cyrilzakka/clinical-trials huggingface dataset:
Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.

Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old.
* Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.

Exclusion Criteria:

* Those who received colistin therapy less than 48 hours
* Those who received colistin therapy through the bronchus
Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients

Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of surgery. When CT examination performed, those patients were in supine position, with the arms stretched upward but bent at the elbow with the hands at the side of the cranium which similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about 1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was identified as the most inferiorly visible nodule in the axilla connected to the lymphatic vessel on the CT imaging monitor. A professional intervention doctor punctured the defined lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv). The needle would stay in the patient's axilla until the surgery. All the lymph nodes including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid tracers were removed, which then would be tested by touch imprint cytology for the intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection. The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients（T1-T2N0）
* Age 18-70
* Accept of SLNB
* Accept our protocol in the informed consent

Exclusion Criteria:

* LABC patients
* Age \< 18
* History of epilepsy
* History of thyrotoxicosis
* Pregnant women
CHF Management Using Telemedicine

The overall objective of this study is to improve clinical outcomes and quality of life for congestive heart failure (CHF) patients by integrating a readily available, low cost technology - the telephone - into coordinated CHF care.

Strong patient-provider communication and vigilant home-based monitoring can be critical elements of successful chronic disease management. Among CHF patients, automated clinical data acquisition via the telephone can improve insight into inappropriate use of medications and onset of fluid overload or edema - indicating deteriorating heart function (notably worsening ejection fraction). Routine, timely monitoring of this data can direct a nurse case manager to the subset of CHF patients likely to benefit from a clinic visit, evaluation, diagnosis, and counseling. This should result in: significantly increased medication compliance, significantly lower emergency department (ED) visits and hospital admissions (both those related to CHF and other conditions related to diminished physical capacity of patients with CHF), and improved physical function.

This study is intended to answer three questions. First, do potentially avoidable acute events (measured by ED visits and hospital admissions) decrease when CHF management is accompanied by systematic telephone-based monitoring as compared with usual care? Second, does medication compliance improve when CHF management is accompanied by systematic telephone-based monitoring as compared with usual care? Third, does perceived health status (physical and emotional function) improve when CHF management is accompanied by systematic telephone-based monitoring as compared with usual care?

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed CHF
* Member of Kaiser Permanente Georgia
Venous Distension in Patients With Aneurysmatic Arterial Disease

The aim of the study is to assess if venous distension in patients with aneurysmatic arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD) and in controls.

Patients with aortic aneurysm and patients with PAOD and Controls will be investigated in the following manner: Duplexsonography with assessment of the arterial diameters in the aorta and leg arteries. Duplexsonography with assessment of venous reflux in proximal and deep veins of both legs Duplexsonography testing of venous distension in the common femoral vein, the great saphenous vein and the femoral vein.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dilatative arteriopathy (DA) the aortic diameter must be \> 3 cm or the popliteal artery diameter \> 1.5 cm
* Patients with arterial occlusive disease (PAOD) defined with an Ankle brachial index (ABI) \< 0.9 and positive criteria in the Edinburgh questionnaire
* Patients able to give informed consent
* Control group of age matched persons without PAOD (ABI \> 0.9) and without DA

Exclusion Criteria:

* Impossibility to stand
* Diabetes
* No given informed consent
* Persons and patients \< 18 years old
* Acute deep venous thrombosis
* History of deep venous thrombosis
Antenatal Allopurinol in Intrauterine Growth Restriction

Growth retardation in utero may be caused by uteroplacental vascular insufficiency. When Doppler ultrasound studies of the umbilical artery are abnormal pathological intrauterine growth restriction (IUGR) can be diagnosed. IUGR fetuses have a higher mortality and morbidity, both perinatally and on the longer term. This is probably due to chronic malnourishment and hypoxia due to placental insufficiency. This placental dysfunction causes generation of harmful free oxygen radicals in the fetus. The IUGR fetus has a diminished antioxidative capacity which means these free radicals cannot be buffered sufficiently. This leads to fetal oxidative stress.

Previous studies have shown that allopurinol can inhibit the cascades that lead to generation of free radicals. High dosed allopurinol also scavenges radicals and binds free iron without adverse effects on the fetus or mother.

As IUGR is associated with placental insufficiency and excessive production of free radicals we hypothesize that antenatal allopurinol administration could lead to a decrease in oxidative stress in the mother and fetus and subsequent improvement of the maternal and/or neonatal outcome.


Eligibility Criteria:
Inclusion Criteria:

Mothers with a gestational age (GA) of 30 to 36 weeks with:

* Foetal growth retardation (growth \<10th percentile) and
* Abnormal Doppler flow in the umbilical cord (umbilical artery pulsatility index (PI)\>95th percentile)

Exclusion Criteria:

* Congenital, chromosomal or syndromal abnormalities
* Positive screening for intrauterine viral infections
* Mothers with gout and high uric acid
* creatinine \> 100 umol/l
* ASAT \> 80 U/l, ALAT \> 80 U/l
* Uric acid \> 0,50 mmol/l
Exercise and Plasticity in Parkinson Disease

We will study the effects of intensive rehabilitation in PD on plasticity with a multimodal approach. We will define first, whether exercise in PD restores the potentiation of the motor cortex to normal levels with both 5 Hz-rTMS PAS and beta modulation and whether such improvements are accompanied by structural changes studied with diffusion MRI tractography and network analysis (Aim 1). With the study of muscle synergies and spatiotemporal organization of the spinal motoneuronal output during gait and reaching movements we will define the presence of functional changes in spinal cord mechanisms and connectivity and whether such changes are global or involve selective districts (Aim 2). Finally, we will study post-exercise changes in sleep pattern, as sleep is impaired in PD and plays a crucial role in the definition of plasticity-related phenomena (Aim 3). This project will generate breakthrough data on the mechanisms of exercise, novel biomarkers to monitor efficacy of treatments and thus, possibly leading to better restorative, disease-modifying and symptomatic therapies for PD.

We will study the effects of intensive rehabilitation in PD on plasticity with a multimodal approach. We will define first, whether exercise in PD restores the potentiation of the motor cortex to normal levels with both 5 Hz-rTMS PAS and beta modulation and whether such improvements are accompanied by structural changes studied with diffusion MRI tractography and network analysis (Aim 1). With the study of muscle synergies and spatiotemporal organization of the spinal motoneuronal output during gait and reaching movements we will define the presence of functional changes in spinal cord mechanisms and connectivity and whether such changes are global or involve selective districts (Aim 2). Finally, we will study post-exercise changes in sleep pattern, as sleep is impaired in PD and plays a crucial role in the definition of plasticity-related phenomena (Aim 3)

Eligibility Criteria:
Inclusion Criteria:

Idiophatic Parkinson Disease

* H\&Y stage I-II stable medication

Exclusion Criteria:

* Severe comorbid medical illness (diabetes, heart disease, hypertension); history of known causative factors (encephalitis or neuroleptic treatment); other neurologic disability; chronic treatment for sleep complaints; history of seizure, including febrile seizures, family history of epilepsy; pacemakers, neurostimulators, tattoos, metal foreign bodies in the head area; recurrent visual hallucinations; fluctuating cognition, attention or alertness; depression (HAMD\> 12) or dementia (MMSE \<24).

Controls will be age- and education- matched subjects.
Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm

Intensive endoscopic surveillance following piecemeal resection of non-pedunculated colorectal lesions (NPCL) ≥20 mm is the current standard of care, given the high recurrence rate of these lesions (15-30%). However, most recurrences are detected at 12 months, are small and unifocal, and can be easily resected endoscopically. Furthermore, thermal margin ablation has demonstrated a reduction in recurrence rates to 5-6%, highlighting the need to optimize current surveillance protocols, which are costly, invasive, and impose a significant clinical burden.

The multicenter SCARFACE clinical trial aims to evaluate whether a reduced surveillance protocol (at 12 and 48 months) is non-inferior to the standard protocol (at 6, 12, and 48 months) in terms of recurrence rates, using a predefined non-inferiority margin. This non-inferiority design aims to determine if the reduced protocol maintains acceptable efficacy while reducing clinical workload and minimizing risks and discomfort associated with intensive follow-up.

Patients will be randomized in a 1:1 ratio into the two surveillance protocols, with an estimated sample size of 746 lesions. The primary objective is to compare the cumulative incidence of recurrence at 12 months. Secondary objectives include characterizing recurrences, assessing complications associated with endoscopic treatments and evaluating the incidence of advanced colorectal lesions. The findings of this study are expected to directly impact clinical guidelines and routine practice, optimizing resource utilization and improving patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a single non-pedunculated colorectal lesion (NPCL) ≥20 mm that has been resected piecemeal and treated with thermal ablation (using snare tip or argon plasma) at the margins as prophylaxis against recurrence, and who are awaiting the initiation of specific endoscopic follow-up.
* Complete colonoscopy with adequate or excellent bowel preparation performed within the last 6 months prior to the resection of the index lesion.
* Signed informed consent.

Exclusion Criteria:

* Resection performed using a cold snare technique due to the high risk of recurrence.
* Histology of the lesion showing malignancy: colorectal cancer with submucosal invasion, regardless of invasion depth in microns.
* Absence of information regarding the grade of dysplasia of the index lesion.
* Personal history of colorectal cancer.
* Incomplete endoscopic resection of the index lesion or any other polyps present in the patient.
* When the endoscopist performing the index colonoscopy expresses doubts about whether the resection was complete.
* Index lesion with prior attempted resection.
* Hereditary cancer syndromes (e.g., adenomatous or serrated polyposis syndromes, Lynch syndrome, etc.).
* Inflammatory bowel disease.
* Severe comorbidities with reduced life expectancy.
* Pregnancy.
* Ongoing cytotoxic treatment or radiotherapy for a malignant disease.
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults

This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.

The BCG vaccine has been widely available for several decades. It is easy and cheap to produce, and when given to neonates or young children it is effective in preventing severe manifestations of disease such as meningeal tuberculosis and miliary tuberculosis. However, in terms of the capacity of the vaccine to protect adult humans it shows a wide range of efficacy, including zero levels of protection. Due to the general realization that BCG is losing its protective effect, particularly in terms of preventing adult-onset tuberculosis, a major effort has been made to try to develop new alternative vaccines. One such candidate, Mtb72F/AS02A, is a polyprotein derived from two known M. tuberculosis antigens adjuvanted with AS02A. Mtb72F/AS02A is a candidate TB vaccine under development for two indications: prevention of primary TB infection in young children in highly endemic areas and as an adjunct to treatment for TB in adolescents and adults.

Eligibility Criteria:
INCLUSION CRITERIA

* Written informed consent
* Healthy PPD-positive volunteers aged 18 to 50 years
* No active pulmonary disease as confirmed by chest X-ray
* No history of extrapulmonary TB
* Seronegative for HIV 1 and 2, HBsAg, and HCV
* Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
* Females : Non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

EXCLUSION CRITERIA

* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
* History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
* Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
* History of hypersensitivity to vaccines or vaccine components
* History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU

The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria
* Subjects must have active disease at Screening as defined by
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4
* Spinal pain \>= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)
* Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) \> upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria
* Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator
* Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline

Exclusion Criteria:

* Other inflammatory arthritis
* Secondary, noninflammatory condition that, in the Investigator's opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of axial spondyloarthritis (axSpA)
* Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA
* Any condition or complicating factor that may interfere with the AU assessment
* Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device
* Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit
* Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit
* Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit
* Cyclophosphamide within 30 days prior to the Baseline Visit
* Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit
* Intravitreal anti-vascular endothelial growth factor (VEGF) therapy
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.

Eligibility Criteria:
Inclusion Criteria:

* A male or female subject 15 years of age or older at the time of the study entry.
* Written informed consent obtained from the subject/ from the parent or guardian of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
* Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
* Non-childbearing potential female

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Use of any registered vaccine within 7 days before the first dose of study vaccine.
* Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 months.
* Use of immunoglobulins within six months preceding the first study vaccination.
* Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
* Any confirmed or suspected human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature \< 37.5°C (or 37 °C in Czech Republic).
* Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
* Pregnant or lactating female
A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension

Evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple interventions reduce its incidence and to assess the value of detailed instruction in increasing patient compliance and willingness to continue bimatoprost therapy, despite the occurrence of hyperemia.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age

  * No prior use of bimatoprost
  * Diagnosis of open-angle glaucoma or ocular hypertension
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to bimatoprost

  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension
  * Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted)
  * History of intraocular surgery within the last 3 months
Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).

The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years.
* Upper limb impairment caused by any stroke (CVA)
* Minimum of trace MMT (1/5) in Biceps and/or Triceps
* Full Passive range of motion in elbow, forearm, wrist, and hand
* Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
* Score of at least 20 on the Mini Mental Status Examination.
* Ability to read and comprehend the English language.
* Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.

Exclusion Criteria:

* Fixed upper limb contractures on affected side.
* Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
* Inability to follow three step directions.
* Severe shoulder subluxation, pain or shoulder dislocation.
* Passive shoulder range of motion less than 45 degrees in flexion and abduction.
* Pain or hypersensitivity in the arm(s)