cyrilzakka/clinical-trials huggingface dataset:
Adductor Canal Block Combined With IPACK vs Genicular Nerves Block in Knee Arthroscopy

This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing knee arthroscopy.

Maintaining patient safety, ensuring best patient outcomes, and optimal pain relief post-operatively are of utmost concern for anesthesia providers. Adequate pain relief attenuates stress responses and long-term chronic pain complications while contributing to improved postoperative outcomes.

Knee arthroscopy is a very common procedure and very often is performed as day-case surgery. Ambulatory arthroscopic surgery of the knee is preferred by the majority of properly selected and well-informed patients. It has been reported that a significant number of patients have moderate to severe pain 24 hours after ambulatory surgery in general and knee arthroscopy in particular and pain affects the patient's activity level and satisfaction. Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease the pain significantly and decrease opioid consumption with minimal effect on quadriceps function. It provides analgesia to the peri-articular and intra-articular aspects of the knee joint but doesn't relieve posterior knee pain which is moderate to severe in intensity.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-60 years
* Both genders
* American Society of Anaesthesiologists physical status classification I - III
* Patients scheduled for elective unilateral knee arthroscopy under spinal anesthesia

Exclusion Criteria:

* Patient refusal
* Preoperative neurological deficits
* Opioid-dependent (opioid intake more than 3 months)
* Chronic pain conditions
* Significant cardiac and respiratory disease
* Pre-existing major organ dysfunction such as hepatic and renal failure
* Coexisting hematological disorder or deranged coagulation parameters
* Psychiatric illnesses
* Allergy to any of the drugs used in the study
Psychosocial Intervention Pilot for Partners in BRCA Testing

A brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring BRCA genetic alterations.


Eligibility Criteria:
Inclusion Criteria:

* Age, married/partnered status

Exclusion Criteria:

-
Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts

Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.

Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-99 years
* Portal hypertension
* Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
* Informed consent

Exclusion Criteria:

* Retraction of consent
Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)

The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated Lipocalin (NGAL) and Intereleukin 18 (IL18).

Kidney transplantation is the best treatment for most patients with end stage renal failure, but limited numbers of suitable kidneys are available for transplantation. So preservation of graft is vital. This necessitates the studies and interventions to improve outcome of renal transplantation surgery.

Delayed Graft Function (DGF) or delay in performance of transplanted kidney means absence of acceptable function in the renal activity in postgrafting phase. DGF is a consequence of ischemic and reperfusion injuries (IRI), and oxygen free radicals have a main role in pathophysiology of DGF. In meta-analysis studies, it has been demonstrated that DGF has a correlation with long and short time graft survival. Despite great advances in the transplantation procedure, dysfunction prevalence has not decreased. Major causes of this problem are the lack of appropriate markers for early diagnosis of DGF and on the other hand lack of appropriate and effective interventions to controll DGF.

Studies have shown that N-Acetyl Cysteine (NAC) can induce GSH synthesis, scavenger of free radicals, and infusion of NAC had similar effects as glutathione.

This is a randomized clinical trial (RCT) on patients who have received kidney transplantation from living donors. Sixty transplanted patients will be randomized into 2 groups. The first group of patients will be treated with NAC 600mg 6 hr before transplantation and two doses of NAC 12 hours apart after transplantation in addition to standard treatment, and the second group will receive only standard antirejection treatment. For all patients entered the study, urinary concentrations of IL18 and NGAL will be measured in designated times. Risk factors of DGF will be compared in two groups and effectiveness of NAC in reducing DGF will be determined.

Eligibility Criteria:
Inclusion Criteria:

* patient receiving transplantation from living donors

Exclusion Criteria:

* having a neoplastic disease
* brain tumor
* having inflammatory diseases in their active phase (SLE)
* an acute infection, meningitis, sepsis
* Sickle Cell Disease
* Pregnancy
* Cardio-renal syndrome
* endogenous Cushing's syndrome
* chronic use of cimetidine
* a history of acute pancreatitis in recent months
* Multiple Sclerosis
* cardiac bypass in a recent month
* cirrhosis due to Hepatitis C
* having Alzheimer's disease
* having a untreated major depressive illness or schizophrenia
* Stroke in recent months
* Hyperoxaluria
* sensitivity to sulfonamides
Remote Assessment of Signs and Symptoms in Palliative Care

Digital health interventions, including remote monitoring of patients, have been identified as a possible way to address current problems within the health service, including insufficient numbers of staff, and an increasing number of patients requiring services.

The aim of this study is to assess the feasibility of using remote monitoring for patients who are receiving palliative care and to see whether remote monitoring can improve care and outcomes for patients and their families.

Participants in this study will complete regular (daily, weekly, monthly) questionnaires online about how they are feeling. They will also be given equipment to measure their vital signs every day. The clinical team will have access to the results and be able to respond to any new problems as they arise. Patients and their carers will then complete a questionnaire at one month to assess satisfaction with the use of remote monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of advanced cancer or another life-limiting condition
* Estimated prognosis greater than 3 months
* Referred for community-based specialist palliative care
* Living in own home (or home of family carer)
* Living with a family carer

Exclusion Criteria:

* Estimated prognosis less than 3 months or more than 12 months
* Cognitive impairment - unable to provide consent / complete assessments
* Non-English speaker
* Living in care home / nursing home / hospice / community hospital
* Not living with a family carer
MR-Evaluation of Renal Function In Septic Patients

A study of renal blood flow and renal oxygenation measured by magnetic resonance after a standardized fluid challenge in critically ill, resuscitated, patients with sepsis due to COVID-19 or other agents.

Critically ill, septic patients with or without acute kidney injury (AKI) above 18 years of age who have been circulatory and respiratory stabilized will be screened for inclusion.

After the patients have been adequately treated with antimicrobial agents, source control and circulatory and respiratory stabilized, the patient will be moved to the Magnetic resonance imaging (MRI)-suite and placed in the MRI-camera. We plan to, at the same time, study renal blood flow (RBF) and oxygenation with 4 different MRI techniques; arterial spin labeling (ASL), Blood oxygen level dependent (BOLD)-technique, T(2) -Relaxation-Under-Spin-Tagging (TRUST) and Phase contrast at two conditions;

1. at baseline after stabilization
2. after intravenous infusion of 7,5 ml/kg mL Ringer's acetate

The following data will be registered:

1. Age, gender, length and weight,
2. concomitant diseases and treatment,
3. present disease and treatment,
4. source of admission - emergency department or ordinary ward,
5. daily laboratory reports,
6. results from other investigations, e.g. x-rays, cultures etc.,
7. recordings from the intensive care unit (ICU) monitors
8. Continuous renal replacement therapy (CRRT) - duration type, flow rate, replacement fluid, etc.
9. dead or alive at discharge and 90 days mortality,
10. renal function at discharge,
11. treatment restrictions,
12. if the patient has died, the results from a possible postmortem examination. As well as all data obtained during the MRI-examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis sepsis (infection and organ dysfuncion) treated in intensive care.
* Manifest Acute kidney injury (AKI) or risk of AKI.
* 18 years of age or older

Exclusion Criteria:

* Pregnancy
* Chronic kidney failure
* Renal Replacement Therapy
* Instability in vital parameters to a degree where MRI is not feasible
* Contraindications for MRI (implants, coils, pacemakers, etc)
French National Registry of Children Born Small for Gestational Age Treated With Somatropin

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)


Eligibility Criteria:
Inclusion Criteria:

* Born small for gestational age
Cognitive Impairment in Patients With Heart Failure

The aim of the present study is threefold: investigating 1) specific cognitive impairments in patients with congestive heart failure, 2) whether cognitive impairments in patients with decompensated heart failure improve after medical recompensation and 3) whether cognitive functioning is related to the long-term prognosis (mortality, rehospitalisation) of those patients.

The daily routine in clinical settings often shows cognitive impairments in patients with congestive heart failure. Recent studies reported declines in cognitive functioning such as executive functions, episodic memory, perceptual speed and attention. However, less is known regarding the differential impairments of cognitive functioning in patients with decompensated heart failure.

Study objectives:

1. Identifying specific cognitive impairments in patients with congestive heart failure compared to healthy controls
2. Evaluating the influence of acute decompensation in congestive heart failure on cognitive functioning
3. Investigating the effects of medical treatment on cognitive functioning in patients with decompensated heart failure
4. Exploring long-term effects of cognitive and physiological status on hospitalisation and/or mortality

Study design:

Cognitive functions of patients with decompensated heart (NYHA III-IV) failure are compared to age and gender matched patients with congestive heart failure (NYHA III-IV) without symptoms of cardiac decompensation and with healthy controls. Decompensated patients are tested before and after medical recompensation. For matched patients and controls, the pretest-posttest timing is based on the recompensation time of the respective patient with decompensated heart failure.

The neuropsychological test battery includes measures of episodic memory, working memory, short-term memory, executive functions, perceptual speed and intelligence. In addition, the study applied standardized questionnaires of self assessed quality of life and depression. Relevant physiological data, such as left ventricular systolic function and N-terminal pro brain natriuretic peptide (NT-pro-BNP), are recorded.

Eligibility Criteria:
Criteria of decompensated heart failure patients

Inclusion Criteria:

* decompensated heart failure patients
* NYHA III-IV
* ejection fraction \< 35%

Exclusion Criteria:

* psychosis
* dementia
* major depression
* reanimation (\<3month)
* patients with assist device system
Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care

Trimodal prehabilitation is a preoperative three-tiered (trimodal) approach to optimizing physical and mental health. It has been found to successfully improve functional recovery in patients undergoing colorectal surgery following an evidence-based enhanced-recovery pathway (ERP). It is unknown whether the same program is effective in patients undergoing a similar surgery for bladder cancer (radical cystectomy).

Objective: To evaluate the appropriateness of a standardized prehabilitation program for implementation into an enhanced recovery pathway for cystectomy patients and determine whether prehabilitation facilitates earlier recovery of functional capacity.

Hypothesis: Prehabilitation will ultimately improve recovery of functional capacity, clinical and patient-centered outcomes in patients undergoing radical cystectomy for bladder cancer.

Design: Participants will follow an 8-week trimodal prehabilitation program consisting of exercise therapy combined with nutritional counseling, protein supplementation, and psychological care; they will be compared to a cohort of participants following ERP care alone.

Conclusion: The proposal will provide insight into the feasibility and effectiveness of trimodal prehabilitation for radical cystectomy patients and may ultimately lead to improved clinical outcomes and reduced morbidity.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age at time of consent for surgery.
2. Documentation of bladder cancer diagnosis as evidenced by diagnostic imaging and biopsy.
3. May or may not receive adjuvant therapy.
4. Written informed consent obtained from subject

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or adherence to the program. This includes:

   1. American Society of Anesthesiologists (ASA) health class status 4-5;
   2. Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
   3. Severe cardiac abnormalities, end-stage organ disease, sepsis, or morbid obesity (BMI greater than 35);
2. Undergoing radical cystectomy for a reason other than bladder cancer.
3. Poor comprehension of English or French
4. Screened by Total Cardiology staff and determined to be inappropriate for prehabilitation at their facility.
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18 years of age.
* Other protocol-defined exclusion criteria may apply.
Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery

The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing coronary artery bypass surgery +/- valvular surgery

Exclusion Criteria:

* pre-existing cognitive impairment or neurodegenerative condition
* any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care

Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.

The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.

Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, necessitating lifelong anticoagulation. Hazards of anticoagulation include bleeding when it is excessive or thromboembolism when the intensity of anticoagulation is below the recommended level. Monitoring the level of anticoagulation is accomplished by analyzing the International Normalized Ratio. Until recently, this was performed at medical laboratories or hospitals, but recent literature suggests that patient self-testing of oral anticoagulation improves patient compliance, medical outcomes, and quality of life.

The objective of this study is to evaluate the time in therapeutic range of patients who self-test their INR compared to patients receiving the usual care. Additionally, we will evaluate the educational components and corollaries of self-testing.

Two hundred consecutively enrolled adults, having undergone implantation of a mechanical heart valve, will be randomized to either self-testing or usual care. Those randomized to the self-testing group will undergo self-testing instruction prior to hospital dismissal. For three months after hospital discharge, subject will record their INR results obtained by self-testing or as prescribed by their primary physician. They will then submit the record of the INR results and complete a survey.

Eligibility Criteria:
Inclusion Criteria:

* Patients that received a mechanical valve while in our hospital
* Age \> 18 years

Exclusion Criteria:

* Pregnant or lactating women
* Patients that have genetic clotting disorders such as Factor 5
* Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
Effects of "Alliance180 Program" on Well-Being

The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers.

The study aims are:

* Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers;
* Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention.

Participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.

All data collection will occur remotely using REDCap (via University of North Carolina, Chapel Hill). As this is a single-arm, feasibility/pilot study, all participants will follow the same protocol.

1. Baseline Research Session: self-report completion of demographic information, perception of safety (Neuroception of Psychological Safety, NPSS) and trauma experience (Posttraumatic Stress Disorder Checklist DSM-5, PCL-5), autonomic reactivity (Body Perception Questionnaire, BPQ), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), and perception of events and goals related to purpose in life (Purpose in Life Scale).
2. Participate in the 3-day Alliance180 Program (intervention), which includes the Transformative Equine Experience.
3. Post-intervention Research Sessions: 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program, self-report completion of perception of safety and trauma experience (NPSS, PCL-5), autonomic reactivity (BPQ), anxiety/depression (HADS) and purpose of events and goals related to purpose in life (Purpose in Life Scale).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Enrollment in an upcoming "Alliance180 Program". (Enrollment is limited to adults who currently or formerly serve as US Veterans, First Responders and/or Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)

Exclusion Criteria:

- Individuals who have previously completed the "Alliance180 Program"