Kornimate/medical-research-clean huggingface dataset:
evaluation of stents to open restricted airways in patients with centrally placed non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: to investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6mwd) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.


Eligibility criteria:
inclusion criteria: * able to give informed written consent in the english language * able and willing to attend st georges hospital / royal marsden hospital for stent insertion (if allocated) and documentation of 6 minute walking distance. * willing to re-attend for follow-up and 6 minute walking distance at st georges hospital / royal marsden hospital 2 weeks later (all patients) * diagnosis of non-small cell lung cancer with centrally placed tumour with some degree of airway obstruction from information from bronchoscopy or ct scan. * ecog performance status: 0-3 exclusion criteria: * relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation problems. * pregnancy * radically treatable disease.

Keywords: bronchial stents airway obstruction non-small cell lung cancer
high intensity aerobic training on primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: now a days aerobic exercise programs has been widely used as non-pharmacological means of treating pain disorders. this study intends to determine the effects of high intensity aerobic training on pain intensity, dysmenorrhea symptoms and quality of life of young girls having primary dysmenorrhea.

this study is a randomized control trial, which will be conducted in shifa tameer-e-millat university (department of rehabilitation sciences). the calculated sample size is 24 individuals using epitool with 95% confidence interval (ci) and power 80%. individual will be screened out according to inclusion criteria. individuals will be allocated randomly into two groups, 12 in high intensity aerobic training group and 12 in low intensity aerobic training group by sealed envelope method. high intensity aerobic training will be use in experimental group. low intensity aerobic training will be used in control group. assessment will be done on baseline day 1 prior to the intervention and after 8 weeks of training.

Eligibility criteria:
inclusion criteria: * unmarried female students. * moderate to severe dysmenorrhea during the last three periods according to the numeric pain rating scale. exclusion criteria: * presence of known chronic disease (heart disease, kidney, respiratory, asthma, diabetes, nervous disorders, blood pressure), limitation on sports/physical activities due to special medical problems. * presence of any disease of reproductive system. * irregular monthly cycle. * use of any particular medications affecting dysmenorrhea before or during the study.

Keywords: pain dysmenorrhae symptoms menstrual symptom questionnaire
asciminib roll-over study

Conditions: Chronic Myelogenous Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Summary: this is a long term safety study for patients who have completed a novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

this is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.

Eligibility criteria:
key inclusion criteria: 1. participant with ph+ cml or ph+ all currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a novartis-sponsored study and, in the opinion of the investigator, would benefit from continued treatment. 2. participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures. key exclusion criteria: 1. participant has been discontinued from parent study treatment. 2. participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study. 3. participant's ongoing treatment is currently approved and reimbursed at country level. 4. pregnant or nursing (lactating) women. 5. women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment. 6. sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information. 7. applicable for participants on bosutinib treatment at the end of the cabl001a2301 and on other tkis for cabl001a2202 study that switch to asciminib treatment: * asymptomatic (grade 2) pancreatitis if not resolved within 28 days * qtcf\>480msec or inability to determine qtc interval * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic myelogenous leukemia cml all cml-ap cml-bp cml-cp myeloproliferative neoplasm chronic phase accelerated phase blast phase abl001 asciminib
a single centre study to assess the long-term performance of the pinnacle™ cup with a ceramic-on-ceramic bearing in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Summary: the purpose of this study is to monitor the performance of the pinnacle™ cup with a ceramic-on-ceramic bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria:
inclusion criteria: i) male or female subjects, aged between 18 and 70 years inclusive. ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) subjects undergoing revision hip replacement. iii) women who are pregnant. iv) subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. v) subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) subjects who are currently involved in any injury litigation claims. vii) subjects undergoing a simultaneous bilateral hip operation. viii) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation. ix) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily

Keywords: hip cementless ceramic-on-ceramic
pharmacokinetics of leritrelvir(ray1216) in participants with severe kidney disease

Conditions: Kidney Impairment

Summary: this study will assess the effect of severe kidney impairment on the pharmacokinetics (pk), safety and tolerability of leritrelvir.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥19 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at screening (calculated as a function of measured height and weight according to the formula, bmi = kg / m2 where m2 is height in meters squared); 2. ability to understand and willingness to sign a written informed consent form; participants with normal renal function only: 3. normal physical examination, vital signs, 12-lead ecg, chest x-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant. 4. glomerular filtration rate (gfr)≥ 90 ml/min 5. age, bmi, and sex comparable to those of subjects of severe renal impairment participants with severe renal impairment only: 6. diagnosis of ckd at least 3 months 7. glomerular filtration rate (gfr)\< 60 ml/min/1.73 m2 exclusion criteria: 1. participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. 2. participants who donated blood or bleeding profusely (\> 400 ml) in the 3 months. 3. pregnant or lactating women, or women of childbearing age with a positive pregnancy test 4. participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks participants with severe renal impairment only: 5. participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period; 6. hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm hg or diastolic blood pressure ≥ 100mm) 7. new york heart association (nyha) class iii or iv congestive heart failure 8. alanine aminotransferase (alt) ≥ 2×uln, aspartate aminotransferase(ast) ≥ 2×uln; serum total bilirubin \> 1.5×uln;
trial to compare the effects of either telmisartan (40-80 mg po once daily) or ramipril (5-10 mg po once daily) on renal endothelial dysfunction in hypertensive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: the primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on no bioavailability in the renal vasculature, measured as renal plasma flow (rpf) in response to ng-monomethyl-l-arginine (lnmma) infusion.

this study was designed as a randomised, double-blind, double-dummy, parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks. after a 4 week run-in period, patients will be randomised to one of the treatment groups and receive either telmisartan 40 - 80 mg or ramipril 5 - 10 mg. the treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment. during the treatment period, 3 visits to the investigator will be scheduled in order to control blood pressure, renal function parameters and safety. in addition, parameters of endothelial function in the renal vasculature, based on a nephrological clearance investigation and a provocation with l-nmma will be measured at baseline and after 9 weeks of treatment. study hypothesis: due to the exploratory nature of the trial, the primary objective to evaluate the effect on rpf in response to l-nmma infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses. comparison(s): the change in rpf from baseline (visit 4) to the end of treatment (visit 7) in response to l-nmma infusion was to be calculated as the change from the pre l-nmma infusion (s1) to the end of the l-nmma infusion (s2). a comparison of treatment groups was to be made using an analysis of covariance (ancova) with pooled centre and treatment included as main effects and rpf (in response to l nmma infusion) at baseline as a covariate. the treatment group difference, adjusted for the other factors in the model, was to be presented with a corresponding 95% confidence interval (ci) and a test of statistical significance. the model was also to be used to provide analysis results for the within treatment group changes.

Eligibility criteria:
inclusion criteria: * hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, gfr \> 80 ml/min (cockroft-gault) exclusion criteria: none
a clinical trial of acamprosate for treatment of methamphetamine addiction

Conditions: Methamphetamine Dependence, Treatment Seeking

Summary: this clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. secondary measures include treatment retention, drug craving, mood, and safety.


Eligibility criteria:
inclusion criteria: * methamphetamine dependence * treatment seeking * urine sample (+) for methamphetamine exclusion criteria: * pregnancy * dependence on other drugs (except nicotine) * dsm-iv axis i disorder unrelated to drug abuse * serious medical condition in clinicians opinion. * aids * untreated syphilis * allergy to acamprosate * methadone, or other orp, maintenance

Keywords: methamphetamine, crystal, treatment
selecting a favorable kir donor in unrelated hct for aml

Conditions: Acute Myelogenous Leukemia

Summary: donors with favorable kir b haplotype gene content have yielded reduced relapse risk and improved leukemia free survival (lfs) in retrospective analyses of unrelated donor (urd) hematopoietic cell transplantation (hct) for acute myelogenous leukemia (aml). specifically, donors with more kir b gene content and those who are homozygous for the centromeric (cen) b haplotype genes (as opposed to the telomeric (tel) genes confer the most protective effect. this study proposes to prospectively test and validate the utility and effectiveness of further informing urd identification and selection by kir genotyping as a supplement to hla matching and the other variables known or suspected to indicate the best urd for a patient. hypotheses: 1. favorable kir donors will improve protection against relapse and improve leukemia free survival (lfs) after urd hct for aml. 2. directed study procedures for rapid kir genotyping and reporting to searching transplant centers (tc) can inform donor search and selection without delay in donor availability for hct.

transplant centers will select the best hla matched, and as appropriate, preferred kir donor.

Eligibility criteria:
inclusion criteria: * patient with acute myeloid leukemia (aml) undergoing screening for potential urd hct * potential urd undergoing screening to provide a hct graft to a patient with acute myeloid leukemia (aml) at a participating institution * provides written consent exclusion criteria: transplant centers will select the best hla matched, and as appropriate, preferred kir donor. in situations where the preferred (best \> better \> neutral) kir donor is not selected in favor of a less favorable kir genotype donor, the center will report one or more defined reasons (donor age; gender; parity; cmv status; abo status; availability/logistics; other) for the choice (among equivalently hla matched donors).

Keywords: acute myelogenous leukemia hematopoietic cell transplantation unrelated donor
acclimatization mechanisms during ascent to 7500m

Conditions: Acute Mountain Sickness

Summary: the trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to muztagh ata (7546m). two groups of mountaineers ascend with different acclimatization time to the summit. the prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.


Eligibility criteria:
inclusion criteria: * healthy, physically fit subject * mountaineering experience exclusion criteria: * any type of cardiac or respiratory disease * regular intake of any medication * history of high altitude pulmonary oedema * severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.

Keywords: altitude illness hypoxia
thrombus aspiration in acute st-elevation myocardial infarction

Conditions: Acute ST-elevation Myocardial Infarction

Summary: thirty patients with acute st-elevation myocardial infarction treated with primary pci and aspiration of thrombus material from the infarct related coronary artery will be included. both cellular and non cellular content of the thrombus will be examined with morphological and immunohistochemical methods and related to time from onset of symptoms to pci, as well as to the degree of myocardial necrosis. furthermore, mrna expression of selected signal molecules will be performed. in addition, peripheral venous blood samples will be drawn and analyzed for signalling molecules and corresponding mrna expression in circulating leukocytes.

observational, cross-sectional study on 30 patients with stemi treated with thrombectomy and pci with stent implantation. composition and characteristics of the coronary thrombi with respect to cell types, genetic expression and presence of specific markers of inflammation, platelet activity, endothelial activation, coagulation and fibrinolysis will be investigated in relation to the levels of these markers in the general circulation, and specifically related to the time axis from symptom to pci, as well as to the degree of myocardial necrosis. intracoronary thrombus will be retrieved by standard aspiration catheter, washed with saline and stored on formalin as advised by the department of pathology, ous ullevål. a specific protocol for morphological and immunohistochemical methods is prepared and has been shown suitable in a pilot study on 5 patients. assessment of coronary timi flow and peripheral blush grade after thrombus aspiration and pci will be done. at the same time, peripheral venous blood will be drawn, processed and stored at -80˚c for later analyses. demographic variables will be recorded.

Eligibility criteria:
inclusion criteria: * both gender * age 18-75 years * typical symptoms of acute myocardial infarction * st-elevation or presumed new left bundle branch block in the ecg * treated with aspiration of thrombus and primary pci in the infarct related coronary artery exclusion criteria: * signs of infection * pulmonary embolism * chronic obstructive pulmonary disease * arrhythmias, abnormal renal and/or liver function * autoimmune disease * malignant disease

Keywords: acute myocardial infarction, thrombus aspiration
evaluation of the effectiveness of the use of a carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the pathogenetic therapy of metabolic-associated fatty liver disease: a prospective cohort study

Conditions: Metabolic-associated Fatty Liver Disease (MAFLD)

Summary: the goal of this observational study is to learn the effectiveness and safety of the use of carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the pathogenetic therapy of metabolic-associated fatty liver disease (mafld)


Eligibility criteria:
inclusion criteria: * patients of both sexes aged 18 to 75 years, who are citizens of the republic of kazakhstan; * patients with a clinically and laboratory confirmed diagnosis of mafld, without severe concomitant diseases; * patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others); * patients who have at least a 7-day gap between the end of other adjuvant therapy and the start of coc and bdd; * patients who voluntarily signed the informed consent form. exclusion criteria: * patients who abuse alcohol according to the audit-c questionnaire; * patients taking coc for more than 4 weeks before signing the informed consent; * patients with contraindications to coc; * patients diagnosed with diabetes mellitus; * pregnancy and lactation; * simultaneous use of levodopa, altretamine, cisplatin, statins; * patients with coinfection with hiv, hbv, hcv; * decompensated liver cirrhosis cpt≥7 points; * gfr ≤ 15 ml/min/1.73 m2; * drug-induced liver damage; * taking narcotic and psychotropic drugs; * malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than \>5 times; * patients with pronounced biochemical activity (alt, ast more than 10 uln) and total bilirubin more than 2 uln; * participation in an interventional clinical trial.
the effect of ketamine on the length of hospital stay of patients hospitalized with suicidal ideation.

Conditions: Suicidal Ideation

Summary: this study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. half of the patients will receive one dose of ketamine in the vein. the other half will receive a placebo. because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.

patients admitted to ummc's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an iv infusion of either saline or ketamine 0.5 mg/kg. the infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. we will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. at completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.

Eligibility criteria:
inclusion criteria: 1. men and women between the ages of 18 and 64 2. patients admitted to the university of mississippi medical center inpatient psychiatry service with suicidal ideations exclusion criteria: 1. lifetime history of schizophrenia or other primary psychotic disorder 2. current psychotic or manic symptoms 3. substance use disorder within one month of admission 4. positive urine toxicology at admission 5. any lifetime abuse of ketamine or phencyclidine 6. systolic bp \>180 mmhg or diastolic bp \>110 mmhg 7. any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion 8. known central nervous system (cns) mass 9. cns abnormalities 10. hydrocephalus 11. glaucoma 12. acute globe injury 13. porphyria 14. untreated thyroid disease 15. known coronary artery disease with poor functional capacity 16. pregnancy 17. currently breast-feeding

Keywords: ketamine suicidal ideation length of stay