Kornimate/medical-research-clean huggingface dataset:
efficacy of trastuzumab deruxtecan in metastatic breast cancer with different her2 expression patterns

Conditions: Metastatic Breast Cancer

Summary: the purpose of this observational study is to learn about the her2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. the main question it aims to answer is: - does the heterogeneity of her2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?


Eligibility criteria:
inclusion criteria: * patients with advanced or locally unresectable breast cancer; * treated with t-dxd (ds-8201, trastuzumab deruxtecan) regardless of line of therapy, hr, and her2 expression level; * her2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion; * measurable lesions with treatment response results that can be evaluated through imaging examinations; * able to follow up with the latest progression-free survival or overall survival. exclusion criteria: * patients with missing basic clinical information or her2 immunohistochemistry staining information; * patients with missing pathological results for both primary and metastatic/recurrent lesions; * patients with no measurable lesions and unable to evaluate t-dxd treatment response; * discontinue t-dxd therapy for unacceptable adverse events or other reasons; * patients lost to follow-up after t-dxd treatment.

Keywords: breast cancer trastuzumab deruxtecan her2
efficacy and safety of silicone cream containing allium cepa extract

Conditions: Cicatrix

Summary: the objectives of this study were to evaluate efficacy and safety of silicone cream containing allium cepa extract in post-cesarean surgical scars treatment. post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). silicone cream containing allium cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. they will be applied 2 times per day (morning and evening) for 3 months. patient and observer scar assessment scale (posas) , vancouver scar scale (vss), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. moreover, adverse effects were also observed.


Eligibility criteria:
inclusion criteria: * age 18-40 years * have post-cesarean surgical scars at least 1 month * reeda scale = 0 score * able to read and write thai * able to follow the research plan * able to meet all the researchers throughout the period of participation in the project exclusion criteria: * apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study * there is radiation in the area of the post-cesarean surgical scars * chronic skin diseases such as psoriasis, chronic dermatitis, allergies * immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study * have a history of silicone allergy or onion extract

Keywords: scar allium cepa post-cesarean
safety and efficacy of boceprevir/peginterferon alfa-2a/ribavirin in interleukin-28b cc allele-positive chronic hepatitis c virus (hcv) genotype 1 participants (p07755)

Conditions: Hepatitis C, Chronic

Summary: the primary purpose of this study is to compare the efficacy of two boceprevir (boc)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis c virus (hcv) genotype 1 who have the il28b cc allele. the regimens differ in the treatment for participants who achieve undetectable hcv ribonucleic acid (rna) at the end of the peginterferon alfa-2a (peg-ifn) plus ribavirin (rbv) 4 week lead-in. participants receive either peg-ifn + rbv (arm 1) or boc + peg-ifn + rbv (arm 2). the hypothesis is that arm 2 is noninferior to arm 1 in the proportion of participants with undetectable hcv rna at follow-up (fu) week 24.


Eligibility criteria:
inclusion criteria: * is ≥ 40 kg and ≤ 125 kg. * documented chc genotype 1 with hcv rna ≥10,000 international units (iu)/ml * has il-28b cc allele gene * has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and fibrotest can also be used for staging of liver disease). exclusion criteria: * co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hepatitis b surface antigen \[hbsag\] or hiv positive). * previously treated with an interferon and ribavirin regimen or hcv direct acting antiviral regimen. * treatment for hepatitis c with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity * receiving any medication(s) within 2 weeks prior to the day 1 visit that are highly dependent on cytochrome p450 3a4 (cyp3a4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events * participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial. * evidence of decompensated liver disease or hepatocellular carcinoma (hcc) * is diabetic and/or hypertensive with significant retinopathy * has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction. * evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years * hemoglobin \<12 g/dl for females and \<13 g/dl for males * neutrophils \<1,500/mm\^3, or \<1,200/mm\^3 for participants of african descent * platelets \<150,000/mm\^3 * direct bilirubin \>1.5 x upper limit of normal (uln) of the laboratory reference range.
effects on plasma exchange on functional capacity of serum albumin, circulatory dysfunction, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure"

Conditions: Liver Cirrhosis; Liver Failure

Summary: the purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".

the purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure", renal disfunction, cerebral disfunction ,and inflamtory response

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old * hepatic cirrhosis diagnosed by biopsy or clinical, analytic and ultra sound data. * acute on chronic liver failure: defined by an acute deterioration in hepatic function produced in 2-4 weeks with jaundice (total serum bilirubin ≥ 5 mg/dl ) and hepatic encephalopathy (≥ grade 2) and/or renal insufficiency (serum creatinine ≥ 2 mg/dl) exclusion criteria: * neoplasm disease including hepatocarcinoma which exceed milan criteria (1 tumour \> 5cm, up to 3 tumours \<3 cm) * active bacterial or fungal infection with hemodynamic instability which require the utilization of vasoactive drugs at moderate dose (\>0,5 μg/kg/min of noradrenaline) * structural moderate to severe cardiopathy (cardiac index \<2l/min/m2) * chronic renal insufficiency in treatment with haemodialysis * chronic moderate o severe pulmonary disease (maximum expiratory volume in a second \<50%) * active transplant * human immunodeficiency virus infection * pregnancy or lactation * acute respiratory distress syndrome (p02/fi02\< 200mm hg) or acute lung injury (p02/fi02\< 300mm hg) * hemodynamic instability (\>0,5 μg/kg/min of noradrenaline) * bleeding in the digestive tract in the previous 72h to the treatment * severe coagulopathy: inr ≥ 3.0 (quick ≤ 20%) and/or platelets \< 30000//mm3 * extrahepatic cholestasis * hepatobiliary surgery in the last 6 months (except laparoscopic cholecystectomy) * concentrations bilirubin ≥ 5mg/dl during the period above 4 weeks previous to inclusion * concomitant participation in an other clinical trial * drug addiction * mental status which does not allow the patient to understand the trial, with the exception of hepatic encephalopathy.

Keywords: cirrhosis cirrhotic patients with acute on chronic liver failure
relatives visit prior to hospital admission & intensive care unit

Conditions: Anxiety; Depression; Care Unit Syndrome

Summary: the present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.


Eligibility criteria:
inclusion criteria: * family of a patient for hospital admission for surgery exclusion criteria: * cognitive impairment
the effects nutrition status and body composition on hd patients' outcome

Conditions: Body Composition; Nutritional Wasting; Malnutrition

Summary: a prospective long-term follow up of hemodialysis (hd) patients' outcome correlates with nutritional status and body composition. we will evaluate the body composition change among hd patients every three months with bioelectrical impedance analysis (bia). the change of body composition will correlated with other clinical data including nutritional, inflammatory parameters and survival.

wasting and malnutrition are common and serious complications in patients on hemodialysis and are strongly associated with adverse outcomes. techniques for assessing nutrition have limitations and, due to metabolic effects and confounding effects of altered hydration and other body composition abnormalities, these limitations are greater in the context of renal failure. bioelectrical impedance analysis is a promising method for the objective assessment and monitoring of body composition. body composition techniques subdivide the body into compartments on the basis of differing physical properties. the different compartments reflect hydration, nutrition/wasting, body fat, and bone mineral content, which are all of great importance in patients on hemodialysis. we will conduct a prospective long-term follow up of hd patients' outcome correlates with nutritional status and body compositions. the patients will receive bia every three months, and other routine clinical data such as dialysis adequacy and monthly biochemical data are collected to analyze. an additional blood sample of 8 ml will be collected every 3 months during the bia survey for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin, fetuin a, fructosamine, il-1, il-6 and transferrin. the follow up period will be as long as possible and the last recruited into this study is in the dec. 2016. these data will be used for the morbidity and mortality analysis to see if body compositions will be more useful and timely than the other nutritional parameters.

Eligibility criteria:
inclusion criteria: * patients at national taiwan university hospital * patients who have received hemodialysis more than 3 months * patients who sign the informed consents exclusion criteria: * patients who have received hemodialysis less than 3 months * patients who refuse to sign informed consents * patients who refuse to draw additional blood for research

Keywords: hemodialysis wasting and malnutrition nutrition status bioelectrical impedance analysis body composition
prospective observational study on postoperative pain and side effect

Conditions: Postoperative Pain

Summary: pain out is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

pain out offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. it collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages. the registry part of the project aims at performing population-based research. furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care. the benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. a web-based information system, featuring two main functions, was developed: a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice. a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations. from 2016 on, sub-projects in mexico, china and several european countries have started. this programs take place over a period of two years during which collaborators carry out a quality improvement project in their hospital using methodology provided by pain out. this includes collection of baseline data in a first phase, analysis of findings according to a protocol provided by pain out, review of findings and developement of improvement measures, implementation of the improvements and assessment of outcomes after a second phase of data collection.

Eligibility criteria:
inclusion criteria: * \>= 18 years or \>= 4 years for sub-project quipsi/pain outinfant * patient is post-op day 1 * patient is at least 6 hours on the ward * patient has given consent exclusion criteria: * patient cannot communicate * patient is cognitively impaired * patient is asleep * patient is too ill * patient does not want to fill in the questionnaire
evaluating the impact of an integrative oncology training program for healthcare providers

Conditions: Integrative Oncology; Medical Education; Palliative Care

Summary: the goal of this study is to learn about the short- and long-term effects of two medical education approaches to teaching integrative oncology (io) in a multi-disciplinary group of healthcare providers attending a national io training. the main question it aims to answer is: does active medical education approach focusing on io-related skills is associated with better training outcomes compared to clerkship-based observation of io clinics? participants (trainees) will answer online survey questions about their knowledge, attitudes, and clinical proficiencies along the training process.

the study is conducted within a multi-centered, prospective, controlled and randomized format, using a mixed quantitative and qualitative methodology. participants eligible for study inclusion are healthcare providers (hcps, nurses, physicians, para-medical, or complementary medicine practitioners), age ≥ 18 years enrolling in a structured io training program. trainees are randomly allocated to either the enhanced io training arm (group a) or standard io training arm of the study (group b). participants in both study arms undergo 110-hour online section of the io training course, followed by 170-hour practical training. those in the enhanced io training arm undergo practical training, based on the five-item competency curriculum adapted from the list of knowledge, skills, and ability-related competencies recommended by the society for integrative oncology. the five-item competency-based curriculum include the following two clinical implementation competencies: * anxiety relief using a mind-body modality (e.g., breathing, relaxation, guided imagery) * improving pain with touch modalities (e.g., acupressure, acupuncture, reflexology), including use of acupressure points with established effectiveness in the reduction of cancer pain participants in the standard io training group (group b) will observe from the side during the io practitioner-patient interaction. the practical section of the training program will include two mentoring days, the first scheduled at the beginning of the 110-hour theory-based io training, the second at the conclusion of this training. participants in both study groups will be exposed during the two mentoring days to between 3-5 clinical io therapeutic interactions with patients admitted to the oncology center.

Eligibility criteria:
inclusion criteria: * healthcare providers (nurses, physicians, para-medical, or complementary medicine practitioners) who have applied to and been accepted for the integrative oncology training program exclusion criteria: * healthcare providers who were not received a letter of support from the medical administrator stating commitment to allocate at least 5 hours weekly post-training to enable the trainee practicing integrative oncology care in the medical center.

Keywords: medical education integrative oncology oncology supportive care
his-bundle corrective pacing in heart failure

Conditions: Right Bundle-Branch Block; Heart Failure; His-bundle Pacing; Cardiac Resynchronization Therapy

Summary: the investigators aim to prospectively evaluate the efficacy and mechanism of benefit of his-bundle pacing enhanced cardiac resynchronization therapy (his-crt) vs. cardiac resynchronization therapy (biv-crt) in patients with heart failure and right bundle branch block (rbbb).

in this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the efficacy and mechanism of benefit of his-bundle pacing enhanced cardiac resynchronization therapy (his-crt) vs. cardiac resynchronization therapy (biv-crt) in patients with right bundle branch block (rbbb) electrocardiogram (ecg) pattern by assessing the improvement in left ventricular ejection fraction (lvef) in the his-crt vs. biv-crt arm at 6 months, and by evaluating changes in ecg biomarkers, nt-pro-brain natriuretic peptide (nt-probnp) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the his-crt vs. biv-crt arm at 6, 12, and 24 months.

Eligibility criteria:
inclusion criteria: * age 18 years or older (no upper age limit) * optimal medical therapy for heart failure by current guidelines * class iia or iib guideline-based indication for crt-d implant in rbbb patients, including one of the following: * new york heart association (nyha) class ii hf symptoms, lvef ≤ 30% and qrs≥ 150 ms (iib); or * nyha class iii-iv a hf, lvef ≤ 35%, and qrs duration ≥ 150 ms (iia); or * nyha class iii-iv a hf, lvef ≤ 35%, and qrs duration 120-149 ms (iib) exclusion criteria: * unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization * left bundle branch block (lbbb) or intraventricular conduction delay (ivcd) ecg morphology * unable or unwilling to follow study protocol * less than 12 months life expectancy at consent * pregnancy or planned pregnancy during duration of the study * on heart transplant list or likely to undergo heart transplant
intravenous autologous mesenchymal stem cells transplantation to treat middle cerebral artery infarct

Conditions: Middle Cerebral Artery Infarction

Summary: this study aims to determine the efficacy of intravenous transplantation of autologous bone marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.


Eligibility criteria:
inclusion criteria: * experiences stroke onset within 2 weeks to 2 months * nihss score of \>10-35 * never received or failed thrombolysis * evidence of unilateral middle cerebral artery infarct on brain mri exclusion criteria: * medically unfit (eg. those are unstable haemodynamically despite treatment, with worsening conscious level and with other serious medical co-morbidity) * evidence of any tumor or other space-occupying lesion on brain mri * evidence of hemorrhagic stroke on brain ct or mri * experiences transient ischemic attack or lacunar infarct * has any acute or chronic infections such as hepatitis b, hepatitis c and hiv * is diagnosed with concurrent malignancy or primary hematological disorders * renal impairment indicated with serum creatinine greater than 200 umol/l or creatinine clearance less than 30 ml/min * liver impairment indicated with serum aspartate transaminase and serum alanine transaminase greater than 4 times upper limit of the normal range * any contraindication to stem cell transplantation or bone marrow biopsy * any co-morbidity which will compromise the ability to obtain adequate stem cells (eg. chronic debilitating diseases, frail patients and patients with known osteoporosis) * any contraindication to brain mri (eg. metal implants, pacemaker, joint implants and ocular implants)

Keywords: bone marrow autologous mesenchymal stem cells unilateral middle cerebral artery infarct
beeac conditioning regimen in malignant lymphoma subjects with indications to autologous hematopoietic stem-cell transplantation

Conditions: Relapsed/Refractory Malignant Lymphomas

Summary: nowadays there is no randomized trials for comparison the effectiveness and tolerability of different conditioning regimens. bendamustine is a unique chemotherapeutic agent that combines alkylating action of nitrogen mustard and the activity of purine antimetabolite. bendamustine has shown its effectiveness for the treatment of patients with chronic lymphoproliferative diseases such as chronic lymphocytic leukemia and several indolent lymphomas. the literature also presents evidence of the effectiveness bendamustine in patients with hodgkin's lymphoma who received multiple lines of prior chemotherapy, including high dose chemotherapy and transplantation of peripheral hematopoietic stem cells. there are also data of using bendamustine as a part of conditioning regimen. in this context, it was planned a study for evaluation the safety and effectiveness of the beeac (bendamustine, etoposide, cytarabine, cyclophosphamide) conditioning regimen prior to autologous transplantation of peripheral hematopoietic stem cells for the treatment of relapsed/refractory malignant lymphomas.


Eligibility criteria:
inclusion criteria: 1. be willing and able to provide written informed consent for the trial 2. be ≥ 18 years of age on day of signing informed consent 3. eastern cooperative oncology group (ecog) \< 2. 4. relapsed/refractory malignant lymphoma patients with indications to autologous hematopoietic stem-cell transplantation exclusion criteria: 1. participation in another clinical trials 2. clinically relevant heart disease: * myocardial infarction during previous 6 months * unstable angina during previous 3 months * congestive heart failure (iii-iv nyha) * clinically relevant ventricular arrhythmias * corrected qt interval (qtc) \> 460 мс on ecg (calculated using frederics formula) * left ventricular ejection fraction ≤ 45% on echocardiogram * atrial hypotension (systolic pressure \< 86 mmhg) or bradycardia (\< 50 per minute, exclusion - drug-induced bradycardia) * uncontrolled arterial hypertension (systolic pressure \> 170 mmhg or diastolic pressure \> 105 mmhg) 3. severe renal dysfunction (serum creatinine \> 250 µmol/l) 4. severe hepatic dysfunction (total bilirubin \> 40 µmol/l) 5. known history of human immunodeficiency virus or active hepatitis b and c 6. psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial 7. hypersensitivity to investigational drugs 8. pregnant or breastfeeding females or males and females with childbearing potential must be willing to use an adequate method of birth control (intrauterine device, vasectomy of female subjects' male partner, contraceptive rod implanted into the skin, combination method - (requires use of two of the following) diaphragm with spermicide, cervical cap spermicide, contraceptive sponge, condom, hormonal contraceptive)

Keywords: hodgkin lymphoma non-hodgkin lymphoma autologous hematopoietic stem-cell transplantation conditioning regimen