cyrilzakka/clinical-trials huggingface dataset:
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.


Eligibility Criteria:
Inclusion Criteria:

* chronic renal anemia;
* continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
* regular hemodialysis for greater than or equal to (\>=) 3 months

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months
* poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
Expression Analysis of Urinary Exosome in Type 2 Diabetic Kidney Disease and Evaluation of Its Clinical Diagnostic Value

Expression analysis of urinary exosome miR-136-5p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value

1. Preliminary screening of miRNAs: Through GEO database and reading related literature, miRNAs differentially expressed in type 2 diabetes and diabetic nephropathy were selected as potential candidate biomarkers for follow-up verification.
2. Collection and treatment of clinical samples: Urine of diabetic patients was collected from the First Affiliated Hospital of Shandong First Medical University in strict accordance with the drainage standard, and the basic information of patients was registered. Meanwhile, the collected samples were divided into type 2 diabetes group and diabetic nephropathy group according to whether the urine was accompanied by UACR≥300/g. Subsequently, the collected samples were centrifuged and retained for supernatant.
3. Isolation and identification of urinary exosomes: Ultrafast centrifugation method was used to separate the treated urine samples of exosomes, and then identified by transmission electron microscopy, nanoparticle analysis and Western blot respectively.
4. Real-time PCR was used to detect the changes in urinary exosomal miRNA expression levels of the two groups of patients, and statistical analysis and correlation analysis of clinical indicators of the differentially expressed mirnas were performed.
5. Target gene prediction and enrichment pathway analysis of differentially expressed mirnas were performed to screen out pathways that might be related to the occurrence and development of DKD, and then the relevant pathways were verified by immunofluorescence, immunocoprecipitate, Western blot, Real- time PCR and other methods.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Previously diagnosed with type 2 diabetes;
3. Typical diabetic symptoms (polydipsia, polydipsia, polyuria and weight loss) plus random blood glucose ≥11.1mmol/l;
4. Fasting blood glucose ≥7.0mmol/l, fasting is defined as at least 8 hours without intake of calories;
5. Oral glucose tolerance test (OGTT) 2-hour blood glucose ≥11.1mmol/ l, using a glucose load equivalent to 75 grams of anhydrous glucose dissolved in water (venous blood was drawn in all patients;
6. With or without UACR≥300mg/g.

Exclusion Criteria:

1. Refused to enroll patients;
2. Type 1 diabetic nephropathy and other special types of diabetic nephropathy; 3.Patients with kidney stones and urinary system infection;

4.Patients with autoimmune system diseases, malignant tumors, and blood system diseases; 5.Patients with severe chronic cardiopulmonary disease, chronic liver and kidney disease; 6.Patients with severe infectious diseases; #7#Use of glucocorticoids, immunosuppressants or cytotoxic drugs.
Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

All clinical variables are gathered from chart review. Data analysis is conducted using SPSS statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or Wilconxon signed test were used fr the analysis differences. Comparison between proportions were analyzed using a chi-square test. A P value \<0.05 was considered statistically significant.

The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic Commitee. All participants provided written consent.

Eligibility Criteria:
Inclusion Criteria:

* Presence of Type 1 diabetes.
* Age \>18 years.
* Patients previously followed in the DIACAM study.

Exclusion Criteria:

* Any other kinds of diabetes.
Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract

Age related cataract is believed to be the main cause of reversible blindness worldwide and in developing countries. Population-based studies have reported that cataract is responsible for 47.8% to 51% of all global blindness.

Several studies compared phacoemulsification and conventional extracapsular cataract extraction regarding several aspects such as postoperative inflammation and visual rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less astigmatism and better postoperative vision .However, Extracapsular cataract extraction is still the operation of choice in some cataract cases.

The normal corneal endothelium is a single layer of uniformly sized cells with a predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the space as the cells cannot regenerate.The minimum cell density necessary for adequate function is in the range of 400 to 700 cells/mm2.

The effect of cataract surgery on corneal endothelium is an important factor that affects postoperative vision .However, it is accepted all over the world that there is definite loss of some endothelial cells with all techniques of cataract surgery. Previously, cataract surgery caused enormous loss of endothelial cells , but with enhancement of equipment and surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.

Specular microscopy is a noninvasive photographic technique that allows visualization and analysis of corneal endothelium. specular microscopy is used to show cell count and cell shape in the scanned area.

Eligibility Criteria:
Inclusion Criteria:

* Cases of senile cataract of both sexes will be included in this study

Exclusion Criteria:

* Corneal endothelial pathologies such as Fuch's dystrophy
* Complicated cataract
* Cataract with history of trauma
* Coexisting eye pathology
Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b

The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.

Background

Multiple sclerosis is a chronic inflammatory autoimmune disease of the central nervous system. Statins are lipid-lowering drugs which inhibit the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA-) reductase, which is the main regulatory enzyme of cholesterol biosynthesis. In recent years many studies have demonstrated, that statins have anti-inflammatory and immunomodulatory properties in addition to their lipid-lowering effects. Therefore, statins may have therapeutic potential in immune-mediated disorders such as multiple sclerosis. Studies in experimental allergic encephalomyelitis (EAE), the animal model for the human demyelinating disease multiple sclerosis, as well as smaller studies in patients with relapsing-remitting multiple sclerosis showed beneficial effect on the course of the disease. But there are also reports of negative impact of statins on multiple sclerosis. Therefore, bigger studies are needed to investigate the therapeutical potential of statins in multiple sclerosis.

Objective

To assess the efficacy, safety and tolerability of the combination of atorvastatin 40mg p.o. daily and interferon-beta 1b sc e.o.d compared to monotherapy with interferon-beta-1b sc e.o.d in patients with relapsing-remitting multiple sclerosis for 12 month after completing the SWABIMS study.

Methods

Multi-center, rater-blinded, parallel-group, two arm, randomized study. Patients with relapsing-remitting forms of MS, respecting all inclusion/exclusion criteria, were randomized in the SWABIMS study in two equal-size parallel arms after three months of treatment with interferon-beta 1b, receiving atorvastatin 40mg/d or not in addition to interferon-beta 1b for 12 month.

After successful completion of the study, patients were asked to participate in the "SWABIMS Follow up study" for another 12 month with ongoing medication.

Eligibility Criteria:
Inclusion Criteria:

* Successful completion of the SWABIMS study
* Written informed consent

Exclusion Criteria

* Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
* Secondary progressive MS
* Uncontrolled severe medical disorder
* Participation in any other studies
Enhanced Tactile (Touch) Spatial Acuity in Upper Limb Amputees

This study will examine whether tactile (touch) abilities at the lip are more acute in people with upper limb amputation compared with healthy normal volunteers. People with an amputated upper limb have an expanded brain representation of the lip that may correlate with heightened tactile spatial acuity.

Normal volunteers will be recruited for this study. Candidates will be screened with physical and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at the University of Tubingen, Germany.)

Participants will sit comfortably in a chair, wearing a blindfold, during the following experiments:

* Plastic domes with grooves are placed on parts of the lower lip on either side for a few seconds. The volunteer is then asked to identify the direction of the grooves relative to the long axis of the lip.
* The participant's arm is placed in a cast and the index finger is immobilized. The same test done on the lip is repeated on the distal part of the index finger.

Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.

Upper limb amputation leads to expansion of the cortical representation of the lip into the adjacent deafferented hand representation. It is conceivable that this enlargement of the lip representation may translate into a behavioral gain. The purpose of this protocol is to test the hypothesis that upper limb amputation in humans results in higher tactile spatial acuity at the lip. This would represent the first demonstration of chronic deafferentation-induced behavioral gains within the somatosensory system.

Eligibility Criteria:
INCLUSION CRITERIA:

Normal volunteers who are willing and able to stay relaxed and collaborative for a period of up to 2 hours.

Subjects with upper limb amputation more than one year before testing.

EXCLUSION CRITERIA:

Neurological or psychiatric disease

Excessive callus at the palm of the fingers

Subjects, who are unable to perform or understand the task
Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

Consecutive patients 12 years or older due for myringoplasty or stapes surgery at the ENT-department, University hospital of Tromsø, in an approximate time span of one year, have been studied with the following audiometric investigations at the preoperative admission, 2, 6 and 12 months postoperatively: Transient otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, speech audiometry using spondaic recognition for air and bone-conduction. Results will be statistically analysed using the Statistical Package for the Social Sciences, with the unoperated ear (paired organ) serving as controls. The goal is to look at alternative methods for analysing the patients' preoperative hearing in order to increase the precision of clinical decision-making. The secondary goal is to elucidate the effects of middle ear surgery on the inner ear.

Eligibility Criteria:
Inclusion Criteria:

* Tympanic membrane perforation without chronic secretion or cholesteatoma
* Suspected otosclerosis

Exclusion Criteria:

* Below 12 years of age
* Patient not consenting to study
* Perioperative findings suggesting chronic otitis or cholesteatoma
* Patients not fluent in Norwegian or unable to cooperate in audiometry
Comparison Between Topical Mitomycin C and Cyclosporine

Pterygium is a disease associated with proliferation of the fibrovascular tissues of the conjunctiva into the cornea and is related to factors such as ultraviolet light exposure, chronic stimulation, inflammation, climate, and genetics.

The first line of treatment for primary pterygium is surgical excision, and despite postoperative adjuvant therapy using mitomycin C, cyclosporine, β-irradiation, argon laser, and bevacizumab, recurrence rates remain high .

Mitomycin C is a metabolic inhibitor extracted from Streptomyces caespitosus that inhibits DNA synthesis .

Cyclosporine is an immunosuppressant that selectively suppresses T-helper cells, controls interleukin synthesis and secretion, and inhibits vascular endothelial growth factor (VEGF)

Bevacizumab is an anti-VEGF antibody that inhibits angiogenesis. Each agent has been studied as an adjuvant therapy to inhibit post-surgery pterygium recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary pterygium
* Pterygium size \> or equal 2mm (the horizontal length of the tissue from limbus to cornea will be measured by slit lamp biomicroscopy).
* Ocular discomfort refractory to medical treatment.
* Visual loss induced by pterygium.
* Adult Egyptian population

Exclusion Criteria:

* Patients who had recurrent pterygium or allergy to topical Cyclosporine.
* Patients who had allergy from Mitomycin C.
* Pregnant women.
* Patients with uncontrollable systemic diseases such as hypertension, diabetes, or cardiovascular diseases.
* Patients with diseases of the eye surface such as conjunctivitis and keratitis.
* Patients with a history of eye surgery within the previous six months.
Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.

The concentration of cipro will be determined using a validated high-performance liquid chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the HPLC system.

Eligibility Criteria:
Inclusion Criteria:

Children who

* are between 1 month and 18 years of age
* are under treatment for any type of childhood cancer
* use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment
* have a PAC for intravenous medication and blood draws.

Exclusion Criteria:

Children will be excluded from this study if we are unable to

* obtain informed consent of both parents and assent of the child (if he/she is over 12 years of age)
* aspire blood from the PAC.
Monitor System for the Safety of Dabigatran Treatment

The purpose of this study is to determine whether dabigatran is associated with higher risk of bleeding in Asia area especially in China clinical practice and whether it need to set up a monitor system.

Dabigatran is administered in a fixed does without laboratory monitoring and is being compared with warfarin (international normalized ratio, but only hundreds of evidence from Asia events in several multicenter, prospective, randomized trails. It remains unclear that whether Dabigatran is safety in China clinical practice and no need of monitor test. We identified participants as those diagnosed as having nonvalved atrial fibrillation, and who initiated dabigatran after diagnosis.We followed up each individual from the first prescription of dabigatran until discontinued use or switch of anticoagulants, death, or other outcomes or until one year later. We categorized bleeding events as major and minor events according to anatomical position. We defined time to bleeding as days between the first dabigatran prescription and the date of the bleeding event. We analyzed the time to the first bleeding event, as well as the time to the first major hemorrhage, intracranial hemorrhage, gastrointestinal bleeding, hematuria, vaginal bleeding, hemarthrosis, hemoptysis, and epistaxis.

Eligibility Criteria:
Inclusion Criteria:

1. Age\>18 y at entry
2. AF documented as follows: The patients has a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG, rhythm strip, pacemaker/implantable cardioverter-defibrillator electrogram, or Holter ECG
3. In addition to documented AF, patients must have ≥1 CHADS2-VAS scores
4. We identified participants as those diagnosed as having AF, and who initiated dabigatran after diagnosis
5. Written, informed consent

Exclusion Criteria:

1. History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
2. Severe, disabling stroke, or any stroke within the previous 14d
3. Acute coronary syndrome within 1 year in AF patients
4. Conditions associated with an increased risk of bleeding

   1. Major surgery in the previous month
   2. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
   3. Gastrointestinal hemorrhage or hematuria
5. Severe renal impairment (estimated creatinine clearace≤30ml/min)
6. Severe liver dysfunction
7. Alcohol abuse or drug addiction
8. Patients who have received an investigational drug at this time
9. Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trail
Diagnosing of Acute Tuberculosis

Sweat proteins are analysed to investigate differences in protein markers in patients with acute tuberculosis and other pulmonary diseases (pneumonia, Bronchitis, chronic obstructive pulmonary disease (COPD)) and healthy individuals. Differences in sweat protein markers in patients with positive and negative tuberculosis Enzyme-linked-immuno-Spot (EliSpot) are investigated.

Differences in sweat protein markers in the course of treatment in patients receiving tuberculostatic therapy are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative
* In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD)

Inclusion Criteria Healthy Donors:

* negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion Criteria:

* Initiation of tuberculostatic therapy before baseline
* Initiation of antibiotic therapy in patients with other pulmonary diseases \> 6 hours before baseline
Most People With Low Back Pain Have Associated Cervicothoracic Musculoskeletal Dysfunction: an Observational Study

In general , the diagnosis of back pain can be broken into three major categories: Mechanical ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders , neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red herrings that must be considered most seriously.

The investigators have observed in their practice that lateral pressure on 5th lumbar vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over cervicothoracic spines reproduce original low back and leg pain. So the question arises whether Cervico-thoracic dysfunction is associated with low back pain with or without radiation to lower extremities?


Eligibility Criteria:
Inclusion Criteria:

* mechanical low back pain with or without radiation to lower limb.

Exclusion Criteria:

* any recent trauma or fractures to cervico-thoracic junction, osteoporosis, inflammatory arthritis, tuberculosis, bone disease, congenital deformity
* vascular disorders
* rapidly progressing neurological deficits
* sudden onset of neurological deficits and all red flags to manual therapy.