Kornimate/medical-research-clean huggingface dataset:
comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts

Conditions: Islet Transplantation; Type 1 Diabetes

Summary: proof of concept study in islet transplantation, two treatment arms (atg sir-tac versus atg sir) each consisting of ten type 1 diabetic patients


Eligibility criteria:
inclusion criteria: * type 1 insulin-dependent diabetic patients * c-peptide \ 180 mg/dl) * diabetic nephropathy * hypoglycaemic unawareness exclusion criteria: * smoker before transplantation * plasma creatinine \> 2 mg/dl * albuminuria \>1000 mg/24 hrs * abnormal liver function * history of thrombosis or pulmonary embolism * history of malignancy, tuberculosis or chronic viral hepatitis * history of any other serious illness which could be relevant for the protocol * hla antibodies * ebv antibody negative * hiv 1 \& 2 antibody positive
long term outcome after ahmed glaucoma valve

Conditions: Glaucoma

Summary: long term results after ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

the development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.

Eligibility criteria:
inclusion criteria: * patients suffering from medically uncontrolled glaucoma * informed consent exclusion criteria: * healthy subjects * under 18 years

Keywords: uncontrolled glaucoma glaucoma drainage device
within-day and between-day repeatability of the breath pattern in healthy children and in children with asthma

Conditions: Asthma; Healthy

Summary: "within-day and between-day repeatability of the breath pattern in healthy children and in children with moderate asthma" is an observational prospective study in outpatient clinic of pediatric allergology \& pulmonology (pap) within the institute of biomedicine and molecular immunology (ibim) of the national research council (cnr) of palermo (ibim cnr), italy. the electronic nose (e-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. to date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma. the breath pattern will be analyzed by collecting, for each child, three samples of the breath through the e-nose. within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). between-day repeatability will be assessed using a third measurement repeated after 7 days. the study is expected to provide information about the accuracy of e-nose measurements for a child population.


Eligibility criteria:
the inclusion criteria for asthmatic children are: 1. moderate asthma (gina 2015); 2. age 6-11 years; 3. no upper airway respiratory infections or exacerbations in the last 4 weeks; 4. steroid-naive asthma; 5. positive bronchodilator response; 6. non smoker. the inclusion criteria for healthy children are: 1. age 6-11 years; 2. no upper airway respiratory infections in the last 4 weeks; 3. non smoker; 4. no history of asthma and respiratory diseases during the life; 5. negative bronchodilator response. the exclusion criteria are: 1. symptoms of acute respiratory infection; 2. immunological and metabolic systemic disease; 3. major malformations of the upper airways; 4. active smoker.

Keywords: breath pattern children repeatability
blepharospasm patient survey for patients with blepharospasm

Conditions: Blepharospasm

Summary: the purpose of this survey is to collect detailed information on patients treated for blepharospasm with incobotulinumtoxina, abobotulinumtoxina and onabotulinumtoxina, including how often they are treated with botulinum toxin, how long their treatment lasts, how satisfied they are with their treatment, and if there is any improvement in their symptoms with the treatment.

this study is open to males and females \> 18 years and \< 81 years with a clinical diagnosis of blepharospasm.

Eligibility criteria:
inclusion criteria: * male or female subject aged \> 18 years and \< 81 years * documented clinical diagnosis of blepharospasm * currently receiving incobotulinumtoxina, abobotulinumtoxina or onabotulinumtoxina exclusion criteria: * previous treatment with rimabotulinumtoxinb in the last 2 treatment cycles
ultrasound imaging technique in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality

Conditions: Breast Carcinoma; Microcalcification

Summary: this clinical trial studies a new type of ultrasound technique, micropure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. micropure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. a group of microcalcifications may indicate that cancer is present.

primary objectives: i. evaluate micropure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard. secondary objectives: i. evaluate micropure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated). ii. evaluate micropure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard. iii. estimate the improvements in patient care that may be achievable if micropure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.

Eligibility criteria:
inclusion criteria: * give written informed consent * be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical excision for the evaluation of a breast lesion or abnormality containing microcalcifications seen on mammography exclusion criteria: * is clinically unstable, severely ill, or moribund
prophylactic racemic epinephrine in anterior cervical discectomy and fusion

Conditions: Dysphagia; Dysphonia; Postoperative Pain

Summary: our double-blinded, randomized control trial will assess the effect of nebulized racemic epinephrine inpatients undergoing anterior cervical discectomy and fusion (acdf) procedures. the investigators have had success in managing post-operative dysphagia in patients undergoing acdf with the administration of this drug. half of the participants will review nebulized epinephrine. the other half will receive placebo.

based on data from the national inpatient sample from 2002-2012, patients undergoing elective primary acdf, diagnosed with dysphagia (4% of total patients), had a two-fold increase in mean length of stay (4.03 compared to 1.56 days; p \< 0.001) and a substantial increase in their total hospital charges (p \< 0.001) versus those not diagnosed with dysphagia. there are very few level i studies which describe successful management of these complications. steroids have shown promise, however, there exist concerns for consequent delayed bony fusion. racemic epinephrine is a mixture of both the r and l isomers of epinephrine which theoretically results in a milder side effect profile and longer shelf-life versus the standard l-epinephrine. traditionally, racemic epinephrine has been administered in a nebulized form for the treatment of severe asthma, laryngeal edema, and bronchiolitis. the most severe side effects that have been reported include tachyarrhythmias and paradoxical bronchospasms, although these reports are rare and limited mainly to single case reports or case series. it confers its therapeutic effect through racemic α-adrenergic and β-adrenergic mediated vasoconstriction of mucosal vasculature decreasing edema and in the respiratory tract, inducing bronchodilation. the pi, has been utilizing nebulized racemic epinephrine at standard dosages (1 unit of 0.5 ml of 2.25% racemic epinephrine) for the treatment of severe post-operative dysphagia in patients undergoing acdf for 20 years. the investigator has achieved marked success with this intervention with no notable associated complications. despite being successfully utilized in this manner for many years in small pockets of the spine community, the use of prophylactic racemic epinephrine for the management of dysphagia has not been described in the literature. the investigators hope to be able to fill this important knowledge-gap with our study data.

Eligibility criteria:
inclusion criteria: 1. patients \> 18 years of age 2. primary two and three-level acdf between c3-7 3. approved pre-authorization to undergo the procedure exclusion criteria: 1. patients \< 18 years of age 2. patients who are unable to give their own consent 3. revision acdf 4. combined anterior-posterior surgeries 5. surgeries involving c2-c3 or c7-t1 6. surgeries related to trauma, infection, or tumor 7. patients with baseline swallowing dysfunction 8. patients currently on steroids 9. patients with severe cardiac disease 10. uncontrolled diabetics as defined by patients with a hba1c \> 8% 11. patients with known allergy to epinephrine
diabetes and nafld

Conditions: NAFLD; Diabetes; NASH; Fibrosis, Liver; Cirrhosis, Liver; Liver Cancer

Summary: non-alcoholic hepatic steatosis (nafld) is characterised by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, with insulin resistance and metabolic syndrome with which it shares the most frequent clinical manifestations (hypertension, dyslipidaemia, visceral adiposity, glucose intolerance). due to the pandemic spread of obesity and diabetes and by virtue of better control of viral hepatitis, nafld is the most common cause of liver damage in western countries with a prevalence of around 20-30% of the general population. the clinical impact of nafld in diabetes is considerable and represents a real driver of the major clinical outcomes that impact on the health of the individual, consequently creating a real 'burden of disease' especially in those populations considered to be at higher risk of disease severity. individuals with diabetes are, in fact, those at greatest risk of developing the clinical sequelae of nafld and often do not receive adequate hepatological support and a correct hepatic pathology. in fact, it has been documented in the literature that the presence of diabetes increases the severity of liver damage, bringing the risk of nash up to 80% and increasing the risk of significant fibrosis to 30-40% of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis. lastly, the increased risk of hepatocarcinoma in subjects with diabetes and nafld should not be overlooked, as documented by our group and confirmed in a large italian case series. in subjects with diabetes, moreover, the presence of nafld is not only associated with worse glycaemic control, but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality. therefore, the possibility of applying the non-invasive fibrosis scores currently available for nafld on a large scale, in a population at high risk of progressive liver disease, would make it possible to characterise (a) the true epidemiology of significant fibrosis (f3 or higher); (b) allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression; (c) understand, in cases with a long history of disease the true prevalence of clinical outcomes; (d) understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes * availability of clinical data for non invasive tests and imaging exclusion criteria: * follow-up in clinic at least 1 year

Keywords: nafld nash liver fibrosis cirrhosis diabetes
randomized controlled trial of total hip arthroplasty

Conditions: Hip Arthritis; Total Hip Arthroplasty (THA)

Summary: the purpose of this study is to compare the effect of total hip arthroplasty and conservative treatment to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis.

the purpose of this randomized controlled study is to compare the effect of total hip arthroplasty and conservative treatment (that consists of self-driven exercises that physical therapists teach to the patients) to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis. also the ill effects and cost effectiveness of total hip arthroplasty and conservative treatment are evaluated. further more the aim is to investigate if total hip arthroplasty alleviates osteoarthritic pain in 12-month follow-up and if it enhances performance and quality of life.

Eligibility criteria:
inclusion criteria: * hip osteoarthritis that is in x-ray pictures ≥2 in kellgren - lawrence classification * primary osteoarthritis * patients symptoms of hip osteoarthritis are so severe, that an experienced orthopedist would suggest total hip arthroplasty as a treatment exclusion criteria: * patients symptoms are so severe that total hip arthroplasty should be done within the next three months * asa \> 3 (asa physical status classification system) * normal contraindications to surgery * previous surgery to the same hip that has the osteoarthritis (including total hip arthroplasty, surgery for fracture, osteotomy, arthroscopy) * the referring orthopedist has placed the patient in line for hip arthroplasty * secondary osteoarhritis

Keywords: hip arthritis total hip arthroplasty tha conservative treatment
establishment of cessation therapy by clinical trials for subjects with betel-quid dependence and oral pre-cancer

Conditions: Addiction

Summary: no medication existed for bq dependence. no clinical trials existed for the drug therapy. previous study showed that bq possessed the antidepressant effect via pathway of monoamine oxidase a (mao-a). an animal model also found that the arecoline from bq has a property as mao-a inhibitor. therefore, the investigators hypothesized that inhibition of the mao-a or antidepressants might reduce the bq addiction severity. the investigators will conduct the randomization and double blinded with placebo controlled study with 90 participants with bq dependence from the family medicine and ear, nose, and throat (ent) outpatient department (opd). all participants shall agree the informed consent. the range of age is from 18 to 65 years old. the participants are diagnosed as bq use disorder without other psychiatry co-morbidity, according to the diagnostic and statistical manual (dsm)-v criteria. those who have severe physical illness, psychiatric illness, and other substance use disorder except cigarettes are excluded. all participants receive the semi-structure interview by dsm-v, international classification of diseases (icd)-10, and mini international neuropsychiatric interview by the psychiatrist. before the intervention, the participants will finish their basic data, daily amount of cigarettes, betel nut, medical history and psycho-social rating scales. next, in addition to counseling, the investigators will continue or modify the optimal antidepressants based on the previous results. the investigators will evaluate their bq use condition as what has been measured in the natural observation study of the first year. the investigators will check the outcome measurement by visual analog scale, betel quid withdrawal severity scale, yale-brown obsessive-compulsive (y-bocs) - betel quid (bq) scale. the investigators also followed their hamilton depression scale; beck depression index; and beck anxiety index in the baseline, 2nd, 4th, 6th , and 8th week. the investigators also obtained the participants' gene type if the participants also agree for the prediction of oral cancers.

we'll conduct the betel-quid (bq) dependence clinical trial since 2016. eligible cases will be enrolled for the following 8 week double-blinded placebo controlled trial. the groups will be divided into three groups. outcome measures include bq use condition, addiction severity rating scale, emotional rating scale including beck anxiety index (bai), beck depression index (bdi), hamilton depression scales (hamds), and urine bq metabolites.

Eligibility criteria:
inclusion criteria: * dsm-v criteria suitable for betelnut use disorder * no severe physical disorder * no major psychiatric illness * chinese speaker exclusion criteria: * severe physical disorder * major psychiatric illness * inability to understand the whole protocol

Keywords: addiction betel-quid drug therapy clinical trial
long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy.

Conditions: Prevention of Incisional Hernia in Emergency Surgery

Summary: observational study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

background. prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. the present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies. methods. this study was a retrospective analysis of patients who underwent an emergency midline laparotomy between january 2009 and july 2010 with a follow-up period of longer than 2 years. long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (group m) and suture (group s) were compared.

Eligibility criteria:
inclusion criteria: * patients undergoing emergency midline laparotomy exclusion criteria: * those with need of concomitant hernia repair. * those who received incisions outside the midline. * those with delayed abdominal closure. * those who died in the immediate postoperative period. * those without a minimum 2 years of follow-up.
management of ischemic heart disease with angiwell-xr (ranolazine)

Conditions: Chronic Stable Angina

Summary: the rationale of mida trial is to determine efficacy and tolerability of ranolazine molecule among pakistan population and obtain firsthand knowledge about the molecule ranolazine.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of coronary artery disease (cad) * patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ett qualifying test * patients developed exercise-induced ecg ischemiai during two qualifying exercise treadmill testsii. * willing and able to provide a written informed consent exclusion criteria: * • factors that might compromise ecg or ett interpretation * patients with resting st-segment depression ≥ 1mm in any lead * left bundle-branch block * patients implanted with pacemaker * patients under digitalis therapy * patients with family history of (or congenital) long qt syndrome * patients with congenital heart disease * patients with uncorrected valvular heart disease * patients with unstable angina, or mi, or coronary revascularization procedure ≤ 2 months prior enter this study * female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential\* who is not using medically recognized method of contraception * \*other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal. • patients are under any one of the following conditions: * new york heart association (nyha) class iii or class iv congestive heart failure (chf) * qtc \> 450 msec at screening * active myocarditis, pericarditis, hypertrophic cardiomyopathy * uncontrolled hypertension (defined as sbp \> 180 mmhg) voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria * use of any investigational product ≤ 4 weeks prior to screening * patients with severe hepatic disease (e.g., liver cirrhosis) * patients with impaired renal function (defined as serum cr \>1.5 mg/dl) * patients with any condition or disease which is considered not suitable for this study by investigator

Keywords: ranolazine pakistan ischemic heart disease
effect of antihypertensive agents over sleep apnea

Conditions: Hypertension; Obstructive Sleep Apnea

Summary: obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. their control could reduce the burden of heart disease across populations. there are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. the demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. the role of fluid retention in sleep apnea is known for several decades. the role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.

this is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with stage i hypertension (140-159/90-99 mmhg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). the primary outcomes will be the variation of apneas/hour and blood pressure. the secondary outcomes will be adverse events, somnolence scale (epworth), ventilatory parameters and c reactive protein. the follow up will last 8 weeks. the sample size will be of 29 participants per group. the project was approved by the ethics committee of our institution.

Eligibility criteria:
inclusion criteria: * patients older than 40 years of age * stage i hypertension (140-159/90-99 mmhg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep) exclusion criteria: * low life expectancy * other indications for the use of diuretics or calcium channel blocker -intolerance or contraindications to the study drugs * pregnancy * established cardiovascular disease (myocardial infarction * stroke * heart failure) * use of more than one drug for hypertension * secondary hypertension * participation in other clinical trial in previous 6 months

Keywords: sleep apnea hypertension treatment diuretics chlorthalidone amlodipine
ischemic preconditioning in endurance athletes

Conditions: Exercise

Summary: the aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners.


Eligibility criteria:
inclusion criteria: * informed consent * healthy * age between 18 and 65 years * endurance-trained (two or more training sessions per week) exclusion criteria: * not applicable