cyrilzakka/clinical-trials huggingface dataset:
Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment

A prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF).

Meropenem is important for management of post-neurosurgical meningitis, but the data about its penetration across blood-brain barrier (BBB) are inadequate. This prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF). A total of 82 patients with post-neurosurgical CNS infection were included to receive meropenem intravenously according to regimen of 2g q8h, 1g q8h or 1g q6h. After infusion of 4 doses, blood and CSF samples were collected simultaneously at predefined timepoints. High-performance liquid chromatography ultraviolet method was used to determine the concentration of meropenem.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* requiring continuous drainage of CSF or gram-negative bacteria were identified from CSF culture
* have temperature fever (T \> 37.5℃)
* have signs of meningeal irritation
* white blood cells in CSF \> 300 × 10\^6/L

Exclusion Criteria:

* hypersensitive to meropenem
* did not receive at least 3 days of meropenem treatment
* are receiving hemodialysis
* unstable vital signs
* have lumbar puncture contraindications and so inappropriate for sample collection
* severe hepatic or renal dysfunction
* status epilepticus
* potential neurodegenerative diseases
* pregnancy
* breast-feeding
The Utility and Cost-Effectiveness Analysis of 18F-FDG PETin Staging Potential Operable Non-Small Cell Lung Cancer

We plan to conduct a prospective study:

1. to evaluate the accuracy of PET in staging patients with potentially operable non-small cell lung cancer;
2. to evaluate the percentage of futile thoracotomy after PET is introduced in the routine staging modalities for NSCLC patient;
3. to establish a decision tree model based on choices between conventional imaging only and additional PET imaging to analyze their cost-effectiveness.

Lung cancer has been a major health issue worldwide, including Taiwan. According to the data published by the Department of Health, Executive Yuan, Taiwan, 2004, lung cancer is already the leading cause of cancer-related death in Taiwan. Non-small cell lung cancer (NSCLC) represents approximately 75-85% of all primary lung tumors. The strongest prognostic factor for survival is whether the tumor can be completely resected. Surgical resection may be performed for those patients without distant or extended lymph node metastasis. Because of the significant morbidity and mortality for surgical procedure of lung cancer, it is therefore very important to identify and exclude those patients who can't benefit from surgical treatment. Conventional staging, using chest/brain X-ray computed tomography, abdominal echography and radionuclide bone scintigraphy, leads to futile thoracotomies in up to 50% of patients.

Since early 1990s, when 18F-FDG PET has emerged as a promising diagnostic imaging tool in nuclear medicine, a large number of studies have been reported without exception that PET is a better staging tool than CT for patients with NSCLC. However, due to the prohibitive cost, PET is not routinely used for the staging of NSCLC in Taiwan. The extra cost accruing from the introduction of this new technology has been the major concerns from the clinical physicians and health policy makers.

A number of economic evaluation studies overseas have shown that PET is cost-effective in NSCLC when added to conventional work-up. However, due to that the sensitivity and specificity of 18F-FDG PET in staging NSCLC, the cost structure of medical expense, the severity of disease for NSCLC patients when they first present in the hospital, may be different between different countries. To the best of our knowledge, there has been no report that provides a practical guide to introduce PET in staging NSCLC. A cost-effectiveness economic evaluation in Taiwan is thus in demand.

Patient eligibility:

Inclusion criteria: Patients with early NSCLC (stage I \& II) Exclusion criteria: (1) patients who are pregnant (2) patients under 18 years old (3) patients who refuse surgical intervention (4) patients who have other known malignancy

Eligibility Criteria:
Inclusion Criteria:

* patients with non-small-cell lung cancer

Exclusion Criteria:

* patients who are pregnant
* patients who are under 18 years old
* patients who do not undergone surgery
* patients who have other known malignancy
Implementing Dementia Care Management Into Routine Care in the Region Siegen-Wittgenstein

Dementia Care Management (DeCM) is an evidence-based model of care in Germany. It has proven its efficacy and cost-effectiveness. However it has not been implemented into routine care so far.

The aim of this trial is to implement Dementia Care Management into routine care in a selected region in Germany and evaluate the process of implementation as well as the effect of Dementia Care Management on participants.

Recruited in regular routine care n=60 people with cognitive impairment and/ or their cares will receive Dementia Care Management provided by specifically trained and qualified dementia care managers for 6 months.

Data will be assessed and analysed prior to the implementation, immediately after having received the intervention and at a later time point.

The effect of the intervention on person-oriented health care outcomes wil be analysed as well as factors associated with that.


Eligibility Criteria:
Inclusion Criteria:

* person with cognitive impairment living in household
* living in the region of Siegen-Wittgenstein
* written informed consent

Exclusion Criteria:

* institutionalisation of person with cognitive impairment
* lacking sufficient communication skills
A Study of LY2775240 in Healthy Participants

This study is conducted to determine the side effects related to LY2775240 given orally to healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into the bloodstream and how long the body takes to get rid of it. Each participant will enroll in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks respectively, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy adult male or a female who cannot get pregnant
* Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive
* Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
* Have known allergies to compounds or drugs similar to LY2775240 or apremilast
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit

Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections.

The main aim of this study is to assess the number of cases and describe the clinical, biological and microbiological characteristics of these cases of severe communautary invasive bacterial infections in children hospitalized in pediatric intensive care units. In addition, the management of these hospitalized children will be described.

Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years (only hospitalized children)
* Severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment).

Exclusion Criteria:

* Refusal by one of the parents or by Child in understanding age
* Nosocomial infection
An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

In this phase II study, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. Patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (PFS-6).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed GBM.
* GBM in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with Temozolomide.
* Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
* No more than one prior line of chemotherapy (Temozolomide).
* Recovery from the toxic effects of prior therapy.
* Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:

  1. Surgery must have confirmed the recurrence.
  2. A minimum of 14 days must have elapsed from the day of surgery to registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
  3. Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration.
* Age ≥ 18 years.
* Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
* Karnofsky-PS ≥ 60%.
* Stable or decreasing dose of corticosteroids within 5 days prior to registration.

Exclusion Criteria:

* Patients unable to undergo brain MRI scans with gadolinium (iv).
* Pre-existing peripheral neuropathy, grade ≥ 2.
* History of intracranial abscess within 6 months prior to registration.
* Anticipation of need for major surgical procedure during the course of the trial.
* Treatment with enzyme inducing antiepileptic agents was not allowed. However, patients whose anticonvulsant was changed to a nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period
Improving Disease Knowledge in Adolescents With Sickle Cell Disease

Increased knowledge about an illness can increase self-management among those afflicted. In order to facilitate people with sickle cell disease living a longer and healthier life, they should be taught to manage their illness.An adolescent with a chronic illness has many unique challenges, in addition to maneuvering the turbulent adolescence period itself. It has been that better knowledge and more positive perceptions of their illness equate not only to better control of their illness but also better quality of life.Studies have also shown the benefits of self-management: when patients are responsible for managing their own illness, their clinical outcomes and quality of life improve and they become less dependent on health care services.

In this study we aim to examine if knowledge, and any changes in knowledge, will each have any association with Quality of Life (QOL) and their perceptions of their illness (IP). We also seek to investigate the effects of an educational booklet, as well as an intervention including the educational booklet with formal counselling on their knowledge, QOL and IPs.

In this inquiry, we wish to apply an educational intervention to determine if there are any improvements in disease knowledge as a result among adolescents attending the Sickle Cell Unit (SCU) in Jamaica. We also wish to examine if knowledge, and any changes in knowledge, will each have any association with Quality of Life (QOL) and their perceptions of their illness (IP).

Our specific hypotheses are:

1. Important predictors of knowledge among adolescents with Sickle Cell Disease (SCD) are gender, age, education of the adolescent as well as of the parents, socioeconomic status, frequency of attendance at SCU, rural/urban residence, and disease severity.
2. The intervention involving training using an educational booklet specific to 'teens living with SCD' will improve knowledge among the adolescents
3. Adding 'individual Counselling' to the intervention will increase the benefits
4. Improvements in knowledge will translate to improvements in QOL and positive IPs.

Eligibility Criteria:
Inclusion Criteria:

* All adolescent patients, ages 13-19 years inclusive, with Sickle Cell Disease that attend the Sickle Cell Unit at University of the West Indies, Mona Campus will be eligible for the study and hence will be asked to participate.

Exclusion Criteria:

* adolescent with neurological disorders e.g. Cerebrovascular accidents or with physical or intellectual disabilities will be excluded.
Metoclopramide for Post-Traumatic Headache. A Pilot Study

Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
* The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
* The plan of the attending emergency physician must include treatment with parenteral metoclopramide.

Exclusion Criteria:

* Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve pinching and entrapment. Historical risk of 25% annually has been reported to decrease by \>80% to under 5% yearly. Since an open wound precedes the large majority (85%) of amputations in diabetes, avoidance of ulcer recurrences is important. This study tests the current academic opinion that nerve decompression will not decrease ulcer recurrence risk. Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.

Diabetes patients with a recently healed, non-ischemic plantar diabetic foot ulcer will be randomized to "best care" standard post-ulcer treatment or to best care plus bilateral nerve decompression by external neurolysis at 4 fibro-osseous tunnel sites in the leg and foot. Comparison of the control group with standard care to the surgical intervention group will be made for subsequent appearance of a plantar foot ulcer and ulcer recurrence risks will be calculated. Additional subjective and objective secondary outcomes will be monitored. Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.

If protection against ulcer occurrence were to be confirmed, a change in the treatment paradigm for diabetic neuropathy and foot ulcer could be appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 Diabetes Mellitus
* Diabetic sensorimotor peripheral neuropathy
* Recently healed plantar neuropathic Diabetic Foot Ulcer (\< 18 months)
* At least one palpable foot or ankle pulse or ABI\>0.8 bilaterally.
* Recent Hgb A1c \< 9.0%
* Ankle edema absent or mild

Exclusion Criteria:

* Ischemic peripheral vascular disease or ankle-brachial index (ABI)\<0.8
* History of peripheral vascular arterial surgery
* History of peripheral nerve or lumbar disc surgery
* alcohol abuse(more than 2 drinks/day)
* untreated thyroid disorders
* B12 or Folate deficiency
* spondyloarthropathies
* hepatic disease
* advanced renal disease
* current lumbosacral radiculopathy or nerve compression
* toxin exposure including chemotherapeutic agents
Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus

Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.

Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.

The systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.

Therefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1DM
* Hospitalization because of DKA
* Age ≥ 12 years.

Exclusion Criteria:

* Diagnosis of T2DM
* Diagnosis of Infection
* Renal impairment
* Malignancy
* ASCVD (atherosclerotic cardiovascular disease)
* History of any medical condition or medications that can change CBC parameters or cause metabolic acidosis
* Pregnancy
Evaluation of an Herbal-Based De-Pigmenting System

The purpose of this study is to evaluate the effectiveness and tolerability of an herbal de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to the other side of the face in treating mottled hyperpigmentation and melasma.

This clinical study is being conducted in order to evaluate the effectiveness and tolerability of a de-pigmenting regimen when used by subjects with mild to severe mottled hyperpigmentation and melasma. Efficacy will be assessed using visual grading, device measurements and digital photography. Tolerance and safety will be evaluated by grading for objective and subjective signs of irritation, and the incidence and severity of adverse events. Efficacy and tolerance of this product are compared to that of Hydroquinone, which is applied to one side of the subject's face while the herbal de-pigmenting regimen is applied to the other side of the face.

The two product pigmentation reducing herbal regimen is based on the novel concept of inhibiting all 14 major and the 3 branch steps in the melanin cascade.

Eligibility Criteria:
Inclusion Criteria:

* Female age 30-65
* Must be in good general health
* Must be willing to use sunscreen on the face daily
* Must be willing to avoid tanning beds and excessive exposure to direct sunlight
* Must be willing to continue using regular cosmetic regimen

Exclusion Criteria:

* Nursing pregnant/ planning to become pregnant during the course of the study
* Using a medication that increases sensitivity to sunlight including doxycycline, minocycline, tetracycline, ciprofloxin, hydrochlorothiazide, and sulfonamides.
* Any known allergies/sensitivities to facial skincare products, anti-aging products, de-pigmenting products, or products containing hydroquinone
* Usage of any new skincare products during the course of the study
* Presence of atopic dermatitis or psoriasis on the face
* Uncontrolled diabetes, hypertension, hypothyroidism, hyperthyroidism
* TCA or other deep peels within 1 year or medium to light peels within 3 months prior to starting the study
* Facial/laser treatment within the last 3 months
* Facial cosmetic surgery within the last 12 months
* Use of product, topical, or systemic medication, known to affect dyschromia, having "whitening" or anti-aging properties
* Physical skin conditions such as excessive hair, scarring, tattoos that might impair evaluations of the test sites
* Active hepatitis, immune deficiency, or autoimmune disease
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins

The purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and practical activity in skill lab with low-fidelity mannequin or simulation class with low-fidelity mannequin.

The airway control is priority in patient resuscitation. The Laryngeal Mask Airway (LMA) can minimize complications, establishing a safe airway. Is fundamental to nurse acquired skills to act in emergency situations; the simulation is a important learning tool for this, because allows a realistic environment and allows to student the possibility of training skills.

Hypothesis: There difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: classroom lecture-dialogued follow of laboratory activity practice with low-fidelity mannequin or simulation in laboratory with low-fidelity mannequin?

The aim of this study is compare the effect of teaching-learning strategies: classroom lecture-dialogued follow of laboratory activity practice with low-fidelity mannequin or simulation in laboratory with low-fidelity mannequin, in the acquisition of knowledge and skills to baccalaureate nursing. This is a randomized controlled trial, the population is all students of baccalaureate nursing of EERP-USP, eighth period, 69 students in total; the sample will be voluntary and composed for students that accept participate of study. The intervention group (IG) will be submitted to simulation class and the control group (CG)to exhibition-dialogued class, and practical activity in skill lab. The study will have 3 steps:

1. The participants will be recruited with letters and posters, randomized to IG or CG and follow submitted to write pre-test.
2. The GI will submitted to simulation in laboratory and de CG classroom lecture-dialogued follow of laboratory activity practice. The focus will be the airway management with emphasis in LMA.
3. All participants will be submitted to write post test and follow to practice test in simulation scenario, with medium-fidelity mannequin, which simulates human physiologic conditions.

The scenario will have a appraiser with a checklist which performance scores of skills and interventions observed. The activities will be filmed and recorded. To data analysis will be used the SPSS software: descriptive statistics, chi-square test, t-test of Student.

Eligibility Criteria:
Inclusion Criteria:

* student must be in the eighth period of course;
* must be registered regular in the baccalaureate nursing course.

Exclusion Criteria:

* absence in any step of study.