cyrilzakka/clinical-trials huggingface dataset:
Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients

The study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.

100 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2022 to April 2024. 50 patients were treated with Insulin Degludec/Liraglutide, 50 were undertaken treatment regime with Insulin Basal Bolus (control group).

The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.

Each patient treated was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels\> 200 mg/dl, triglycerides\> 150 mg/dl and HDL levels \<40 mg/dl regardless of the patient's gender.

Among the cases enrolled, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) hypercholesterolemia.

Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six months from the time of recruitment.

The glycemic variability was assessed by continuous glycemic monitoring with the analysis of Time in Range

The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2
* Mild-moderate Hyperglycemia (180-400 mg/dl)
* Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)

Exclusion Criteria:

* Diabetes mellitus type 1
* Diabetic ketoacidosis
* Hyperosmolar coma
* Severe hypoglycaemia
* Acute Pancreatitis
* Cancer
* use of corticosteroids
* pregnancy
* Chronic kidney disease (\< 30 ml/min) or hemodialysis
Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo

* Vertigo complaint is one of the common cause of patients who applied to emergency services.
* Patients who have applied to emergency services with vertigo complaint mostly have nausea as an additionally symptom to this complaint and anti-emetic agents can be used in their treatments very often.
* The investigators purpose is to investigate the advantages of Dimenhydrinate and metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by nausea

* Vertigo describes the illusion of being subject to an involuntary movement, usually rotational, of the patient or the patient's surroundings which is caused by sudden tonic neural activity.
* The management and episodic treatment of patients with spontaneous vertigo related nausea-vomiting symptoms are somewhat controversial in the emergency department setting.
* Patients admitted to the emergency department with complaints of vertigo in addition to a large portion of the symptoms are accompanied by nausea and antiemetic agents are frequently used in the treatment.
* An ideal treatment should be rapid in onset and effective, and lack debilitating side effects.
* Although a wide variety of classes of pharmacologic agents and modalities are used, the emergency department treatment of acute spontaneous vertigo and associated with nausea- vomiting has not been well studied.
* It has been reported that the most commonly used medications for parenteral treatment of vertigo and nausea-vomiting in emergency department are dimenhydrinate (DMT) and metoclopramide (MTP).
* It has a depressant action on hyper-stimulated labyrinthine function and antiemetic effects, believed to be due to the antihistamine.
* Dimenhydrinate inhibits vomiting by affecting the histaminic receptor and cholinergic receptor function center of vestibular nucleus in the central vestibular system.
* Dimenhydrinate reduces the symptoms of vertigo with depressant effects on the labyrinth function by this means.

Eligibility Criteria:
Inclusion Criteria:

* between 18 to 65 years old patients,
* had vertigo and accompanied nausea or vomiting \[VAS (visual analog scale) score \>5\] during their emergency department episode of care for which the attending physician recommended intravenous antiemetic medication.

Exclusion Criteria:

* abnormal vital signs,
* women who were pregnant or lactation,
* those with a history of epilepsy,
* acute psychiatric symptoms,
* organic brain disease,
* parkinson's disease or phaeochromocytoma,
* or any known allergy to the study drugs,
* uncooperative individuals,
* use of any antiemetic drug in the previous 8 hours or previous delivery of intravenous fluids during the emergency department episode of care,
* currently undergoing chemotherapy or radiotherapy,
* mechanical obstruction or perforation,
* gastrointestinal bleeding,
* inability to understand study explanation or outcome measures (any reason),
* known allergy or previous adverse reaction to metoclopramide or dimenhydrinate,
* and patients who refused to participate study.
Family Study of Lymphoproliferative Disorders

Blood and lymph node cancers can begin in either the lymphatic tissues (as in the case of lymphoma) or in the bone marrow (as with leukemia and myeloma), and they all are involved with the uncontrolled growth of white blood cells. There are many subtypes of these cancers, e.g., chronic lymphocytic leukemia and non-Hodgkin lymphoma. Since there is evidence that these cancers cluster in families, this study aims to understand how genetics and environmental exposures contribute to the development of these cancers.


Eligibility Criteria:
At least 2 living, blood related relatives, affected with a lymphoproliferative disorder.
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to coronary artery bypass graft and at least one saphenous vein graft

Exclusion Criteria:

* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Estimated glomerular filtration rate (eGFR)\<15 mL/min
Assessment of Sedation During Endoscopy

Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic retrograde cholangiopancreatography). However, assessment of the level of sedation during these procedures is not investigated in detail.

The purpose of this study is to compare different sedation scales and bispectral index during sedation in endoscopic procedures in order to find the best suited assessment method for sedation under these conditions.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion Criteria:
Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients

Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mTc.

Superparamagnetic iron oxide (SPIO) is novel, non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative Magnetic Resonance Imaging (MRI) scanning. Guidance on pre-operative MRI use is rather limited, though fundamental in the intended research process.

Hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative MRI protocol for melanoma patients. The acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants;
* Participants should be ≥18 years of age at the time of consent;
* Participants should be willing to provide informed consent.

Exclusion Criteria:

* Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself;
* Standard MRI exclusion criteria:
* Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator);
* Any other metal implants;
* Claustrophobia;
* MR-incompatible prosthetic heart valves;
* Tattoos inked with metallic dye.
* Participants who refuse to provide informed consent.
Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.

Respiratory distress syndrome (RDS) is one of important cause of mortality in neonates. This study was designed to evaluate the amniotic fluid lamellar body counting for predicting fetal lung maturity.

Eligibility Criteria:
Inclusion Criteria:

* Women, with 28-37 weeks of gestational age, who had been decided to terminate their pregnancy, were enrolled in the study

Exclusion Criteria:

* Chorioamnionitis
* Intra Uterine Fetal Death (IUFD)
* Blood in amniotic fluid
* Rupture of placenta and patient dissatisfaction were the exclusion criteria.
Trident II Tritanium Acetabular Shell Outcomes Study

The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.


Eligibility Criteria:
Inclusion Criteria:

A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.

B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.

C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.

D. Patient is a candidate for a primary cementless total hip replacement.

E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusion Criteria:

F. Patient has a Body Mass Index (BMI) ≥ 40.

G. Patient is diagnosed with Inflammatory Arthritis.

H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.

J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).

L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.

M. Patient has had previous open surgery to the affected joint, not including arthroscopy.

N. Patient requires implantation of a constrained liner.

O. Patient has a known sensitivity to device materials.

P. Patient is a prisoner.
Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study

osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw

Exclusion Criteria:

* Tumoral recidivism
* Precocious stop of pentoclo
Hiatus Hernia in Old

hiatus hernia in frail patient is common and requires suregry

severe frail patients had high incidence of recurrence

Eligibility Criteria:
Inclusion Criteria:

* EP aged ≥60 years for giant sliding HH with

Exclusion Criteria:

* • who required a concurrent abdominal procedure at the same time as fundoplication (e.g., cholecystectomy)(n=5)

  * esophageal dysmotility(n=2)
  * progressive systemic sclerosis (n=1)
Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression

This study explores the differential efficacy of Spanish or English versions of a mindfulness intervention on Depression levels, using a pre test post test design and an active control condition (health education).

This study is a randomized controlled trial (RCT) with an experimental condition (MAPs Mindfulness intervention) and an active control group (Health Education), using a pretest and immediate posttest research design. Both conditions are comprised of a 6-week group intervention, which will be administered at the UCLA Westwood Medical Campus. The sample (N=80) will be drawn from a population of adults (18-65 years old), residing within a 10mile radius of the UCLA Westwood Medical Campus. To determine initial eligibility, potential participants will self-select based on perceived high levels of stress. Participants will respond self-report questionnaires to assess for psychological symptoms and will be drawn blood samples (180ml total) to assess levels of pro inflammatory cytokines before and after the interventions. Participants will attend a total of 8 visits.

Eligibility Criteria:
Inclusion Criteria:

* In order to determine eligibility, interested participants will be phone screened. To qualify for the study, participants have to be fluent in either Spanish or English, validated by self-report at phone screening. Additionally, during the phone screening participants had to complete a 4-item version of the Perceived Stress Scale (Cohen \& Williamson, 1988) and score above the 50th percentile (a score of 9 or higher) in order to be eligible

Exclusion Criteria:

* People not meeting any of the above criteria.
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.

Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings.

Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. It is a relatively rare disorder, accounting for only 3% of all primary brain tumors but due to its anatomical localization represents an important clinical and diagnostic challenge in onco-hematology. different MRI patterns of the peritumoral area (PTA) might correlate with different histopathological sensitivity regarding diagnostic potential out of contrast-enhanced region (CER). Improvements in the understanding of PTA diagnostic potentials is of great help in diagnosing patients with deep-seated lesions, who would otherwise be not eligible for stereotactic biopsy and therefore for a consequent adequate treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs

Exclusion Criteria:

* Severe hepatic dysfunction
* Severe renal dysfunction
* Severe heart failure
* myocardial infarction and stroke within 90 days
* Hyperreactivity against contrast agents
* Pregnancy
Safety and Efficacy of Empagliflozin in GSD1b Patients With Neutropenia

Treatment of neutropenia of Glycogenosis type 1b patients with empagliflozin

Symptoms of glycogen storage disease type Ib (GSD Ib) include - among others - hypoglycemia, hepatomegaly and neutropenia with concomitant neutrophil dysfunction, which results in recurrent bacterial and fungal infections, and inflammatory bowel disease.

At present filgrastim is the only available drug to treat neutropenia in GSD Ib patients; it stimulates neutrophil production, but doesn't restore their function. Part of GSD Ib patients doesn't respond to filgrastim treatment. The latest research results showed, that neutropenia and neutrophil dysfunction in GSD Ib patients are results of extensive accumulation of 1,5-anhydroglucitol-phosphate. Empagliflozin, a SGLT2 inhibitor, inhibits renal glucose and 1,5-anhydroglucitol reabsorption and is an effective and safe method of treatment of neutropenia in this group of patients. Empagliflozin (Jardiance®) is a drug, which is registered in Poland to treat type II diabetes in adults. The aim of our study is to evaluate the efficacy and safety of neutropenia in patients with GSD Ib with empagliflozin (Jardiance®).

Eligibility Criteria:
Inclusion Criteria:

* Minimum age 4 weeks old female Or Male
* GSD1b confirmed by genetic analysis with neutropenia and/or reduced respiratory burst
* Informed consent signed by the parents/assigns, and the recipient (\>13 years old)

Exclusion Criteria:

* Risk of non-compliance
* Chronic renal diseases (eGFR \< 60 ml/min/1,73 m2)
* Active urinary tract infection (temporal criterion, up to recovery)
* Participation in another clinical trial (minimum 6 months from the end of participation until the date of signing the Informed Consent Form)
* Participation in therapeutic experiment, in addition to the experimental treatment with empagliflozin (minimum 12 months from the end of participation until the date of signing the Informed Consent Form)
* Pregnancy, breastfeeding
* Allergy to Empagliflozin
* Lack of informed consent
Periodontal Infection and Prematurity Study

This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 6 and 20 completed weeks

Exclusion Criteria:

* Periodontal treatment during the pregnancy
* Antibiotic use within 2 weeks of enrollment
* Use of antimicrobial mouthwash within 2 weeks
* Multiple gestation
* Known mitral valve prolapse
Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis

This study seeks to describe, for children undergoing uveitis surveillance following a new diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a randomised comparative study of routine slit lamp examination (SLE) versus imaging based (anterior segment optical coherence tomography, OCT) surveillance in order to inform the development of a larger multi-centre trial.

This study will compare imaging-based surveillance to routine clinical surveillance for uveitis in children with juvenile idiopathic arthritis (JIA) in order to support the design of a future study.

Childhood uveitis is a rare inflammatory eye disease. Half of all children with uveitis also have a joint disorder: juvenile idiopathic arthritis (or JIA). Children with JIA must travel to a specialist centre every three months to have eye examinations in an attempt to pick uveitis up early enough to prevent visual loss.

Optical coherence tomography (OCT) is a non-contact non-irradiating imaging modality. The investigators have recently demonstrated that novel application of OCT for uveitis detection in children is feasible, acceptable to families, repeatable, sensitive, and specific. The investigators have also found that families welcome the objectivity of imaging-based diagnosis. Standardised operating protocols for image acquisition and analysis have been developed across three imaging platforms (Optovue, Casia and Heidelberg OCT machines).

The investigators will be undertaking a feasibility study which compares routine clinical examination based uveitis surveillance to imaging based surveillance in order to provide the necessary information to address this issue in a larger scale clinical trial of clinical and cost-effectiveness, and explore issues around the impact of objective disease metrics on family perceptions of disease and treatment, as well as the perceptions of children, families and clinical staff on the use of automated diagnostic tools.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for uveitis surveillance
* Aged 2-12 years

Exclusion Criteria:

* A previous / existing diagnosis of uveitis
* Any co-existing ocular or neurological abnormality which impacts on current corrected visual function, or could impact on future corrected visual function
* Developmental/learning difficulties that preclude concordance with examination / informed assent