Kornimate/medical-research-clean huggingface dataset:
post marketing study to evaluate the two dose regimens of nicardipine injection in hypertensive emergency patients

Conditions: Hypertension Emergency; End-organ Damage

Summary: to compare the efficacy and safety of two dose adjustment regimens (i.e. weight-based and non-weight-based) for the treatment of chinese hypertensive emergency patients.

this study is a prospective, multi-center, open-label, randomized and controlled study. subjects are selected from hypertensive emergency patients with a bp (blood pressure) of \>180/120mmhg (sbp/dbp) and accompany with end target organ damage. all subjects are randomized into two groups receiving the nicardipine injection: control group (at a weight-based dose adjustment, i.e. according to the current package insert approved by sfda) and study group (at a non-weight-based dose adjustment, i.e. according to the package insert approved by fda). patients meet the inclusion/exclusion criteria are randomly allocated at 1:1 proportion to control group and study group. before the treatment, investigators should define the target bp value for every subject according to different illness state, according to the bp, the dose of nicardipine injection is adjusted through different methods until reaching of target bp value. after reaching target bp value or 60min after the dosing initiation, bp and pulse rate are measured every 5\~15min for 2h. two to six hours after dosing, bp should be controlled at 160/100\~110mmhg, and the maintenance dose is determined by the investigators according to the illness state.

Eligibility criteria:
inclusion criteria: * systolic blood pressure (sbp) ≥180mmhg and/or diastolic blood pressure (dbp) ≥120mmhg, and with the evidences or manifestations of end-organ damage (i.e. with any following hypertension emergency symptom: chest pain, short breath, upper abdominal discomfort, syncope, vertigo, blurred vision, consciousness, hematuria or ischemic change under 12-lead ecg) * able to and voluntary to complete this study according to this study protocol, and sign the informed consent form by himself/herself (or via his/her legal guardian) exclusion criteria: * allergy to the nicardipine injection or its compositions * serious aortic valve stenosis * peri-operative hypertension * cerebral hemorrhage caused by the cerebrovascular malformation, hemangioma or cerebral infarction, cerebral hemorrhage into cerebral ventricle, and cerebral trauma with concomitant cerebral hemorrhage * other possible influencing factors for the safety or efficacy judgment in the investigators' opinions

Keywords: nicardipine hypertension calcium blocker
evaluation of cta on the assessment of brain death

Conditions: Brain Death

Summary: at present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial doppler, eeg, evoked potential and apnea test in clinical practice. some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. the american academy of neurology (aan) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. ct cerebrovascular angiography (cta) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. however, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the aan a recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that cta can be used as a new confirmation test for clinical judgment of brain death. this study aims to explore the value of cta in the judgment of patients with brain death.


Eligibility criteria:
inclusion criteria: * recruiting, no definite exclusion criteria: * recruiting, no definite

Keywords: brain death ct angiography
validation of a new innovative method for specific marker detection in celiac disease

Conditions: Celiac Disease in Children

Summary: celiac disease (cd) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (hla-dq2/dq8). gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of cd-autoantibodies against transglutaminase 2 (anti-tg2) and endomysium (ema). in symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of cd is clearcut. however, 10-30% of patients evaluated for suspected cd show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential cd. in such cases the diagnosis may remain uncertain. cd-autoantibodies are produced by intestinal b-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. intestinal cd-antibodies (i-cd-abs) are a marker of cd, have a high sensitivity and specificity for cd and identify those patients with potential cd who are at risk of progression to villous atrophy. i-cd-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (emabiopsy). the diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. however, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. there is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected cd patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays. in order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the emabiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. the obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-tg2 assay (rapid intestinal anti-tg2 assay).


Eligibility criteria:
inclusion criteria: - patients undergoing an elective esophagogastroduodenoscopy (egd) for suspected celiac disease (cd), eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease. exclusion criteria: * bleeding disorders * patients fulfilling the new european society for paediatric gastroenterology hepatology and nutrition (espghan) guidelines for diagnosing cd (version 2020) for a serology-based cd diagnosis * subjects in whom intestinal biopsies are not indicated as part of the diagnostic process

Keywords: celiac disease intestinal antibodies rapid test
surgiwraptm to reduce soft tissue attachment & incidence early post-operative bowel obstruction in colorectal surgery

Conditions: Adhesions; Colectomy

Summary: the purpose of this study is to determine if the use of surgiwraptm: (1) prevents/lowers the incidence of grade 2 or higher soft tissue attachments under the incision made during abdominal surgery, (2) reduces post-operative bowel obstruction.


Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older of either gender * patient has primary diagnosis requiring a two-stage colectomy or procto-colectomy * patient or his/her legal representative has read and signed the institutional review board (irb) approved informed consent form before randomization. * patient must be able and willing to follow study procedures and instructions. exclusion criteria: * patient is participating in another clinical study which may influence adhesion formation. * patient has had barriers, solutions, or anti-adhesive therapy, other than surgiwraptm, as planned at randomization, placed in the abdomen at the time of the initial surgery * patient who, at the initial surgery, had administration of irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs, or dextran 70 * patient has one or more medical condition(s), including severe renal, hepatic, hematologic, neurologic, or immune disease that, in the opinion of the investigator, would make the patient an inappropriate candidate for this study. * patient is taking chronic (i.e., \> 2 weeks) therapeutic doses of medications known to affect healing such as nonsteroidal anti-inflammatory drugs. prophylactic aspirin (less than or equal to 325 mg once daily) for cardiovascular indications will be permitted in patients. * patient has an infection in the intra-abdominal or pelvic area.

Keywords: surgery colectomy proctocolectomy adhesions
a study of fluconazole in the treatment of fungal infections of the throat in patients with weakened immune systems

Conditions: Candidiasis, Esophageal; HIV Infections

Summary: to determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with aids.

patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. patients undergo follow-up at 2 weeks post-treatment.

Eligibility criteria:
inclusion criteria patients must have: * aids or other immunocompromising condition. * candidal esophagitis. * life expectancy of at least 2 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * evidence of non-candidal systemic fungal infection. * abnormalities that may preclude esophagoscopy or endoscopy. * unable to tolerate fluconazole. * unable to give informed consent. * enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the pfizer clinical monitor). * other condition that would make patient unsuitable for enrollment. concurrent medication: excluded: * concomitant oral or topical antifungal agent. * other experimental medications. patients with the following prior condition are excluded: history of allergy to imidazoles or azoles. prior medication: excluded: * any oral or topical antifungal therapy within the past 3 days. active use of illicit or illegal drugs.

Keywords: esophagitis fluconazole acquired immunodeficiency syndrome candidiasis immunocompromised host
cancer-associated muscle atrophy and weakness: an investigation of etiology

Conditions: Metastatic Cancer; Cachexia; Cancer

Summary: this study is designed to gain a better understanding of the mechanisms leading to muscle wasting and metabolic abnormalities in skeletal muscle of cancer patients.


Eligibility criteria:
inclusion criteria: * age 35-80 years * diagnosis of metastatic cancer with cachexia (≥5% drop in body mass in less than 12 months), metastatic cancer without cachexia (\<5% drop in body mass in 12 months) or no history of cancer but similar in age and sex as other groups. exclusion criteria: * current use of vitamin d analogs * fasting plasma glucose ≥126 mg/dl * renal failure (serum creatinine \> 1.5mg/dl) * chronic active liver disease (bilirubin \> 17mmol/l, ast\>144iu/l, or alt\>165iu/l) * contraindications to mri (e.g., pacemaker, ferrous materials within body). * active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment) * renal insufficiency/failure (serum creatinine \> 1.5mg/dl) * oral warfarin group medications or history of blood clotting disorders. * people who have taken bevacizumab * platelet count \<100,000 per ul * pregnancy or breastfeeding * alcohol consumption greater than 2 glasses/day or other substance abuse * untreated or uncontrolled thyroid disorders * debilitating chronic disease (at the discretion of the investigators) * previous injury/trauma/surgery to the region being measured without full recovery * pain in the area to be assessed * any medical condition affecting the ability to execute a maximal muscle contraction * the presence of infections, highly communicable diseases (aids, active tuberculosis, veneral disease, hepatitis) or metastatic bone disease that may interfere with safely executing maximal effort. * significant neurological or musculoskeletal disorders or disease that may interfere with safely executing maximal contraction * any congenital, developmental, or other bone disease or previous surgeries that may interfere with successful testing
acute acetaminophen ingestion: does repeated acetaminophen blood test have an interest?

Conditions: Acetaminophen Overdose

Summary: acetaminophen is the first drug involved in voluntary drug poisoning. according to the studies conducted in the usa and in the united kingdom, it is the first cause of acute liver failure, and this poisoning is responsible of 10 percent of liver transplants each year in these countries. mortality is about 1/3 at the stage of acute liver failure. the main risk factors are malnutrition and chronic alcoholism. ease of access to this toxic and highly correlated with factors predisposing socio-economic field are an important issue, including the speed and appropriateness of care are key factors both in terms of reducing morbidity mortality in socio-economic terms for the community.a nomogram defines a statistical threshold from which the blood concentration of paracetamol has a significant risk of liver toxicity. the blood paracetamol dosage practiced today at the 4th hour after ingestion of a toxic dose, but there is no consensus on whether or not to repeat this dosage during the treatment, as the first result is beyond the threshold or not.the administration of the antidote nac (n-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a protocol that can vary in different services.in the absence of clear guidelines, the question of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion if the initial paracetamol blood measurement is below the curve nomogram remains open.is it possible to limit blood tests to a single assay paracétamolémie to h4 when it is below the curve, and thus enable the return home of the patient's somatic point of view (excluding psychiatric care when is voluntary drug intoxication), with consequences in terms of costs (hospital days) and duration of treatment?


Eligibility criteria:
inclusion criteria: * patients over 18 years * having taken a single dose of acetaminophen * with a supposed ingested dose over 4 grams exclusion criteria: * patients treated with n-acetyl * cysteine before their admissions in the participating units * with repeted ingested doses * pregnant and nursing wifes * patients unable to give their consent to the study
study comparing tension-free vaginal tape with the monarc procedure for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: urinary incontinence is a major health issue in women. it is estimated to affect 30 - 40% of older women. stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. a woman's lifetime risk of surgery for sui is 4%, with nearly 1/3 of surgery being performed for recurrences. many different surgical procedures have been described for the treatment of sui and there is no general agreement as to the most effective. this study compares the safety and efficacy of the tension-free vaginal tape procedure to the monarc subfascial hammock procedure in the treatment of stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * urinary incontinence symptoms * urodynamic stress incontinence confirmed with multichannel urodynamic testing * age of at least 21 years * desires surgical correction of stress urinary incontinence exclusion criteria: * post-void residual volume \>100cc * detrusor overactivity on preoperative multichannel urodynamic testing * history of previous synthetic, biologic or fascial sub-urethral sling * desires future childbearing * chronic inguinal or vulvar abscess or history of hidradenitis suppurativa * history of bleeding diathesis or current anti-coagulation therapy * inguinal lymphadenopathy or inguinal/vulvar mass * current genitourinary fistula or urethral diverticulum * reversible cause of incontinence (i.e. drug effect) * contraindication to surgery

Keywords: stress urinary incontinence sling procedures tension-free vaginal tape transobturator
a study of a new medicine (gw679769) for the treatment of social anxiety disorder

Conditions: Social Anxiety Disorder; Anxiety Disorders

Summary: the purpose of this study is to test the safety and efficacy of gw679769 and paroxetine in subjects with social anxiety disorder


Eligibility criteria:
inclusion criteria: * patients with generalized social anxiety disorder as the primary diagnosis. * if female, must commit to consistent and correct use of an acceptable method of birth control. exclusion criteria: * patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening. * patients with body dysmophic disorder, schizophrenia, schizoaffective disorder, or a bipolar disorder. * patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal. * patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months. * patients with an unstable medical disorder. * female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study. * patients who are taking other psychoactive medications.

Keywords: social anxiety disorder anxiety psychiatry
high protein diet versus normal protein diet in treating patients with minimal hepatic encephalopathy

Conditions: Liver Cirrhosis

Summary: a total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. they will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. randomization will be conducted by an external monitor and will keep the secret codes until the end of the study. all patients will be provided with structured menus and two snacks a day as an amaranth protein supplement. the supplement will content the same amount of fiber but the protein content will vary depending on the group to which the patient is assigned.

the protein in the diet is a major source of ammonia in blood, which is considered one of the factors involved in the pathogenesis of hepatic encephalopathy. however ; it is also known than the restriction on the consumption of protein predisposes to depletion of muscle mass, and increase the risk to develop overt hepatic encephalopathy, due to the muscle role in the detoxification of ammonia in presence of liver failure. currently, the type and amount of protein in the diet to treat minimal hepatic encephalopathy (mhe) is unknown. in this study, the investigators will administrated two types of protein content in patients with mhe: a high protein diet (1.5 g/kg/day) vs a normal protein diet (0.8 g/kg/day) during 1 month.

Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis of any etiology * men and women between 18 and 70 years. * right-holders of the mexican social security institute * patients who agree to participate in the study and signed the informed consent exclusion criteria: * recent history of alcohol abuse and/or drugs (less than 6 weeks). * illiterate * alcoholic cirrhosis * history and/or diagnosis of overt hepatic encephalopathy * consumption of psychotropic medications (benzodiazepines, antiepileptics) * patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements. * history of chronic renal disease or heart failure * patients with gastrointestinal bleeding * history of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests * diagnosis of bacterial overgrowth * diagnosis of liver cancer * patients with ophthalmologic disorders

Keywords: minimal hepatic encephalopathy nutrition
prevacid vs lifestyle modifications for the treatment of lpr

Conditions: Laryngopharyngeal Reflux

Summary: the purpose of this study is to evaluate changes in scores on the reflux finding score and reflux symptom index over a 24 week period. to enroll subjects must score at least a 13 on the reflux symptom index and at least a 5 on the reflux finding score. all subjects will receive education on lifestyle modifications with a nutritionist and exercise trainer. all subjects will be expected to comply with lifestyle modifications for the entire study period of 24 weeks. half of all subjects will receive prevacid 30mg bid and half will receive placebo bid for 24 weeks. subjects will have 4 office visits over 24 weeks and weekly contacts with the study staff to assess reflux symptom index and any health or medication changes.

the results of studies evaluating ppi therapy versus lifestyle modifications for the treatment of lpr have not been conclusive. however, many of these studies were conducted at tertiary care centers. we will look at patients presenting with lpr symptoms in a community setting. all subjects will have an exam of their larynx via laryngoscopy at each of the 4 study visits (screening, week 6, week 12, and week 24). based on exam findings, the physician will complete the reflux finding score. the subjects will also complete the reflux symptom index weekly to assess for changes in their symptoms. the statistical analysis of this study will include evaluating changes in the reflux finding scores and reflux symptom index scores over the 24 weeks of study participation.

Eligibility criteria:
inclusion criteria: symptoms of lpr for at least one month, score of 5 or greater on reflux finding score, score of 13 or greater on reflux symptom index, and willing to follow lifestyle modifications. exclusion criteria: currently taking ppi twice daily for the treatment of lpr, women who are pregnant or lactating, history of duodenal or gastric ulcer in the past 5 years, erosive esophagitis, or esophageal obstruction, history of any hypersecretory condition, history of barrett's esophagus, history of hematemesis in the past 6 months, currently taking ketoconazole, digoxin, iron, ampicillin, theophylline, warfarin, or sucralfate, or suspected disease of the larynx not related to lpr.

Keywords: laryngopharyngeal reflux prevacid lifestyle changes reflux finding score reflux symptom index laryngoscopy