cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke

Magnetic resonance imaging (MRI) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions.

It was observed that a post-contrast three-dimensional turbo-spin-echo T1weighted sequence showed striking post-contrast vascular hyperintensities (PCVH) in ischaemic territories. The aim is to evaluate the prevalence and the meaning of this finding.

This study included 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset from September 2014 through September 2016. Two neuroradiologists blinded to clinical data analysed the first MRI assessments.


Eligibility Criteria:
Inclusion criteria:

* Patients aged 18 and older at onset of an acute ischaemic stroke
* Availability of at least one pre-therapeutic MRI performed in our centre within 12 h of stroke onset, including a post-contrast 3D TSE T1-weighted sequence.

Exclusion criteria:

* Patients with posterior fossa strokes
* Patients with known intracranial vasculitis or MoyaMoya disease
* Presence of severe MR imaging artefacts preventing correct interpretation
Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .


Eligibility Criteria:
Inclusion criteria:

* Non-pregnant women
* Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion
* Women who delivered only by caesarean section

Exclusion criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to lidocaine.
* Women refuse to participate in the study
Open Lung PEEP in Thoracic Surgery

During thoracic surgical procedures, while ventilating with a protective tidal volume, an open lung approach consisting of a recruitment maneuver followed by an individualized positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we performed a multicenter observational study in 17 Spanish teaching hospitals of patients undergoing one lung ventilation (OLV). In addition, we analyzed the association between the driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and finally the association between the individualized PEEP and relevant patient preoperative or intraoperative variables.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing one lung ventilation

Exclusion Criteria:

* No exclusion criteria
Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia

The main objective of this study is to compare the median exposures at pharmacokinetic equilibrium of the two modalities of administration: 4-hours infusion of ceftolozane-tazobactam at a dosage of 2 gram three times a day vs 1-hour infusion of 2 gram three times a day.

Intensive care unit patients with ventilator associated-pneumonia often develop severe and rapidly life threatening Gram-negative Bacillus infections. Moreover, they present pathophysiological disturbances responsible for major pharmacokinetic changes (volume of distribution and glomerular filtration) which may lead to drugs under-exposure. Any delay in management or inadequate antibiotic therapy can have serious consequences in terms of prognosis. The association ceftolozane-tazobactam is an alternative to carbapenems in documented infections. Ceftolozane is a new cephalosporin, marketed, in combination with tazobactam (beta-lactamase inhibitor) under the name ZERBAXA®. ZERBAXA® is active on Gram-negative Bacillus, including Pseudomonas aeruginosa.

This is a prospective, randomized, open pharmacokinetic/pharmacodynamic study that compares two modalities of administration of a novel antibiotic, ZERBAXA® ceftolozane-tazobactam, by 4-hours infusion at the dosage of 2 gram three times a day vs. 1-hour infusion at the dosage of 2 g three times a day, among patients with ventilator associated-pneumonia to Pseudomonas aeruginosa.

The patient will be randomized either in the 4-hours or in the 1-hour infusion group. Follow up visits are daily for any intensive care patient. Those provided for biomedical research are carried out during the treatment period, at Day 15 and Day 28. For the pharmacokinetic study, 7 blood samples will be collected from 24 hours to 48 hours after the first ZERBAXA® administration.

Eligibility Criteria:
inclusion criteria

* patients with ventilator associated-pneumonia to Pseudomonas aeruginosa
* patients hospitalized in intensive care units
* Pseudomonas aeruginosa susceptible to ceftolozane-tazobactam
* Simplified Acute Physiological Score II (SAPS II () \> 20
* Expected duration of survival \> 7 days
* Informed consent of the patient or, failing that, the patient's close or trustworthy person
* Affiliated to a social security scheme or equivalent

Non inclusion criteria:

* history of allergy to one of the two molecules
* history of allergy to betalactamines
* Strain Isolated resistant to Ceftolozane-Tazobactam combination
* Renal insufficiency with a glomerular filtration rate evaluated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \< 50 ml/min
* Patient on dialysis or under continuous hemodiafiltration
* pregnant or nursing women
* patient benefiting from a system of legal protection for adults
* patient with active immunodepression.
Middle-Ear Implant With MET V Transducer (Aka MET V System)

The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.

The MET V System is an investigational, fully-implantable middle ear hearing prosthesis. A mixed hearing loss has both a sensorineural component and a conductive component that results when sound being delivered to an impaired cochlea is attenuated by a disordered outer or middle ear.

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women, 18 years of age or older
* Moderate to severe mixed hearing loss, as a result of a combination of sensorineural hearing loss and chronic ear disease, prior failed tympanoplasties, severe otosclerosis, radical mastoidectomy, or congenital abnormality as evidenced by the following in the ear to be implanted:

  * Bone conduction thresholds are measurable at 0.5,1,2,3 and 4 kHz
  * Bone conduction thresholds are 20 dB or poorer at greater than 2 kHz
  * Air conduction thresholds are 35 dB or poorer at 0.5,1,2,3 and 4 kHz
* Air-bone gap in ear to be implanted is greater than 15 dB at three or more frequencies from 0.5 - 4 kHz
* Word recognition appropriate for sensorineural component of loss
* Non-fluctuating and stable hearing status

  a. as defined as by no significant change or progression in the bone conduction thresholds \>15dB at two consecutive octaves for at least 12 months.
* English Speaking (fluent)
* Realistic expectations for the device
* Willingness to sign the informed consent and participate in the study

Exclusion Criteria:

* Vestibular disorder, including Meniere's Syndrome
* Recurring otitis media over the past year (\>2/year)
* Non-organic hearing loss
* Retrocochlear hearing loss
* Central auditory nervous system disorder
* Medical contraindications to surgery or use of the device
* Women who are pregnant or at risk of becoming pregnant
* Developmentally delayed or manifesting organic brain dysfunction
* Persons with physical or geographic limitations that may render them incapable of completing scheduled study visits
Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects

This study aims to evaluate and select the best combination of polyphenol and white kidney bean ingredients in the acute glycemic modulation after a complete meal by measuring blood glucose and insulin.


Eligibility Criteria:
Inclusion Criteria:

* Glycemia: 100-125mg/dL
* Both sexes
* Overweight BMI range (27-32)
* Age: 20-50 years old

Exclusion Criteria:

* Metabolic/Chronical disease
* Menopausal women
* Being pregnant, breastfeeding or wanting to have a baby
* Former obese with a history of yoyo effect
* Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery
* Having started or quit smoking, having a high alcohol consumption
* Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months
* Allergy to olive, artichoke, black currant, grapefruit, grape, white kidney bean, olive, pomegranate.
the Diameter of Double-lumen Tube Measured by Different Methods

The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.

The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.

Eligibility Criteria:
Inclusion Criteria:

BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia

Exclusion Criteria:

Age younger than 18 yr or older than 70 yr

* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation function
Effect of Lyon and Schroth Techniques on Adolescent İdiopathic Scoliosis

Today, it is known that the conservative treatment of scoliosis is gaining importance. In addition, no study has been found comparing the efficacy of two important conservative treatment methods, the Schroth and Lyon method, in adolescent idiopathic scoliosis. Accordingly, this study was conducted to compare the effectiveness of schroth and Lyon exercises in individuals with AIS.


Eligibility Criteria:
Inclusion Criteria:

* Participants were between ages 10-18,
* Volunteered for the study,
* Diagnosed with adolescent idiopathic scoliosis,
* Cobb angle between 10-30 degrees,
* 0-3 Risser sign,
* Sanders classification 0-4 ,
* Lenke curve type 1

Exclusion Criteria:

* Participants who other type of scoliosis
* Previous spinal surgery
* Exercise contraindications
* Rheumatological disease
* Another neuromuscular problem were excluded from the study.
Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Subjects with insulin treatment for at least 24 weeks
* Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
* HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired renal function
* Cardiac diseases
* Uncontrolled hypertension
* Subjects with known malignant tumour
* Total daily insulin dose greater than or equal to 100 IU
Evaluation of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Periodontal Health and Salivary Parameters

Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients.

Method: A total of 30 pediatric patients aged 7-12 years were treated with a total of 30 appliances including 15 clear aligners (Group A) and 15 labiolingual spring hawleys (Group B). In the clinical examination of the patients, dental caries status was evaluated by DMFT and dft index, periodontal health status was evaluated by probing pocket depth measurements and plaque, gingival and probing bleeding indices. In addition, saliva and dental plaque samples were taken and salivary parameters and microbiologic structure of plaque were analyzed. All these procedures were performed in 2 different time periods for each patient; before and after the treatment. The results were statistically evaluated using SPSS (SPSS Statistics v23.0 for Windows, Chicago, IL, USA).

In the clinical examination of the participants, dental caries status was evaluated by DMFT and dft index, and periodontal health status was evaluated by probing pocket depth measurements; PI, GI, SDI. In addition, saliva and dental plaque samples were taken and salivary parameters (flow rate, pH and buffering capacity) and microbiological structure of plaque were analyzed.

Eligibility Criteria:
Inclusion Criteria:

• Dental anterior crossbite

Exclusion Criteria:

* Skeletal anterior crossbite
* Systemic disease
* Regular medication use
Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of amifostine plus chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

OBJECTIVES: I. Determine the incidence and duration of moderate and severe acute esophagitis in patients with limited stage small cell lung cancer treated with amifostine chemoprotection plus chemotherapy and radiotherapy. II. Determine the tumor response to this regimen in these patients.

OUTLINE: Course 1: Patients receive amifostine IV over 5 minutes daily, followed by radiotherapy twice daily Monday through Friday for 3 weeks. Patients receive cisplatin IV over 30-60 minutes on day 1, and etoposide IV over 1 hour on days 1, 2, and 3. Courses 2-4: Patients receive amifostine over 15 minutes on day 1, followed by cisplatin IV over 30-60 minutes and etoposide IV over 1 hour every 3 weeks. Patients are followed at 1 month, then every 3 months until death.

PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 1-2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer confined to one hemithorax Measurable disease No pleural effusion(s)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and alkaline phosphatase no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal (8.9-10.3 mg/dL) Cardiovascular: No history of congestive heart failure or myocardial infarction within the past 6 months No uncontrolled or unexplained rhythm disturbance or symptoms of unstable ischemic heart disease Other: Not pregnant Fertile patients must use effective contraception No prior or concurrent malignancy within the past 5 years, except: Basal or squamous cell skin cancer Carcinoma in situ of the cervix No concurrent infection No significant uncontrolled hyponatremia No other significant concurrent medical or psychiatric illness which would preclude compliance No antecedent hearing loss Afebrile for at least 3 days unless fever due to tumor or obstructive pneumonia

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No drugs that could potentiate nephrotoxicity of cisplatin (e.g., aminoglycosides or lithium)
Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients

Patients at high complexity with severe chronic diseases can require several admission in intensive care units (ICU) to overcome acute exacerbations by the use of assisted ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of patients often needing weaning procedures due to a long-lasting period of mechanical ventilation. These patients are often under chronic conditions with recurrent symptoms, reduced effort tolerance and depression.

Weaning process is a frail step in the medical history of a patient who has survived an acute episode of respiratory failure and has spent a period of time under mechanical ventilation. Patients are followed for the duration of in-hospital stay, an expected average period of 4 weeks.

When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually managed by GPs and by the hospital where he has been admitted to following re-exacerbations. The conventional approach is for sure inadequate for this type of patient whose clinical complexity, disability and frailty need for a continuity of care through a higher complex approach of management.

A structured program of Home Rehabilitation could be a possible solution to this problem. Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy of a home rehabilitative network for prolonged weaned patients discharged from a weaning unit.

Patients referred to the Fondazione Salvatore Maugeri for prolonged weaning are enrolled and trained in an individualised program of home care in order to recover their own autonomies. Home care compares 2 arms: usual care vs physiotherapist (PT)-assisted care. Usual care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance, periodical in-hospital visit. The PT-assisted home care is supported by PT at least 2 times/month, autonomous 50 min physical activity/working day by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Few brief educational lessons by PT preceded the training activity. Every two weeks, PT calls the patient by phone for an educational reinforcement.

Eligibility Criteria:
* General Inclusion criteria: 1. Signature of the informed 2. Good expectation of life
* Specific Inclusion Criteria : Score of general dependences \< 19 according to the Critical Patients Autonomy Planning (CPAP) Scale

Exclusion Criteria:

* Patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis.
* Unstable patient conditions as daily variability of the blood arterial pressure \>20%, arrhythmias, PaO2/FiO2 \< 300, unsatisfactory respiratory pattern, haemoglobin \< 7 g /dL, temperature \> 38°C, presence of neurological or orthopaedic side effects, and recent embolisms from TVP. Refusal.
Evaluation of Ankle Propriocement and Stability

The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.

The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability using differents tests, questionnaires and instrument:

* Delos system (computerized oscillating platform)
* Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
* modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)

Eligibility Criteria:
Inclusion Criteria:

* patients who must undergo surgery;
* patients of both sexes aged between 18-40 years;
* patients who have given their informed written consent to participate in the study;
* patients who have given their consent to reach the Hospital to perform the 4-month check-up

Exclusion Criteria:

* patients with BMI\> 30 kg / m2;
* patients with rheumatoid arthritis;
* patients with chronic inflammatory joint diseases;
* patients with pre-existing abnormalities of the ambulatory kinematics (amputations, neuro-muscular diseases, polio, hip dysplasias);
* patients with Severe arthrosis of the ankle (Kellgren-Lawrence\> 3);
* patients with Severe knee arthritis (Kellgren-Lawrence\> 3);
* patients with ACL injury;
* patients with severe postural instability;
* patients with cognitive impairments;
* patients with concomitant neurological diseases.
Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) \[Glassia®\] in the Treatment of New Onset Type-1 Diabetes.

The study objectives are:

* To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes
* To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.


Eligibility Criteria:
Main Inclusion Criteria:

* Subject (or parent/guardian) willing and able to sign an informed consent
* Age 8-25 (inclusive) years
* Recently diagnosed with T1DM
* Basal C-peptide ≥ 0.2 pmol/mL
* Positive for at least one diabetes-related autoantibody
* Ability and consent to comply with completion of patient diary
* No significant abnormalities in serum hematology, serum chemistry
* No significant abnormalities in urinalysis
* No significant abnormalities in ECG
* For women of child bearing potential, non-pregnant, non-lactating female patients

Main Exclusion Criteria:

* IgA deficient subjects
* Subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
* Subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
* Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
* Clinically significant intercurrent illnesses
* Pregnant or lactating women
* Current use of any medication known to influence glucose tolerance
* Current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.