cyrilzakka/clinical-trials huggingface dataset:
L-PRF in Cranial Surgery

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair (= primary objective).

The investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)
* Age ≥ 18 years
* Written informed consent
* Willing to comply with the study schedule

Exclusion Criteria:

* Participation in another clinical trial with study drugs or devices
* Pregnancy
Use of V-Loc Suture for Mid-face Lifting in Short-flap Rhytidectomy

This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when using a short flap, short incision technique in during a traditional face-lift. The objective of this study is to assess the suture's potential in elevating the mid-face when a traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will elevate the mid-face more effectively when using a short flap, short incision technique on a traditional facelift.

A total of 25 patients who are already receiving a traditional Lifestyle Lift will be asked to participate. Once the consent form has been signed by the patient, the facelift will be performed as scheduled and the Vloc suture will be added to the mid-face area. Each patient will be added to a database and their progress will be tracked with photos taken before, at 6 weeks, and at 6 months following the procedure. All data stored will be locked into a hard drive that can only be accessed by the research staff and the doctor. The text data will be used by research staff for reports and articles.

\* you must already have purchased and scheduled a facelift procedure with Lifestyle Lift to participate in this trial. The addition of only the V-loc suture is at no cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to receive a Lifestyle Lift will be asked to participate. The first 25 patients who have consented will be included into the study.

Exclusion Criteria:

* Any patient who is not able to receive a facelift for whatever reason, or who do not want a facelift will not be apart of this study
Association Between Clinical Effect of Morphine With PCA After Surgery and Pharmacogenetics

Identification of the genetic polymorphisms that could be correlated either with a better clinical response or with a major predisposition of patients to develop tolerance and/or side effects to the treatment with morphine.

Valuation of the medium morphine dose (mg/kg/die) necessary to maintain NRS\<4 in the first 24 hours post-surgery in the two groups of patients, A e B. Group A: homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both homozygous and heterozygous patients for the less frequent allele (about 20%).

In order to avoid the bias related to alterations in metabolism, patients with Cmax and AUC of morphine (and metabolites M6G and M3G) \>2 standard deviation higher than expected population curve ("outliers") will be excluded for the primary purpose.

Eligibility Criteria:
Inclusion criteria:

* Males and females over 18 years, under 75 years, scheduled for postoperative pain control by PCA morphine administration
* HIV negative
* Classification American Society of Anesthesiologists (ASA) I: without systemic disease
* Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
* Undergoing abdominal and urologic major surgery (neither urgent nor emergency surgery)
* Signed informed consent

Exclusion criteria:

* Usual assumption of analgesic opioids
* Cognitive alterations nor mental retardation
* Severe hepatic/renal insufficiency (cholinesterase \<3000 mU/ml, total bilirubinaemia \<2 mg/dl and creatininaemia \<1.2 mg/dl)
* Inpatients in intensive therapy, either with sedation and/or mechanic ventilation.
* Allergies to morphine and derivates
Is Drainage Necessary After Total Hip Replacement?

The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.

After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.

Eligibility Criteria:
Inclusion Criteria:

* Primary Hip Arthroplasty
* Lateral Hardinge Approach
* Non-cemented Acetabular and Femoral Components
* Length of Skin Incision between 10 and 20 cm

Exclusion Criteria:

* Coagulative Disorders
* Previous Surgery in the same limb
* Age below 18 years old
Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II)

Current treatments for Parkinson's Disease (PD), including pharmacological (levodopa) and surgical (DBS) methods, have limited impact on postural instability. Physical therapy (PT) for PD is becoming increasingly used as a means to induce benefits on patient balance. However, limits in efficacy and consistency still exist. In this study, the investigators will test the effects of TDCS+TUS combined with PT on postural instability of PD patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician;
2. Complaints about balance impairment or postural instability due to PD (self-report);
3. Age from 40 to 90 years old;
4. Taking stable medications for PD for at least 30 days.

Exclusion Criteria:

1. Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
2. History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions;
3. History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;
4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
5. Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc.;
6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);
7. Pregnancy.
8. Epilepsy or disorders that significantly increase likelihood of seizures including: severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
9. Recent (\<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.
10. Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).
11. Bed or wheelchair-bound
A MEDiterranean Diet in Rheumatoid Arthritis

The MEDRA study is a 12-week randomised controlled trial that aims to assess effects of a Mediterranean dietary telehealth intervention compared to the Irish Healthy Eating guidelines on the physical function and quality of life of adults living with Rheumatoid Arthritis in Ireland. Investigators will be able to determine how closely people living in Ireland can accept the Mediterranean dietary practices and adhere to them with dietetic input and guidance.

Rheumatoid arthritis (RA) is a long-term inflammatory disease which commonly occurs in the small joints of the hands, wrists and feet leading to swelling, pain and stiffness in the affected joints. The condition is two to three times more prevalent in women than in men. Although it might occur at any age, the incidence of the disease is highest between the ages of 40 and 65 years. Currently, there is no treatment that provides complete remission of the disease for people living with RA. Treatment of RA aims to reduce the symptoms and improve the health of the patient. Although diet is not part of the mainstream treatment, many studies have reported beneficial effects of certain diets on RA symptoms. The MEDRA study will examine the habitual dietary intakes of people living with RA in Ireland and will explore whether people with RA will benefit from either a Mediterranean dietary pattern or the Healthy eating guidelines in Ireland. This small scale study will provide useful information on whether people with RA in Ireland can adhere to a Mediterranean dietary pattern and whether the intervention will have beneficial impact on the physical function and quality of life. This is important work prior to proceeding to larger intervention studies.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year
* Definite diagnosis of rheumatoid arthritis according to ACR or EULAR criteria
* Full access to Internet/smartphone
* English speaking

Exclusion Criteria:

* Age \<18 years
* Breastfeeding, pregnant or trying to get pregnant.
* Patients who have commenced nutritional supplements or a new dietary regime in the month prior to study enrolment.
* Patients who do not have access to the Internet/smartphone
Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data


Eligibility Criteria:
Inclusion Criteria:

* All patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition
* Adult patients (\>18 years)

Exclusion Criteria:

* No informed consent
Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry \[IHC\] (may be based on archival samples) and is metastatic.
* Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
* Prior fluoropyrimidine-containing regimen (5-fluorouracil \[5-FU\], capecitabine, or uracil/tegafur \[UFT\]), for the first-line treatment of metastatic disease.

Exclusion Criteria:

* A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy
* Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
* Known or documented brain metastases
Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.

This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with at least T2 stage tongue SCC who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake.
* Proficient in spoken and written English

Exclusion Criteria:

* Patients who are planned for total glossectomy
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.

Parents or guardians instilled patients' assigned study medications once on the day of surgery (Day 0) and 4 times daily (QID) beginning on the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days (dependent upon the Investigator's determination of adequate response to treatment). Patients were evaluated for safety and efficacy on the following visits: Day 0 (day of surgery), Day 1, Day 8 ± 1 day, Day 15 ± 2 days and Day 29 ± 2 days (end of study drug treatment). Additional safety visits occurred at 1 week after the last dose + 2 days and at 3 Months + 1 week. No inferential statistical analysis was planned for this study. Data was summarized using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 3 years of age.
* Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
* Informed consent signed by a parent or legal guardian.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
* Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
* Patients with posttraumatic cataract.
* Active uveitis in the study eye.
* Ocular neoplasm in the study eye.
* Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
* Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
* Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
* History of steroid-induced intraocular pressure (IOP) rise.
* Currently on medication for ocular hypertension or glaucoma in the study eye.
* Diabetes.
* Other protocol-defined exclusion criteria may apply.
Gene Therapy for Diabetic Macular Edema

FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients ≥18 years old at the time of signing the ICF;
* Clinically diagnosed with CI-DME
* HbA1c≤10%
* The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters

Exclusion Criteria:

* Presence of any other intraocular diseases other than CI-DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.


Eligibility Criteria:
Inclusion Criteria:

* Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) \> 12.5 mg/dL (3.1 millimoles /L) at screening by local laboratory
* Last IV bisphosphonate treatment must be \>/= to 7 days and \</= to 30 days before the screening corrected serum calcium
* Adults (\>/=18 years)
* Adequate organ function as defined by the following criteria:
* serum aspartate aminotransferase (AST) \</= 5 x upper limit of normal (ULN)
* serum alanine aminotransferase (ALT) \</= 5 x upper limit of normal
* serum total bilirubin \</= 2 x upper limit of normal

Exclusion Criteria:

* Evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
* Receiving dialysis for renal failure
* Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening CSC
* Treatment with cinacalcet within 4 weeks prior to the date of the screening CSC
* Thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
* Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
* Female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
* Female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
* Subject will not be available for follow-up assessment.
* Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact on the general morbidity and risk of stroke, AF is a great concern for public health. Several mechanisms, including endothelial dysfunction and inflammatory processes, have been postulated as predisposing factors for AF, as well as for stroke.

Both clinical and experimental studies highlight inflammation as a predisposing factor for AF and its complications. Nevertheless, the source of high inflammatory proteins in patients with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac (left femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation in AF patients.

The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also help to define the site of endothelial dysfunction and of production of this thrombogenic factor.

Although AF is associated with an increased risk of stroke, the risk is not homogeneous. Permanent and persistent AF are associated with similar thromboembolic risk to that of paroxysmal AF.


Eligibility Criteria:
Inclusion Criteria:

* Patient for which an electrophysiology exploration or ablation is programmed;
* Patient who have given written informed consent.

Exclusion Criteria:

* Pregnant women;
* lung disease history (all sources);
* inflammatory disease history (all types);
* Anti-inflammatory treatment;
* left ventricular ejection fraction \<35%;
* history of stroke;
* Participation in other ongoing clinical trial.