cyrilzakka/clinical-trials huggingface dataset:
Home-based Psychoeducation for Older Adults With Frailty: A Feasibility Trial

This study aims to test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are

1. Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate?
2. Is home-based psychoeducation feasible and acceptable for older adults with frailty in the community?

Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different:

* Intervention group: psychoeducation
* Control group: physical health education

Participants will receive two home visits for data collection. An individual interview will be conducted with participants in the experimental group to explore their experiences.


Eligibility Criteria:
Inclusion Criteria:

(1) aged 65 years or over; (2) meeting frailty criteria by FRAIL scale (score 3 or above) ; (3) mentally competent screened by The Abbreviated Mental Test (AMT≥6) ; (4) able to speak and understand Cantonese; (5) living at home; (6) having experience using a smartphone (e.g.: sending messages, watching videos)

Exclusion Criteria:

(1) have a visual or hearing problem or a language barrier that may affect their communication or understanding; (2) being unfit for home-based exercise, as defined by having one point or above at either the 25-item Home Falls and Accidents self-reported screening tool (HOME-FAST), which is a comprehensive tool for identify home hazards for fall (3) are currently practising exercise for at least 150 minutes per week in previous four weeks; (4) are receiving active psychiatric or antidepressant treatment or joining other physical exercises or rehabilitation programmes
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).


Eligibility Criteria:
Inclusion Criteria:

* Completed participation in Study APL2-C3G-310 through the week 52 visit requirements
* Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator
* Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310
* Received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines
* Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
* Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
* Participants above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study
* Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration

Exclusion Criteria:

* Female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug
* Inability or unwillingness to cooperate with the requirements of the protocol
* Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results
* Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction

Background Correction of post traumatic and post-ablative orbita defects remains a challenge for the maxillofacial surgeon. The purpose of such intervention is the restoration of both function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention to the orbitavolume. Unfortunately, the results of such interventions today are still somewhat unpredictable.

The aim of this study is to determine whether 3D virtual planning combined with intra-operative navigation can increase the predictability of the outcome in function and aesthetics.

Study design Retrospective study. Demographic data, diagnostic and surgical parameters will be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in Brainlab software, and compared to the non-defected orbit.


Eligibility Criteria:
inclusion criteria

* patients of all genders
* patients of all ages
* patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016
Effects of Age on Amino Acid Delivery to Tendon

Dietary amino acid supplementation may provide an effective means to promote tendon injury recovery and enhance collagen synthesis. While most published research has been completed in animal models, research with young adults has shown that a leucine-rich whey isolate consumed during a chronic resistance training (RT) intervention resulted in greater gains (\~60%) in tendon CSA when compared to placebo. Leucine-rich diets have also improved tendon collagen content in rodents. Further, in our preliminary work utilizing microdialysis, we demonstrate that oral consumption of a leucine-rich amino acid beverage increased delivery of amino acids to tendons in young adults (21-30 years). However, whether aging alters the delivery of amino acids to tendons after oral consumption has not be investigated. In order to optimize amino acid dosing for chronic interventional studies, we wish to determine if aging influences amino acid concentration in the peritendinous (space around the tendon) space after oral consumption.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* body mass index \>35 kg•m-2, those on medications known to affect protein or collagen metabolism, e.g. acetaminophen, ibuprofen, or prescription cyclooxygenase inhibitors, previous history of tendinopathy, or diabetes.
Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of upper GI-bleeding
* Endoscopic verified high-risk ulcer (Forrest I-IIb)
* Primary haemostasis achieved

Exclusion Criteria:

* Expected lifetime \< 1 month
* Upper GI-cancer found at endoscopy
Cardio Protective Effect of SGL2I in Hemodialysis Patients and Its Impact on Patient Quality of Life

If this study has a cardio protective effect it will affect the mortality and morbidity of advanced CKD patients and improve their quality of life

Cardiovascular disease is the leading cause of mortality, accounting for \>50% of deaths with known causes, while cardiovascular mortality is 9-fold higher in these patients compared with age- and sex-matched individuals in the general population Particularly, heart failure poses a significant challenge in the management of ESKD. It frequently develops after initiation of dialysis and is a prominent mortality risk factor among these patients When CKD patients develop HF, increased sodium and fluid retention, and vascular tension will lead to increased preload of the heart. The increased ventricular wall pressure will lead to release biomarkers like natriuretic peptides (NP). Therefore, biomarkers of myocardial stretch are commonly used in the diagnosis and prognosis evaluation of HF. It is worth noting that the negative predictive value of NP is extremely high (0.94-0.98), while the positive predictive value is slightly lower, (0.44-0.57) for chronic heart failure (CHF) and (0.66-0.67) for acute heart failure (AHF), Commonly used myocardial stretch marker include NT-pro BNP .

NT-pro BNP has the advantage that Accuracy of negative diagnosis is extremely high; The prognostic value is the most powerful, especially in CKD stages 4-5 and dialysis patients Traditional therapies to prevent CVD complications in the general population have shown to be ineffective in Chronic kidney disease (CKD). To address the unmet need, further research is needed to evaluate novel therapeutic strategies to improve cardiovascular outcomes among patients on dialysis .

Over the last several years, Sodium-glucose transporter type 2 (SGLT2) inhibitors have been shown to confer substantial kidney and cardiovascular benefits among patients with type 2 diabetes, heart failure, and/or high-risk CKD .

Secondary analyses from these landmark trials demonstrated consistent benefits of SGLT2 inhibitors across many subgroups, supporting the widespread use and incorporation in clinical practice guidelines of this new kidney and cardio protective drug class.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stage5 (i.e., eGFR \< 15 mL/min/1.73m2) (Inker et al., 2021)

Exclusion Criteria:

* patients who refuse to sign consent
* Patients with acute heart failure , will exclude patients with known prior ischemic heart diseases or ischemic cardiomyopathy
* Autosomal dominant polycystic kidney disease (ADPKD).
* Type 1 diabetes mellitus
* History of ketoacidosis in the last year.
* Known hypersensitivity to SGLT2 inhibitors.
* Known severe hepatic impairment (Child-Pugh class C)
* Pregnant or breastfeeding females
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in other clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.

Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.

Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed:

* quality of life,
* performance status,
* pain rating,
* analgesic administration and
* adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Age \>= 18 years old.
* Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
* Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.
* A maximum of two chemotherapy lines for metastatic disease.
* A maximum of two hormone therapy lines for metastatic disease.
* Normal, minimally altered renal function (serum creatinine \< 1.5 x Upper Normal Limit (UNL)).
* Normal serum calcium levels.
* Performance status 0,1 (World Health Organization (WHO)).
* Negative pregnancy test before study recruitment.

Exclusion Criteria:

* Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.
* Metastasis in CNS.
* History of hypersensitivity to bisphosphonates.
* Pregnant or lactating women.
* Third chemotherapy line for metastatic disease.
* Third hormone therapy line for metastatic disease.
* Males.
Diaphragm Plication in Adults With Phrenic Nerve Paralysis

The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year
* With reduced VC, at least in supine position and no significant change in VC for at least 6 months
* At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea

Exclusion Criteria:

* No informed consent obtained
* Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....
* Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease
* Known diseases resulting in abnormal blood coagulation
* Proven oncological origine of the phrenic nerve paralysis
* Age below 18 yrs old
Firmonertinib Combined With Chemotherapy as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC

This is a phase II study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage II-IIIB resectable NSCLC patients.

In this open-label, single-arm, phase 2 study, 31 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive firmonertinib for 12 weeks combined with carboplatin/cisplatin and pemetrexed for 4 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Provide informed consent prior to any study specific procedures
2. at least 18 years of age
3. Histology or cytology diagnose of non-small cell lung cancer within 60 days
4. ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
5. Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging),
6. According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
7. EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
8. Without prior anti-tumor treatment
9. Withe adequate organ function of hematology, liver and kidney
10. Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age

Exclusion Criteria:

1. Dual or multiple primary NSCLC
2. Any prior anti-tumor treatment
3. With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
4. Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
5. With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
6. Laboratory tests indicate insufficient bone marrow reserve or organ reserve
7. Women with pregnancy or breastfeeding
8. Patients with known or suspected drug allergies, or other contraindications
9. Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
10. Patients who are currently or previously enrolled in any other anti-tumor clinical study.
Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults

(From NIH reporter) Each year \>16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

Each year \>16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and above
* Having surgery scheduled to last \> or = to 2 hours at Duke University Medical Center (ie Duke Hospital, Duke Medicine Pavilion, Duke Regional Hospital, Durham VA, Duke Raleigh Hospital)

Exclusion Criteria:

* Anticoagulants (per ASRA guidelines)
* Current use of chemotherapeutic agents with known cognitive effects.
Lifestyle Modification in the Treatment of NAFLD.

The project will study the impact of individually tailored lifestyle counselling compared to standard care on the parameters of NAFLD/NASH in patients with metabolic syndrome. The factors affecting the outcome (including clinical and laboratory parameters and microbiome profiling) will be evaluated.

Non-alcoholic fatty liver disease (NAFLD), the hepatic manifestation of a metabolic syndrome, is a leading cause of chronic liver disease worldwide. NAFLD is associated with type 2 diabetes, obesity and genetic factors. Despite intensive effort and numerous trials, as of today there is no approved treatment for NAFLD. Weight reduction is recommended, but no long-term control study assessing the evolution of NAFLD/NASH (non-alcoholic steatohepatitis) during lifestyle modification is available.

The main objective of presented project is to compare the progression of NAFLD/NASH in patients with metabolic syndrome randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up. The investigators hypothesize that professionally tailored life-style counselling in patient with metabolic syndrome and NAFLD will improve liver fat content and other non-invasive parameters of liver disease, and factors (including gut microbiota) affecting progression/regression of NAFLD will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with NAFLD and metabolic syndrome

Exclusion Criteria:

* Etiology of liver disease other than NAFLD.
* Presence of malignant disease.
* Uncontrolled cardiovascular disease
* Pregnancy.
Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Signed informed consent
* All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature \< 36.0º C), tachycardia (heart rate \> 100 beats/minute), hypotension (systolic blood pressure \< 90 mm Hg) or other clinical features of sepsis.
* All cases of right-sided native valve endocarditis due to MRSA
* Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study
* Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses