Kornimate/medical-research-clean huggingface dataset:
multi-center study of different doses domperidone in feeding intolerance

Conditions: Feeding Intolerance; Premature Birth; Domperidone Overdose; Gastric Retention

Summary: the purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant

the premature infant have been divided into four group.the first group take the 0.2mg/kg/tds domperidone as treatment ,while the other group take the 0.4mg/kg/tds domperidone,0.6mg/kg/tds domperidone and the placebo respectively . an objective index has been decided to evaluate the severity of feeding intolerance in the premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .the residual glucose will be drawed out from the gastric tube. the residual percentage is the main result of the study. the main result will be compared by the secondary result to help to explain the accuracy. the secondary result is the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago. any adverse effect will be recorded and analysed to figure out whether is associate with the domperidone.

Eligibility criteria:
inclusion criteria: * the residual milk and glucose over 55% * abdominal distention or vomiting; * reduce,delay or disruption of enteral feeding exclusion criteria: * four weeks before the start of this study had participated in other clinical trials * pulmonary hypertension; * infants with necrotizing enterocolitis * gastrointestinal tract malformation, congenital heart disease * pre-existing qt extend/between long qt syndrome; * ascites * have been used or will use drugs suppress cyp3a4 * other risk factors for prolong the qt

Keywords: feeding intolerance premature infant domperidone
carvedilol for pre-primary prophylaxis of esophageal varices in cirrhosis

Conditions: Cirrhosis

Summary: patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. after baseline evaluation, the participants will be randomized to receive either placebo or carvedilol 12.5 mg bd. after randomization they will be followed up for one year.


Eligibility criteria:
inclusion criteria: * patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices. exclusion criteria: * any contra-indication to beta-blockers * any past evl or sclerotherapy * any past history of surgery for portal hypertension * significant cardio or pulmonary co-morbidity * any malignancy * refusal to participate in the study
suprainguinal fascia iliaca block versus peng block for hip arthroplasty analgesia

Conditions: Postoperative Complications; Postoperative Pain; Weakness, Muscle; Motor Activity

Summary: in recent years, suprainguinal fascia iliaca block (sfib) has emerged as a reliable analgesic option for primary total hip arthroplasty (tha). in 2018, a new block was described, termed pericapsular nerve group block or peng block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. in this randomized trial, the investigators will compare us-guided sfib and peng block in patients undergoing primary tha. since the main benefit of pengb stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that peng block will result in significantly less motor block compared to sfib.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * american society of anesthesiologists classification 1-3 * body mass index between 20 and 35 (kg/m2) exclusion criteria: * adults who are unable to give their own consent * pre-existing neuropathy (assessed by history and physical examination) * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, international normalized ratio ≥01.4 or prothrombin time ≥ 50) * renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * allergy to local anesthetics (las) * pregnancy * prior surgery in the corresponding side of the inguinal or suprainguinal area * chronic pain syndromes requiring opioid intake at home
diclofenac for prevention of post-erc pancreatitis

Conditions: Common Bile Duct Diseases

Summary: the study aims at assessing the effectiveness of diclofenac for prevention of post-ercp pancreatitis. it will be undertaken embedded in the swedish national register for gallstone surgery and ercp (gallriks). patients are randomised to diclofenac prior to the ercp or no prophylaxis. gallriks is used to identify which patients fulfill the eligibility criteria and which patients develop pancreatitis after the ercp.

endoscopic retrograde cholangiopancreatography (ercp) is a procedure commonly performed for diagnosing changes in the bile ducts or managing outflow obstruction. although ercp may in most cases be performed safely, there is a risk of developing acute pancreatitis following the procedure. the risk has been estimated to 5-10%, with an increased risk in women, younger patients and in case the cannulation is difficult. phospholipase 2 is crucial in the pathogenesis of acute pancreatitis. as diclofenac is a potent inhibitor of phospholipase 2, it has been suggested that it may be used for prevention of post-ercp pancreatitis. there is some evidence for the effectiveness of diclofenac, but more studies are needed to confirm that it reduces the risk of post-ercp pancreatitis. in order to test whether diclofenac reduces the risk for post-ercp pancreatitis, a register-based randomized controlled study is planned. the study will be conducted embedded in the swedish register for gallstone surgery and ercp (gallriks). gallriks includes data corresponding to the eligibility criteria as well as outcome measures. gallriks will also be used to record which patients have been screened for inclusion. patients who meet the eligibility criteria are invited to the study. if they accept inclusion, they are randomized to 100 mg diclofenac prior to the ercp or np prophylaxis. no blinding is done. the aim is to include 1000 patients. when 500 patients have been included, an interim analysis will be performed, comparing the incidence of pancreatitis and mortality in the two groups. a retrospective review of the patient records will be performed for those who develop pancreatitis.

Eligibility criteria:
inclusion criteria: * patients undergoing ercp exclusion criteria: * decision to perform ercp taken intraoperatively * intolerance/allergy against nsaid * patients taking nsaid daily * severe cardiac fail (asa\>4) * kidney failure (gfr\<30 ml/min) * coagulation disorder * history of peptic ulcer bleeding * history of abdominoperineal resection * pregnancy * patients who do not understand swedish

Keywords: endoscopic retrograde cholangiopancreatography pancreatitis diclofenac
full-spectrum endoscopy in colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.

colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in west countries. colonoscopy is the gold standard for prevention of colorectal cancer disease. screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. advanced technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population. the investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. one arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (endochoice) (330º angle view)

Eligibility criteria:
inclusion criteria: * patient referred for colorectal cancer screening with positive fecal inmunological test. * age between 50 and 69 years exclusion criteria: * history of colonic resection, * high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome, * inflammatory bowel disease, * patients with lower gastrointestinal bleeding symptoms, * acute diverticulitis, * colonic strictures, * poor bowel preparation (boston scale less than 5 points)

Keywords: full-spectrum endoscopy polyp detection rate colorectal cancer colorectal screening adenoma detection rate endoscopic innovations
a novel approach for reducing hyperoxaluria and kidney stone risk.

Conditions: Hyperoxaluria

Summary: this pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug tenapanor, which was recently fda-approved for treating hyperphosphatemia in patients with chronic kidney disease. tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.

the proposed proof-of-concept studies will determine whether tenapanor reduces urine oxalate in normal human subjects receiving a high-oxalate diet in a crossover placebo-controlled short-term metabolic study. study design screening - one 24-hour urine for analysis of stone-risk profile, one blood sample for comprehensive metabolic panel and cystatin c, one stool sample for fecal calprotectin, physical exam, social and medical history, vital signs, demographic information, personal information.this is a two-phase study, each phase is 5 days in duration. phase 1: the subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg tenapanor or placebo twice a day just prior to the morning and evening meals. on days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile. washout: the subjects will undergo a 9-day washout period. phase 2: the subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg tenapanor or placebo twice a day just prior to the morning and evening meals. on days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile.

Eligibility criteria:
inclusion criteria: * normal, healthy adult volunteers exclusion criteria: * personal history of kidney stones * pregnant or nursing * recurrent urinary tract infections * lithogenic urine chemistry at baseline (oxalate \> 45 mg/24 h, urine calcium \> 300 mg/24 h) * chronic kidney disease (egfr \< 90 ml/min/1.73m2) * personal history of gi disease, gi obstruction, or gi surgery * chronic diarrhea * intestinal inflammation (fecal calprotectin \> 120 mcg/g) * drugs which are substrates of oatp2b1 (e.g. enalapril) * chronic use of sodium polystyrene sulfonate, angiotensin-converting enzyme inhibitors, diuretics, antacids, alkali treatment, or carbonic anhydrase inhibitors.
covid-19 seroprevalence study in french guiana

Conditions: Coronavirus Infection; Severe Acute Respiratory Syndrome; SARS-CoV Infection; Covid19

Summary: serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-sars-cov-2) antibodies in the population to assess the extent of the infection and the covid-19 immunity of the population in french guiana.

serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-sars-cov-2) antibodies in the population to assess the extent of the infection and the covid-19 immunity of the population in french guiana. this study is a interventional study that present minimal risks and constraints. the results of the study will allow estimation of covid-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the french guiana territory.

Eligibility criteria:
inclusion criteria: * person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with covid-19; * state of health compatible with a blood sample as defined in the protocol exclusion criteria: * inability to consent * person under guardianship or curatorship * known pathology or a health problem contraindicated with the collect of blood sample.

Keywords: sars-cov-2 covid-19 serology french guiana
a cohort study of patients with intracranial hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: as one of the most serious forms of acute stroke, the early mortality rate of intracerebral hemorrhage(ich) can be as high as 30-40%. the incidence of intracerebral hemorrhage increases with the increase of age. under the circumstance of the aggravation of aging in china, intracerebral hemorrhage brings a certain burden to families and society. the results of several studies in recent years have failed to provide new therapeutic approaches for the treatment of cerebral hemorrhage. therefore, novel therapeutic approaches is urgently needed for ich. primary and secondary prevention, acute inpatient care, and poststroke rehabilitation are all critical. the objective of this cohort study is to explore factors that might influence the long-term prognosis of patients with ich and to further identify new potential targets for intervention.

the observational cohort study will be used to find the possible treatment methods and predictors of functional outcome. the medical records of patients will be collected, including age, sex, comorbid conditions, toxic habits, use of medications (antiplatelets, anticoagulants, and antihypertensives), systolic and diastolic blood pressure, glasgow coma scale (gcs) score, and national institutes of health stroke scale (nihss) score on admission. image data will also be collected. follow-up information will be obtained from the medical records or telephone interviews.

Eligibility criteria:
inclusion criteria: * primary intracerebral hemorrhage * over 18 year-old exclusion criteria: * secondary intracerebral hemorrhage, such as aneurysmal, hemorrhagic transformation of ischemic stroke, cavernomas, arterio-venous malformations, central venous thrombosis, trauma-related, or tumor. * pregnant patients. * any condition which, in the judgment of the investigator, might increase the risk to the patient.
infection detection by breath analysis

Conditions: Infection, Community-Acquired; Communicable Disease; Respiratory Infection

Summary: the purpose of this feasibility study is to test a device which analyzes breath and may allow doctors and health professionals to immediately determine if an ill patient has a specific type of bacterial infection. this will allow a health professional to provide immediate targeted antibiotics to properly start treatment without delay.

community acquired, or hospital acquired \[nosocomial\] infections \[pathogens\] are a common cause for morbidity and mortality. initiation of antibiotic treatment is by best guess or using a broad spectrum antibiotic. the improper administration of antibiotics is known to lead to the developing specter of antibiotic resistant organisms. certain community acquired bacterial infection such as streptococcus upper respiratory tract infections carry increased risk of morbidity secondary to risk of developing abscess, glomerulonephritis, and/or rheumatic fever. commonly, most upper respiratory tract infections are caused by viruses. however due to the unknown pathogen causing an upper respiratory tract infection, with the risks of potential chronic severe complications from streptococcus, initial treatment starts with either an antibiotic, or a typical 3day wait for bacterial culture result. quite often, the wait-and-see approach in the community is not undertaken because of the difficulty in returning for a follow-up appointment. the risk of a developing antibiotic resistant bacteria is well-known and is one of the greatest health threats worldwide leading to longer hospitalizations, higher medical costs and death, according to the world health organization. thus a point of care device which would enable physicians or other medical practitioners to promptly discriminate between streptococcal or other antibiotic sensitive pathogens versus non antibiotic sensitive viral causes of specific upper respiratory tract infectious pathogens is needed.

Eligibility criteria:
inclusion criteria: * able and willing to participate in this study * availability of signed informed consent * healthy, not on any medication * able to provide a breath sample * having a condition (eg. suspected strep throat, mrsa, c difficile) which would require a swab/sample for culture exclusion criteria: * under the age of 6years * eating food or drink (excluding water) within 2 hours of breath test time * pregnant or breastfeeding * chronic obstructive pulmonary disease (copd) * inability to comply with study procedure/unable to follow directions * currently taking antibiotics or other medication (excluding analgesics)

Keywords: infection
the effect of preprocedural subanesthetic ketamine on pain and anxiety

Conditions: Epidural Catheterization; Thoracic; Procedural Pain

Summary: the thoracic epidural catheterization (tec) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. the aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the tec procedure.

the study aimed to assess the impact of subanesthetic intravenous ketamine administration on pain and anxiety during thoracic epidural catheterisation (tec) procedure, which can be uncomfortable and frightening for patients when performed awake due to the possibility of pain. after receiving approval from the clinical research ethics committee of keçiören education and research hospital (keah; id:238), this prospective and randomized study will include 60 adult patients with asa physical status i-iii who are scheduled for elective thoracic surgery via thoracotomy. the study will randomly assign patients into two groups: group p (n=30) receiving an intravenous placebo and group k (n=30) receiving intravenous (iv) 0.15 mg kg-1 ketamine. randomisation will be performed using a computerised table of random numbers. patients with chronic pain, bleeding disorders, drug use, liver disease, severe metabolic and endocrine problems, a history of ketamine or local anaesthetic allergy, infection at the site of intervention, or refusal of tec will be excluded. patients who report acute pain during preoperative evaluation, have a tec time of more than five minutes (from needle insertion to catheter insertion), and require more than two tuohy needle attempts will be excluded. vital parameters and anxiety levels of each patient will be recorded before premedication. anxiety (vas-a) and pain (vas-p) scores will be measured using the visual analogue scale. patients will be transported to the operating theatre 20 minutes after premedication. intravenous administration of 0.15 mg/kg iv ketamine or placebo will take place 3 minutes before tec placement.

Eligibility criteria:
inclusion criteria: * patients who underwent elective thoracic surgery via thoracotomy * patients with asa physical status i-iii exclusion criteria: * describing chronic pain, * have a bleeding disorder, * having a history of analgesia drug use, * have a history of liver disease, * have serious metabolic and endocrine problems, * have a history of allergy to ketamine and local anesthetics, * have an infection in the intervention area, * rejecting thoracic epidural catheter, * describing acute pain in any part of the body during the preoperative evaluation, * thoracic epidural catheter duration greater than five minutes (time from needle entry to catheter placement) * patients requiring more than two tuohy injection attempts

Keywords: ketamine pain anxiety subanesthetic
expanded access program for epcoritamab

Conditions: Large B-cell Lymphoma; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Primary Mediastinal Large B-cell Lymphoma (PMBCL); High Grade B-cell Lymphoma (HGBCL); Grade 3B Follicular Lymphoma

Summary: the purpose of this program is to provide investigational epcoritamab, an antibody also known as gen3013 (duobody-cd3xcd20), in an expanded access setting for eligible patients with relapsed and/or refractory (r/r) large b-cell lymphoma (lbcl) who have a high unmet medical need with no other treatment options. it is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons. access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

this is a multicenter program conducted within the united states. the program will consist of screening, treatment (cycle 1 day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.

Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * r/r cd20+ mature b-cell neoplasm * eastern cooperative oncology group performance status (ecog ps) 0, 1, or 2 * ≥ 2 prior lines of antineoplastic therapy, including ≥ 1 anti-cd20 monoclonal antibody (mab) * fluorodeoxyglucose (fdg) positron emission tomography (pet)-avid and measurable disease by computed tomography/magnetic resonance imaging (ct/mri) * patients considering the eap should have no other available therapeutic option and cannot be eligible for other epcoritamab trials. * patients considering the eap must be located in proximity to a us site given that the eap is currently available only in the united states. * prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (icf), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program. exclusion criteria: * any prior therapy with an investigational bispecific antibody targeting cd3 and cd20 * prior treatment with car-t therapy within 100 days prior to first epcoritamab administration * primary central nervous system (cns) lymphoma or known cns involvement by lymphoma * confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed. * active hepatitis b or hepatitis c * known clinically significant cardiac disease * pregnancy or breastfeeding * known hypersensitivity to allopurinol or rasburicase

Keywords: epcoritamab gen3013 diffuse large b-cell lymphoma lymphoma duobody-cd3xcd20 bispecific antibody early access double-hit dlbcl triple-hit dlbcl follicular grade 3b transformed dlbcl high-grade b-cell lymphoma primary mediastinal large b-cell lymphoma (pmbcl)