeks
5. vision acuity better than 0.1
6. no local drug using history or with at least 2 weeks blanking period

Exclusion Criteria:

1. allergy to any of the drug ingredient
2. being or going to be pregnant or in lactation period
3. with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
4. with any eye surgery history in the past six months
5. usage of hormone for replacement therapy
Study of Subclinical Viral Infection

Chronic allograft injury is the leading cause of graft loss in renal transplantation. The shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. Strategies to prolong graft survival are urgently needed. The pediatric and young adult transplant population is one in which repeat transplantation is inevitable and therefore, this group is one who will especially benefit from intervention to prolong graft survival. The hypothesis of this proposal is that subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic allograft injury. The young age of the proposed study population is an ideal one to evaluate this objective due to the high prevalence of seronegative recipients. The studies outlined will determine the temporal relationship betWeween subclinical viremia, renal allograft infection and allograft injury. This will be the first prospective study in renal transplant recipients to systematically monitor subclinical viral infection both in peripheral blood and in the renal allograft with concurrent quantitative measures of renal function, allograft fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes because they evaluate a spectrum of renal allograft injury and represent different stages - from early to late - in the pathophysiology that leads to renal allograft dysfunction. In addition, the role of virus specific T cell immune responses in the control of subclinical viral infection and associated allograft injury will be determined. These data are critical as they will provide insights into the pathogenesis of injury and will guide development of interventions strategies. Importantly, the current treatment strategies for viral disease do not prevent subclinical viral infection. Thus, the results of this study may identify that prevention, prophylaxis and/or treatment of subclinical viral replication as a long term strategy to prevent chronic allograft injury and prolong graft survival.


Eligibility Criteria:
Inclusion Criteria:

* Subject and/or parent guardian must be able to understand and provide informed consent or assent
* Male or Female, Seattle Children's Hospital participants must be 1-\<21 yrs and University of Washington Medical Center participants 18-25yrs.
* Diagnosed with End Stage Renal Disease (ESRD)

Exclusion Criteria:

* Inability or unwillingness of subject and/or parent guardian to provide informed consent
* Pregnancy