Kornimate/medical-research-clean huggingface dataset:
systemic chemotherapy plus lenvatinib and toripalimab for hcc with extrahepatic metastasis

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with hepatocellular carcinoma with extrahepatic metastasis

systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for advanced hepatocellular carcinoma. lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (pd-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. no study has evaluated systemic chemotherapyplus lenvatinib and toripalimab. thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * presence of extrahepatic metastasis * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 30 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * history of immunotherapy * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma lenvatinib toripalimab systemic chemotherapy oxaliplatin, leucovorin, 5-fluorouracil extrahepatic metastasis
vacuum myofascial therapy device and physical activity for the treatment of chronic non-specific low back pain. a single blind randomized clinical trial

Conditions: Chronic Nonspecific Low Back Pain

Summary: the term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks

this study aimed to investigate the efficacy of a vacuum myofascial therapy device (vt) for improving pressure pain thresholds (ppts), functionality, range of motion (rom), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. methods: a randomized controlled trial in which participants with non-specific low back pain (np) were randomly assigned to either an experimental (vt) or a comparison physical therapy program (ptp) group.

Eligibility criteria:
inclusion criteria: * patients diagnosed of chronic nonspecific low back pain that do not improve with conventional physiotherapy or pharmacological therapy protocols. * subjects who are in an active state of pain exclusion criteria: * individuals who have received surgery intervention in the spine * individuals have received the proposed treatment in one month´s period previously. * individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema. * pregnant women can not receive this treatment intervention.

Keywords: negative pressure vacuum low back pain physical therapy modalities cupping
a study of peg-rhg-csf and rhg-csf used for aplastic anemia granulocyte deficiency

Conditions: Severe Aplastic Anemia

Summary: this study was a single-center,open-label,randomized,dose-exploring prospective study.patients with granulocytotic aplastic anemia who received cytokine treatment with peg-rhg-csf or rhg-csf were enrolled.clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of peg-rhg-csf and rhg-csf in patients with severe aplastic anemia.

this study was a single-center,open-label,randomized,dose-exploring prospective study.patients with granulocytotic aplastic anemia who received cytokine treatment with peg-rhg-csf or rhg-csf were enrolled.clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of peg-rhg-csf and rhg-csf in patients with severe aplastic anemia.research objectives: to explore the reasonable injection frequency of long-acting peg-rhg-csf in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.disease classification of aplastic anemia: a total of 45 cases of saa/vsaa with anc\ 0.5×109/l,the drug was stopped,and then anc\<0.5×109/l was temporarily supplemented with one dose of the original group of drugs.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years old, male or female, or weight≥50kg. 2. patients with severe or very severe aplastic anemia of absolute neutrophil value\< 0.5×109/l 3. ecog score ≤ 2 points. 4. normal renal function. exclusion criteria: 1. patients with clonal chromosomal abnormalities. 2. patients with previous malignant tumors. 3. patients with severe or uncontrolled infectious diseases and /or bleeding. 4. patients with aids or syphilis positive. 5. severe organ dysfunction. 6. patients used gm/g-csf,peg-rhg-csf,interleukin-11 within 2 weeks before admission. 7. allergic to g-csf or peg-rhg-csf related components. 8. participated in other clinical trials within 6 months.

Keywords: g-csf
irreversible electroporation(ire) for unresectable renal pelvic and ureteral neoplasms

Conditions: Renal Pelvic and Ureteral Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable renal pelvic and ureteral neoplasms.

by enrolling patients with unresectable renal pelvic and ureteral neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable renal pelvic and ureteral neoplasms.

Eligibility criteria:
inclusion criteria: * renal pelvic and ureteral neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable renal pelvic and ureteral neoplasms
efficacy and safety of the lidoderm patch applied to patients with osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: patients with knee pain due to osteoarthritis (oa) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the lidoderm patch compared with placebo in treating knee pain from oa.


Eligibility criteria:
key inclusion criteria: * male or female patients ≥37 years with moderate-to-severe oa related pain in one knee * body mass index (bmi) ≤40 kg/m2 * symptomatic oa of the index knee diagnosed with a functional capacity of ii or iii according to acr criteria classification note: patients with symptomatic contralateral knee oa with persistent pain ≤2 cm on a 0-10 cm pi-nrs for ≥2 months will be allowed to participate. * unchanged dose of analgesic medication for oa for at least 4 weeks prior to screening and for the duration of the study * able and willing to complete all paper and e-diary assessments required by protocol key exclusion criteria: * pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint * compromised integrity of the intact, superficial skin layer * a grade 1 or 4 kellgren and lawrence score on radiographic examination * recent injury to either knee causing pain and interference with daily activities (eg. walking) * recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and qol * known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product

Keywords: osteoarthritis knee lidoderm lidocaine topical patch adjunct therapy
assessing the link between smoke carcinogen biomarkers and lung cancer risk - 1

Conditions: Tobacco Use Disorder; Lung Cancer

Summary: lung cancer is the leading cause of cancer death in the united states. currently it remains impossible to predict which smokers will get cancer. each puff of a cigarette delivers a mixture of over 60 known carcinogens. biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. the purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.

lung cancer is the leading cause of cancer death in the united states. approximately 90% of lung cancer is caused by cigarette smoking. while most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. currently it remains impossible to predict which smokers will get cancer. each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. most of these carcinogens require metabolic activation before they can negatively affect cell dna and cause cancer. biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. the purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer. this observational case-control study will involve a random selection from a group of smokers who are participating in the prostrate, lung, colon, and ovarian cancer (plco) screen trial. the chosen cases will include 300 incident lung cancer cases and 300 controls (participants who have had no diagnosis of lung cancer). demographic and baseline data from the plco database will be obtained. prior baseline blood samples from the plco trial will be obtained as well. based on age, sex, and smoking history, participants will be grouped into triplets in order to pool their blood samples. these samples will then be analyzed to determine whether distributions of biomarker levels in lung cancer participants differ from those in non-lung cancer participants. this study will not involve recruitment of any participants, as data and samples from the plco trial will be used and no new blood samples will be obtained.

Eligibility criteria:
inclusion criteria: * screening arm participants in the prostate, lung, colon, and ovarian screen trial (plco) * reported smoking on baseline questionnaire of plco * contributed biorepository samples exclusion criteria: * unstable physical or mental health

Keywords: lung cancer cotinine nnal carcinogens case-control snps
procalcitonin and threatened premature delivery

Conditions: Pregnancy; Premature Delivery

Summary: among all patients hospitalized for threatened premature delivery (tpd), the rate of premature birth (pb) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of pb. currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of ap in case of map. the purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .


Eligibility criteria:
inclusion criteria: * age \> 18 year * ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st quarter performed between 10 and 14 weeks with a measurement of the crown-rump length * hospitalization for preterm labor between 24 and 36 weeks of gestation * intact membranes, * not opposed to participate in the study exclusion criteria: * pregnancy uncertain term (no early ultrasound) * pregnancy combining a condition that can interfere with the assays performed, * uterine malformation known * multiple pregnancy, * premature rupture of membranes, * chrorio-amnionitis, * fetal malformation known * strapping * gb\> 15000 and crp\> 10 mg / l, * no affiliation to a social security scheme. * woman with a measure of legal protection

Keywords: pregnancy premature birth procalcitonin
identification of desaturation episodes by means of continuous measurement of oxygen saturation during hemodialysis

Conditions: ESRD; Sleep Apnea; Oxygen Deficiency

Summary: the clinical diagnosis of sleep apnea is difficult among esrd patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. however, the evaluation of patients with possible sleep apnea is the same among esrd patients as in the general population.


Eligibility criteria:
inclusion criteria: * age ≥18 years and able to give written informed consent to the study * on chronic hemodialysis for ≥ 90 days at time of enrollment * ability to read * consent to have video recording taken during study visit exclusion criteria: * subjects with cognitive impairment to consent * sickle cell anemia * prescription of nasal oxygen * simultaneous participation in another clinical trial that may affect breathing frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to the outcomes of interest to this study * use of a breathing device, e.g. cpap * central venous catheter used as vascular access for hemodialysis * artificial fingernails (may disturb the measurement of the watchpat) * use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study). * permanent pacemaker * sustained non-sinus cardiac arrhythmias.
safety and efficacy of cariprazine in schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Eligibility criteria:
inclusion criteria: * patients who have provided informed consent prior to any study specific procedures * patients currently meeting the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the structured clinical interview for diagnostic and statistical manual of mental disorders, fourth edition (scid) * structured clinical interview for the positive and negative syndrome scale (scipanss) total score ≥ 80 and ≤ 120 * diagnosis of schizophrenia for a minimum of 1 year before visit 1 * patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ecg) exclusion criteria: * patients with a dsm-iv-tr diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar i or ii disorder * patients in their first episode of psychosis * pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study * pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders * known or suspected borderline or antisocial personality disorder or other dsm-iv-tr axis ii disorder of sufficient severity to interfere with participation in this study * substance abuse or dependence within the prior 3 months

Keywords: schizophrenia acute schizophrenia psychotropic drugs antipsychotic agents mental disorders dopamine agents central nervous system agents
a study of narmafotinib given in combination with modified folfirinox in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer Metastatic

Summary: this study is testing narmafotinib, a type of drug called a focal adhesion kinase (fak) inhibitor, when it is given in combination with 4 chemotherapy drugs in a regimen called folfirinox, to patients who have pancreatic cancer which has metastasised (spread). the study is being run in 2 parts. part a will test increasing dose levels of narmafotinib in at least 3 people per dose at up to 4 dose levels to assess safety. part b will test 2 of the dose levels from part a in 20 people per dose, to select the best dose to take forward into future studies. participants will take narmafotinib as oral capsules every day. they will also receive mfolfirinox chemotherapy on day 1 and and day 15 of 28-day cycles.


Eligibility criteria:
inclusion criteria: * aged at least 18 years at the time of consent. * confirmed diagnosis of metastatic pancreatic adenocarcinoma (pdac) within the 6 weeks prior to study start and have not received treatment for metastatic pdac. * have measurable disease by recist v1.1. * eligible for treatment with mfolfirinox as standard of care therapy. * eastern cooperative oncology group (ecog) performance score of 0 or 1 * have a life expectancy of \> 3 months. * adequate organ function * agree to use effective contraception. exclusion criteria: * pregnant or breast-feeding * have received any investigational medicinal product (imp) within 30 days or 5 half-lives (whichever is longer) prior to day -7. * neuroendocrine or acinar cell pancreas tumors. * known brain metastases. * conditions that could interfere with the swallowing or absorption of study medication. * received previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. * received cytotoxic doses of any 5-fu based chemotherapy. * any chemotherapy related toxicities greater than grade 1 from prior neoadjuvant or adjuvant therapy for pdac. * human immunodeficiency virus (hiv) infection and/or history of hepatitis b infection or known to have active hepatitis b or c. * uncontrolled angina, myocardial infarction, coronary stenting, stroke, or cerebrovascular accident within 1-year prior to the first dose of study drug. * history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis. * clinical signs of active infection at the time of screening or baseline. * clinically significant allergies to narmafotinib, mfolfirinox components (or any of their excipients) that are not likely to be well controlled with pre-medication or other supportive measures. * any of the conditions or events outlined in the contraindications or special warnings and precautions sections of the mfolfirinox component package inserts. * peripheral neuropathy \> grade 1. * prior treatment with narmafotinib or other fak inhibitor within the 2 years prior to screening.

Keywords: pancreatic cancer pdac pancreatic ductal adenocarcinoma
autonomic phenotype before and after akt inhibition

Conditions: Diagnosis of Melanoma

Summary: some akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. there are no current data on whether this autonomic failure presents in humans at clinically used doses. we will test the hypothesis that akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.


Eligibility criteria:
inclusion criteria: * diagnosed with melanoma with a braf mutation and relapse following therapy with a braf inhibitor * enrolled in a clinical trial through the vanderbilt ingram cancer center (vicc) including an arm with an oral akt inhibitor * able and willing to provide informed consent exclusion criteria: * factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule * unable to give informed consent

Keywords: melanoma autonomic failure hypotension akt therapy
sunnaas international network´s stroke study

Conditions: Cerebral Stroke

Summary: a descriptive study of the stroke rehabilitation content in specialized clinics in seven countries: procedures for admission to rehabilitation, services available and provided to patients, as well as duration of the stay and discharge routines. an observational study of changes in regard to the physical function, quality of life and psycho-social factors in stroke patients before and after specialized rehabilitation

the descriptive study is two folded: 1) description of the rehabilitation centers and the content the respective clinic presents as specialized rehabilitation. a description of the expected change this input will result in in form of patients change in adl and life satisfaction, with repeated measurements: 2a) reports of change in activities of daily living from baseline, to one fixed time (18-22 days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively fixed time) . 2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months after discharge. since the times for admission is expected to vary, which will be described under 1),we also want to measure if and how this difference might influence results. therefore a fixed measure is inserted between admission and discharge. we have added a "relatively" fixed date at 6 months post stroke in order to see if change of function from specialized rehabilitation will differ in a longitudinal perspective, and if possible to see if the difference in time to admission (time from debut till admission in specialized rehabilitation)might influence results. 3) description of psycho- social factors at 6 and 12 months post discharge

Eligibility criteria:
inclusion criteria: * primary diagnosis of stroke, in need of specialized comprehensive rehabilitation, voluntary participation exclusion criteria: * sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with stroke that will influence outcomes

Keywords: stroke, rehabilitation, multidisciplinary, description