cyrilzakka/clinical-trials huggingface dataset:
The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids

There has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. Previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. Therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

It is well known that blood glucose level is elevated in diabetes patients more than non-diabetes patients who underwent the epidural steroid injection. However, there has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. Previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. Therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

Eligibility Criteria:
Inclusion Criteria:

* subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic
* subjects older than 20 yrs.

Exclusion Criteria:

* ASA (American society of Anesthesiologists class) III or more
* severe cardiopulmonary disease or brain disorder
* Subjects diagnosed uncontrolled diabetes with complications
* subjects undergoing hormone therapy
* subjects with active infection
* subjects with pregnancy
* subjects with recent stress condition such as surgery or trauma
* subjects with active neurologic disorder
* those with anticoagulation therapy
Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder

This study was done to investigate whether platelet rich plasma(PRP) injections are effective in the management of adhesive capsulitis of the shoulder(AC).Patients were randomized to 2 groups, and one group took PRP injections for 3 times every two weeks, while the other group took saline injections in same frequency and volume. A standardized exercise programme was also applied to all patients.

Patients were then evaluated with Shoulder Pain and Disability Index(SPADI), Visual analogous scales for pain and disability, Ranges of Movements and use of analgesics in before, after and 3rd month of the therapy.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old and having a shoulder pain with restriction for 3 months at least, and 9 months at most(Pain VAS being \>40 mm, and loss of ROM for affected side more than %25 of unaffected side).

Exclusion Criteria:

* Subjects were excluded if they had uncontrolled diabetes, active inflammatory diseases, ongoing pregnancy, severe anemia, psychiatric diseases that may affect compliance or cancer. Patients who had a history of trauma, recent injection therapies(\<3 months), surgery or allergy to local anaesthetics, or signs of complex regional pain syndrome, local infections or use of non steroidal anti-inflammatory drugs throughout the study were also excluded.
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.

Patients will then be followed-up every week during one month and then every month during one year.

This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).

It began including patients in January 2005 and will last until December 2007.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Signature of informed consent
* Critical leg ischemia with ankle pressure \< 70 mmHg
* Ischemic ulcer or gangrene
* No possibility of surgical revascularization
* No possibility of angioplasty

Exclusion Criteria:

* Cancer
* Suspicion of a cancer on X-Ray, mammography or elevated PSA
* Age \< 18
* Life expectancy \< 6 months
* Active retinopathy
* Angioplasty or surgical revascularization within 3 months
* Stoke within 3 months
* HIV + or HCV/HBC+
A Study of Switching Avatrombopag and Rh-TPO in ITP

Thrombopoietin receptor agonists (TPO-RAs) represent a highly effective and well-tolerated second-line ITP treatment that provides excellent responses.If there is cross-resistance between 2 drugs for the treatment of adult ITP is still unkonwn.The purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-TPO in adults with ITP.

Thrombopoietin Receptor Agonists (TPO-RAs) are novel treatments for patients with chronic Primary Immune Thrombocytopenia (ITP). According to the findings of mechanism-based studies, rhTPO competes with endogenous TPO for binding to TPO-R while avatrombopag has an additive effect with endogenous TPO, indicating that the treatment mechanism and side-effect profiles could be somewhat different between these drugs. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-TPO in adults with ITP.This is a non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to avatrombopag or vice versa will be enrolled. The reason for switch will be recorded. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.

Eligibility Criteria:
Inclusion Criteria:

1.18 years or older 2.Primary ITP 3.Failed initial glucocorticosteroid treatment, 4.Applying rhTPO or Eltrombopag as subsequent treatment 5.Switch from rh-TPO to eltrombopag or vice versa 6.Normal neutrophils 7.Available follow-up at least 6 weeks after switching

Exclusion Criteria:

1. HIV positive status, or active infection of HBV or HCV
2. Suffering from a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk for participation in this study (i.e. cancer or pre-cancer, immunocompromised, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (i.e. stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure \[classified as NYHA III-IV\], severe lung dysfunctions, etc))
3. History of thrombosis plus two or more risk factors as defined in Caprini thrombosis risk assessment model
4. Lactating or pregnant women, or WOCBP who are unwilling to use highly effective contraceptive measures during the study period
5. Abnormal liver and renal functions: AST or ALT or total bilirubin ≥1.5 × ULN, and/or creatinine ≥176.8 μmol/L
6. Women of childbearing potential (WOCBP) that are pregnant or wish to become pregnant during the prospective phase of the study.
7. Other conditions which the investigator considers inappropriate for enrollment
Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.

The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.

This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with FH (genetically defined LDL-receptor mutation or Dutch score \>8) on statin treatment only
* Hypertriglyceridaemia on a random blood sample (triglycerides \>1.5mml/L)

Exclusion Criteria:

* Subjects with diabetes mellitus
* major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam)
* patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.
Platelet Rich Plasma (PRP) and High Intensity Focused Ultrasound (HIFU) in Management of Stress Urinary Incontinence (SUI): Pilot Study

Previous studies Results show (PRP) is safe and effective in treating SUI, other studies show the result of energy base devices (Co2 laser, HIFU) are effective in treating of SUI .

This study add the effect both HIFU and PRP together in treating SUI.

What is stress urinary incontinence (SUI)? Stress urinary incontinence (SUI) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly. With mild SUI, pressure may be from sudden forceful activities, like exercise, sneezing, laughing or coughing. If your SUI is more severe, you may also leak with less forceful activities like standing up, walking or bending over. Urinary "accidents" like this can range from a few drops of urine to enough to soak through the clothes SUI is a very common bladder problem for women. Key SUI statics About half of women age 65 and above find that they sometimes leak urine. How can SUI Affect life? Many people find that SUI gets in the way of daily and social activities. It can affect family and sexual relationships. Some people even begin to feel isolated and hopeless because of it The pelvic floor supports the bladder and urethra. If this area gets stretched, weakened or damaged, then SUI can happen. Pregnancy and childbirth can cause this.

PRP is extremely rich in growth factors and cytokines which regulate tissue reconstruction, PRP is an easily procedure and relatively inexpensive biological material, it is produce directly from patient blood and inject PRP under urethra to restore bulbourethral ligment .

HIFU is an energy-based medical technology with many clinical applications, a device is a non-invasive procedure that provides collagen remodeling and synthesis that may repair and restore pelvic floor and pubourethral ligment, it is non-invasive therapeutic technique, that uses non-ionized ultrasonic waves that provides collagen that tight the endopelvic fascia and adjacent tissues .

Eligibility Criteria:
Inclusion criteria:

* Women complain of SUI is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change (American Urological Association 2017).
* Positive cough test when filled urinary bladder.
* Women chose non-invasive management rather than surgical management. • • Among the 20 patients enrolled, the average age was 30-60 years old.
* Urodynamic study proven the diagnosis.

Exclusion Criteria:

* Patient of previous operation or radiation
* Uncontrolled diabetes Neuromuscular disorder
* Uncontrolled psychiatric diseases
* Pregnancy
* Lactation
* Virgin
* Sepsis
* Active carcinoma
* Cystocele.
* Antiplatelet drug intake less than 7 days before and after procedure. - bleeding disorder.
* Patients cannot deal with Questionnaires.
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
* Subjects must have provided IRB approved written informed consent.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
Achieving Portal Access With Scorpion Post-Approval Study 2

Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access

Exclusion Criteria:

1. TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature
2. Inaccessible medical records
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants

The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.

To determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.

Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.

One of the following echocardiographic criteria of a duct size \> 1.5 mm, a left atrium-to-aorta ratio \> 1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.

Three consecutive blood sample from infants for 3 days before dose application of drugs(ibuprofen and paracetamol will be obtained.

The relation of pharmacokinetics of drugs to drug response will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Birth weight below 1250 gram
* Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* Severe thrombocytopenia \< 60.000
* Severe intracranial bleeding (Grade III - IV)
* Intestinal abnormality and necrotising enterocolitis
Quantitative Cardiac Parametric Mapping

The overall goal of this project is to evaluate the clinical potential of fast quantitative myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18-90 years of age.
* Subject must be previously diagnosed with or suspected to have one of the following conditions.
* Myocardial ischemia or infarction (group 1)
* Hypertrophic cardiomyopathy (group 2)
* Infiltrative cardiomyopathy (group 3)
* Myocarditis (group 4)
* Subject must have been referred for a clinically indicated CMR.

Exclusion Criteria:

* Subject has any implanted device or condition in which an MR scan would be contraindicated.
* Subject has an acute psychiatric disorder or is cognitively impaired.
* Subject is using or is dependent on substances of abuse.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject has previously entered this study.
* Subject has an allergy against MRI contrast agents.
* Subject is in acute unstable condition.
Treatment of AIDS Vacuolar Myelopathy With Methionine

The purpose of this study is to determine whether methionine, an amino acid present in low doses in the normal diet, can improve myelopathy or stop its progression.

Myelopathy is usually a late complication of AIDS, and until recently its symptoms were rarely recognized, masked by the general state of disability or the presence of other neurological complications. With prolonged survival and improved quality of life of HIV-infected patients, myelopathy is increasingly becoming a common source of disability. The cause of AIDS-myelopathy is unknown, but it is probably an indirect effect of the long-term presence of the HIV virus in the nervous system rather than the result of a direct infection. The purpose of this study is to determine whether methionine, an amino acid present in low doses in the normal diet, can improve myelopathy or stop its progression.

Eligibility Criteria:
Between 18 and 80 years of age
Stroke Unit in the Philippines: Is it Effective

This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing the functional outcome between those patient admitted in the general neurology wards and stroke units using modified Rankin Scale

This study aims to look into functionality of patient admitted in the stroke unit in the Philippines

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients admitted in participating SUs starting June 2016 during acute stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by CT-Scan or MRI, will be included

Exclusion Criteria:

* Patient who had previous of stroke and secondary cause of intracerebral hemorrhage such as trauma, arteriovenous malformation and aneurysm are not included in the study. Those who transferred from other institutions will be excluded. And also, patients who are below 18 years old are excluded in the study
Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury

The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, the investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).

Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in southern China , with an annual incidence of 15 to 50 cases per 100,000 people. NPC is both radiosensitive and chemosensitive. Recently, many new drugs including docetaxel and cisplatin have been incorporated in the induction chemotherapy phase of NPC. The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury, and appropriate management of these toxicities can help patients improve tolerance for chemotherapy. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, it is important to determine the risk factors to predict chemotherapy-induced liver injury. The investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced nasopharyngeal carcinoma.
* Patients scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy.
* Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment.
* Minimum age of 18 years.
* Life expectancy at least 3 months.

Exclusion Criteria:

* Patients previously received chemotherapy
* Patients who have liver metastases.
* Patients who take other drugs that may affect liver function
Study of Recombinant Human Thrombin for Bleeding During Surgery

The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.

This is a Phase 3 multiple site, randomized, double-blind, controlled trial designed to evaluate the comparative efficacy and safety of rhThrombin and bovine thrombin in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access.

After establishing eligibility, subjects will be randomized in a 1:1 ratio to receive rhThrombin (1000 U/mL) or bovine thrombin (1000 U/mL). During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or bovine thrombin) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s) and time to hemostasis (TTH) will be assessed for up to 10 minutes. Bleeding appropriate for TTH evaluation is defined as mild to moderate bleeding, either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities. Blinded study drug may also be used at additional appropriate bleeding sites. Study participants will have follow-up visits at about 2 days and 1 month after surgery. Approximately 400 to 600 patients will participate in the study. The final sample size will be determined based on blinded interim results.

Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access

Exclusion Criteria:

* Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery
* Subject has history of heparin-induced thrombocytopenia
* Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment
* Subject has received blood products within 24 hours prior to surgery