Kornimate/medical-research-clean huggingface dataset:
validity and security of reh-acteoside therapy for patients of iga nephropathy

Conditions: IGA Nephropathy

Summary: this prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of iga nephropathy.

reh-acteoside (general acteoside of rehmanniae leaves) contains more than 10 kinds of bio-active mucopolysaeccharide, among which acteoside is the most effective ingredient, constituting 30 percent. it has been reported that acteoside can reduce mesangium lesion of iga nephrology-model ddy-mice, mainly by reducing the expressing of tgf-β1, reducing proliferation of mesangial cell and glomerular sclerosis. research also suggested that conjunctive use of reh-acteoside and benazepril showed better effect on reducing proteinurine than single use of benazepril, with no obvious side effect at the same time. thus, we start this clinical trial to evaluate the effect and security of reh-acteoside therapy for patients of iga nephropathy. we set 3 groups: methylprednisolone group, reh-acteoside group and methylprednisolone with reh-acteoside group. after followed-up for 8 weeks, remission of proteinuria and change of renal function will be evaluated.

Eligibility criteria:
inclusion criteria: age 14\~70 years, regardless of gender clinical evaluation and renal biopsy diagnostic for iga nephropathy. average urinary protein excretion of 1.0\~3.5g/24h on two successive examinations. egfr ≥ 50 ml/min/1.73 m2 willingness to sign an informed consent (patients under 18 years old need legal guardian to sign). exclusion criteria: secondary igan such as systemic lupus erythematosus, henoch-schonlein purpuric nephritis and hepatitis b -associated nephritis. rapidly progressive nephritic syndrome (crescent formation≥50%). acute renal failure, including rapidly progressive igan. renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (ctx、mmf、csa、fk506). recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis b or hepatitis c infection), a rise more than 2.5 folds of current alt, ast or tbil level. history of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease). any active systemic infection or history of serious infection within one month. other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases). active tuberculosis malignant hypertension that is difficult to be controlled by oral drugs. known allergy, contraindication or intolerance to the steroids. pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception. malignant tumors excessive drinking or drug abuse mental aberrations current or recent (within 30 days) exposure to any other investigational drugs.

Keywords: iga nephropathy proteinurien reh-acteoside prednisolone
levita magnetic grasper device safety and performance study

Conditions: Benign Gallbladder Disease

Summary: the purpose of this study is to determine the levita magnetic grasper device safety and performance in laparoscopy.


Eligibility criteria:
inclusion criteria: * patient is between 18 and 60 years of age * undergoing elective cholecystectomy due to: * cholelithiasis (gallbladder stones \< 2.5cm in longer measurement (length or width)) * gallbladder polyps as assessed by ultrasound * absence of non-correctable coagulopathy (inr \< 1.4 or, platelet count of \< 50,000/mcl) * patient has a body mass index (bmi) ≤ 35 kg/m2 and over 20 * patient, or authorized representative, signs a written informed consent form to participate in the study, prior to any study mandated determinations or procedure exclusion criteria: * emergency presentation with acute gallbladder disease * pancreatitis * jaundice * scleroatrophic gallbladder as shown by ultrasound * biliary tract stones diagnosed before or during surgery * acute cholecystitis * gallbladder empyema * ongoing peritoneal dialysis * previous abdominal surgery or laparotomy (presence of any previous upper umbilical incision) * presence of umbilical hernia or previous umbilical hernia * american society of anesthesiologists (asa) score of iii or iv * patient is undergoing treatment for chronic pain of any origin * significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure) * patients with signs of gallbladder perforation diagnosed by ultrasound * suspicion of biliary cancer * patients with severe peritonitis * contraindications to pneumoperitoneum * known allergy to paracetamol or nsaids * patients with metallic implants (such as pacemakers, prosthesis, etc) * previously diagnosed or suspected of having a history of choledocholithiasis based on any alterations in plasma hepatic enzymes * has a biliary tract \> 7mm in size as determined by ultrasound * has a gallbladder wall thickness that is \> 5mm * diabetic blood coagulation issues * has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.) * history of endoscopic papillotomy (i.e: preoperative indication of endoscopic retrograde cholangiopancreatography (ercp) * patient is pregnant or wishes to become pregnant during the length of study participation or lactation * patient is not likely to comply with the follow-up evaluation schedule * patient is participating in a clinical trial of another investigational drug or device * patient is mentally incompetent or a prisoner * known or suspected drug or alcohol abuse * patient has systemic infection or evidence of any surgical site infection (superficial or organ space) * patient has compromised immune system or autoimmune disease (wbc \ 20,000), including prior or pending treatment for hiv or hep. c * patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy
first-in-man, dose-escalation trial of c-met kinase inhibitor emd 1204831 in subjects with advanced solid tumors

Conditions: Solid Tumors

Summary: emd serono has closed enrollment into this trial prior to determination of maximum tolerated dose (mtd). emd serono has decided not to pursue the development of emd 1204831 in patients with advanced solid tumors for reasons other than safety.

this is a an open-label, dose-escalation, first-in-man (fim) study designed to explore the safety, tolerability, pharmacokinetics, and clinical activity of an investigational drug, emd 1204831, in patients with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. subjects will receive emd 1204831 twice a day (bid) during each 21-day cycle until disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: main inclusion criteria 1. histologically or cytologically confirmed solid tumor, either refractory standard therapy or for which no effective standard therapy is available 2. measurable or evaluable disease, as defined by recist 1.0 3. men or women aged ≥ 18 years 4. ecog performance status of 0 to 2 5. adequate hematological function: hemoglobin ≥ 9.0 g/dl; neutrophils \> 1.5 x 109/l; platelets ≥ 100 x 109/l 6. adequate liver function: total bilirubin ≤ 1.5 x uln; ast/ alt ≤ 2.5 x uln 7. for subjects with liver metastases: total bilirubin ≤ 1.5 x uln; ast/alt ≤ 5 uln 8. adequate renal function: serum creatinine \ 60 ml/min 9. resolution of all acute chemotherapy, radiotherapy or surgery-related aes to grade ≤1, except for alopecia 10. recovery from any surgical intervention 11. subjects enrolling after the mtd has been determined must present specific c-met alterations (overexpression, amplification, mutation) exclusion criteria: main exclusion criteria 1. received chemotherapy, immunotherapy, hormonal therapy (except subjects with prostate cancer), biologic therapy, or any other investigational agent or anticancer therapy within 28 days (or five half-lives for non-cytotoxics, whichever is shorter), of day 1 of trial treatment (six weeks for nitrosureas or mitomycin c) 2. received extensive prior radiotherapy on more than 30% of bone marrow 3. symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptics and requiring high doses of steroids 4. medical history of liver fibrosis/ cirrhosis 5. medical history of surgery within six weeks prior to enrollment 6. neuropathy grade ≥ 2 7. requires concurrent treatment with a non-permitted drug 8. absence or abnormal pupillary reflex

Keywords: phase 1 advanced solid tumors refractory to standard therapy patients with solid tumors, either refractory to standard therapy or for which no effective standard therapy is available
chemoimmunotherapy and radiation in pancreatic cancer

Conditions: Locally Advanced Malignant Neoplasm

Summary: the goal of this study is to evaluate the safety of combination treatment that includes chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.

this study is for borderline resectable and advanced pancreatic cancer patients. patients will receive chemotherapy with gemcitabine and immunotherapy with daily tadalafil during the first 21 days of treatment. on study day 22, patients will receive the first of three planned doses of radiation therapy and continue daily tadalafil. patients are then evaluated to determine if they are candidates for pancreaticoduodenectomy. patients who are not candidates will continue daily tadalafil and receive gemcitabine chemotherapy. patients who have surgery will resume daily tadalafil and gemcitabine chemotherapy following recovery from surgery. patients will receive up to four cycles of gemcitabine.

Eligibility criteria:
inclusion criteria: * pancreatic adenocarcinoma * locally advanced unresectable disease, or borderline resectable disease * ecog (eastern cooperative oncology group)performance status 0 or 1 * ability to provide consent and comply with study protocol * women of child-bearing potential must have a negative pregnancy test and avoid pregnancy during the study exclusion criteria: * age \< 18 * history of other malignancy in previous 2 years except carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer * previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation to the target field * clinically active autoimmune disease or active infection * history of heart attack within 90 days or stroke within 6 months, hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (nyha \>= class 2 in last 6 months), unstable angina, or angina during sexual activity * use of nitrates or nitroglycerin * history of hereditary degenerative retinal disorders including retinitis pigmentosa * chronic systemic corticosteroid use at supra-physiologic doses * use of recreational drugs called 'poppers' like amyl nitrite and butyl nitrite * blood test results (neutrophils \< 1000 /ul (microliter); hemoglobin \< 9 gm /dl; platelet count \< 1000 cells / ul; significant coagulopathy; significant liver or renal dysfunction

Keywords: pancreas pancreatic cancer immunotherapy chemotherapy radiation surgery pancreaticoduodenectomy
glioma developmental and hyperactive ras tumor (dhart) board

Conditions: Glioma

Summary: this study will collect medical records, scan results, and complete surveys to create a registry about people with a neurofibromatosis type 1-associated brain tumor (nf1-associated glioma). a registry is a collection of health information about individuals, and it is usually focused on a specific diagnosis or condition. this registry study will help the researchers learn more about the diagnosis, treatment, and quality of life of people with nf1-associated glioma. the researchers want to understand what happens as a result of different treatments for nf1-associated glioma and how these treatments and the disease itself affect people's lives over a period of time. information collected during this study could affect how doctors diagnose, test, and treat nf1-associated glioma, and the study could help future patients with this type of cancer.


Eligibility criteria:
inclusion criteria: * clinical diagnosis that meets nih criteria for nf1 disease by either 1) documented clinical record establishing nf1 or 2) self-reported with supported documentation upon medical record collection. * willing to have historical and future nf1 related health records sent to registry for review. * radiologic or pathologically confirmed glioma. * individuals ≥18 years of age on the date of informed consent. exclusion criteria: * unwillingness to sign informed consent. * no proficiency in english or spanish as determined by the investigator.

Keywords: nf1-associated glioma neurofibromatosis registry 22-199
gpc3-car-t cells for the hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a single center, single arm, open-label, phase i study to evaluate the safety and efficacy of gpc3-car-t cells in patients with hepatocellular carcinoma.

gpc3-car-t cells is a novel car-t cells which designed for the cell membrane protein glypican-3. patients with hepatocellular carcinoma will be enrolled, and gpc3-car-t cells will be intravenously infused with a escalated dose of 1×106, 3×106, 10×106 gpc3-car-t cells. tumor markers and gpc3-car-t cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). the aim of this clinical trial is to evaluate the safety and efficacy of gpc3-car-t cells therapy in patients with hepatocellular carcinoma. the primary endpoint is the safety of car-t cells including the effect ratio of crs and icans, orr. the secondary endpoint is the car-t ratio and car gene copied number in pb, pfs, os and dor.

Eligibility criteria:
inclusion criteria: 1. age ≧18years, gender unlimited. 2. failure or intolerance after at least first-line treatment. 3. gpc3 positive(ihc) 4. patients must have at least one target lesion available for evaluation. 5. bclc b or c. 6. child-pugh grade a or b 7. ecog is 0 or 1 (one week before enrollment.) 8. estimated life expectancy ≥ 3 months. 9. functioning of major organs are normal. 10. women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside. 11. patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures. exclusion criteria: 1. there are uncontrollable active infections that need systemic treatment. 2. hiv antibody is positive or syphilis antibody is positive. 3. pregnant or lactating women. 4. hepatic encephalopathy. 5. patients with organ failure: * heart: nyha heart function grade iv; * liver: grade c that achieves child-turcotte liver function grading; * kidney: kidney failure and uremia; * lung: symptoms of respiratory failure; * brain: a person with a disability. 6. it is undergoing systemic hormones therapy. 7. impact results show that over 50% of the liver is occupied by tumor . 8. patients who are still in the observation stage of other antitumor drugs 30 days before blood collection. 9. patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion. 10. abnormal thyroid function ≧level 3. 11. active autoimmune diseases require systemic treatment during the first two years of screening. 12. patients have mental illness or history of drug abuse. 13. patients are participating in other clinical studies. 14. the researchers found that it was unsuitable for the recipients to be enrolled.
the elfie-hypertension

Conditions: Hypertension

Summary: the elfie-hypertension randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension.

the elfie-hypertension randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension. the study will also evaluate whether this digital health intervention compared to usual care will improve diastolic blood pressure, adherence to anti-hypertensive medication, anti-hypertensive treatment intensification, body mass index, hypertension knowledge, self-care, quality of life, and the need for unscheduled cardiovascular-related medical assessment. the hypothesis is that the elfie solution will improve blood pressure control in individuals with hypertension

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 75 years * male and female patients * hypertension diagnosis based on the local guidelines criteria * uncontrolled blood pressure (systolic blood pressure ≥ 140 mmhg) on the screening visit * patients in whom medication adherence needs to be improved according to the healthcare provider clinical judgment * use of at least 1 anti-hypertensive medication * ownership of an active smartphone with operational system ios (version 13.0 or later) or android (version 8.0 or later) with access to the internet on 3g, 4g or 5g * ability to use a smartphone app exclusion criteria: * refusal to provide written informed consent * current use of a health app with the aim to improve medication adherence and blood pressure control * illiteracy to read in the local language * known cognitive decline, dementia, or diagnosis of severe psychiatric conditions (depression, schizophrenia, bipolar disorder) * known use of illicit drugs or alcoholism * current participation in a cardiovascular randomized clinical trial * life expectancy \< 1 year

Keywords: blood pressure digital health intervention
a study of trastuzumab emtansine in patients with her2-positive metastatic breast cancer and normal or reduced hepatic function

Conditions: Breast Cancer

Summary: this open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with her2-positive metastatic breast cancer and normal or reduced hepatic function. patients will receive trastuzumab emtansine intravenously on day 1 of each 3-week cycle. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically or cytologically documented invasive metastatic breast cancer * human epidermal growth factor receptor 2 (her2) -positive disease * adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol) * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * left ventricular ejection fraction \>/=50% * normal hepatic function, or mild to moderate hepatic impairment (child-pugh class a or b) exclusion criteria: * history of grade \>/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab * investigational therapy or any other anticancer therapy \</=28 days before first study treatment * previous treatment with trastuzumab emtansine * brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment * history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage i uterine cancer, or other cancers with a similar outcome as those mentioned above * current peripheral neuropathy of grade \>/=2 * child-pugh class c hepatic impairment * encephalopathy \>/= grade 2 * for patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis b and/or hepatitis c * active hepatitis a, b and/or c * current unstable ventricular arrhythmia requiring treatment * history of symptomatic chf (nyha classes ii-iv) * history of myocardial infarction or unstable angina within 6 months of enrollment * history of a decrease in lvef to\<40% or symptomatic chf with previous trastuzumab treatment * pregnant or lactating women * known hiv infection
improving patient understanding of preeclampsia

Conditions: Preeclampsia

Summary: participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.


Eligibility criteria:
inclusion criteria: * 12-40 weeks pregnant * no significant hearing or vision impairment * english speaking exclusion criteria: * active diagnosis of preeclampsia * significant hearing or vision impairment * non-english speaking

Keywords: patient understanding and counseling
managed access program for momelotinib in myelofibrosis

Conditions: Myelofibrosis; Primary Myelofibrosis

Summary: compassionate use access to momelotinib/gsk3070785 for eligible participant with diagnosis of intermediate or high-risk myelofibrosis (mf), including primary myelofibrosis (pmf) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (pv/et)), with anemia.


Eligibility criteria:
inclusion criteria: * written informed consent can be obtained from the patient or legally authorised representative as per local regulations * diagnosis of intermediate or high-risk myelofibrosis (mf), including primary myelofibrosis (pmf) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (pv/et)), with anemia * 18 years or older (at the time consent is obtained) * the patient is willing to abide by the contraception requirements. * no known hypersensitivity to momelotinib, its metabolites, or any of the formulation excipients exclusion criteria: * pregnant or breastfeeding female

Keywords: momelotinib gsk3070785
trial of safety, tolerability and efficacy of trametinib (snr1611) in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (snr1611) in the treatment of amyotrophic lateral sclerosis.

trametinib (snr1611) is a mek inhibitor that downregulates the mapk/erk pathway. in this study, the potential of mapk/erk pathway downregulation through trametinib (snr1611) as a therapeutic treatment for amyotrophic lateral sclerosis (als) will be evaluated.

Eligibility criteria:
main inclusion criteria: * patients diagnosed as definite, probable or probable-laboratory-supported als according to el escorial criteria. * patients of less than 2 years after the onset of als. * patients who meet the criteria of k-alsfrs-r score and forced vital capacity. main exclusion criteria: * patients with primary lateral sclerosis, progressive muscular atrophy or lower motor neuron disease. * patients who have history of als treatment of edaravone or stem cell therapy within 16 weeks before screening. * patients who have permanently ceased the administration of riluzole due to lack of tolerability and/or efficacy. * patients in class ii to iv according to the new york heart association functional classification. patients with myocardial infarction, unstable arrhythmia, and/or significant cardiovascular disease such as unstable angina within 12 weeks before screening. * patients who do not meet the criteria of laboratory tests and medical/operation history.

Keywords: als lou gehrig's disease