Kornimate/medical-research-clean huggingface dataset:
a study of xiongdan wan treating depression

Conditions: Major Depressive Disorder

Summary: this is a prospective, single-arm, open-label study to evaluate the safety and efficacy of xiongdan wan monotherapy in patients with major depressive disorder(mdd), conducted in shang hai mental health center. following a screening period, subjects who meet the entry criteria will be treated with 450mg xiongdan wan pills three times daily for 8 weeks.


Eligibility criteria:
inclusion criteria: 1. meets the diagnostic and statistical manual of mental disorder, fourth edition text revision (dsm-iv-tr) criteria for major depressive disorder (mdd): a single or recurrent episode without psychotic features. codes are as follows: f32.0, f32.1, f32.2, f33.0, f33.1, f33.2. 2. outpatients. 3. male or female subjects aged 18-65 years. 4. hamd-17 score of the baseline period and screening period is 18-24. 5. women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month. 6. the patient fully understands and signs the informed consent form. exclusion criteria: 1. patient has survived a suicide attempt or has acute suicidal tendencies (hamd-17 item3 ≥3). 2. comorbidity according to dsm-iv-tr, axis-i except for major depressive disorder. 3. hamd-17 reduction ratio ≥25% within one week from the screening to the baseline period. 4. depressive episode secondary to psychiatric illness or somatic disease. 5. serious and unstable diseases such as cerebrovascular disease; liver and kidney disease; disease of internal secretion (abnormal thyroid function); hemopathy; seizures, or other encephalopathies. 6. history of alcohol or drug abuse over the last 6 months. 7. allergic history to xiongdan wan, or serious drug allergic history. 8. pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months. 9. clinically significant changes in ecg or laboratory tests, including \>1.5 times the upper limit of normal liver function; over the limit of normal renal function and blood sugar; abnormal cardiac troponins; obvious abnormity in the thyroid function. 10. treatment with modified electroconvulsive therapy (mect) or repetitive transcranial magnetic stimulation (rtms) in the past three months. 11. treatment with a systematic psychological treatment in the past three months.
trial to compare the relative pharmacodynamic properties of different glucagon dosages

Conditions: Diabetes Mellitus Type 1

Summary: the ultimate goal of the pcdiab project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with t1dm.

the study is planned as open, randomised 3-period cross-over in patients with t1dm. the study will include a total of 6 completing patients. the study is not blinded due to the exploratory nature. at each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/l), and a prefixed glucagon dose will be given per glucose level. the sequence of glucagon dose strength for the three dosing days will be randomized.

Eligibility criteria:
inclusion criteria: * male or female subjects with diabetes mellitus type 1 , as defined by the american diabetes association1. * age ≥ 18 and ≤ 65 years. exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products. * receipt of any investigational medicinal product within 3 months or 5 half-lives of that imp before randomisation in this trial.
lactate clearance according to the presence of hepatic dysfunction

Conditions: Sepsis; Liver Failure

Summary: the purpose of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction.

lactate clearance is well known to be associated with mortality in patients with severe sepsis and septic shock. to normalize lactate levels is one of important goals of early resuscitation of sepsis patients. lactate clearance can be changed by various factors including patient characteristics, severity of shock, and treatment. in particular, hepatic dysfunction might impair the clearance of lactate because liver is a principal organ for lactate metabolism. however, an association between lactate clearance and hepatic failure has not been evaluated during initial resuscitation of patients with severe sepsis and septic shock. the primary goal of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction. the secondary goal is to evaluate if lactate clearance is associated with mortality even in patients with hepatic dysfunction.

Eligibility criteria:
inclusion criteria: * patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival exclusion criteria: * terminal malignancy or illness with a expected survival \< 4 months * patients who previously signed "do not resuscitate" or "do not intubate" orders * patients who do not undergo the early goal-directed therapy

Keywords: sepsis lactic acid shock resuscitation
anemia in older adults

Conditions: Anemia; Nutritional Deficiency; Inflammation

Summary: a cross-sectional study with 829 older mexican adults were recruited from july to september 2015, from four localities in the southern region of méxico. older adults were interviewed at their homes and a fasting blood sample was obtained for analysis of micronutrient status (iron deficiency, vitamin b12 deficiency, folate deficiency, vitamin a deficiency and biomarkers of inflammation). the aim of the study was to identify the main causes of anemia in older adults with higher rates of anemia according to the recent data of the mexican national health and nutrition survey.

a survey with cross-sectional design was applied in 829 older mexican adults, recruited during the period july to september 2015, from four localities in the southern region of méxico: including champotón, campeche, mérida, and valladolid. older adults were interviewed at their homes to collect nutrition, health, cognitive and dietary information. anthropometric measures and functionallity tests were also collected. a finger prick capillary blood sample was collected to measure hemoblobin in situ using hemocue. anemia was defined according to who criteria. a fasting venous blood sample was collected in 803 older adults. serum was separated and frozen at -20°c to measure ferritin, retinol, vitamin b12, folate, iron, soluble transferrin receptor, c-reactive protein, interleukin 6, alpha glycoprotein 1, hepcidin, erythropoietin in the laboratory of nutrition of the national institute of public health. the study protocol was approved by research, biosecurity and ethics committees of the national institute of public health. participants received a detailed explanation of the study procedures and signed an informed consent form prior to data collection.

Eligibility criteria:
inclusion criteria: * community-dwelling older adults who wish to participate in the study * ambulatory older adultos * older adult with own decision making exclusion criteria: * non demented * non oxygen dependent * no disability

Keywords: anemia older mexican adults vitamin a deficiency iron deficiency vitamin b12 deficiency
transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency

Conditions: Iron-deficiency; Internal Medicine; Transferrin; Ferritinemia

Summary: transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency


Eligibility criteria:
inclusion criteria: * ≥ 65 years old * patient hospitalized in the internal medicine and geriatry service * patient affiliated with a social security scheme * patient signed an informed consent exclusion criteria: * risk benefit balance not in favor of iron deficiency check-up * patient in palliative care
spirometric response to bronchial thermoplasty in patients with severe asthma

Conditions: Asthma

Summary: the investigators hypothesis is that there will be improvement in fev1 in patients with severe asthma. this is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.

the investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. the procedure will have been done according to the recommended protocol of three separate sessions. for each patient all available spirometric data obtained before and after thermoplasty will be used. data will be collected from two centers, ou medical center and st. francis hospital in tulsa, ok. all procedures done at st. francis have been performed by a single physician and he is providing their spirometric data for the investigators study. the following data will be collected for all participants undergoing bronchial thermoplasty: age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.

Eligibility criteria:
inclusion criteria: * \>18 years of age * severe asthma diagnosis * decreased fev1 exclusion criteria: * \< 18 years of age

Keywords: asthma thermoplasty
fecal microbiota transplant (fmt) capsule for improving the efficacy of gi-agvhd

Conditions: GVHD

Summary: this study aims to determine whether the fecal microbiota transplant (fmt) capsule improves the response rate of gi-agvhd in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation


Eligibility criteria:
inclusion criteria: * 1. gvhd within 100 days after allogeneic hematopoietic stem cell transplantation (allo hsct); 2. age 18 - 65 years old, regardless of gender; 3. patients with grade 3 or 4 gastrointestinal involvement (agvhd) according to the international alliance (magic) classification standard; 4. patients with glucocorticoid resistant gi agvhd are diagnosed. according to the expert consensus of chinese allogeneic hematopoietic stem cell transplantation for the treatment of hematological diseases (iii) - acute graft-versus-host disease (2020 edition), the definition of glucocorticoid resistant acute gvhd is thomas' hematopoietic cell transplantation: stem cell transplantation (5th edition) glucocorticoid resistance was defined as pd at 3 days, nr at 7 days or cr not reached at 14 days after first-line treatment. 5. ecog 3 points or less; 6. stop prophylactic antibiotics at least 12 hours before fmt treatment; 7. be able and willing to sign informed consent; 8. patients who are capable of swallowing capsules and can complete the study; exclusion criteria: * 1. there are active but uncontrolled infections, except gvhd complicated with infectious diarrhea; 2. gastrointestinal perforation, active gastrointestinal bleeding, small intestinal obstruction, toxic megacolon or other serious gastrointestinal diseases not caused by gvhd; 3. have a history of severe allergic reaction; or known to be allergic to any ingredient of intestinal bacteria capsule xbi-302; 4. any serious disease that can increase the risk of patients participating in the study; 5. female subjects with positive pregnancy test and lactation, or female subjects of childbearing age who refuse to take contraceptive measures during the study; 6. according to the judgment of the researcher, the patients with high dynamic diarrhea can not stay in the intestine for enough time to dissolve the capsule. 7. hiv, hbv, hcv and syphilis are positive; 8. after colectomy; 9. participate in other intervention clinical studies within 4 weeks before the screening period; 10. the expected survival time is less than 12 weeks; 11. the basic body function test is inferior to the following standards: total neutrophils (neu) \ 1.5 times the maximum normal value (uln), albumin (alb) \< 25g / l; 12. there is any situation that the researcher thinks is not suitable for inclusion (any history of medical history, treatment history or abnormal test data that may confuse the results of this study, interfere with the subject's whole participation in the study, or harm the interests of the subject).
assessment of fluid responsiveness in patients after cardiac surgery

Conditions: Hemodynamics; Patient Monitoring

Summary: to overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (svv and ppv) during spontaneous breathing, a passive leg raising (plr) manoeuvre has been suggested as a reliable predictor of fluid responsiveness. aim of this study was to evaluate fluid responsiveness using svv, ppv and plr during the transition from controlled to spontaneous breathing in cardiac surgery patients

in patients after elective off-pump cabg are enrolled hemodynamic measurements are performed in the postoperative period upon arrival in the icu using a picco2 system (pulsion medical systems, munich, germany). controlled fluid challenges (500 ml) are done at 3 time-points: a) during controlled mechanical ventilation b) during pressure support ventilation with spontaneous breathing and c) after extubation. stroke volume (sv), svv and ppv as well as standard hemodynamic parameters (map = mean arterial pressure, hr = heart rate) are assessed. a plr is performed before fluid administration at all 3 time points. a positive response is defined as an increase in sv\>15 %. prediction of fluid responsiveness will be tested by auc (area under the receiver operating characteristic - roc - curve).

Eligibility criteria:
inclusion criteria: * preserved left ventricular function * regular heart rhythm exclusion criteria: * emergency procedures * intra- and extra-cardial shunts * aortic and tricuspid valve insufficiencies * peripheral arterial occlusive disease

Keywords: functional hemodynamic parameter passive leg raising stroke volume variation pulse pressure variation
compassion s3 post-approval study

Conditions: Complex Congenital Heart Defect; Dysfunctional RVOT Conduit; Pulmonary Valve Insufficiency; Pulmonary Valve Degeneration; Pulmonary Valve; Obstruction

Summary: this study will monitor device performance and outcomes of the sapien 3 transcatheter heart valve (thv) system in subjects with a dysfunctional right ventricular outflow tract (rvot) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

this is a single arm, prospective, multicenter post-approval study.

Eligibility criteria:
inclusion criteria: 1. dysfunctional rvot conduit or previously implanted surgical valve 2. rvot/pv with ≥ moderate regurgitation and/or a mean rvot/pv gradient of ≥ 35 mmhg exclusion criteria: 1. inability to tolerate an anticoagulation/antiplatelet regimen 2. active bacterial endocarditis or other active infections

Keywords: transcatheter pulmonary valve replacement transcatheter pulmonary valve implantation sapien 3
comparison of detection rates between two commonly used bone density measurement methods

Conditions: Osteoporosis; Diagnosis; Dual Energy X-ray Absorptiometry; Quantitative Computed Tomography

Summary: 72 adult patients who underwent lumbar spine anteroposterior dxa and qct examinations at qianfoshan hospital in shandong province from january 2019 to december 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient. 1. record the patient's age, gender, height, and weight; review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.). 2. retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by ge healthcare lunar prodigy dual energy x-ray absorptiometry from the database, and take the average (dxa bone density value). according to the diagnostic criteria of the diagnosis and treatment guidelines for primary osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis. 3. identify the lumbar spine bone density values (qct bone density values) measured by the ge gemstone cthd750 ct instrument from the database. according to the diagnostic criteria of the chinese quantitative ct (qct) diagnosis guidelines for osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis. 4. statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by dxa and qct respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. the data was analyzed and processed using spss 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, p\<0.05 indicates statistically significant difference; explore whether the difference in detection rates between the two is related to factors such as weight; calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 and above, regardless of gender 2. the interval between dxa and qct examinations shall not exceed 3 months. exclusion criteria: 1. individuals with other metabolic and bone diseases causing focal bone destruction of the vertebral body 2. incomplete key information
glycosaminoglycan scores as monitoring biomarkers in advanced renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: in this study, glycosaminoglycan (gag) profiling in subjects diagnosed with metastatic renal cell carcinoma (mrcc) is hypothesized to be useful in monitoring drug response and predict radiological response. to this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. a positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0-2 * diagnosis of renal cell carcinoma * metastatic disease * predicted life expectancy over 2 months * patient referred for first line drug therapy * standard imaging evaluation 12 weeks prior to inclusion * planned for standard imaging within 16 weeks after start of therapy * informed consent exclusion criteria: * lack of proper compliance to accept continuous samplings
tissue procurement protocol for patients undergoing neoadjuvant systemic therapy for breast cancer

Conditions: Breast Cancer

Summary: this study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

this protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Eligibility criteria:
inclusion criteria: 1. all patients must have a primary measurable invasive breast cancer with the primary tumor intact (t1, 2, 3, or 4, any n, m0 or m1). recurrent disease in the breast is also eligible. 2. the patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast. 3. the clinical plan for patients with recurrent or m1 disease must include breast surgery after neoadjuvant systemic therapy. this would include patients with non-bulky m1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy. 4. patients must have had mammography performed at the university of michigan, or outside film review prior to enrollment. 5. all patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the university of michigan institutional review board standards. - exclusion criteria: 1. breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound. 2. tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound. 3. patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. patients who received tamoxifen or other agents for prevention of breast cancer may be included. 4. patients with another active systemic malignancy in the past year. -
green (sustainable) ventolin - pharmacokinetics (pk) study in healthy participants

Conditions: Asthma

Summary: this study will be conducted to compare the pk of salbutamol administered via metered dose inhalers (mdi) containing propellants 1,1-difluroethane (hfa-152a) and 1,1,1,2-tetrafluoroethane (hfa-134a) in healthy participants.


Eligibility criteria:
inclusion criteria: * aged 18 to 55 years, inclusive, at screening * body mass index 18.0 to 30.0 kilograms per meter square (kg/m\^2), inclusive, at screening * weight: greater than or equal to (\>=)50 kg * at screening, females must not be pregnant or lactating, or of non-childbearing potential * female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception * male participants, if not surgically sterilized, must agree to use adequate contraception * good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator * willing and able to sign the informed consent form exclusion criteria: * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data * history or presence of any form of asthma, including childhood asthma and exercise induced asthma * current enrollment or past participation in this clinical study * participants with clinically significant abnormalities * a positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse * positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (sars-cov-2) on day -1 or any known close contact with a person who tested positive for sars-cov-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission * impairment which would prevent the correct and consistent use of an mdi, as determined by the investigator

Keywords: cross-over healthy volunteers salbutamol pharmacokinetics