Kornimate/medical-research-clean huggingface dataset:
convalescent plasma in the treatment of covid 19

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); COVID; Coronavirus

Summary: the purpose of this study is to collect blood from previously covid-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening covid-19 infection.

the purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with covid-19. 1 to study the efficacy of plasma from patients recovered from covid-19 infection with a high neutralizing antibody titer (nat) as treatment for individuals who are critically ill with covid-19. 2. determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with covid-19.

Eligibility criteria:
inclusion criteria: * all genders * age \> 18 yrs and \< 90 yrs * must have laboratory confirmed covid-19 * must provide informed consent * must have severe or immediately life-threatening covid-19, severe disease is defined as: * dyspnea, * respiratory frequency ≥ 30/min, * blood oxygen saturation ≤ 93%, * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300 * lung infiltrates \> 50% within 24 to 48 hours life-threatening disease is defined as: * respiratory failure, * septic shock * multiple organ dysfunction or failure exclusion criteria: * no gender exclusion * age \ 90 yrs * covid-19 negative

Keywords: sars-cov-1, covid, coronavirus, convalescent plasma, plasma
neoadjuvant triplet chemotherapy regimen in patients with locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: this study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

in this pilot phase ii study, the investigators enrolled chinese adults(age 18 to 70 years) with locally advanced stage ii/iii rectal cancer. the neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5fu 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mfolfox or 4 cycles of xelox. primary outcome measures of this phase ii trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed locally advanced rectal cancer; 2. 18-70 years ； 3. clinicalstage:t3,4a,n0,m0;t1-4a,n+,m0; 4. tumor from anus \>5cm and ≤15cm; 5. ecog=0-1; 6. available organ function:alt≤1.5xuln;ast≤1.5xuln;tbil≤1.0xuln; neut≥2×109/l;plt≥100×109/l;hb≥90g/l;creatinine≤1.0xuln; 7. informed consent; 8. ugt1a1:ugt1a1\*1/ugt1a1\*1,ugt1a1\*1/ugt1a1\*28,ugt1a1\*1/ugt1a1\*6; exclusion criteria: 1. clinical stage t4b or unresectable disease; 2. history of pelvic radiotherapy; 3. history of chemotherapy within 5 years; 4. history of chronic diarrhea; 5. tumor causes intestinal obstruction, intestinal perforation, and severe bleeding; 6. hepatitis b surface antigen positive; hepatitis c virus infection; cirrhosis of the liver for any cause; 7. ugt1a1:ugt1a1\*28/ugt1a1\*28,ugt1a1\*6/ugt1a1\*6; 8. other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer; 9. myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency; 10. mental illness;pregnant or lactating women;

Keywords: 5-fluorouracil rectal cancer irinotecan oxaliplatin neoadjuvant chemotherapy
measurement of serum potassium rate during accidental hypothermia.

Conditions: Accidental Hypothermia; Hyperkalemia; Cardiac Arrest

Summary: serum potassium rate (pr) is a key indicator for medical management of patients with accidental hypothermia particularly for hypothermia related cardiac arrest (ca). experts recommend a cut-off value for pr of 12 mmol/l for all hypothermic victims and 8 mmol/l for avalanche casualties. any patient presenting a pr lower than the cut-off value should be considered for extracorporeal rewarming. this therapeutic strategy is vital for patient survival. however, there is no consensus about what type of vessels should be punctured in order to obtain an accurate potassium rate and what type of measurement technics should be used to measure this potassium rate. the investigators hypothesize that potassium rate in these patients will differ by 1 mmol/l in blood samples collected from a peripheral vein in contrast to a central vein. the investigators study is a prospective observational, multicentre study.


Eligibility criteria:
inclusion criteria: * hypothermia related cardiac arrest * age \> 18 years * core temperature \< 30° c measured in oesophagus at hospital admission exclusion criteria: * age \< 18 years * known condition of pregnancy or breastfeeding women * evidence of trauma-related cardiac arrest * cardiac arrest in which reanimation is not justified (frozen body, final stadium of an incurable disease, advance health care directive)
a study of hs135 for the treatment of pulmonary arterial hypertension in adults

Conditions: Pulmonary Arterial Hypertension (PAH)

Summary: a study of hs135 for the treatment of pulmonary arterial hypertension in adults

phase 1b, multicenter, open-label, multiple ascending dose study assessing the pharmacokinetics, safety, pharmacodynamics, and efficacy of hs135 added to background pulmonary arterial hypertension (pah) therapy

Eligibility criteria:
inclusion criteria: 1. male and female patients, 18 years of age and older. 2. body mass index (bmi) 18.5 and 40 kg/m2 and body weight at or below 120 kg 3. documented diagnostic rhc at any time prior to screening. 4. diagnosis of who pah group 1. 5. symptomatic pah classified as who fc ii to iv. 6. baseline rhc performed during the screening period documenting a minimum pvr of ≥ 5 wood units (wu) or ≥ 400 dyn・sec・cm-5 and a pulmonary artery wedge pressure (pawp) of ≤ 15 mmhg. 7. on stable doses of at least 2 background pah therapies. exclusion criteria: 1. left ventricular ejection fraction \< 50% at screening. 2. any symptomatic coronary disease events within 6 months of the screening visit. 3. uncontrolled systemic hypertension. 4. history of restrictive, constrictive or congestive cardiomyopathy. 5. history of atrial septostomy. 6. patients who have an abnormality in the echocardiogram or in the 12-lead ecg that, in the opinion of the investigator, increases the risk of participating in the study. 7. pulmonary function test (pft) values of forced vital capacity (fvc) and or fev1 \< 60% predicted at the screening visit or within 6 months prior to the screening visit.
the trial of shr6508 in secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the study is being conducted to evaluate the efficacy and safety of shr6508 among chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. diagnosed with end stage renal disease receiving maintenance hemodialysis 3. male or female 4. meet the body mass index standard 5. stably use of concomitant medication of other therapies of shpt 6. meet the standard of ipth level, cca exclusion criteria: 1. subjects with a history of malignant tumor 2. subjects with neuropsychiatric diseases 3. subjects with a history of cardiovascular diseases 4. subjects with gastrointestinal diseases 5. subjects with a history of surgery 6. subjects with a history of blood loss 7. abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 8. subjects with a treatment history of similar drugs 9. allergic to a drug ingredient or component 10. pregnant or nursing women 11. no birth control during the specified period of time 12. subject with a history of alcohol abuse and drug abuse 13. participated in clinical trials of other drugs 14. the investigators determined that other conditions were inappropriate for participation in this clinical trial
relation of blood-boron levels with body mass index

Conditions: Obesity

Summary: according to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index.

in the results of our experimental study on mices we revealed that low dose oral boric acid intake cause seriously body mas reducing. although blood and urine analyses support high glucose, lipid and middle protein catabolisms, but the mechanism was unclear. there are some diseases according to blood elementary deficiencies, like hypothyroidi in hypoiyodinemia, hiperparathyroidi in hypocalcemia, etc. we hypothesised that hypoboronemia may be corralated to body mass index level.

Eligibility criteria:
inclusion criteria: * body mas index levels in over 19 peoples exclusion criteria: * known chronic, morbid and malign diseases

Keywords: obesity, etiology, pathogenesis, treatment
a study to learn about how the flu and covid-19 vaccines act in healthy people

Conditions: Influenza; COVID-19 (Coronavirus Disease 2019)

Summary: the purpose of this study is to learn about how the flu and covid vaccines act when given alone or when mixed together. this study is seeking healthy participants aged 18 or older. all participants in this study will receive only 1 shot to their arm, either a flu or covid vaccine, alone or mixed. participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.


Eligibility criteria:
inclusion criteria: * participants 18 years of age or older * healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study exclusion criteria: * vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment * vaccination with any investigational or licensed covid 19 vaccine within 150 days of enrollment. * receipt of antiviral therapies for influenza (eg, tamiflu) within 180 days prior to day 1. refer to the study contact for further eligibility details
exocrine pancreatic function testing in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: purpose the purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (epf). the investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (cf). exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit. hypotheses endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis. new functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase. mri and ultrasound methods can give volume output estimate in cystic fibrosis patients. contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients. elastography/ ceus can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients. immunohistochemical quantification of secretin/ cholecystokinin (cck) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.

study design: observational, cohort studies. patient characterization: age, gender, and genetic status from electronical records. exocrine function testing (epf): secretin stimulated ultrasound and short endoscopic secretin test (est). faecal elastase. imaging: transabdominal ultrasound of the liver and pancreas. secretin stimulated mri. contrast enhanced ultrasound (ceus) of the pancreas using sonovue contrast. endpoints: study 1: exocrine pancreatic function by duodenal bicarbonate/ enzymes related to genetics and f elastase. study 2: ultrasound parenchymal changes of the pancreas related to genetics and epf. study 3/4: pancreatic secretion by ultrasound, mri and est related to epf study 5; perfusion of the pancreas by ceus related to epf study 6: genotype-phenotype conciderations of the cf pancreas.

Eligibility criteria:
inclusion criteria: * diagnosis cystic fibrosis. age over 15 years. assigned to routine control at department of lung diseases, haukeland university hospital. exclusion criteria: * unable to concent, allergies to sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.

Keywords: cystic fibrosis pancreas exocrine function ultrasound contrast ultrasound
phase i safety and tolerability study of cediranib (recentin™, azd2171) in combination with chemo in first line lung cancer patients

Conditions: Lung Cancer

Summary: this study is to assess the safety and tolerability of cediranib (recentin™, azd2171)in combination with etoposide and cisplatin (ep) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom ep would be a standard therapy.


Eligibility criteria:
inclusion criteria: * cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which ep would be considered a standard therapy, required at the time of diagnosis.) * no prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.) * who performance status 0-2 exclusion criteria: * untreated unstable brain or meningeal metastases * patient with inappropriate laboratory tests values * inadequate bone marrow reserve.

Keywords: lung cancer azd2171 cediranib recentin etoposide cisplatin
coenzyme q10 in relation to the antioxidative vitamins, oxidative stress and inflammation in coronary artery disease patients during statin therapy

Conditions: Coronary Artery Disease

Summary: cardiovascular disease (cvd) is the leading cause of taiwan. american heart association (aha) indicated that cvd patients with statin therapy would decrease the recurrence of cvd. the goal for lipid lowering in cvd patients was set at the level of low-density lipoprotein cholesterol (ldl-c) below 100 mg/dl. coenzyme q10 is recognized as a lipid soluble antioxidant, statin treatment might affect the level of coenzyme q10. therefore, the purposes of this study are going to investigate the relation of coenzyme q10 with other antioxidant vitamins (vitamin a and e), the markers of lipid peroxidation, antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (cad) patients during statin therapy. the study is going to design a placebo-controlled study. the investigators will recruit coronary artery disease (cad) patients who are identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery, and healthy subjects. cad subjects are randomly assign to placebo and coenzyme q10 supplements (150 mg/bid = 300 mg/d) groups. intervention is going to administration for three months. fasting blood will be obtained in each month and determine the concentration of antioxidant vitamins, lipid peroxidation markers, antioxidant enzymes activities after intervention. meanwhile, the investigators will measure the level of inflammatory markers in all subjects of this study. hopefully, the results of this study could provide information of coenzyme q10 supplementation for clinical dietitian in advising cad patients who are under statin therapy.


Eligibility criteria:
inclusion criteria: cad patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery and under statin therapy. exclusion criteria: * age \< 18 years old * pregnancy women * taking antioxidant vitamins supplements
optimizing veteran-centered prostate cancer survivorship care

Conditions: Prostate Cancer

Summary: this study will provide much needed information about how to optimize the quality of care and quality of life of veterans who are survivors of prostate cancer.

although there are nearly 150,000 prostate cancer survivors in the va, there has been little research to understand and improve survivorship care for this large population of veterans. a substantial proportion of prostate cancer survivors in the general population have significant side effects from treatment (surgery or radiation therapy) that often persist for years, including incontinence, erectile dysfunction, and metabolic syndrome, all of which can contribute to decreased quality of life. the investigators' pilot data suggests that va prostate cancer survivors experience similar or worse symptom burden to that of the general population of survivors. to address the need to improve patient-centered survivorship care management for veterans with prostate cancer, the investigators propose a 4 year study with two aims: 1) to conduct a randomized controlled trial to compare a personally tailored automated telephone symptom management intervention for improving symptoms and symptom self-management to usual care. the investigators expect that those in the intervention group will have more confidence in symptom self-management and better symptom self-management and prostate cancer quality of life following the intervention, and that these outcomes will translate to more efficient use of services for these veterans, and 2) to compare utilization of services among those in the intervention group to those in the control group.

Eligibility criteria:
inclusion criteria: * veteran patient at one of the four study sites (ann arbor va, cleveland va, pittsburgh va, st. louis va) * history of treatment for prostate cancer treated by surgery, radiation or androgen deprivation therapy between 1-10 years prior to identification exclusion criteria: * no phone number on file * not able to converse on the telephone in english * treated for metastatic disease or non-prostate cancer * dementia or other significant mental impairment

Keywords: prostate cancer survivorship intervention telemedicine
sleep restriction and obesity

Conditions: Obesity

Summary: insufficient sleep may be one of the most common, and most preventable, obesity risk factors. the investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. the investigators hypothesize that sleep restriction will result in increased energy balance.

numerous studies have reported that self-reported short sleep duration is associated with obesity and weight gain. insufficient sleep may be one of the most common, and most preventable, obesity risk factors. given that sleep restriction is largely voluntary and potentially correctable, understanding the mechanisms that link insufficient sleep to positive energy balance and the development of obesity, particularly visceral obesity, is crucial to clinical applications, public health policy, and informing future studies. the investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. the investigators will combine energy balance, biomarker, and imaging data with state-of-the art sleep monitoring to provide unambiguous data on the effects of sleep restriction on obesity. together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest strategies to reduce this risk.

Eligibility criteria:
inclusion criteria: * age 18-40 years * bmi of 18.5-30 kg/m2 * not a current smoker or tobacco user * no chronic medical or psychiatric disorders * on no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices * history of normal sleep patterns, defined as nocturnal sleep duration of 6.5-8 hours per night without regular daytime naps exclusion criteria: * the investigators will exclude subjects who have any medical or psychiatric disorders * history of anxiety or depression * those taking any medications other than non-sedating antihistamines or oral contraceptives will be excluded * those found to have depression on a depression screening tool (bdi-ii) will be excluded * current smokers will be excluded * all female subjects will undergoing a screening pregnancy test and excluded if positive * subjects found to have significant sleep disorders will be excluded
impact of black seed oil on hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.

evaluation of the effect of black seed oil in hemodialysis patients via: * evaluation of serum endothelin-1 levels * evaluation of serum malondialdehyde (mda) levels * evaluation of serum total antioxidant capacity (tac) levels * evaluation of quality of life (qol) * evaluation of fatigue scale

Eligibility criteria:
inclusion criteria: * age ≥ 20 years old * three to four times per week hemodialysis * being on hemodialysis for at least 6 months * ability and willingness to cooperate in the study exclusion criteria: * pregnancy or lactation * cigarette smoking or substance/alcohol abuse * having active infectious diseases * receiving steroidal or nonsteroidal anti-inflammatory drugs * using nigella sativa oil regularly * changes in treatment methods (dialysis) or medications during the supplementation

Keywords: black seed oil nigella sativa hemodialysis
study of the long-term safety and outcomes of treating pulmonary embolism with the indigo aspiration system

Conditions: Pulmonary Embolism

Summary: the objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the indigo aspiration system for the treatment of pulmonary embolism (pe).


Eligibility criteria:
inclusion criteria: 1. clinical signs and symptoms consistent with acute pe with duration of 14 days or less 2. rv/lv ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (cta) or echocardiogram 3. frontline endovascular treatment with the indigo aspiration system per ifu 4. patient is ≥ 18 years of age 5. informed consent obtained per institutional review board/ethics committee requirements exclusion criteria: 1. contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) 2. stage iv (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation 3. known serious, uncontrolled sensitivity to radiographic agents 4. life expectancy \< 180 days 5. patients on ecmo 6. pregnant patients 7. current participation in another investigational drug or device study that may confound the results of this study. studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 8. other medical, social, or psychological conditions that, in the opinion of the investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study