cyrilzakka/clinical-trials huggingface dataset:
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow

The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow.

The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).

The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation. The clinical purpose is to restore the function and flexibility of the elbow requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.

Two sites will be involved in this study. The aim is to include a total of 83 consecutive series cases operated with the ToggleLoc 2.9 mm in the elbow. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop and intraop will be available in medical notes. The patients will be asked to complete patient questionnaires during a minimum 1 year follow up visit/phone call. In addition, any complications and adverse events that occured since the surgery will also be collected during the follow-up visit/phone call.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received the ToggleLoc 2.9 mm Soft Tissue device for soft tissue to bone fixation in the elbow.
* Patients 18 years or older and skeletally mature.
* Patients capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.

Exclusion Criteria:

* Infection.
* Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue.
* Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
* Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
* Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
* Off-label use.
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer

This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast cancer (TNBC). The study is composed of dose escalation and expansion parts. Every subject will subject tumor tissue used for biomarker evaluation. Each subject will receive KN046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Age of 18 or above;
* Histology confirmed locally advanced unresectable or metastatic triple-negative breaset cancer;
* (KN046 monotherapy) failed at least one prior anthracycline and taxane containing systemic treatment, (KN046 plus nab-paclitaxel) systemic treatment naive;
* Measurable disease at baseline;
* ECOG 0-1;
* Adequate organ functions.

Exclusion Criteria:

* Untreated active CNS metastasis or leptomeningeal metastasis;
* Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment;
* Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; History of uncontrolled intercurrent illness; Known severe hypersensitivity reactions to antibody drug.
Extension Study of Participants From SPG302-ALZ-101

This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALZ-101 with mild to moderate Alzheimer's Disease (AD)

This is an open-label extension study of SPG302-ALZ-101 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with mild-to-moderate AD. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate AD
* Clinical laboratory values within normal range or \< 1.5 times ULN
* Life expectancy of \>2 years
* Able and willing to provide written informed consent
* Must have participated in all study activities of SPG302-ALZ-101, the parent study

Exclusion Criteria:

Any physical or psychological condition that prohibits study completion

* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection that will not be resolved by first day of study intervention.
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* History of chronic alcohol use or substance abuse in the last 5 years
* HIV, hepatitis B and/or hepatitis C positive
* Vaccines within 14 days
* Receipt of investigational products within 30 days
* Blood donation within 30 days
* Pregnant or breastfeeding
MIRODERM™ for Complex Wounds in an Inpatient Setting (MIRODERM CLOSure)

This study is being conducted to collect data on the performance of Miromatrix Wound Matrix (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Have a complex study wound which will require an autograft or delayed primary closure procedure and which may or may not include tunneling and/or undermining
* Have a study wound with a total post-debridement surface area ≥50cm2 and ≤250cm2 with no dimension \>25cm, and a minimum depth of ≥0.5cm
* Have a study wound which is expected to take at least 4 weeks to reach autograft or delayed primary closure using standard care and NPWT
* Have a study wound that will be treated with NPWT regardless of study participation
* Be in an inpatient setting
* Be able and willing to sign the consent form and comply with all study visits and procedures

Exclusion Criteria:

* Be pregnant or be planning to become pregnant during the study
* Be contraindicated for NPWT (necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, exposed organs)
* Be immunocompromised or at risk of immunosuppression (e.g. be HIV positive, be experiencing organ rejection, be a recent, current, or anticipated chemotherapy recipient) as determined by the Investigator
* Be taking a Tumor Necrosis Factor (TNF) blocker
* Be participating in another research study
* Have a sensitivity to porcine material
* Have a life expectancy of less than 1 year
* Have a study wound which is a third degree burn wound
* Have a study wound that is infected
* Have a study wound that is a pressure ulcer/wound
* Have a study wound with sinus tract(s) leading to other open area(s)
* Have a wound that is being treated or expected to be treated with either HBOT or topical wound oxygen therapy
* Have a study wound which has been treated with a cellular and/or tissue-based product within last 30 days
BENEFIT Extension Study

To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.


Eligibility Criteria:
Inclusion Criteria:

* All patients randomized and treated at least once in study 304747

Exclusion Criteria:

* Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.


Eligibility Criteria:
Inclusion Criteria:

* Serum sodium levels 115 to \< 130mEq/L
* Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria:

* Clinical evidence of volume depletion or dehydration
* Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
* Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (glycine + N-acetyl-cysteine(GlyNAC)) reduces oxidative stress and chronic post surgical pain (CPSP) in patients undergoing total knee arthroplasty (TKA).

One of the most common surgical procedures performed in older adults is total knee arthroplasty (TKA), with an estimated 1 million TKAs performed annually in the United States. TKA directly addresses the pathology underlying knee joint pain and mobility limitations resulting from osteoarthritis. For most patients, TKA is effective for pain reduction and increasing function. However, a subgroup of 15-20% of TKA patients report unsatisfactory long-term pain outcomes well after postsurgical healing has occurred despite technical success of the procedure. Chronic postsurgical pain (CPSP) following TKA has been reported to be worse than the preoperative pain in 7% of TKA patients at up to 4-years. A potential biological mechanism is perioperative oxidative stress (OS),

The proposed project seeks to confirm the mechanistic role of OS in post-TKA CPSP and test the hypothesis that a perioperative intervention to reduce OS may reduce risk for CPSP post-TKA. This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (GlyNAC) reduces OS and CPSP in patients undergoing total knee arthroplasty (TKA).

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination)
* Ability to read and write in English sufficiently to understand and complete study questionnaires
* Undergoing unilateral primary TKA
* Medical diagnosis of osteoarthritis
* Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10.

Exclusion Criteria:

* Diagnosis of pre-existing neuropathy
* Untreated hypo/hyperthyroidism
* Untreated heart disease
* Alanine transaminase/aspartate transaminase \>2x upper-limit of normal range
* serum creatinine \>1.5 mg/dl
* Pregnancy
* Complex Regional Pain Syndrome (CRPS) diagnosis prior to undergoing TKA
* Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or malignancy
* Presence of current clinically significant chronic pain conditions outside of the lower extremity ( daily pain for \>3 months and greater ≥3/10 in intensity or the focus of medical care)
* Presence of other medical conditions that in the opinion of the orthopedic surgeon co-investigators would make a patient's study participation unsafe
Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer

This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, male or female.

Histologically confirmed advanced colorectal cancer with microsatellite stable (MSS)/proficient mismatch repair (pMMR) status confirmed by immunohistochemistry (IHC) or molecular testing.

No restriction on prior immunotherapy or combined anti-angiogenic agents (e.g., bevacizumab or small-molecule TKIs).

ECOG performance status of 0-2.

At least one post-treatment efficacy evaluation.

Life expectancy ≥3 months.

Chidamide treatment duration \>3 weeks

Exclusion Criteria:

- 1. Malignancies in other organs or systems, except for cured basal cell/squamous cell skin cancer or cervical carcinoma.

2. Severe comorbidities that may interfere with efficacy or safety analysis. 3. Conditions deemed unsuitable for study inclusion by the investigator.
Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery

Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. There is a paucity in the literature regarding postoperative renal outcomes after esophageal surgery, with a wide range of incidence.

The investigators will conduct a historical cohort study aiming to evaluate the incidence of postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery. Secondary, the investigators will assess the progression of the acute injury and the association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as increase in hospital stay and mortality. The investigators will also identify risk factors associated with acute kidney injury occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Elective esophagectomy

Exclusion Criteria:

* End-stage renal disease
* Missing data for acute kidney injury definition
* Second surgery (for patients having multiple surgeries performed during a 30-day period, only the first in each period will be included)
Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF

Cystic fibrosis (CF) is an autosomal recessive disease caused by alterations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. In addition to pulmonary involvement, the presence of exocrine pancreatic insufficiency also increases the risk of survival, as it is associated with malnutrition and deficiency of fat-soluble vitamins, such as vitamin D.

Vitamin D, in addition to its role in bone health, in the case of CF patients with chronic inflammation, it has been suggested that many of the cytokines that regulate the inflammatory response contain elements that respond to vitamin D, so vitamin D could play an essential role in the regulation of the inflammatory response in CF, which could favor lung function.

However, more than 50% of CF patients present vitamin D insufficiency or deficiency, despite the different schemes suggested for supplementation in different age groups, which suggests that new strategies are needed to normalize vitamin D levels, which will allow us to see its clinical effect on the inflammatory response, by decreasing the number of exacerbations and thus perpetuating or improving lung function, as well as on bone mineral health.

Randomized double-blind clinical trial in patients aged 5 to 18 years attending the CF Comprehensive Care clinic in Mexico City. The intervention group will receive an intensification of vitamin D supplementation, with increments of 4000 IU depending on serum levels, the control group will receive supplementation according to the treatment guidelines of the Cystic Fibrosis Foundation, and the dose will be doubled depending on serum levels. In both groups vitamin D levels will be measured at 3, 6, 9, and 12 months, spirometry and sputum culture will also be performed to evaluate the pulmonary function, densitometry to evaluate the bone mineral density and body composition, together with anthropometric evaluation and quantitative bone ultrasound at each visit, in the biochemical evaluation, calcium/creatinine ratio and alkaline phosphatase will be taken at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis

Exclusion Criteria:

* Another chronic disease (HIV, cancer, renal failure)
* 25-OH-VitD levels \< 10 ng/ml or \> 30 ng/ml
Exercise Training in a Geriatric Hospital Ward

The aim of the study is to describe the effects of physical exercise consisting of strength, balance and flexibility training on functional abilities and the length of stay in older (+75) patients hospitalized in a primary-care health- center hospital.

Hospitalization of older people is connected with several adverse events. Hospitalization increases the risk of disability and long-term institutionalization. Immobilization during hospitalization can lead to deterioration of muscle strength and falls. Earlier studies have shown that strength training is beneficial even in the oldest old. Rehabilitation based on strength training exercises can prevent decline in functional capacity and shorten the length of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* age 75 years or older
* ability to walk independently or assisted or move unassisted in a wheelchair

Exclusion Criteria:

* patients in long-term care
* those who are bedridden
* severe circulatory disease
* acute bone fracture
* terminal disease
* acute infection.
Home Walking Exercise Training in Advanced Heart Failure

Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea and fatigue. Evaluating the effects of complementary intervention (such as exercise training) on functional status and QOL are clinically important and relevant to HF patients.

In the last decade, hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic balance. These programs may be costly for patients to perform. Improved peak VO2 may not necessarily translate into improved functional status and quality of life. To date, the effects of a home walking exercise program alone on functional status, QOL and autonomic tone has not been evaluated.

Background:

Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea and fatigue. Evaluating the effects of complementary intervention (such as exercise training) on functional status and QOL are clinically important and relevant to HF patients.

In the last decade, hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic balance. These programs may be costly for patients to perform. Improved peak VO2 may not necessarily translate into improved functional status and quality of life. To date, the effects of a home walking exercise program alone on functional status, QOL and autonomic tone has not been evaluated.

Objectives:

The specific aim was to compare functional status (FS), quality of life (QOL) and autonomic tone in 2 groups of advanced HF patients (nurse-managed home walking exercise (HWE) group vs. control group).

Methods:

A randomized controlled trial comparing a 12-week nurse-managed progressive HWE protocol to usual activity was conducted in 79 HF patients (78\[99%\] male; mean age 62.6 � 10.6 years; EF 27 � 8.8%; 63 \[80%\] NYHA II, 15\[20%\] NYHA III-IV; HF duration 39.2 � 41.8 months) from a VA medical center and a university affiliated medical center. The 12- week HWE program is once a day, 5x a week and initiated at 10 minutes and progressively increases in duration and intensity up to 60 minutes. Pre- and post-study measures were FS (peak VO2 and ventilatory threshold via CPX, 6-minute walk test (6MWT) and a Heart Failure Functional Status Inventory (HFFSI)), QOL (Cardiac Quality of life Index (C-QLI), SF-36, and Dyspnea-Fatigue Index (DFI) with global rating of symptoms), and autonomic tone (norepinephrine (NE) and heart rate variability (HRV)). Intention-to-treat analysis with repeated measures ANOVA was used to identify group differences.

Status:

Completed.

Eligibility Criteria:
Inclusion Criteria:

Should have a stable heart failure in the past 3 months (Max Age is 80)

Exclusion Criteria:
Stroke and Carotid-Cerebral Vascular Disease After CABG

Review the data of patients who underwent coronary artery bypass grafting (CABG) at the Department of Cardiovascular Surgery in Ruijin hospital from March 2020 to May 2022, including medical history, head and neck CTA, head CT scan, and early postoperative (within 7 days after surgery) neurological complications (defined as a composite of stroke, delayed awakening and severe delirium) . Case-control and retrospective cohorts were built to explore risk factors of early postoperative neurological complications, And its association with baseline carotid-cerebral vascular disease.

Describe the epidemiological data of early postoperative neurological complications (stroke, delayed awakening, and severe delirium) after CABG surgery (within 7 days after surgery); explore independent risk factors of compound neurological complications, build predictive models; compare the effects of carotid-cerebral artery disease on early postoperative compound neurological complications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received CABG at the department of cardiac surgery in our hospital.
2. Surgery that patients received includes both isolated and combined CABG surgery.
3. Includes both cardiopulmonary and non-cardiopulmonary bypass.

Exclusion Criteria:

1. Without complete preoperative examination data, such as carotid-cerebral artery CTA, head CT imaging results and so on.
2. Without complete baseline medical history and 7 day post-surgery record.