cyrilzakka/clinical-trials huggingface dataset:
TACE With Thermosensitive Nanogel Versus Embosphere for HCC

To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.

This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
2. Liver function status: Child-Pugh A or B
3. Eastern Cooperative Oncology Group score: 0-2 points;
4. With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
5. Willing to participate in this trial and sign the informed consent.

Exclusion Criteria:

1. The target lesion has been embolized before or require combined with other treatment(s);
2. Diffuse or with extrahepatic metastasis;
3. Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
4. Severe renal dysfunctions (creatinine clearance rate \<30 ml/min);
5. Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
6. Main portal vein was completely occluded and no collateral blood supply was established;
7. With uncorrectable arteriovenous fistula or portal vein fistula;
8. Severe cachexia or hepatic encephalopathy;
9. With active infection;
10. Significant reductions in white blood cells or platelets (white blood cells\<3.0x109/L, platelets\<50x109/L) that cannot be corrected;
11. Pregnant or lactating women;
12. Difficulty in selective catheterization;
13. With the severe risk of non-target embolization;
14. Severely allergic to contrast agents or the embolic materials;
15. Participating in ongoing trial;
16. Unsuitable judged by the investigator.
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease.

Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+).

The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study


Eligibility Criteria:
Inclusion Criteria:

* Study group:
* presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
* presence of moderate residual mitral regurgitation at discharge.
* Control group:
* presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
* presence of residual mitral regurgitation of at least mild grade at discharge.

Exclusion Criteria:

* none
A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients

30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.

The study presents two parts : a preliminary validation study and a clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of ARDS based on American-European Consensus Conference criteria

Exclusion Criteria:

* \>3 days since ARDS criteria were met and mechanical ventilation was started
* History of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month
* Pre-existing chronic obstructive pulmonary disease
* Major chest wall abnormalities
* Chest tube with persistent air leak
* Abdominal distension
* Body mass index \>30
* Pregnancy
* Known intracranial abnormality
* Enrollment in another interventional study
Randomized Trial of Peer Led Education-Project Dulce

The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.

To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) \> 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.

Eligibility Criteria:
Inclusion Criteria:

* Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c \> or = 8%.

Exclusion Criteria:

* Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c \< 8,pregnant with gestational diabetes
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate (CBR) of GSK3326595 in monotherapy and Part 2 will be expanded to study GSK3326595 in combination with 5-Azacitidine which will be composed of a dose escalation phase followed by dose expansion cohort of GSK3326595.


Eligibility Criteria:
Inclusion Criteria:

* Males and females greater than or equal to (\>=)18 years of age (at the time consent is obtained).
* Diagnosis of MDS, CMML or AML
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
* Adequate organ function
* A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.

Exclusion Criteria:

* History of, or known, central nervous system (CNS) involvement
* Prior solid organ transplantation
* Known allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or its excipient
* Prior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitor
* History of a second malignancy, excluding non-melanoma skin cell cancer, within the last three years
* Active severe or uncontrolled infection
* History of optic nerve neuropathy or neuritis.
* History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
A Modified Approach for the Closure of Oral Sinus Communications

The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of Oro-antral communication
* Patients with adequate radiographic status
* Patients who read and signed the informed consent
* Patients without periodontal disease
* Patients≥18

Exclusion Criteria:

* Pregnancy or breastfeeding patients
* Patients compliance and patients with mental disorders
* Patients with diabetes
* Patients with osteonecrosis
* Patients with head and neck cancer
Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.

Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.

Eligibility Criteria:
Inclusion Criteria:

* No need for orthodontic treatment
* Maximum 2 teeth have been extracted
* Having efficient occlusal contacts
* Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Exclusion Criteria:

* Treated with stabilization splint before
* Partial edentulous patients
* Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
Parkinson's Foundation Surveys

Parkinson's Foundation Surveys is an initiative seeking to periodically survey people with Parkinson's disease (PD), their care partners and medical professionals to better understand specific aspects of living with PD.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to be contacted by the Parkinson's Foundation for surveys and any future research opportunities
* Anyone who self-reports that they have a diagnosis of Parkinson's disease
* Care partner of a person with Parkinson's disease
* Any health professional that regularly works with people with Parkinson's disease
* 18 years of age or older

Exclusion Criteria:

* People who report that they do not have a diagnosis of Parkinson's disease, are not a care partner to someone with PD or do not work with people with PD in the health setting
* An individual younger than 18 years of age
The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), multicenter study to determine the efficacy, safety, and tolerability of canagliflozin 300 mg compared to sitagliptin 100 mg (an antihyperglycemic drug) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 720 patients with T2DM who are receiving combination therapy with metformin and sulphonylurea will receive the addition of once-daily treatment with canagliflozin 300 mg or sitagliptin 100 mg capsules for 52 weeks. Patients will participate in the study for approximately 59 to 72 weeks. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self monitored blood glucose (SMBG) measurements. The primary outcome measure in the study is the effect of canagliflozin compared to sitagliptin on hemoglobin A1c (HbA1c) after 52 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single-blind placebo for 2 weeks before randomization. After randomization, patients in the study will take double-blind canagliflozin 300 mg or matching sitagliptin 100 mg for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea
* Patients in the study must have a HbA1c between \>=7 and \<=10.5% and a fasting plasma glucose (FPG) \<300 mg/dL (16.7 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* or a severe hypoglycemic episode within 6 months before screening
Genetic Abnormalities and Biological Changes of Panic Disorder Patients After Pharmacotherapy

We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in this study for 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Panic disorder

Exclusion Criteria:

* Other major medical or psychiatric illnesses
A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C

The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age, inclusive
* primary diagnosis of chronic HCV infection, genotype 1
* Interferon-based treatment-naïve
* Body Mass Index of 18 to 30, inclusive

Exclusion Criteria:

* patients previously treated with Interferon-based therapy
* patients with diabetes mellitus
Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index

The primary aim of this study is to compare reintubation rate when using standard medical therapy (SMT) versus a monitoring tool, Integrated Pulmonary Index (IPI), to alert clinicians of the patient's respiratory status and need for therapy after planned extubation.

The study is designed as a randomized controlled trial to compare two methods to guide application of clinical interventions after planned extubation: SMT versus IPI based clinical management among adult patients admitted in the ICU and receiving mechanical ventilation for ≥24 hours. Each mechanically ventilated subject within the inclusion criteria and with a physician order for extubation will be randomized to either the SMT or IPI based clinical management group. Once the extubation order is placed by the medical team, the patient will be randomized to IPI monitoring group or standard medical management group. Patients randomized to IPI group will be placed on IPI monitoring after extubation.Respiratory Therapist (RT) will extubate and connects the patient to EtCO2 cannula (Medtronic, Minneapolis, MN) and will turn on IPI monitoring on the Philips monitor. Any subject with decrease in IPI by 1 within 1 hour of extubation or IPI ≤ 4 after 1 hour of extubation will be assessed by RT and will receive standard medical therapy based on respiratory department protocols. IPI monitoring will be continued for up to 72 hours after extubation. Patients randomized to control group will receive standard medical therapy based on the respiratory department protocols. All patients will be clinically monitored for 72 hours after extubation to assess the extubation outcome. Patients that require reintubation will be reintubated based on the medical team decision and will be discontinued from the study. Patients that do not require reintubation after 72 hours will successfully complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 years and older, endotracheally intubated and receiving assisted mechanical ventilation for more than 24hours, and
* Subjects under planned extubation based on the medical team approval

Exclusion Criteria:

* Subjects who are less than 18 years old,
* are pregnant,
* have tracheostomy tube as they do not qualify for extubation,
* have do-not-resuscitate or do-not-intubate orders,
* accidental or self-extubated patients,
* reintubation after study enrollment,
* are extubated terminally, or
* receiving extracorporeal membrane oxygenation (ECMO)
IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.

Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) \> 21 mm Hg
* visible angle structures over 360° on gonioscopy
* age = 18 years

Exclusion criteria:

* Intraocular Inflammation
* patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
* monocle situation
* anterior chamber lenses (incl. iris claw)
* secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)
Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery

Right ventricular dysfunction (RVD) is common following cardiac surgery, and it is characterised by impaired right ventricular function that can lead to decreased cardiac output and hemodynamic instability. RVD is consistently associated with poor outcomes.

The mechanisms behind RVD post-surgery involve changes in preload, after load, and RV contraction. Factors linked to higher incidence of postoperative RVD include decreased tricuspid annular plane excursion (TAPSE), elevated preoperative pulmonary artery pressure, lung diseases, duration of extracorporeal circulation, and left valve surgery.

While predictive scores for RVD exist for left ventricular assist device (LVAD) patients, no such models are available for other cardiac surgeries. Identifying specific predictors could lead to models that identify high-risk patients, allowing for tailored monitoring and treatment strategies.

The primary aim of this study is to create a preoperative risk score for predicting the development of right ventricular dysfunction following adult cardiac surgery through a retrospective analysis on patients who underwent heart surgery.

Postoperative RVD will be defined as:

- Echocardiographic parameters suggestive of RVD (at least 2 out of 3): TAPSE \< 16 mmHg; right ventricular fractional area change (RVFAC) \< 35%; right ventricular end systolic dilation \> 3 cm (measured from the septum to the free wall).

AND

- Need for inotropic and/or pulmonary vasodilator drug support and/or mechanical support.

Data will be collected retrospectively on: demographic characteristics; basic patient characteristics (weight, height, Body Mass Index -BMI, etc.); preoperative pharmacological therapy; preoperative comorbidities; abnormalities in blood tests; chest X-rays and ECGs; abnormalities in coronary angiography and carotid ultrasound; preoperative echocardiographic examination: TAPSE, Left Ventricular Ejection Fraction- LVEF, valvular pathologies, Pulmonary Artery Systolic Pressure- PAPs, pericardial effusion; type of surgical intervention; occlusion of the posterior interventricular coronary artery (acute or chronic); duration of the surgical procedure; duration of extracorporeal circulation; non-revascularized right coronary artery disease; blood product transfusions; postoperative pharmacological therapy (with particular regard to the use of inotropes/pulmonary vasodilators/vasopressors); postoperative echocardiographic examination: TAPSE; RVFAC; right ventricular dilation at end-systole; postoperative complications; Intensive Care Unit (ICU) length of stay and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* elective or urgent cardiac surgery at Campus BioMedico between January 2016 to December 2023
* postoperative echocardiogram execution
* ASA class I-IV

Exclusion Criteria:

* age \< 18 years
* inotropic therapy at the time of surgery
Congenital Hand and Upper Extremity Malformations

Getting the incidence of upper limb anomalies in our department from 2000 to 2020 and classifying them using IFSSH classification and OMT classification

A retrospective look at the past 20 years illustrated the changes and developments that characterize the world of hand surgery. During these years, old techniques were developed and standardized, new surgical techniques were described, our knowledge improved and illustrated by better classification systems, and new ideas were born that would guide the future of hand surgery. Limb deformities are among the most common birth defects in infants. Over the past 150 years, many classifications of limb abnormalities based on bone morphology and anatomy have been developed.

Congenital anomalies of the hand require consistent and reproducible terminology, and it is a universal language that allows discussion of complex clinical entities, treatment indications and outcome comparisons.

Ideally, the classification of congenital anomalies of the hand will depend on the etiology, giving some indication of the location in the molecular pathway and / or the anatomical location in the developing limb bud where the error occurs and the moment when the fault occurs. The terms should be understandable to geneticists, anatomists, pathologists, and surgeons, and they should allow easy interpretation to parents and, where appropriate, children affected by these conditions. The classification of congenital anomalies of the upper extremity and the important association of these anomalies with systemic disorders and syndromes are described in this study. Depending on the classification, examples are given for each class of anomalies.

Eligibility Criteria:
Inclusion Criteria:

- All patients with congenital upper limb anomalies in last 20 years in Assiut university hospital.

Exclusion Criteria:

* Conditions that were considered to be difficult to correctly classify because of late presentation, a large span of clinical presentation, extremely rare conditions, and conditions difficult to differentiate from traumatic conditions were excluded (ie, congenital radial head dislocation, congenital tumorous conditions, Marfan syndrome)