Kornimate/medical-research-clean huggingface dataset:
changes in body- and liver-composition during low calorie diet in morbidly obese

Conditions: Obesity

Summary: the purpose of this study is to determine what changes occur in body- and liver-composition during four weeks of low calorie diet in morbidly obese females

preoperative weight loss prior to laparoscopic gastric bypass is desirable as this reduces liver volume and thus facilitates the visualization of the gastro-esophageal junction. weight loss is often achieved through low-calorie diet (lcd); however the ideal duration of lcd treatment is unknown. morbidly obese female patients awaiting laparoscopic gastric bypass are recruited. they are, as all our patients, treated during four weeks with lcd to achieve a decrease in liver size. during this period they are examined on day 0, 3, 7, 14 and 28 after commencing lcd. at each evaluation, body composition is assessed through bioelectric impedance analysis (bia), liver volume and intrahepatic fat through magnetic resonance imaging. a questionnaire regarding quality of life and lcd-related symptoms is administered as well. at surgery two samples of subcutaneous fat and one sample of omental fat is taken. we do not assign patients to different treatments, instead all are treated similarly according to our routine preoperative regimen.

Eligibility criteria:
inclusion criteria: * awaiting laparoscopic gastric bypass * residing near uppsala exclusion criteria: * weight above 140 kg * metal implants such as pacemaker or intracerebral clips * failure to understand or comply with study protocol

Keywords: liver volume gastric bypass magnetic resonance imaging
post-marketing safety study in japan in participants with high risk of severe exacerbation of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) mrna-1273 covid-19 vaccine

Conditions: SARS-CoV-2

Summary: the goal of this study is to assess the adverse events in the acute phase observed after vaccination with the mrna-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation specified in covid-19.

data collected from the jdmc claims database between august 2020 to november 2021.

Eligibility criteria:
inclusion criteria: * participants registered to receive the mrna-1273 vaccine in the pep up vaccination history database * participants who have a history of vaccination with the mrna-1273 vaccine in the pep-up vaccination history database and have underlying diseases. data period for confirmation of presence/absence of underlying disease is august 2020 to november 2021. exclusion criteria: * underlying diseases that were determined undetectable by the pre-screening of jmdc * participants who did not consent to the questionnaire

Keywords: mrna-1273 mrna-1273 vaccine sars-cov-2 sars-cov-2 vaccine coronavirus virus diseases messenger rna covid-19 covid-19 vaccine moderna
urokinase-plasminogen activator (upa) inhibitor wx-uk1 in combination with capecitabine in advanced malignancies

Conditions: Advanced Malignancies

Summary: the purpose of this study is to determine the safety, tolerability, maximum tolerated dose (mtd), pharmacokinetics, and pharmacodynamics of the combination of wx-uk1 and capecitabine in patients with advanced malignancies.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of a non-hematologic malignancy that is either unresponsive to currently available therapies or for which there is no known effective therapy. * patient willing to give informed consent, understand and comply with study procedures/restrictions * age\>=18 * patients must have an ecog performance status of 0, 1, or 2 * life expectancy of \> 12 weeks * negative serum pregnancy test for women of child-bearing potential and not nursing. fertile patients must use effective contraception during and for 30 days (women) or 4 months (men) after treatment with wx-uk1. * measurable or non-measurable disease. patients without clinical or radiologic evidence of disease are not eligible. * laboratory parameters (obtained within the screening period): wbc \>= 3 g/l, neutrophils \>= 1.5 g/l, platelets \>= 100 g/l, hgb \>= 9 g/dl), total bilirubin \<= 1.5 x uln, asat/alat/ap/ggt \<= 2.5 x uln, serum creatinine \<= 2 x uln. exclusion criteria: * history of hypersensitivity to the study drugs or chemically related compounds or any of the excipients * history of or current neurological disorder, in particular an active or treated seizure disorder * known standard therapy for the patient's disease that is potentially curative or known to extend life expectancy. * carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease. * concurrent or prior (within 4 weeks prior to start of wx-uk1 treatment for cytotoxic chemotherapy, biological-, endocrine-, investigational- or radiotherapy and 6 weeks for nitrosoureas, mitomycin-c) * uncontrolled infection * significant cardiac disease (nyha classification iii or iv * contraindication to an infusion volume of 1000 ml over 2 h * history of or current blood coagulation disorders * history of or current bleeding disorder (including cerebral bleeding, recurrent massive nose bleeds, hematuria or unexplained bruising) * diabetes mellitus, if not controlled by insulin, oral anti-diabetic agents or diet alone * anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except heparin flush to keep a port open or coumadin 1 mg/day or asa 100mg/d) * active serious illness that renders the patient unsuitable for study entry or multiple blood sampling * illness or condition that might alter the absorption, distribution, metabolism and elimination of wx-uk1 * known hepatitis b/c or hiv infection * contraindication to capecitabine intake as specified in the spc such as dpd-deficiency or concomitant intake of sorivudine or sorivudine related compounds * known hemorrhagic brain metastasis
stem cells for treatment of bronchopleural fistula

Conditions: Bronchopleural Fistula

Summary: bronchopleural fistula (bf), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. without effective therapy, treatment of bf is a challenge, with a high rate of mortality and teratogenicity. the investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to investigate the application of umbilical cord mesenchymal stem cells in the treatment of bronchopleural fistula.


Eligibility criteria:
inclusion criteria: * diagnosed with bronchopleural fistula by imaging or bronchoscopic examination * typical symptom of bronchopleural fistula, such as fever, cough, purulent sputum, weight loss... * patients present compromised conditions, who can only accept a conservative treatment. exclusion criteria: * absolute contraindication of bronchoscopic examination and treatment * with previous treatment of cell therapy, including stem cells.
implications for quality of life and quality of care in patients with hereditary haemochromatosis

Conditions: Hereditary Haemochromatosis

Summary: patients with hereditary haemochromatosis will be interviewed/questioned about their quality of life and the delivered quality of care in the hospital.

patients with hereditary haemochromatosis will be interviewed/questioned about their quality of life and the delivered quality of care in the hospital during follow-up

Eligibility criteria:
inclusion criteria: * phase 1: experts in the field of haemochromatosis (hepatologists, hematologists, endocrinologists, general practitioner, nurses, ...) * phase 2: patients with hereditary haemochromatosis, treatment with phlebotomy since 3 months, dutch/english speaking exclusion criteria: * patients with secondary iron overload * phlebotomy treatment less than 3 months * language: no dutch or english
kaiser permanente evaluation of medically tailored meals in adults with medical conditions at high readmission risk

Conditions: Heart Failure; Chronic Kidney Diseases; Diabetes Mellitus, Type 2

Summary: this study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).

for the kp nourish study, eligible members hospitalized within participating kaiser permanente northern california medical centers will be identified and screened electronically and pre-randomized to 1 of 3 arms (medically tailored meals alone vs. medically tailored meals with remotely delivered enhanced nutritional counseling sessions vs. usual care). patients enrolled in the medically tailored meals arm will receive 1 medically-tailored meal per day for 10 weeks after hospital discharge. patients enrolled in the medically tailored meals with enhanced nutritional counseling arm will receive 1 medically-tailored meal per day for 10 weeks after discharge with up to 3 remotely delivered nutritional counseling sessions with a registered dietician nutritionist during the same time period. patients enrolled in the usual care arm will continue to receive their typical standard of care management. all enrolled patients will complete a questionnaire for patient-reported outcomes (i.e., self-efficacy, social isolation, patient satisfaction, and caring science domains) at baseline and at 10 weeks after discharge and followed electronically for total resource utilization and 30-, 60-, and 90-day outcomes.

Eligibility criteria:
inclusion criteria: * hospitalized at kaiser permanente santa rosa, santa clara, san francisco, oakland, or san rafael medical centers * kaiser permanente member at admission * has a prior history of at least one of the following: 1. heart failure 2. diabetes mellitus 3. chronic kidney disease exclusion criteria: * receiving primary care at kaiser permanente facilities outside of kaiser permanente santa rosa, santa clara, san francisco, oakland, or san rafael medical centers * language interpreter needed * admitted from skilled nursing facility or nursing home * homeless at admission * residence outside the geographic area covered by the medically tailored meals vendors * prior history of organ transplant

Keywords: medically tailored meals nutritional counseling food is medicine
curcumin therapy in patients with impaired glucose tolerance and insulin resistance

Conditions: Type 2 Diabetes; Pre-diabetes; Insulin Resistance; Cardiovascular Risk

Summary: the incidence rate of type 2 diabetes in thai populations is high and increasing every year. cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among diabetic patients. this disease is now becoming a major health problem and causes a great economic loss to the country. evidence shows that curcumin, thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. however, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in patients with impaired glucose tolerance (pre-diabetes) and insulin resistance.


Eligibility criteria:
inclusion criteria: * patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose ogtt. exclusion criteria: * have been diagnosed with diabetes by the results of fpg \>/=126 mg/dl * present with secondary peripheral arterial disease (pad) * present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease * receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (pwv) * receive antihypertensive or lipid-lowering drugs (arb, acei, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of c-reactive protein (crp) * present with kidney failure (serum creatinine \> 2.0 mg/dl) or in the process of renal dialysis * present with hepatitis (alt level \>/= 3 times the upper limit) * receive any herbal medications or curcumin * present with high blood sugar from other causes apart from type 2 diabetes such as receiving steroid drugs, cancer or pancreatic cyst * present with infection or inflammation that have effect on the level of crp * pregnancy or breastfeeding * have a history of gall bladder diseases or removal
chlorhexidine against sodium hypochlorite as skin antiseptics

Conditions: Infectious Diseases

Summary: the physicians have few options for skin antisepsis. alternatives for common use antiseptics are costly or ineffective. in order to have more options, this study is needed. the investigators want to know if there are differences between the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.

sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. since it has been used successfully in caring for the exit side of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. in a recent study perform by our group it was demonstrated that 10% sodium hypochlorite was not inferior than povidone-iodine. it has been demonstrated as well that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior to povidone-iodine. the aim of this study is to know if 10% sodium hypochlorite has a similar effect that the best current option for skin antisepsis.

Eligibility criteria:
inclusion criteria: * healthy adult volunteers exclusion criteria: * history of skin allergies or atopy, as well as reactions to soaps, chlorine or latex

Keywords: antiseptics administration cutaneously chlorine compounds anti-infecting agents, local
a first in human study to evaluate safety, tolerability, pharmacology of hs-10390 in healthy subjects

Conditions: IgA Nephropathy; Focal Segmental Glomerulosclerosis

Summary: the purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (pk),and pharmacodynamics (pd) of hs-10390 in healthy subjects.

this is a phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (sad and mad) study to evaluate the safety, tolerability, pk, and pd of different doses of hs-10390 tablet(s) in healthy subjects. during the sad and mad periods, there will be approximately 6and 3 sequential cohorts respectively. a sentinel dosing strategy will be used in the first cohort ofsad. the mad study will start after sufficient safety and pk data of sad period are obtained.

Eligibility criteria:
inclusion criteria: * healthy male or female subjects between the ages of 18-45 years * have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing * have signed the informed consent form approved by the irb exclusion criteria: * history or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator * have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, aids and syphilis * have a history of or current allergic disease * have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse * smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine * clinically significant abnormal physical examination, vital signs, clinical laboratory values,ecgs or imaging tests * pregnant or breastfeeding female subjects

Keywords: hs-10390 safety tolerability pharmacokinetics pharmacodynamics
the efficacy of adductor-canal-block (acb) in patients after knee arthroscopy

Conditions: Meniscus Lesion; Pain (Knee); Diagnostic Knee Artroscopy; Minor Knee Surgery

Summary: the purpose of this study is to determine whether adductor-canal-block (acb) is superior to placebo when it comes to analgetic efficacy after knee-arthroscopy.


Eligibility criteria:
inclusion criteria: * 18-80 years * knee-arthroscopy * written consent * asa i-iii * bmi 19-35 exclusion criteria: * unable to communicate in danish * allergic reactions toward drugs used in the trial * pregnancy * abuse of alcohol/drugs * daily opioid intake * infection at injection site * can not be mobilised to 5 meters of walk; pre-surgery

Keywords: adductor canal block (acb) diagnostic knee arthroscopy saphenous nerve pain ultrasound block
proof-of-concept study of act001 in adult patients with recurrent glioblastoma harbouring stat3-high signature

Conditions: Recurrent Glioblastoma

Summary: this trial will study the effectiveness of act001 in adult patients whose glioblastoma have recurred with a stat3-high signature after standard-of-care treatment with at least radiation therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of gbm according to 2021 who classification * availability of tumor tissue representative of gbm from definitive surgery or biopsy and tested to harbour stat3-high signature * previous treatment with at least radiation therapy * documented recurrence of malignant glioma by diagnostic biopsy, resection or mri performed within 21 days of study enrolment per rano criteria. there is no limit on number of previous recurrences or lines of treatment * at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) n new enhancement on mri outside of the radiation treatment field * an interval of at least 4 weeks after the last administration of any investigational agent or any other treatment prior to first dose of stat3 inhibitor * age 21 years or older on the day of signing informed consent * karnofsky performance status (kps) of 70 or higher * patient has adequate bone marrow, renal, and hepatic function ≤ 21 days prior to study enrolment (step 2) as follows: * absolute neutrophil count (anc) ≥1,500/mm3 * platelets ≥ 100,000/mm3 * hemoglobin (hgb) ≥ 9.0 g/dl (note: the use of transfusion or other intervention to achieve hgb ≥ 9.0 g/dl is acceptable.) * renal function: calculated creatinine clearance ≥ 30 ml/min by the cockcroft-gault formula * hepatic function: total bilirubin, aspartate aminotransferase (ast), and alanine aminotransferase (alt) ≤ 1.5 times upper limit of normal (uln). patients with gilbert's syndrome documented in medical history may be enrolled if bilirubin is \< 3 times uln. exclusion criteria: * presence of extracranial metastatic or leptomeningeal disease * previous or current treatment with a jak or stat3 inhibitor * previous or current treatment with bevacizumab/vegf inhibitor * patient is a lactating or pregnant female. * symptomatic intra-tumoural haemorrhage * severe, active co-morbidity, defined as follows: * patients with clinically defined acquired immune-deficiency syndrome (aids)-defining illness. * active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the investigator may put the patient at high risk of toxicity * any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
increase in capillary plexus density level following the use of ozurdex for the treatment of dme

Conditions: Diabetic Macular Edema; Diabetic Retinopathy; Retinal Ischemia

Summary: the objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of dme, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on octa, as well as a decrease in size of the foveal avascular zone (faz).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and older. 2. diagnosis of diabetes mellitus (type 1 or type 2). 3. at least one eye meets the study eye criteria listed. 4. visual acuity 20/30 - 20/200 snellen equivalent 5. have received no previous treatment for diabetic macular edema,(treatment naïve) 6. mild to severe non-proliferative diabetic retinopathy 7. diabetic macular edema present on optical coherence tomography (oct) central subfield: ≥ 300µm. 8. able and willing to provide informed consent. exclusion criteria: 1. have had any prior ocular treatment. 2. have had prior retinal surgical ( i.e. pars plana vitrectomy). 3 .have any clinical evidence of proliferative diabetic retinopathy. 4. have a hba1c of greater of 10%. 5. evidence of glaucoma or who are labeled glaucoma suspect at screening (defined as c/d \>/= 0.5 with correlated nfla thinning or iop\>25mmhg). 6. have a contraindication to ozurdex.

Keywords: diabetic macula edema diabetic retinopathy retina ischemia
saliva mrna expression profiling for early stage non-small cell lung cancer screening

Conditions: Non-Small Cell Lung Cancer

Summary: this is a pilot study to test the feasibility of using gene expression from saliva to identify patients with early-stage non-small cell lung cancer (nsclc). the primary objective of this study is to compare gene expression profiles from saliva from healthy controls and patients with early-stage non-small cell lung cancer. to be eligible, patients with non-small cell lung cancer, must not yet have received treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). health control participants may participate if they meet eligibility criteria listed below. eligible enrollees will be asked to submit a one time saliva sample and complete a study questionaire.


Eligibility criteria:
inclusion criteria: 1. patients with untreated stage i-ii nsclc or healthy control subjects: with a \> 20 pack year history of cigarette smoking or never smokers (defined as less than 100 cigarettes over subject's lifetime) * the investigators recognize that pathologic confirmation is not always available prior to surgical resection of a lung mass. to account for this, subjects with a suspicious lung mass concerning for lung cancer, can be enrolled on this trial, and submit a saliva sample prior to surgical resection (ideally within 45 days of planned surgery). 2. adults age 40-79 3. ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and fda guidelines exclusion criteria: 1. no active pulmonary infection, i.e. bronchitis or pneumonia for 6 months 2. no use of steroid inhalers for \> 6 months 3. no other prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers from which the patient has been disease-free for 5 years

Keywords: non-small cell lung cancer screening saliva gene expression healthy control subject