Kornimate/medical-research-clean huggingface dataset:
oxford ovarian cancer predict chemotherapy response 01

Conditions: Ovarian Cancer

Summary: the purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.

while paclitaxel is very effective in killing cancer cells in a proportion of patients, some patients don't respond to this treatment. as with any chemotherapy, paclitaxel is associated with unpleasant side effects. we are doing this study to try and understand what is happening in cancer cells in different individuals after paclitaxel treatment that make them respond differently to the same treatment. we hope that this study will enable us to develop a method to identify women who are suitable for this form of treatment. we also want to understand why some cancer cells don't get killed with paclitaxel. this information will help us to select treatment to suit an individual patient, and thus improve the outcome of treatment and avoid giving treatment that will not benefit the patient.

Eligibility criteria:
inclusion criteria: * female ≥ 18 years of age * newly diagnosed and histology confirmed primary high grade serous ovarian cancer, high grade serous fallopian tube cancer and primary peritoneal carcinoma. * radiological and laparoscopic confirmation of figo stage 3c or 4 ovarian cancer. * radiological evidence of omental or peritoneal deposits that are accessible for radiology-guided biopsy. * at least one lesion on ct scan measuring at least 2 cm in maximum diameter performed in the past 31 days. slightly older scans may be accepted at the discretion of the ci providing the results are considered to remain clinically relevant. * eastern cooperative oncology group (ecog) performance score of 0-2 * life expectancy of at least 6 months. * the patient is willing and able to provide written informed consent and comply with the protocol for the duration of the study, and scheduled visits and examinations. * acceptable haematological and biochemical indices exclusion criteria: -

Keywords: ovarian cancer, paclitaxel
carvedilol post-intervention long-term administration in large-scale trial

Conditions: Myocardial Infarction

Summary: the purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with st-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.

beta-blocker therapy is recommended after st-segment elevation acute myocardial infarction (stemi) in the current guidelines although its efficacy in those patients who have undergone primary percutaneous coronary intervention (pci) has not been adequately evaluated. the purpose of this study is to evaluate whether beta-blocker, carvedilol improves 6-year clinical outcomes in patients with stemi and preserved left ventricular ejection fraction after primary pci. the design of this study is multicenter, open-label, randomized controlled trial enrolling 1300 patients without any exclusion criteria.

Eligibility criteria:
inclusion criteria: * patients with stemi after primary pci * patients with left ventricular ejection fraction more than or equal to 40% exclusion criteria: * patients with left ventricular ejection fraction less than 40% * patients with contraindication for beta-blocker * patients with implantable cardioverter defibrillators * patients with end-stage malignancy

Keywords: myocardial infarction adrenergic beta-antagonists percutaneous coronary intervention
a study to assess the efficacy and safety of burfiralimab(hzvsf-v13) and oad (oral antiviral drug)

Conditions: Chronic Hepatitis B

Summary: this is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, phase iia clinical study. this study has been designed to evaluate the change in hbsag (log10 iu/ml) after administration of hzvsf-v13 50 mg/dose and hzvsf-v13 200 mg/dose in combination with an oral antiviral agent (tenofovir or entecavir, including salt-free or salt-modifying drugs) compared to an oral antiviral agent in combination with a placebo (normal saline) in patients with chronic hepatitis b who are stably receiving an oral antiviral agent (tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks.

among the subjects who provided a voluntary written consent to participate in this clinical study, the patients with chronic hepatitis b who are stably receiving an oral antiviral agent (tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks prior to the screening visit can be considered as potential subjects of this study. only the subjects who completed the final eligibility evaluation at the baseline visit (visit 2) after the screening tests will be randomized to the hzvsf-v13 50 mg combination group, hzvsf-v13 200 mg combination group (study group) and placebo combination group (control group) at a 1:1:1 ratio at each site. the randomized subjects will receive intravenous administration of hzvsf-v13 or the placebo to match hzvsf-v13 four times with 4 weeks interval for a total of 12 weeks, and oral administration of 1 tablet of an oral antiviral agent will be given once daily for a total of 48 weeks.

Eligibility criteria:
inclusion criteria: 1. those who have a history of a diagnosis of chronic hepatitis b more than 24 weeks prior to screening and have been maintaining hbsag positive at screening 2. those who have an hbv dna level that is below \<20 iu/ml 3. those who have been receiving tenofovir (including tenofovir's salt-free or salt-modifying drugs), or entecarvir (including entecavir's salt-free or salt-modifying drugs) stably for ≥24 weeks prior to screening and anticipated to maintain the identical drug with equivalent dosage and administration during the clinical trial. exclusion criteria: 1. those with a history of clinically significant chronic liver disease caused by other than chronic hbv infection at the time of screening 2. patients with a signs of loss of liver function and decompensation of liver disease 3. patients with uncontrolled diabetes (hba1c \>7.5%) 4. patients with uncontrolled hypertension
dexmedetomidine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain

Conditions: Dexmedetomidine; Adjuvant; External Oblique Intercostal Plane Block; Thoracotomy; Pain

Summary: this study aims to evaluate the role of dexmedetomidine as an adjuvant in external oblique intercostal plane block for post-thoracotomy pain.

external oblique intercostal plane block (eoipb) is a novel block that has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both sexes. * american society of anesthesiology (asa) physical status i-iii. * scheduled for open thoracotomy. exclusion criteria: * patients with neurological or intellectual disability. * infection at the injection site. * drug abuse. * allergic reaction to local anesthetics. * coagulation abnormalities. * pregnancy. * body mass index (bmi) ≥35 kg/m2. * severe cardiovascular problems. * diabetic neuropathy.
a multicenter, prospective, real-world study of a regimen containing tucidinostat for primary treatment of dlbcl

Conditions: DLBCL

Summary: this is a prospective, observational, multicenter, cohort study with 400 newly treated dlbcl patients. to evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large b-cell lymphoma

the study was divided into 2 cohorts. cohort 1: dlbcl patients diagnosed unfit/ unfit. a person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator. reference options for a combination regimen include c-r2, c-r-mini-chop, etc. cohort 2: patients diagnosed with dlbcl who cannot be classified as unfit/ unfit. reference options for a combination regimen include cr-chop, c-pola-r-chp, etc.

Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old, male or female; * 2. no previous treatment for dlbcl, including chemotherapy, targeted therapy and immunotherapy; * 3. del \[diffuse large b-cell lymphoma with double expression of myc and bcl2 (immunohistochemical myc≥40%, bcl2≥50%)\] was confirmed by pathology; or non-double expression but at least one of the following:; 1. tp53 or other epigenetic gene mutations (as in: actb, bcl6, bcor, crebbp, ep300, ezh2, hist1h1c, hist1h1e, hist1h2bk, hist2h2ab, irf4, kmt2a, kmt2c, kmt2d, myc, myd88, nsd2, rag1, setd1b sf3b1, sin3a, tbl1xr1, tet2, tox, tp53, trip12, trrap, ube2a) 2. myc and bcl2 double hit * 4. plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results); * 5. voluntarily sign informed consent. exclusion criteria: * 1. patients currently enrolled or planning to participate in any interventional clinical trial; * 2. the expected survival time is less than 6 months; * 3. there are any other reasons that the investigators believe are not suitable for patients to participate in this study.

Keywords: tucidinostat dlbcl
qungasvik (toolbox): prevention of alcohol/suicide risk in alaska native youth

Conditions: Suicide; Alcohol Use Disorder

Summary: for the past 20+ years the investigators have focused on addressing two interrelated public health issues, alcohol use disorder (aud) and suicide in alaska. there is no greater source of health disparity in american indian and alaska native (ai/an) communities than that involving aud and suicide, and no greater necessity in addressing this disparity than the development of sustained, trusting, collaborative, and non-exploitive research relationships with those who historically experienced forced acculturation and exploitation. yup'ik community leaders have made addressing aud and suicide among their highest priorities. working with yup'ik community members, the investigators developed a multilevel (individual, family, peer, and community) intervention that uses a culturally-based aud and suicide prevention framework. the qungasvik (kung-az-vik; a yup'ik word meaning 'toolbox') intervention is a yup'ik an approach to prevention organized and implemented utilizing a local indigenous theory of change and process model to build protective factors against aud and suicide. the purposes of the proposed research are to: (a) validate results obtained from previous smaller intervention studies aimed at reducing the incidence of aud and suicide in 12-18 year old yup'ik alaska native (an) youth; and (b) learn more about the relative importance of the individual, family, peer, and community variables that underscore the qungasvik intervention. this study will: (a) assess the efficacy of the qungasvik intervention through a two group community level trial using an interrupted time series design with wait-listed control, and (b) examine mechanisms of change in response to intervention. specific aims (sa) of the project are to: (sa1) test the qungasvik intervention efficacy through impact on the ultimate outcome variables of reasons for life and reflective processes on alcohol use consequences, and on suicidal ideation and alcohol use; (sa2) examine the mechanisms of change in response to the qungasvik intervention through (a) self-report outcome measures of protective factors (b) social network assessment and (c) process evaluation; (sa3) test levels of fidelity of the implementation of the intervention with regard to the yup'ik indigenous theory-driven intervention model outlined in the qungasvik manual of operations.


Eligibility criteria:
inclusion criteria: * alaska native youth 12-21 years exclusion criteria: * children under the age of 12

Keywords: alaska native alcohol indigenous rural suicide prevention multi-level small samples dynamic wait-listed design stepped wedge design protective factors reasons for life
prospective evaluation of etravirine for hiv-infected patients in need of lipid-lowering drugs

Conditions: HIV Infection

Summary: dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (ldl) cholesterol and reduced high-density lipoprotein (hdl) cholesterol levels, is common in hiv-infected individuals, and has been associated with hiv infection itself and antiretroviral therapy (art). these abnormalities are well-established markers of cardiovascular (cvd) risk in the general population. studies have suggested an increased risk of cvd associated with art exposure over and above that conveyed by traditional cardiovascular risk factors. in hiv population to reduce lipid parameters, the most usual clinical strategy remains to add a statin treatment. recent studies suggested art switch can represent an interesting alternative to statins to reduce lipid plasma levels. the purpose of this study is to evaluate the frequency with which the replacement of lpv/r (lopinavir/ritonavir), atz/r (atazanavir/ritonavir), drv/r (darunavir/ritonavir) or efv (efavirenz) by etr (etravirin) in dyslipidemic patients with suppressed viremia would obviate the necessity to administer statins. a prospective, phase iii study in which the statin treatment of dyslipidemic hiv patients on antiretroviral drugs (arvs) will be interrupted during 4 weeks is proposed. at week 4, patients qualifying for a lipid lowering drug (calculated ldl-c≥ 3mmol/l) will replace efv, lpv/r, drv/r or atz/r by etr. the proportion of patients not qualifying anymore for a statin treatment at 12 weeks (i.e. after 8 weeks of etr treatment) will be determined. additionally, the lipid level changes will be assessed at 12 weeks. inflammatory markers will be measured at baseline, at drug switch and at the end of the study study drug will be provided by the drug manufacturer (janssen-cilag, ag). compliance for study drug will be done at week-4 and week-12, returned study medication will be counted and the amount notified on the case report form (crf).


Eligibility criteria:
inclusion criteria: * on statin treatment for at least 3 months (fluvastatin, simvastatin, pravastatin, rosuvastatin, or atorvastatin) for primary prevention of cardiovascular disease * hiv ribonucleic acid (rna) below 50 copies/ml, minimum duration 3 months * on a stable (\> 3 months) arv treatment including at least one of the following drugs: lpv/r, atz/r, drv/r, or efv * no previous virological escape or virological escape documented with a genotype at the time of failure only showing a k103m mutation. exclusion criteria: * probability of cardiovascular complications of \> 20% according to the swiss gsla ("groupe de travail lipide et athérosclérose"/swiss atherosclerosis association) guidelines * previous cardiovascular disease (including stroke) * known diabetes * known intolerance of etr * presence of a documented drug mutation (excluding the k103m) * regimen including non-boosted atz * known hyperlipidemia before arv initiation

Keywords: hiv infection lipid lowering drugs etravirine patient statin treatment efv or boosted pi antiretroviral treatment
comparison of prone position and standard electrocardiogram in covid-19 patients

Conditions: COVID-19 Acute Respiratory Distress Syndrome; Cardiovascular Diseases; Arrhythmias, Cardiac

Summary: prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ards) and in covid-19 infection. a large number of patients with covid-19 suffered from new-onset cardiac disease, therefore, ecg is crucial. however, there is limited data on the effects of prone position on the ecg in covid-19 patients.

prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ards) and in covid-19 infection. the evidence showed that a large number of patients with covid-19 suffered from new-onset cardiac disease due to inflammatory processes or cytokine storm, therefore, ecg is crucial for making the diagnosis including arrhythmias and myocardial infarction. however, there is limited data on the effects of prone position on the ecg in covid-19 patients. therefore, we aimed to identify differences of electrical parameters between prone position and standard ecg including the difference in amplitude and duration of p, qrs, pr interval, qt interval, st-segment between both positions (supine and prone). furthermore, we aimed to compare clinical diagnosis from ekg between prone position and standard ecg by the cardiologists.

Eligibility criteria:
inclusion criteria: * covid-19 patients who were admitted to the covid-19 specialized ward * age 18 -80 years old * suffered from pulmonary infiltration exclusion criteria: * intubated patients * cardiac arrest patients whether at presentation or during the study period * ecg cannot be performed due to anatomical defects or superficial skin problems

Keywords: covid-19 electrocardiogram ards prone position
fast versus slow application of vulsellum during intrauterine device insertion

Conditions: Improving Quality of Life

Summary: intrauterine device insertion requires use a vulsellum to stabilize the cervix. patient's often complain that its placement is one of the most uncomfortable parts of this procedure


Eligibility criteria:
inclusion criteria: * women not taken analgesics or anxiolytics in the 24 hours prior insertion * women not taken misoprostol prior to intrauterine device insertion * women who will accept to participate in the study exclusion criteria: any contraindication to intrauterine device placement
biomarkers in tumor tissue samples from patients with stage iii, stage iv, or recurrent endometrial cancer

Conditions: Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer

Summary: this research study is studying biomarkers in tissue samples from patients with stage iii, stage iv, or recurrent endometrial cancer. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (dna) and identify biomarkers related to cancer.

primary objectives: i. to determine the frequency of topoisomerase 2-alpha (topo2a) gene copy number alterations (including deletions, gains, and amplification), immunohistochemical expression, and chromosome 17 polysomy in tumor tissue samples from patients with advanced or recurrent endometrial carcinoma treated with anthracycline-based therapy on gynecologic oncology group (gog)-0177. ii. to assess the relationship between topo2a gene copy number alterations, topo2a protein expression, chromosome 17 polysomy, and human epidermal growth factor receptor 2 (her2) status in tumor tissue samples from these patients. iii. to assess the association between topo2a status (topo2a gene copy number alterations and topo2a protein expression), or chromosome 17 polysomy and clinical covariates (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, regimen type). iv. to assess the association between topo2a status or chromosome 17 polysomy with measures of clinical outcome including response, progression-free survival, and overall survival of patients treated with this regimen. v. to evaluate the potential identification of cut points for topo2a protein expression with potential prognostic value in patients treated with this regimen. outline: archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and expression and chromosome 17 polysomy by fluorescent in situ hybridization (fish) and immunohistochemistry (ihc). clinical information associated with each endometrial carcinoma sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, and regimen type) is also collected.

Eligibility criteria:
inclusion criteria: * chemotherapy-naïve women with histologically documented measurable stage iii, stage iv or recurrent endometrial carcinoma with known her2 status who participated in gynecologic oncology group (gog)-0177 are eligible * patients must have given permission for their archival formalin-fixed, paraffin-embedded primary, metastatic or recurrent tumor to be submitted and used for gog-0177, and at least one to three unstained slides must be available for fish analysis of topo2a and cep17 and immunohistochemical staining for topo2a exclusion criteria: * women who were not eligible or evaluable on gog-0177 * patients who do not have at least one unstained slide archival formalin-fixed, paraffin-embedded primary, metastatic or recurrent tumor available for fluorescence in situ hybridization (fish) analysis of topo2a and cep17 or immunohistochemical expression of topo2a
an open-label study of the safety of interferon gamma-1b in patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Disease

Summary: open-label therapy will be administered to up to 220 patients, following completion of either intermune protocol gipf-002 part b or protocol gipf-004, to assess the long-term safety of subcutaneous interferon gamma-1b. the study duration will be 5 years.

open-label therapy will be administered subcutaneously. patients enrolled will continue to receive interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. patients not taking interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

Eligibility criteria:
inclusion criteria: * enrollment in protocol gipf 002 part b or gipf-004 * completion of the end of treatment visit in protocol gipf-002 part b or the study completion visit in gipf-004 * able to understand and sign a written informed consent form and comply with the requirements of the study exclusion criteria: * pregnancy or lactation * lack of adherence to either gipf-002 or gipf-004 study protocols and treatment regimens * if principal investigator deems patient is unsuitable for study

Keywords: idiopathic pulmonary fibrosis ipf lung actimmune interferon gamma intermune