Kornimate/medical-research-clean huggingface dataset:
a study to collect and evaluate the safety and efficacy information of korean multiple myeloma patients treated with revlimid®, after approval of marketing authorization for new drug in korea

Conditions: Multiple Myeloma

Summary: the main purpose of revlimid® due (drug use examination) is to collect and evaluate the safety information of korean multiple myeloma patients treated with revlimid® according to the approved package insert, after approval of marketing authorization for new drug in korea. in addition, the efficacy information of revlimid® in clinical practice is collected and evaluated. this due is a multi-centre, observational and non-interventional post-marketing surveillance. the patients can be recruited through both drug use examination after the initiation of post marketing surveillance(contract with institution) and patient access program(pap) that was performed before revlimid® reimbursement. total 624 patient has enrolled in pms by 07sep2016. validation process for eligibility for safety assessment has been conducted by site monitoring process by 07dec2016. revlimid® due is to investigate frequency and change of adverse events(aes) /adverse drug reactions(adrs), serious adverse events(saes)/serious adverse drug reactions(sadrs), unexpected ae/adr and unexpected sae/sadr, and to scrutinize factors influencing safety \& efficacy of the drug. it is necessary to examine patients' demographics and baseline characteristics, medical history, status of revlimid® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.


Eligibility criteria:
inclusion criteria: * korean male or female who are diagnosed with multiple myeloma * in-patients or out patients during the revlimid® drug use examination period who are intended to be treated with revlimid ® * patients who are registered for risk management program of celgene exclusion criteria: * there's no exclusion criteria

Keywords: multiple myeloma revlimid lenalidomide observational korea post marketing surveillance[pms]
mini lateral shoulder approach

Conditions: Shoulder Impingement Syndrome; Rotator Cuff Tendinopathy; Adhesive Capsulitis and Frozen Shoulder Syndrome

Summary: the incision is very useful and easy for the direct lateral shoulder joint exposure.

the skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, the dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally. after clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly. throw this approach can be made acromioplasty and rotator cuff tears repair especially upper part of rotator cuff tear very easily. for wound closure the acromionic deltoid origin is reattached to the acromial edge by long period synthetic absorbable sutures as pds and pdo, or non absorbable sutures as polyester suture, under skin and skin sutures are made.

Eligibility criteria:
inclusion criteria: * patients presented with shoulder impingement syndrome refractory to conservative treatment and local steroid injection * patients presented with adhesive capsulitis and frozen shoulder syndrome refractory to conservative treatment and local steroid injection * patients without femur head immigration on x-ray * patients with injury for one month to six months maximum exclusion criteria: * patients with femur head immigration on x-ray * patients with injury for more than six months * un controlled diabetes mellitus type 1 and 2 * patients with non controlled vascular hypertension * significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization * patients with history of carpal tunnel release surgery failure

Keywords: shoulder shoulder approach lateral shoulder approach shoulder impingement syndrome rotator cuff tendinopathy adhesive capsulitis frozen shoulder syndrome
remodulin® to oral treprostinil transition

Conditions: Pulmonary Arterial Hypertension

Summary: this multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable pulmonary arterial hypertension (pah) from continuous intravenous (iv) or subcutaneous (sc) remodulin infusion to oral treprostinil (ut-15c sustained release (sr) tablets). this study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.


Eligibility criteria:
inclusion criteria: * between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of pah * have stable disease as confirmed by recent right heart catheterization and a baseline 6mwd of at least 250 meters * have been receiving remodulin for at least 90 days and at a stable dose for at least 30 days prior to the baseline visit; the dose of remodulin must be between 25-75 ng/kg/min, inclusive * must be also receiving an endothelin receptor antagonist (era) and/or a phosphodiesterase-5 inhibitor (pde-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to baseline exclusion criteria: * who functional class iii and iv subjects will be excluded

Keywords: pulmonary arterial hypertension ut-15c sr pah
long-term efficacy of drug-coated balloon versus drug-eluting stent in large de novo coronary lesions

Conditions: Coronary Artery Disease; Drug-coated Balloon

Summary: to evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(rvd=2.75\~4.0mm).

patients were randomly assigned (1:1) to receive angioplasty with dcb or implantation of a des. dual anti-platelet therapy was given according to current guidelines. follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. the primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (tlf) at 12 months follow up.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years and ≤80 years, regardless of gender; 2. de novo lesion in a native coronary artery; 3. stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia; 4. reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and timi flow ≥1; 5. the subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting); 6. the subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up. exclusion criteria: 1. reference vessel diameter \ 4.0 mm; 2. in stent restenosis; 3. left main lesion, chronic complete occlusion lesion; 4. ostial lesion ≤2mm from the lm, or bifurcation lesion with branch vessel diameter≥2.5mm; 5. there is a large scale of thrombus in the target vessel, and the thrombus grade \>3 after thrombolysis or aspiration; 6. severe heart failure (nyha iv); 7. severe renal failure (gfr\<30ml/min) or undergoing hemodialysis treatment; 8. severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal); 9. patients with vein graft restenosis after bypass or severe heart valve disease; 10. pregnant or breastfeeding female patients; 11. the life expectancy of the patient is less than 12 months; 12. the subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications; 13. anemia (women's hemoglobin \<117g/l, or men's hemoglobin \<134g/l), or thrombocytopenia detected before the intervention within 6 months (\<100×10⁹/l); 14. planned to perform non-cardiac surgery within 12 months after index procedure; 15. the subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint; 16. heart transplant patients; 17. allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel; 18. the investigator judged that the patient had poor compliance and could not complete the study as required.
pilot study of raltegravir lipodystrophy iisp

Conditions: HIV Infection

Summary: the substitution of raltegravir for the nrtis will result in some reversal of the long term adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with the chronic use of nrtis. changing the haart regimen in patients with a sustained virological response from a pi plus nrti to a regimen of the pi plus raltegravir will likely result in continued virologic efficacy.

a prospective, non-controlled, non-randomized, single center study of a treatment regimen of a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor in combination with raltegravir in patients with hiv-1 infection who have been, and continue to be, fully controlled on a standard haart regimen of a pi or an nnrti plus 2 nrtis, and the effect of the change in regimen on peripheral fat distribution. this pilot study will contain 30 patients who will be followed over a period of one year starting from the date of the medication change from an nrti-based regimen to a raltegravir-based nrti-sparing regimen. potential changes in fat distribution (fat content as assessed by fat volume) will be measured with serial mri's of the thighs.

Eligibility criteria:
inclusion criteria: 1. hiv-1 positive 2. any patient on a boosted pi plus 2 nrtis. 3. visual evidence peripheral fat wasting 4. hiv-1 viral load fully suppressed at least 9mths. exclusion criteria: 1. historical resistance to pi patient receiving 2. no prior exposure to raltegravir, elvitegravir, other hiv-1 integrase inhibitor. 3. no contraindications to serial mri scanning. 4. no contraindications to utilization of raltegravir. 5. not currently receiving any medications drug-drug interaction w/ raltegravir.

Keywords: nrti-regimen raltegravir elvitegravir hiv-1 integrase inhibitor fat waste
transversalis fascia plane vs ilioinguinal and iliohypogastric nerve block for the treatment of cpip

Conditions: Inguinal Hernia; Groin Hernia

Summary: the aim of this study was to compare the efficacy of ultrasound (us)-guided transversalis fascia plane block (tfp) and ilioinguinal (ii) and iliohypogastric (ih) nerve block in the treatment of chronic post-herniorrhaphy inguinal pain (cpip) refractory to conservative treatments. for this evaluation, a numerical rating scale (nrs) will be used before and after both interventions.

chronic post-herniorrhaphy inguinal pain (cpip) after inguinal hernia surgery significantly affects quality of life and daily activities. the incidence of this condition ranges from 15% to 53% and its management is often challenging. cpip is defined as pain lasting more than three months and can be diagnosed if no organic cause can be found to explain the pain at the end of this period. there are various methods in the treatment of cpip, including medical therapy, nerve blocks and surgical intervention. the inguinal region is mainly innervated by the ilioinguinal (ii) and iliohypogastric (ih) nerves. these nerves are the most commonly damaged structures after inguinal hernia surgery. however, the ii and ih nerves can be easily blocked in isolation throughout their entire course in the groin area or in the abdominal wall at different injection sites using fascial plane blocks such as transversalis fascia plan block (tfp). these blocks are frequently preferred because of their ease of application and wide analgesic effects. therefore, studies investigating the efficacy of fascial blocks that provide ease of application are increasing. although tfp and ii-ih blocks have been used in the treatment of acute postoperative inguinal pain, they have been used in a limited number of studies for cpip; however, no study has compared the efficacy and advers effect rates of these methods. the primary aim of this study is to compare the efficacy of these two treatment modalities. the secondary aim is to determine the incidence of adverse events associated with us-guided tfp and ii-ih nerve block therapy. a total of at least 80 patients will be enrolled for comparison, 40 patients in each group. the nrs score will be compared both within and between groups before, 1 month after and 3 months after treatment.

Eligibility criteria:
inclusion criteria: * complaints of inguinal pain \>12 weeks post-herniorrhaphy surgery * \>18 years of age * failure of conservative pain management exclusion criteria: * other causes of inguinal pain (haematoma, infection, tubo-ovarian disease, abscess, etc., gynaecological, urological and organic pathologies after inguinal hernia, etc.) * pregnancy * coagulopathy, antiaggregant/anticoagulant/antiplatelet use * unstable psychiatric illness

Keywords: ultrasonography ilioinguinal and iliohypogastric nerve transversalis fascia plane block
terlipressin infusion in variceal hemorrhage

Conditions: Terlipressin Adverse Reaction

Summary: randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. efficacy will be assessed by clinical improvement in symptoms and signs of gi bleed. to assess safety, frequency and degree of adverse reactions will be observed. periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.

randomized, open label trial, conducted on patients admitted with acute variceal hemorrhage at the aga khan university hospital, karachi (akuh). patients will be followed in clinic after discharge to assess survival for 6 weeks. intravenous terlipressin will be obtained from clinical trials unit, akuh pharmacy in standard iv infusion form. following complete clinical and laboratory evaluation, assessing the patient for eligibility, informed consent will be obtained from all the participants who are willing to be part of this study. after obtaining the informed consent, study participants will be randomized into the intervention arm (continuous infusion of terlipressin) or the control arm (bolus form of terlipressin). participants who are randomized to the intervention arm will be administered a continuous infusion of terlipressin at a rate of 0.5mg/hour for the first 24 hours. participants randomized into the control group will be administered a bolus form of terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. in case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of akuh. the trial will be conducted in in-patient units of akuh where eligible patients are admitted. it may include emergency room, special care unit and general ward. moreover, patients will be followed up by phone calls and in outpatient's clinics to assess survival six weeks post discharge.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 60 years 2. either gender 3. a diagnosis of liver cirrhosis; 4. initial presentation with acute gastroesophageal variceal bleeding 5. willing to provide informed consent to participate in the study (by study subject or next of kin) exclusion criteria: 1. age \ 60 years 2. not willing to provide consent due to any reason 3. no liver cirrhosis 4. acute upper gastrointestinal bleeding unrelated to varices; 5. use of somatostatin or octreotide. 6. hepatocellular carcinoma (hcc)outside milan's criteria 7. advance cardiovascular, pulmonary or renal disease (e.g. asthma, hypertension, arrhythmia, renal insufficiency) 8. history of hypersensitivity to terlipressin 9. pregnancy 10. patients already admitted at akuh who develop upper gi bleed during admission.

Keywords: terlipressin drug continuous infusion bolus form
prebiotic fibre supplementation and gut microbiota in non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) is a condition where accumulation of fat in the liver leads to metabolic dysfunction. currently there are no approved treatments for nafld. part of the metabolic dysfunction may arise through changes in the gut microbiota. prebiotic fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota; therefore they may have potential as part of a dietary strategy for nafld treatment.

the main objective of this study is to assess the effect of prebiotic fibre supplementation, in conjunction with diet-induced weight loss, on reduction in liver fat and injury. primary objective - determine the change in hepatic injury (fibrosis and inflammation) and hepatic fat (percent fat) over 6 months in nafld patients treated with prebiotic or placebo during weight loss. secondary objectives - determine the changes in appetite, body composition, glycemic and insulinemic responses, quality of life with prebiotic or placebo during weight loss, and examine mechanisms related to prebiotic-induced changes in gut microbiota and lipogenesis.

Eligibility criteria:
inclusion criteria: * adult subjects diagnosed with nafld on the basis of abnormal liver enzymes (alt\>1.5x upper limit of normal) and ultrasonography * exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease * aspartate aminotransferase and alanine aminotransferase ≤10x upper limit of normal * patients with type 2 diabetes treated with diet and exercise alone or metformin exclusion criteria: * cirrhosis of the liver (fibroscan \>17.5 kilopascal or fibrotest \>0.8) or clinical features of cirrhosis. * alcohol consumption \>20g/day (2 standard drinks) in women or \> 30g/d (3 drinks) in men * alternate (e.g. tpn) or concomitant etiology for abnormal liver enzymes. * history of decompensated liver disease including ascites, encephalopathy or variceal bleeding * concomitant use of any weight loss medication, previous bariatric or other intestinal surgery * presence of active infection, pregnancy or lactation * regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment * antibiotic use within 3 months prior to enrollment * weight loss \>3 kg within preceding 3 months to enrollment * uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections * use of agents such as vitamin e, omega-3 fatty acids or medications with evidence for effects on nafld (pioglitazone, glucagon-like peptide-1 analogues, dipeptidyl peptidase iv inhibitors, ursodeoxycholic acid) * patients with type 2 diabetes where hba1c is \>9%

Keywords: dietary intervention prebiotic fibre weight loss gut microbiota obesity liver fat hepatic fibrosis
induction of allergen specific bronchial immunotolerance after specific immunotherapy

Conditions: Mite Allergy; Allergic Asthma

Summary: one aim of this study was to find out if the bronchial allergen provocation (bap) is an appropriate method to appraise the efficacy of a specific immunotherapy (sit). the investigators had one group of children receiving sit and one group of patients who denied a sit although they had an indication for it. retrospectively the investigators analysed the data of the first bap and blood parameters specific ige-mite, total ige before sit (november 2008 till february 2010). prospectively the investigators analysed the lung parameters and allergic labor parameters that we got in the course of the second bap. the investigators mean parameter was pd20fev1-mite. another aim of the investigators study was to find specific immunological differences between children who improved because of sit and those who showed no improvement. thus, the investigators compared the levels of total ige, cumulative ige-mite and specific ige-mite before and after sit and the levels of specific igg-mite and specific igg4-mite after sit.

one aim of this study was to find out if the bronchial allergen provocation(bap) is an appropriate method to appraise the efficacy of a specific immunotherapy (sit). we had one group of children receiving sit and one group of patients who denied a sit although they had an indication for it. retrospectively we analysed the data of the first bap (pd20fev1, vc, fev1, fev1/vc (%), eno) and allergic blood parameters like specific ige-mite, total ige, cumulative ige before sit (november 2008 till february 2010). prospectively we analysed the lung parameters and allergic labor parameters that we got in the course of the second bap. our mean parameter was pd20fev1-mite. another aim of our study was to find specific immunological differences between children who improved because of sit and those who showed no improvement. thus, we compared the levels of total ige, cumulative ige-mite and specific ige-mite before and after sit and the levels of specific igg-mite and specific igg4-mite after sit. additionally all patients answered a questionnaire according to isaac about their clinical symptoms, their quality of life and their medication score.

Eligibility criteria:
inclusion criteria: * informed consent * between 5 and 18 years of age * diagnosis of a moderate asthma bronchiale (i-ii) in the last 12 months or rhino conjunctivitis * no exacerbation \> 4 weeks before visit exclusion criteria: * age \ 18 years, * fev1 \< 75% * no cooperation to undergo the bap, * exacerbation within the last 28 days before visit * other serious illnesses * taking part in other clinical trials \< 30 days

Keywords: specific immunotherapy bronchial allergen provocation specific ige specific igg specific igg4 sit