cyrilzakka/clinical-trials huggingface dataset:
Postoperative Analgesic Efficacy of PENG and QLB Blocks in Hip Surgeries

This prospective, randomized, single-blinded study compares the postoperative analgesic efficacy of the Pericapsular Nerve Group (PENG) block and Quadratus Lumborum Block (QLB) in hip surgeries under spinal anesthesia. Conducted from July 1 to November 15, 2024, the study focuses on time to first rescue analgesia and total analgesic consumption within the first 48 hours postoperatively in patients over 40 years undergoing elective hip surgery. Fifty patients will be randomized into two groups (PENG or QLB) using a sealed envelope method. The study will assess pain scores, opioid consumption, and side effects, hypothesizing that both blocks provide effective analgesia but seek to identify which offers superior efficacy. Statistical analysis will be performed with SPSS, aiming to contribute valuable insights into analgesic techniques for hip surgeries.

This is a prospective, randomized single-blinded study comparing the postoperative analgesic efficacy of Pericapsular Nerve Group (PENG) block and Quadratus Lumborum Block (QLB) in hip surgeries performed under spinal anesthesia. The study, planned from July 1 to November 15, 2024, aims to evaluate key outcomes such as the time to first rescue analgesia and total analgesic consumption within the first 48 hours postoperatively. The primary population includes patients over 40 years undergoing elective hip surgery with specific inclusion and exclusion criteria. Fifty patients will be divided into two groups, receiving either QLB or PENG block, using a sealed envelope randomization method.

PENG block targets specific nerves to provide analgesia without motor block, preserving motor function. QLB involves injecting a local anesthetic into the fascia near the quadratus lumborum muscle to block thoracoabdominal nerves and provide broad analgesia. Data on pain scores (NRS), opioid consumption, and side effects will be collected at different time points.

The study hypothesizes that both blocks can provide effective postoperative analgesia, with potential benefits such as reduced opioid consumption and early mobilization, but aims to determine which block is superior in efficacy.

Statistical analysis will be conducted using SPSS, and findings will contribute to the literature on analgesia techniques for hip surgeries.

Eligibility Criteria:
Inclusion Criteria:

* "Patients aged over 40 years who are scheduled to undergo hip surgery under spinal anesthesia and classified as ASA 1-3 will be included in the study."

Exclusion Criteria:

* Patients who refuse the procedure.
* Patients who will receive general anesthesia or peripheral nerve blocks such as a combination of femoral and sciatic nerve blocks.
* A history of allergy to local anesthetic agents.
* Patients with dementia.
* Patients with multiple trauma.
* Patients with severe hearing or vision impairments.
* Patients with a local infection at the site of the block application.
* Patients with a Body Mass Index (BMI) \> 30.
* Patients with a history of severe neurological, cardiovascular, renal, or hepatic disease will be excluded from the study.
Hemodynamic Assessment of Distal Revascularization Interval Ligation

Our study seeks to define the effect of each component of the distal revascularization interval ligation (DRIL) procedure on the in vivo distal blood pressure of patients with ischemic steal, and to determine whether the interval ligation component of the DRIL procedure is necessary or not.

This study will involve identification of patients with ischemic steal who are deemed candidates for distal revascularization with interval ligation (DRIL), followed by prospective data collection of intraoperative noninvasive data at key points in the operation.

After informed consent, chart review will be performed to identify patient characteristics as well as details of their presentation of steal syndrome, including symptomatology, duration, characteristics of contributory arteriovenous access, and preoperative data including upper extremity/forearm pressures, fistula flow data, and finger pressures with and without fistula compression.

Patients will have noninvasive intraoperative measurement of bilateral forearm blood pressure measurements using automated blood pressure cuffs within sterile bands on the operative side as well as the contralateral ("control") side. Automated blood pressure measurements will then be performed at four time points in the operation, simultaneously on both arms (operative versus control):

1. After surgical exposure but before any intervention has been performed,
2. After clamping of the brachial artery after dissection and control of the vessel to assess for the effect of interval ligation (IL) alone on the forearm blood pressure.
3. After performance of the distal revascularization (DR) but BEFORE interval ligation of the brachial artery.
4. After completion of the procedure, including both distal revascularization AND interval ligation (DRIL).

The performance of blood pressure measurements will not alter the performance of the operation, nor will this have any influence on intraoperative decision-making. Intraoperative patient positioning and set-up will be unaffected by the addition of a distal forearm blood pressure cuff for data acquisition. Neither the pre-operative selection or post-operative care will be influenced by participation in this study, nor by the data acquired. It should be noted that this technique is intermittently used as standard of care when needed in current practice.

Patients will be assessed for symptom improvement and DRIL patency at their standard 14 day, 3 month, 6 month, 9 month and 1 year follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* \>18 yo patients with CKD with a functioning antecubital-based arteriovenous fistula and evidence of ischemic steal as defined above

Exclusion Criteria:

* Patients identified as undergoing "prophylactic" or "preemptive" DRIL procedure at the time of fistula/graft creation (ie, do not have documented steal at present)
* Patients unable to provide informed consent, life expectance of less than one year
* Inability to reliably or accurately measure contralateral blood pressures due to heavily calcified vessels documented preoperatively
Influence of of a Lipid Emulsion on Inflammatory Response and Hepatic Function

Lipid emulsions are an essential part of parenteral nutrition, both as a part of energy supply, and as a source of essential fatty acids. It has been shown that the fatty acid composition of cell membranes is influenced by the fatty acid profile of dietary lipids, and may therefore be responsible for modulation of immune response. The aim of this study was to assess the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil compared with a lipid emulsion based on olive and soybean oil on the inflammatory response and hepatic function in postoperative intensive care unit (ICU) patients.

Fatty emulsions are an indispensable part of parenteral nutrition, because they deliver energy and essential fatty acids. Furthermore, lipids are involved in the structure and function of cell membranes and receptors, modifying gene expression, and modulating the inflammatory and immune response. In addition, fatty acids are precursors of prostaglandins and other eicosanoids and have therefore important metabolic functions.A promising substrate in the development of lipid emulsions can be seen in fish oils containing solutions. With regard to the current literature, fish oil have a potential benefical influence on the pathophysiological response to endotoxins and exert important modulations on eicosanoid and cytokine biology.

However, there are no studies avaibale comparing fish oil containing fatty emulsions to a lipid emulsion based on olive and soybean oil with regard to inflammatory response and hepatic function.

Therefore, the aim of this study was to evaluate the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil compared to a lipid emulsion based on olive and soybean oil on the inflammatory response and hepatic function in postoperative intensive care unit (ICU) patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Elective operative procedure, and indication for parenteral nutrition over 5 postoperative days
* ASA I-III
* Haemoglobin \> 10 g/dl
* Ability and acceptance to agree to the study participation
* Written informed consent

Exclusion Criteria:

* Liver insufficiency (ASAT, ALAT \> 40 U/l)
* Renal insufficiency (creatinine \> 1.4 mg/dl)
* Pancreas insufficiency
* Emergencies
* Women in child bearing age and missing negative pregnancy test, pregnancy or lactation
* Diseases from the central nervous system (such as M. Parkinson and multiple sclerosis)
* Alcohol and drug abuse (including opioid abuse)
* Acute pulmonary oedema
* Decompensated cardiac insufficiency
* Insulin-dependent diabetes mellitus
* Overweight (body mass index \> 30 kg/m2
* Cachexia (body mass index \< 18 kg/m2)
* Psychiatric disorders
* Hypersensitivity to egg, coconut or soy proteins
* Patients taking chronic corticoids
* Allergy to any of the study agents
* Refusal from the patient to participate in the study
* Participation in another study project
The HUNT for Heart Failure" Risk Score

In this population study aim is to evaluate risk factors for heart failure and combine these into a new heart failure risk score.

Secondly, the heart failure risk score will be internally and externally validated, and compared with established heart failure risk scores. Additionally, the prevalence of heart failure as well as the distribution of the heart failure risk score in the general population will be evaluated.

Explore which clinical risk factors or patient characteristics in a general population that are associated with increased risk for heart failure events and combine these into a new population-based heart failure risk score ("The HUNT for heart failure risk score") for predicting heart failure risk

Validate the newly developed heart failure risk score internally in the HUNT2 database

Compare the predictive ability of the new heart failure risk score with established heart failure risk scores (the ABC Health HF risk score, the Framingham HF risk score) and an established Norwegian cardiovascular risk score (NORRISK 2)

Estimate the prevalence of likely ("undiagnosed") heart failure , i.e., patients at high risk of HF, in a general population by using both the established heart failure risk scores and the newly developed heart failure risk score, and compare the heart failure event rate between those at high risk of heart failure and those with established heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the third or second wave of the HUNT study

Exclusion Criteria:

* Not willing to participate
* Missing vital data
Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers

Millions of Americans have late-stage Alzheimer's and related dementias (ADRD), causing suffering due to loss of awareness of self and family, progressive dependency, physical and neuropsychiatric symptoms, and physical, emotional and financial strain for caregivers. Investigators now propose a multi-site randomized clinical trial of the ADRD Palliative Care (ADRD-PC) program for persons with late-stage ADRD and their family caregivers, triggered during hospitalization. Investigators aim to learn if this program of dementia-specific palliative care, standardized caregiver education, and transitional care is effective to reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and to improve caregiver outcomes of communication, shared decision-making and distress.

Investigators have designed the ADRD Palliative Care (ADRD-PC) program of dementia-specific palliative and transitional care, and shown its feasibility and potential efficacy. Delivered by interdisciplinary hospital palliative care teams, ADRD-PC addresses 1) prognostic awareness, 2) symptom management, 3) shared decision-making, and 4) transition to community support services.

The research objective is to conduct a multi-site efficacy randomized clinical trial (RCT) of the ADRD-PC program. Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD (Global Deterioration Scale (GDS) 6-7 or GDS 5 with significant co-morbidity) with their family caregivers, and an additional 50 dyads that identify as Hispanic/Latino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), Indiana University, and Emory University. The primary hypothesis is that ADRD-PC will reduce hospital transfers (Aim 1). Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment, symptom control, use of community palliative care or hospice, and nursing home transitions (Aim 2); and caregiver outcomes of communication, decision-making and distress (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

People with ADRD Inclusion Criteria:

* aged 55 or older
* hospitalized
* have a physician-confirmed diagnosis of ADRD
* staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher

Caregiver Inclusion Criteria:

* the adult (aged 18 or older) legally authorized representative (LAR) for healthcare and have capacity to serve in this role
* support the person with ADRD
* can complete interviews in English or Spanish.

Exclusion Criteria:

Dyads will be excluded if

* the LAR is not a family caregiver
* the patient currently receives palliative care or hospice
* patient or caregiver would be unduly stressed
* dyad is not successfully randomized.
Cardiac Resynchronization Therapy in Pulmonary Hypertension

This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.

This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
* LVEF ≥ 50%
* Baseline 6MWT distant \<400 meters
* Baseline NYHA Functional class ≥ III

Exclusion Criteria:

* LVEF \< 50%
* 6MWT duration \> 400 meters
* NYHA Functional class \< III
* Left bundle branch block
* Non-sinus rhythm
* Severe aortic stenosis (Aortic valve area \< 1 cm2)
* Severe mitral regurgitation
* Acute cardiac failure
* Dependency on intravenous inotropies
* Severe obstructive pulmonary disease
* Hypertrophic obstructive cardiomyopathy
* Amyloidosis
* Dependence on pacing
Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments

This study aims to assess the effectiveness of chat-based intervention on reducing risky alcohol consumption to inform clinical practice for providing ABI to risky drinkers attending AED in Hong Kong.

Alcohol use is a major risk factor for non-communicable diseases and 6th leading cause of death and disability-adjusted life years. The prevalence of alcohol consumption has increased since 2008 after introduction of zero tax on alcohol with strength \<30% (e.g., wine and beer) and due to promoting the city as Asia's wine hub. ABI reduced alcohol intake by about 20g/week at 12-month follow-up in primary healthcare populations. Given the relatively low prevalence of risky alcohol drinkers in Hong Kong, testing ABI in clinics may face difficulties in recruitment. Alcohol use is associated with problems such as injury and violence requiring accident and emergency department (AED) services, thus AEDs in Hong Kong are more feasible places to recruit subjects for delivering ABI.

Primary hypothesis: The Intervention group has significantly larger reduction of weekly alcohol consumption compared with the Control group at 12-month follow-up

Secondary hypotheses: Compared with the Control group, the Intervention group has lower AUDIT scores, fewer episodes of heavy/binge drinking, lower re-attendence at AED and reduced alcohol-related harms at 6-month and 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* HK resident able to read/communicate in Cantonese/Putonghua. This may exclude potential subjects from other countries with higher alcohol consumption than local Chinese, but quality of the chat-based intervention is important for the research hypothesis, and it will not be feasible to recruit other language speakers (e.g., English) in the present study.
* Aged ≥18 with proficiency in using IM Apps (e.g., WhatsApp, WeChat). Those aged \<18 are excluded as other studies suggest they have different patterns of alcohol drinking and reduction from adult drinkers.

Exclusion Criteria:

* Those unable to understand or receive face-to-face ABI due to severe traumatic injury, unconscious, or drunk patients unable to follow commands
* Anticipated to be admitted to in-patient department for \>1 week, which will interfere with the chat-based intervention
* Having psychiatric/psychological diseases or receiving regular psychotropic medication
* Participating in other alcohol reduction or abstinence programmes
Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions

The purpose of this study is to test the efficacy of delivering an exercise and healthy lifestyle program, Smart Aging, to older adults.

The Smart Aging Program is designed to be scalable, implementable, and sustainable in the real world. This program joins patients and their clinicians with community-based fitness centers. The Smart Aging Program looks to use already existing resources to deliver an innovative program to increase physical activity in older adults.

The program begins at the patient-physician level. The program is conducted in community-based fitness centers, the participant's home (home exercise, monitoring) and also sends physical activity data back to the clinician using mobile technology.

The Smart Aging Program consists of a personalized and structured exercise program combined with lifestyle education and mobile-health monitoring. The exercise program includes a 12-week initiation phase, followed by a 40-week maintenance phase.

Eligibility Criteria:
Inclusion Criteria:

* Clinician referred
* Ambulatory: walk unassisted and successfully complete the 6 minute walk test without rest
* Sufficiently fluent in English to participate in study procedures
* Sedentary or underactive by the Telephone Assessment of Physical Activity61

Exclusion Criteria:

* Clinically-significant systemic or psychiatric illness that may affect safety or completion
* Diagnosis of dementia; use of dementia medications (cholinesterase inhibitors, memantine)
* Myocardial infarction or unstable coronary artery disease (e.g., angina, arrhythmia) in last 6 months.
* Cerebrovascular event (stroke or transient ischemic attack) in the last 6 months
* Cancer diagnosis in the last 2 years (except non-metastatic basal or squamous cell carcinoma or cancer in remission in the absence of treatment for at least 2 years)
* Significant pain or musculoskeletal disorder limiting the ability to participate safely
* Another member of the household enrolled in the study
Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.

Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The Second Hospital of Shandong University. Eight of these 214 patients were converted to thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to a history of left upper lobectomy, and the other seven patients were due to bleeding controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014 to August 2016, and these patients were defined as the open group. The data from the patients in the open group were compared with those of the patients who underwent thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography to evaluate the clinical TNM stage. The operations were performed by a single surgical team. This study was approved by the ethics committee and Medical Administration Division of the Second Hospital of Shandong University. Written informed consent was obtained from each of the enrolled patients. All methods performed in the investigator's study were conducted in accordance with the relevant guidelines and regulations.

Eligibility Criteria:
Inclusion Criteria:

oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery

Exclusion Criteria:

poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection
Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma

The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2 i.v.) and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. Safety and efficacy will be evaluated. Treatment will be administered in 4-week cycles until patients discontinue due to disease progression or unacceptable toxicity or for other reasons.

Patients who discontinue the study treatment for reasons other than documented disease progression will be followed for disease assessments every 8 weeks until progression. All patients will be followed for survival until 3 years have passed from their entry into the study, or they have discontinued the follow up earlier.


Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of MM based on IMWG definitions (Rajkumar, 2014)
* Prior treatment with 1 to 3 prior lines of therapy
* Relapsed or relapsed and refractory MM
* Measureable disease at screening based on central laboratory assessment
* ECOG Performance status ≤ 2
* Acceptable lab values prior to starting study treatment

Exclusion Criteria:

* Primary refractory myeloma
* Prior treatment with DAC inhibitors including panobinostat
* Prior treatment with carfilzomib
* Allogeneic stem cell transplant recipient with graft versus host disease (either active or requiring immunosuppression)
* Any concomitant anti-cancer therapy besides the study treatment (bisphosphonates are permitted only if commenced prior to the start of screening period)
* Intolerance to dexamethasone or contraindication to carfilzomib or dexamethasone
* Unresolved diarrhea ≥ CTCAE grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)

Other protocol-defined inclusion/exclusion criteria may apply.