cyrilzakka/clinical-trials huggingface dataset:
Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)

This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections.

Profound, prolonged neutropenia (Absolute neutrophil count\<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome.

Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia. The primary objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in preventing proven or probable IFI during neutropenic episodes.

Eligibility Criteria:
Inclusion Criteria:

* Adults or adolescents (age\>13 years) and weight\> 34kg, either gender
* Disease definition: Anticipated or documented prolonged neutropenia (ANC\<500/mm3 2) Eastern Cooperative Oncology Group (ECOG) performance score of less than 3.
* Female subjects of childbearing age must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation).
* Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hcG) at Baseline or within 72 hours before the start of the study drug.

Exclusion Criteria:

* Female subjects who are pregnant, intend to become pregnant, or are nursing.
* Excluded prior treatments: Subjects previously treated with AMB, FLZ, or ITZ for proven or probable IFI within 30 days of enrollment.
* Excluded treatments prior to specific study phases: Subjects who have taken the following drugs: those known to interact with azoles and that may lead to life-threatening side effects.
* Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
* Subjects who are participating in any other blinded clinical study within 30 days of study entry.
* Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at Baseline or likely to require dialysis during the study).
* Subjects having an ECG with a prolonged QTc interval by manual reading: QTc greater than 450 msec for men and greater than 470 msec for women.
* Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN.
Study to Evaluate Safety & Effectiveness of Spinal Sealant

To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for a spinal procedure that requires a dural incision
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris

This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.


Eligibility Criteria:
Inclusion Criteria:

- Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.

Exclusion Criteria:

- Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.
Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection

Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 20 years
* End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023
* Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited
* Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021
* Can be used LINE application throughout the study

Exclusion Criteria:

* Allergy to gentamicin or components
* Previous systemic antibiotics use within 90 days before recruited
* Previous peritoneal dialysis-related infection within 28 days before recruited
* Immunosuppressants used
* Prospective follow up less than 2 months
* Don't sign informed consent
Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and dyskinesias for at least three months

Exclusion Criteria:

* Surgical treatment for PD
* Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
* Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply
Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC

New treatment strategies have been developed in lung cancer targeting the Epidermal Growth Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds rates to the treatment and should be treated with a EGFR inhibitor as first line of treatment. Some wild type patients do as well respond but selection of these patients is more difficult.

Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer (11C-erlotinib) in tumors has showed promising results for selection of responders.

The investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Lung Cancer patients with non-small cell histology and stage IV disease who are candidate for erlotinib treatment as first/ second/ third line of treatment

Exclusion Criteria:

* pregnancy
* severe dyspnoea
Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)

Purpose:

Evaluation of the CAR™ 27 for the creation of compression anastomoses.

Indication:

Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design:

Prospective, open labeled study.

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects:

15 patients estimated up to three months to enroll.

Duration of Treatment:

During the operation - creation of the anastomosis.

Duration of Follow-up:

Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints:

To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Cholecalciferol Intervention to Prevent Respiratory Infections Study

This is a feasibility double-blind randomised controlled trial in 32 participants. It evaluates the feasibility of a full trial which will examine the efficacy of weekly supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent frequency and severity of objectively-verified symptomatic acute respiratory tract infection, overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of the most common aetiologic viral pathogens.

The hypotheses of the full study are:

Primary The group treated with vitamin D3 will have a significantly lower frequency of symptomatic respiratory tract infections than controls.

Secondary

1. Among persons with detected viral colonisations of the nasopharynx, treated persons will have a lower frequency of symptomatic respiratory tract infection resultant than controls.
2. Treated group will have significantly less severe symptomatic RTIs than controls.
3. Treated group will have significantly shorter symptomatic RTI durations than controls.

For the pilot, a cohort of 32 healthy young adults satisfying inclusion criteria will be randomised to cholecalciferol supplement or identical placebo and evaluated daily for the occurrence of RTI symptoms and evaluated weekly for the presence of respiratory colonisation by relevant pathogens using nasopharyngeal swab and polymerase chain reaction using selected pathogen-specific primers. This pilot will demonstrate the logistic feasibility of the proposed study design and provide preliminary data which will inform a larger study to be undertaken next year.

Eligibility Criteria:
Inclusion Criteria:

* Students undertaking study at the MS1 building of University of Tasmania Medical Sciences Precinct (17 Liverpool St Hobart TAS) for the full duration between May and September 2012

Exclusion Criteria:

* Persons who have used tobacco within the 6 months preceding study entry
* Persons who have used any vitamin D (cholecalciferol or ergocalciferol) supplements or calcium supplements within the 3 months preceding study entry and/or persons who refuse to not start taking any such supplement during the study
* Persons using any immunomodulatory medication, diuretic medication, antiepileptic medication, or barbiturates.
* Persons who presently have been diagnosed with any chronic infectious disease (e.g. HIV, tuberculosis), chronic immune deficiency or autoimmune condition, or respiratory condition (e.g. asthma, chronic obstructive pulmonary disease).
* Persons who are hypersensitive to vitamin D.
Functional Medical Imaging Quantization in Prostate Cancer

Prostate cancer is the most common cancer in men over 50 years old and the third leading cause of cancer death. Because of the variety of prostate cancers, different treatments exist.

Several criteria guide this management in daily practice: PSA level; TNM stage (digital rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological differentiation with the Gleason score, to which can be added other prognostic criteria: growth and doubling time of the serum PSA, number of positive biopsies and percentage of cancer lesions by biopsy.

Functional imaging by PET and MRI is increasingly used in daily clinical practice to characterize prostate cancer, either during initial discovery or during recurrence. In this context, it is the qualitative visual analysis that is mainly used. Quantitative image analysis could add new criteria to guide patient management.

Consequently, the objective of this study were:

* Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer
* Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both perfusion MRI and histological parameters.


Eligibility Criteria:
Inclusion Criteria:

Patients with prostate cancer histologically proven included in Brest University Hospital between 01/07/2012 and 01/10/2015 and underwent F-choline PET/CT and pelvic MRI Patient consent

Exclusion Criteria:

No lesion on dynamic acquisition on PET/CT and/or on pelvic MRI
Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage

Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.

Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.

It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female Adults ≤18 years of age.
* Hospitalised in the neurological intensive care unit of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon following an aneurysmal meningeal haemorrhage of any modified Fischer score, previously diagnosed by cerebral CT scan.
* Patients admitted to the neurological intensive care unit or the NICU of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon for an intra-parenchymal haematoma.
* Patient who has been informed and has formulated his/her non-opposition, or close relative of the patient who has been informed and has formulated his/her non-opposition.
* Affiliated to a social security scheme.

Exclusion Criteria:

* Non-aneurysmal SAH
* Ischaemic stroke
* Patients with previously known platelet function disorders
* Pregnant or breast-feeding women
* Patients under legal protection (guardianship, curatorship, safeguard of justice)
* Patients under compulsory psychiatric care
* Patients taking part in a study which may interfere with the present study
Pupil Response in Patients on Opioids.

Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain intensity, sedation score, and other side effects of opioids. Measurements of the concentration of opioids and their active metabolites in blood.

Pupil size reflects the balance between sympathetic and parasympathetic systems. Pupil size and reaction are also influenced by drugs, where opioids result in miosis, an effect that is not considered to be influenced by opioid tolerance. However, cancer patients on high-dose opioids do not always present small pupil size.

We want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids. In addition to pupil size measurements under standard room light conditions, two pupil size reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and the reflex dilation during a standardized noxious stimulus. On the same time we will assess pain intensity, sedation score, and other side effects of opioids while measuring the concentration of opioids and their active metabolites in blood. In addition we will register all concomitant medication that also might influence pupil size and reaction. Patients on more than 60 morphine equivalents pr day will be included.

Eligibility Criteria:
Inclusion Criteria:

* In-patients and out-patients at Oslo University Hospital with cancer pain who have use opioids (morphine, oxycodone, fentanyl or methadone or a combination of these drugs) at least for periods of 4 weeks, and use opioids corresponding to at least 60 mg oral morphine equivalents pr day

Exclusion Criteria:

* Patients who have undergone eye-surgery that may influence pupillary reflexes
* Patients on local medication that may influence pupillary reflexes
* Patients with amyloidosis, multiple sclerosis, Horner's syndrome, or ongoing migraine attack
* Patients with brain tumor
Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS

It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes


Eligibility Criteria:
Inclusion Criteria:

1. Age more than 65 years old
2. Arterial Hypertension: predialysis SBP \>140 mmHg and/or DBP \>90 mmHg in at least 50% over the previous month dialysis sessions or receiving at least one antihypertensive pharmacological drug including diuretics, disregarded blood pressure value
3. On a three times per week hemodialysis schedule
4. Time on hemodialysis less than 6 months
5. Able to measure their blood pressure at home (by themselves or with the aid of the care giver)
6. Signed informed consent

Exclusion Criteria:

1. Active neoplastic disease
2. Mental illness
3. Pregnancy
4. Single needle treatment
5. Inability, as judged by the investigator, to follow or understand the protocol instructions
6. Blood flow rate less than 200 mL/min
7. Patients who at the time of recruitment need clinical indication for special renal replacement therapies and/or on treatment with one of the following modalities: HDF or similar diffusive-convective therapies, treatment time \>5h, blood temperature control, isolated UF profiling of Na/UFR
8. Patients with a life expectancy shorter than 6 months
9. Patients in a list for transplant within the next 6 months
10. Predialysis Hemoglobin level greater than 13.5 g/dl
11. History of major cardiovascular events during run in period
Radio/Pathological Evaluation of Tongue Cancer Infiltration

The aim of the study is to assess the good correlation and prediction of the DOI for the post-operative pathological results and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* patients chirurgically treated for an OSCC
* T1 T2 T3
* CT scanner in their medical file

Exclusion Criteria:

* T4
* R+ résection
* Artefacts on CT scanner
Effect of Anaesthesia on Basic Aminoacids

Basic amino acids are acids that contains amino groups more than carboxylic groups. At least five basic amino acids namely; Arginine, citrulline, ornithine, lysine and hydroxylysine metabolize in our body. Loss of body protein represents a typical feature of the catabolic response to surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* ASA II,III

Exclusion Criteria:

* Emergency surgery
* Associated renal or liver disease
* Chronic disease as D.M
Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients

Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.

After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (\>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 65 years, ASA 1,2

Exclusion Criteria:

* Included less than 70% or more than 130% of ideal body weight
* Neurologic disorder
* Use of psychoactive medication, including alcohol intake during the last 48 hours