Kornimate/medical-research-clean huggingface dataset:
a study of nb004 as monotherapy or combination therapy in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase 1, open-label, multicenter study to assess the safety, tolerability, and pharmacokinetics of nb004 administered as monotherapy or combination therapy in subjects with advanced solid tumors

this study is a phase 1, open-label, multicenter study of nb004 administered orally in patients with histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are metastatic for which all standard treatment options have been given and are ineffective, or is no longer eligible for additional standard treatment options. the study is comprised of a dose escalation phase to determine the maximum tolerated dose and the rp2d and an expansion phase to further explore the safety and preliminary antitumor activity of nb004.

Eligibility criteria:
inclusion criteria: 1. males or females of any race\>(=)18 years age. 2. histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1). pathologically confirmed locally advanced or metastatic solid tumors with kras g12c mutation as determined by a test that has been approved by fda or local health authority (part 2\&3). 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. life expectancy\>(=)12 weeks. 5. adequate organ and marrow function. 6. measurable or evaluable disease. exclusion criteria: 1. prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose. 2. toxicities from previous anti-cancer therapy that have not recovered as required. 3. brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis. 4. active infection including hepatitis b, hepatitis c, and human immunodeficiency virus (hiv): 5. female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose. 6. male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose. 7. received prior treatment with a pim kinase inhibitor.
evaluate efficacy and safety of chlorasolv when treating pressure ulcers in need of debridement

Conditions: Pressure Ulcer

Summary: this is an open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of chlorasolv when used on pressure ulcers in need of debridement. approximately 54 subjects will be enrolled to have 47 evaluable subjects (calculated dropout range 15%). chlorasolv will be applied 1-2 times per week for 12 weeks or until the wound is deemed clean, whichever occurs first i.e. end of treatment. a follow-up visit for wound status evaluation will be performed 6 weeks from end of treatment. total time in investigation will be maximum 12+6 weeks. subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. photographs of the wound pre and post debridement will be taken at baseline, every week during the treatment period, at end of treatment and at the follow-up visit. photographs will be used to calculate (by pictzar digital planimetry system) the area of devitalized tissue in the wound as well as wound size and calculation of volume. wound depth and undermining will be estimated by the investigator at all investigational visits. a treatment diary will be used in-between the weekly investigational visits to collect any further treatments. the treatment diary will also be filled-in during the follow-up period of 6 weeks.


Eligibility criteria:
inclusion criteria: 1. pressure ulcer in need of debridement 2. male or female, 18 years of age and above 3. able to read and understand the patient informed consent and to provide written informed consent. if written consent is not possible due to the condition of the patient, one impartial witness shall sign and date the informed consent. exclusion criteria: 1. known allergy/hypersensitivity to any of the components of chlorasolv 2. pregnancy or breastfeeding 3. subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator 4. subjects not suitable for the investigation according to the investigator's judgment or other significant medical conditions that the investigator determines could interfere with compliance or investigation assessments 5. wound requiring more than two (2) chlorasolv syringes for one treatment

Keywords: pressure ulcer debridement chlorasolv
epidemiology of occult hepatitis c virus infection in patients born before 1969 in the hospital setting: a spontaneous opportunistic screening initiative.

Conditions: Hepatitis C, Chronic; Hepatitis C; Hepatitis

Summary: the goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis c virus chronic infection in general population born before january 1st 1968 in italy. the main questions it aims to answer are: what is the prevalence of hepatits c virus infection in general population born before january 1st, 1968? what rare the characteristics of these patients compared to the general population? what is the prevalence of patients tested hcv positive who are referred to the hepatology outpatient clinic for further evaluation? what is the prevalence of patients with hcv infection detected during the study and treated with direct antiviral agents during follow up? participants will be tested with a point of care screening test (meridian, bioscience) able to detect anti-hcv antibodies to detect the presence of antibodies against hcv.


Eligibility criteria:
inclusion criteria: * patients born before january 1st 1968 who lived in italy referred to any departments of the policlinico a. gemelli exclusion criteria: * patients born after january 1st 1968 * known infection of hepatitis c virus * previous treatment against hepatitis c virus

Keywords: hepatitis c virus
the clinical evaluation of probiotics product in patients with various functional bowel disorders and helicobacter pylori infection

Conditions: Bowel Dysfunction; Helicobacter Pylori Infection

Summary: people nowadays tend to have irregular diet and routine due to the stress at work. this condition may cause intestinal microflora imbalance, and in the long term may lead to constipation, diarrhea, gastroenteritis, gastric ulcer and other gastrointestinal diseases. helicobacter pylori infection, which can trigger gastrointestinal inflammation and ulcer, is commonly treated by antibiotics. this treatment, however, can reduce the diversity of the intestinal microflora, causing diarrhea, flatulence and nausea. clinical trials showed that probiotics and prebiotics supplementation could regulate gastrointestinal function, including alleviating constipation, ameliorating antibiotic-associated diarrhea and flatulence, enhancing the effect of h. pylori treatment, and restoring the balance of intestinal microflora. this probiotics product is a supplement containing several types of probiotics and prebiotics which has been marketed for years. this project aims to observe the effectiveness of probiotics product consumption by h. pylori-infected patients in relieving the gastrointestinal symptoms and restoring their intestinal microflora.


Eligibility criteria:
inclusion criteria (part i : for patients with bowel disorders): * constipation : must include 2 or more of the following: * straining during at least 25% of defecations * lumpy or hard stools in at least 25% of defecations * sensation of incomplete evacuation for at least 25% of defecations * sensation of anorectal obstruction/blockage for at least 25% of defecations * manual maneuvers to facilitate at least 25% of defecations * fewer than 3 defecations per week * diarrhea : * the passage of 3 or more loose or liquid stools per day and lasting more than 1 week, or more frequently than is normal for the individual. inclusion criteria (part ii : for patients with helicobacter pylori infection): * campylobacter-like organism test (clo test) positive exclusion criteria (part i \& ii) * prior upper digestive tract surgery * a history of cancer * lactose intolerance * allergy to penicillin * prior antibiotics therapy in the last month * prior probiotics supplement more than once a week in the last three weeks
effects of auditory stimulation during verticalization with erigo in patients with disorder of consciousness

Conditions: Consciousness Disorders

Summary: aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.


Eligibility criteria:
inclusion criteria: * vegetative state or minimally conscious state diagnosis * \>3 months from acute brain injury exclusion criteria: * no clinical stability * sepsis * orthopaedic contraindications for verticalization * deep vein thrombosis * weight \>130 kg * height \>210 cm
effects of online app weight loss programs on liver health in obese adults

Conditions: NASH; Fatty Liver; NAFLD; Weight Loss

Summary: the primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.


Eligibility criteria:
inclusion criteria: * male or female, \>18 years of age, inclusive, at day -7. * bmi of 30.00 to 49.99 kg/m2, inclusive, at day -7. * has no plan to change smoking habits during the study period. * has ability to access study related online programs and apps. * willing to follow study instructions, as well as complete online questionnaires. * understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, sponsor and collaborator. exclusion criteria: * self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the pi. * self-reported type 1 diabetes. * history of gastrointestinal surgery for weight reducing purposes. * participation in a weight loss trial or a program/service intended to alter body weight (e.g., noom, weight watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of day -7. * extreme dietary habits (e.g., atkins diet, very high protein, intermittent fasting) or eating disorder. * female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. the method of contraception must be recorded. * female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder. * unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of day -7. * exposure to any non-registered drug product within 30 d of day -7. * recent history of (within 12 mo of day -7) or strong potential for alcohol or substance abuse. alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits). * alt or ast \> 5 x uln at baseline.
gemcitabine plus cisplatin with or without bintrafusp alfa (m7824) in participants with 1l btc

Conditions: Biliary Tract Cancer; Cholangiocarcinoma; Gallbladder Cancer

Summary: study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled phase 2/3 part. in the phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (soc) (gemcitabine plus cisplatin) improves overall survival (os) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic biliary tract cancer (btc) compared to placebo, gemcitabine and cisplatin.


Eligibility criteria:
inclusion criteria: * are participants with histologically or cytologically confirmed locally advanced or metastatic btc * participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment * at least 1 measurable lesion according to recist 1.1 * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 at study entry and at week 1, day 1 prior to dosing * life expectancy of \>= 12 weeks, as judged by the investigator * adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol * hepatitis b virus (hbv) deoxyribonucleic acid (dna) positive participants must be treated and on a stable dose of antivirals * other protocol defined inclusion criteria could apply exclusion criteria: * previous and/or intercurrent cancers * receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression * participants with symptomatic central nervous system (cns) metastases * significant acute or chronic infection including known history of positive test for human immunodeficiency virus (hiv), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis b and hepatitis c) requiring systemic therapy at study entry and at week 1 day 1 prior to dosing. * active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * history of or concurrent interstitial lung disease * history of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease * chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization * prior therapy with any antibody/drug targeting t-cell coregulatory proteins (immune checkpoints) * other protocol defined exclusion criteria could apply

Keywords: metastatic biliary tract cancer cholangiocarcinoma gallbladder cancer ampullary cancer m7824 bintrafusp alfa transforming growth factor-beta programmed death-ligand 1
using preoperative anxiety score to determine the total dose of butorphanol for sedation

Conditions: Preoperative Anxiety Score; Total Dose of Butorphanol

Summary: orthopedic surgeries are considered to be discomfortable and the sense of fear and anxiety of patients who already have preoperative anxiety may be aggravated by intraoperative stimulation, which may contribute to postoperative complications. previous studies have found that high anxiety predicts increased sedative requirements. therefore, the investigators explored the relationship between anxiety and intraoperative butorphanol requirements and the investigators evaluated the specific sedative requirement which can keep satisfactory sedative state for patients by preoperative anxiety score

a total of one hundred and eighteen patients who were to undergoing lower limb orthopedic procedures with spinal anesthesia were selected，the amsterdam preoperative anxiety and information scale was used to evaluated the degree of preoperative anxiety one day before the surgery. patients in preoperative anxiety group were randomly allocated to two groups: butorphanol group (group a) and physiological saline group (group b); patients in non-preoperative anxiety group were also randomly allocated to two groups: butorphanol group (group c) and physiological saline group (group d). in group a and group c, patients received an intravenous loading dose of 15ug/kg butorphanol 5 min before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the ramsay sedation score reached 4 points, group b and group d received an infusion of the same volume of physiological saline. the sedation scores were recorded 10 min after getting into the operation room and 5, 10, 15, 30min after infusion of butorphanol or physiological saline. the duration when ramsay sedation score reached 4 points in group a and c, adverse events and post-operative visual analgesia scale scores were also recorded and compared.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa)ⅰ-ⅱ * 18-75 years * scheduled for elective low limb orthopaedic procedures under spinal anesthesia exclusion criteria: * central system disease * cardiovascular disease * autonomic nervous system disease * long term use of analgesic, sedative, and anti-anxiety drugs * psychosis * a patient with a language communication disorder not willing to cooperate with the experimenter

Keywords: butorphanol preoperative anxiety sedation recommend dose
far infrared treatment for kidney diseases

Conditions: Kidney Failure

Summary: renal failure or kidney failure is a situation in which the kidneys fail to function adequately. it is divided into acute and chronic forms; either form may be due to a large number of other medical problems.

there are many causes of chronic kidney disease. the most common cause is diabetes mellitus. acute renal failure is a rapidly progressive loss of renal function, generally characterized by body fluids disturbances and electrolyte derangement. it is believed that far infrared radiation of the central nervous system, the endocrine system and the kidneys will help in the management of renal failure and a possible cure.

Eligibility criteria:
inclusion criteria: * people with kidney diseases exclusion criteria: * none

Keywords: kidney failure, acute kidney failure, chronic renal insufficiency
aging and frailty study

Conditions: Effects of Chemotherapy; Aging; Frailty

Summary: the purpose of this research study is to compare methods to help personalize the prediction of chemotherapy side effects for older adults and to evaluate whether chemotherapy causes changes in the body that are associated with aging.

primary objective: describe mean and variation of the electronic frailty index-cancer, geriatric measures, patient reported outcomes, and biomarkers of aging of chemotherapy, and their change.

Eligibility criteria:
inclusion criteria: * age 65 years and older * planned to initiate a new chemotherapy regimen * solid tumor malignancy of any stage or lymphoma * any performance status * ability to understand and the willingness to sign an irb-approved informed consent document (either directly or via a legally authorized representative). * life expectancy of ≥3 months exclusion criteria: * initiating biologic, endocrine or immunotherapy only. * hematologic malignancy other than lymphoma. * concurrent radiation therapy. * planned inpatient chemotherapy.
clopidogrel versus adenosin in non urgent percutaneous coronary intervention (pci)

Conditions: Stable Angina; Percutaneous Coronary Intervention

Summary: percutaneous coronary intervention (pci) is associated with up to 30% incidence of myonecrosis, as reflected by elevation of cardiac enzymes in a successful procedure. apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after pci might be distal embolization of atherogenic materials from plaque disruption causing obstruction of blood ﬂow at capillary level resulting in micro-infarction. recent studies have suggested that pretreatment with adenosine in the cath lab and clopidogrel and statins greater than 6 hours before may be associated with a reduction in infarct size after reperfusion therapy for acute myocardial infarction. whether pretreatment with adenosine decreases the incidence of myonecrosis in patients undergoing non-urgent pci is not fully known. the investigators propose that adenosine-induced hyperaemia can potentially ameliorate the deleterious effects of distal embolization associated with non-urgent pci through dilatation of the microvasculature. mechanistically, this may reduce capillary obstruction by facilitating the throughput passage of embolized platelet thrombi out to the venous end of the coronary circulation, thereby reducing the incidence of post-pci myonecrosis. in this prospective, randomized, open-label study, the investigators evaluated the incidence of myonecrosis after non-urgent pci with a treatment with intracoronary adenosine compared with pretreatment of loading dose of clopidogrel 300/600 mg \>/\< 6 hours.


Eligibility criteria:
inclusion criteria: * baseline creatine-kinase (ck) and creatine-kinase-myocardial band (ck-mb) had to be within normal limits (a normal ck and ck-mb and elevated troponin allowed inclusion) exclusion criteria: * occlusion resulting in thrombolysis in myocardial infarction (timi) grade 0 antegrade ﬂow * thrombus-laden lesions * significant left main coronary stenosis * left ventricular ejection fraction 30% * inability to give informed consent * bradycardia with heart rate below 50 b.p.m. * allergy to adenosine * the occurrence of myo-cardial infarction within one week

Keywords: stable angina percutaneous coronary intervention myonecrosis
ghrelin and insulin resistance

Conditions: Obesity; Insulin Resistance; Normal Weight,Healthy Controls

Summary: ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. the purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.


Eligibility criteria:
inclusion criteria for rygb group: * age 18-65 * bmi \> 35 kg/m2 * scheduled for bariatric surgery at vanderbilt university medical center inclusion criteria for lean group: * age 18-65 * bmi \< 30kg/m2 exclusion criteria: * prior bariatric surgery * serum creatinine \> 1.5 mg/dl * hepatic enzyme elevations \> 2x upper limits of normal * current use of warfarin or clopidogrel * intercurrent infections * females with positive pregnancy test * abnormal ecg

Keywords: obesity insulin resistance ghrelin
efficacy of t-dxd in the treatment of her2-positive bcbm after prior pyrotinib

Conditions: Breast Cancer

Summary: to evaluate the efficacy and safety of t-dxd in the treatment of her2-positive breast cancer with brain metastases after treatment with pyrotinib


Eligibility criteria:
inclusion criteria: (1) women ≥18 years of age :(2) pathological diagnosis of her2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or fish(fluorescent in situ hybridization); (3) imaging evidence of brain metastases; (4) progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ecog score ≤3 points; (6) the efficacy of t-dxd should be evaluated at least once after treatment; (7) bone marrow and organ functions are basically normal; (8) complete medical records exclusion criteria: * has uncontrolled or significant cardiovascular disease * has history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, has current ild/pneumonitis, or suspected ild/ pneumonitis that cannot be ruled out by imaging at screening * has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study