Kornimate/medical-research-clean huggingface dataset:
medical and economic evaluation for intermediate-risk prostate cancer

Conditions: Prostate Cancer

Summary: the aim of the present phase iii study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. the study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years; * life expectancy of greater than 10 years; * prostate adenocarcinoma histologically proven; * prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: psa between 10 ng/ml and 20 ng/ml, and/or a gleason score of 7 and/or a t2b. karnofsky performance status ≥ 60% and consequently performance status ecog 0-2. * the patient has to be the beneficiary of the social security system (order n° 2006-477 from april 26th 2006); * the signed consent form. exclusion criteria: * psa level \> 20; * gleason \> 7; * clinical t3a or t3b or mri (a simple suspicion/ doubt on the mri regarding the t3a won't be an exclusion criterion); * prostate volume \> 60 cc; * pelvic lymph nodes involvement at dissection or imaging (adp \> 1.5 cm); * concurrent hormone therapy; * the presence of distant metastasis (m1); * history of abdominal or pelvic irradiation; * history of prostate resection in the previous 6 months and/or not allowing the implantation of markers; * history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma); * urinary discomfort with an ipss (international prostate symptom score) \> 15 (without alpha-blocking); * inflammatory bowel disorder such as ulcerative colitis or the crohn's disease; * other undergoing study that may interfere with the present study; * patient under legal protection measure.

Keywords: prostate external beam radiotherapy brachytherapy boost economical evaluation
assessment of the diagnostic role of serum insulin-like growth factor binding protein-3 as a potential biomarker for colorectal cancer (crc) in egypt

Conditions: Colorectal Cancer

Summary: 1. evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as colorectal cancer 2. correlation between the diagnostic efficacy of insulin like growth factor binding protein 3 with routine marker carcinoembryonic antigen.

colorectal cancer is the third most common cancer diagnosed in the usa and the world's fourth most deadly cancer .the incidence and the mortality rate of colorectal cancer has decreased due to effective cancer screening measures. besides an ageing population and dietary habits of high-income countries, unfavourable risk factors such as obesity, lack of physical exercise, and smoking increase the risk of colorectal cancer. the incidence of early-onset colorectal cancer diagnosed in patients under the age of 50 years- has been increasing around the world. the insulin-like growth factor (igf) system composed of two ligands, their receptors and regulatory proteins. igfbps regulate the cell cycle, and the function of igfbps in transcriptional regulation, dna damage repair and apoptosis induction suggest that they are closely associated with tumour development, progression, and therapy resistance. insulin-like growth factor peptides play important roles in regulating cell growth, cell differentiation, and apoptosis, and have been demonstrated to promote the development of colorectal cancer. researchers found that igfbp3 has the potential to be used as early indicator for colorectal cancer diagnosis. moreover, igfbp3 as a risk factor for carcinogenesis has been demonstrated in many cancers. igfbp3 as a tumour suppressor was reported to be down-regulated in some cancers. but some other publications showed its overexpression is associated with poor prognosis for several cancers including pancreatic endocrine neoplasms. meanwhile, epidemiological studies indicated that higher circulating igfbp3 level were an increased risk of breast cancer.

Eligibility criteria:
inclusion criteria: 1. patients at south egypt cancer institute and diagnosed colorectal cancer patients 2. patients not went to surgery exclusion criteria: 1. patients receive any anti-cancer therapy. 2. patients diagnosed with other concomitante cancer or chronic diseases
zebutinib combined with immunochemotherapy in the treat of newly treated cll patients without 17p-/tp53 mutation

Conditions: Chronic Lymphocytic Leukemia

Summary: to investigate limited course of treatment of zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/tp53 mutation


Eligibility criteria:
inclusion criteria: * cll patients with indications for treatment according to iwcll; * ct/mri shows measurable lesions; * ecog score is 0-2; * no pregnancy plans during treatment exclusion criteria: * richter transformation; * 17p-/tp53 amplification ≥20% (fish); * received steroids within 7 days before starting treatment; * have previously received treatments for chronic lymphocytic leukemia; * vaccine live attenuated vaccine within 4 weeks of randomization; * any life-threatening disease; * central nervous system leukemia; * apoplexy, history of intracranial hemorrhage; * hiv or hcv or hbvpositive
a study to investigate the influence of hepatic insufficiency on the pharmacokinetics of doravirine (mk-1439) (mk-1439-019)

Conditions: HIV-1 Infection

Summary: this study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (pk) of doravirine (mk-1439). in part 1, pk of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in part 1, study part 2 was to evaluate pk of doravirine in participants with mild hepatic insufficiency.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 19 and 40 kg/m\^2 * continuous non-smoker or moderate smoker of \<20 cigarettes or equivalent per day. agrees to consume \<=10 cigarettes or equivalent per day from the time of screening through the period of sample collection. * in good health and with no clinically significant electrocardiogram abnormality * hepatic impairment participants: diagnosis of chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. part 1 only: score of 7 to 9 on the child-pugh scale. part 2: score of 5 to 6 on the child-pugh scale. * females of childbearing potential: sexually inactive for \>=14 days before study drug administration and throughout the study, or using 2 acceptable methods of barrier contraception from screening until 14 days after study drug administration. exclusion criteria: * mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the study * history or presence of clinically significant medical or psychiatric condition or disease * history or presence of drug abuse within the past 2 years * history or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds * female participant who is pregnant or lactating * positive results for breath alcohol or urine drug screen (unless due to prescription drug use and is approved by the investigator) at screening * positive for hiv at screening * unable to refrain from or anticipates the use of any drug known to be a significant inhibitor or inducer of cytochrome oxidase cyp3a or p-glycoprotein, or any medication or substance which cannot be discontinued at least 14 days before study drug administration and throughout the study. * donation of \>500 ml of blood or had significant blood loss within 56 days before study drug administration * plasma donation within 7 days before study drug administration * dosed in another clinical trial within 28 days before study drug administration * healthy control participants only: positive for hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) at screening;
prophylaxy of postoperative nausea and vomiting in patients undergoing laparoscopic surgery

Conditions: Postoperative Complications; Postoperative Nausea and Vomiting

Summary: postoperative nausea and vomiting (ponv) is one of the most commonly reported adverse effects of anesthesia. the general incidence of vomiting is approximately 30%, nausea at 50% and the ponv rate can go up to 80% in high-risk patients without prophylaxis. prevention of these episodes in high-risk patients improves satisfaction and well-being rates. therefore, it becomes important the adequate control of ponv, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. this study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of ponv in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.

the study included 60 patients at high risk for ponv (apfel-score 0, i, ii, iii and iv) scheduled for elective laparoscopic surgeries at the central surgical center of irmandade da santa casa de misericórdia in são paulo. inclusion criteria will be asa i or ii of either sex, in the age range of 18 to 70 years. in this study, the recruited patients will be allocated randomly into three groups. the group a will receive oral 600 mg gabapentin 2 h before surgery. the group b will receive oral 150 mg pregabalin 2 h before surgery. the group c will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. this study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic procedures * apfel score 0, i, ii, iii and iv * asa i / ii exclusion criteria: * patients with surgery converted to open before thirty minutes of surgery * patients who were exposed previously to gabapentin or pregabalin patients who have allergy to any medicine used in the study * patient who have to any cognitive impairment * illiterate patients * patients who refuse to participate in the study

Keywords: anesthesia complications nausea vomiting
qstat pilot reference range study

Conditions: Coagulation Disorder

Summary: the objective is to determine the initial reference range intervals for the parameters reported by the quantra system with the qstat cartridge.

this is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the quantra system with the qstat cartridge. the threshold for the clot stability to lysis (csl) parameter will be determined from the csl reference range.

Eligibility criteria:
inclusion criteria: * subject is 18 years or older * subject is willing to participate and has signed a consent form * subject's laboratory coagulation test results at screening are within each test's normal reference range. exclusion criteria: * subject is younger than 18 years * subject has a history of a coagulation disorder * subject is pregnant or lactating * subject is currently taking medications known to alter coagulation * subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening * subject had a blood transfusion or surgery within the last month * drug abuse * excessive alcohol consumption * subject is unable to provide written informed consent * subject is incarcerated at the time of the study * subject previously participated in this study
cobalamin status in young children with gastrointestinal symptoms or feeding problems

Conditions: Vitamin B 12 Deficiency

Summary: during fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. during the last years we have detected cobalamin deficiency in a number of infants admitted to the pediatric department with various symptoms, including neurological symptoms and feeding problems. cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition. in this study we want to establish the prevalence of cobalamin deficiency in infants with gastrointestinal symptoms and/or feeding problems. cobalamin status will be investigated in all children aged 8 months and younger, admitted to the pediatric department with these symptoms. in a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status. study hypothesis: cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.


Eligibility criteria:
inclusion criteria: * children below 8 months of age * clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms exclusion criteria: * children with syndromic disease

Keywords: cobalamin deficiency infant nutrition cobalamin supplementation feeding problems gastrointestinal symptoms
melatonin treatment and inflammation, oxidative stress and autonomic function in connection with surgery

Conditions: Oxidative Stress; Inflammatory Stress; Myocardial Ischaemia

Summary: the purpose of this study is to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

laparoscopic gall bladder surgery is connected with changes in the body resulting in cell damage and inflammation. melatonin is a hormone produced in brain and regulate sleep rhythm, temperature, production of other hormones and function of organs. furthermore melatonin can modify cell damage and inflammation. after surgery the production of melatonin is disturbed. the purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

Eligibility criteria:
inclusion criteria: * indikation for laparoscopic cholecystectomy * women between 18 and 70 years old exclusion criteria: * men * acute cholecystectomy * pancreatitis * renal insufficient * well-known liver insufficient * cardiovascular disease (arrhythmia, well-known ischaemic heart disease) * drug therapy (digoxin, ca-antagonist, amiodaron, beta-blocker) * anticoagulation therapy (marevan and marcoumar) * praeoperative therapy with opioid, anxiolytica and hypnotica) * well-known sleep disease * endocrine disease in drug therapy (diabetes mellitus, thyroid disease) * daily alcohol consumption (more than 5 drinks) * bad compliance (language difficulty, mental problems etc.) * pregnancy and breast-feeding * lack of written consent
evaluation of therapeutic effect of bandage contact lenses ( bcl) on dry eye caused by sjogren's syndrome

Conditions: Sjögren's Syndrome Patients With Severe Dry Eye

Summary: the purpose of this study is to evaluate the therapeutic effect and safety of therapeutic bandage contact lenses treating dry eye caused by sjögren's syndrome.

comparisons were made between sjögren's syndrome patients with severe dry eye on the subjective and objective therapeutic effects of the overnight therapeutic bandage contact lenses at different period (i.e. before wearing, after wearing 3 weeks, after another 3 weeks with new lens and after 6 weeks without wearing ) based on the results of examinations.

Eligibility criteria:
inclusion criteria: * gender: male or female between 18\~70 years old without wearing contact lens. * diagnosis and classification: all patients should have the symptoms and signs of severe dry eye (conforming to grade 3 or 4 in dews2007). should have at least two positive symptoms such as dryness, foreign body sensation, burning, asthenopia, red eye or secretion. tear film breakup time (tfbut) shorter than 5 seconds and/or schirmer i less than 5 mm/5 min. corneal fluorescein staining more than 6 scores and (or) more than 3 scores of bulbar conjunctiva lissamine green liquor. * both eyes of all patients were preliminarily examined, the patients with single eye that meets the criterion were also investigated. objective indicators were investigated on each eye. while the ocular surface disease index (osdi) scores and sf-36 results were evaluated on an individual base. * all patients should not participate in other medical tests in the past 2 weeks. * should either not be treated with other medicine at present, or have been treated with other medicine but had paused more than 2 weeks exclusion criteria: * pregnant or maternity: exclude the patients who are or will be pregnant or during breast feeding. * other surface diseases: exclude the patients who are suspected or complicated by other obvious ocular surface diseases. * severe systemic diseases: exclude the patients with severe primary diseases in heart, brain blood vessel, liver, kidney, hematopoietic system and so on. * intraocular surgery or trauma: exclude the patients with intraocular surgery or trauma during 6 months. * hormone replacement therapy : exclude post-menopausal women who are treated in hormone replacement therapy. * lacrimal punctum: exclude the patients who have been treated with lacrimal punctum in 1 month. * glaucoma or high iop: exclude the patients who have glaucoma or high intraocular pressure (iop) sores. * exclude the patients who are sensitive to steroid. * exclude the patients who can't wear the therapeutic bandage contact lens during the clinical study. * immunosuppressive therapies: exclude the patients who are using systemic steroid or immunosuppressive therapies which may influent the results of the evaluation of the therapeutic effect. * excluding the patients who may not be suitable for the clinical examination.

Keywords: dry eye therapeutic bandage contact lenses the quality of life
extension study of pimavanserin in subjects with major depressive disorder and inadequate response to antidepressant treatment

Conditions: Adjunctive Treatment of Major Depressive Disorder

Summary: to assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.


Eligibility criteria:
inclusion criteria: 1. completed the antecedent study, study acp-103-054 or study acp-103-059 2. may benefit from longer term therapy with open-label pimavanserin treatment 3. if the subject is female, she must not be pregnant or breastfeeding. she must also be of nonchildbearing potential or must agree to use acceptable methods of contraception exclusion criteria: 1. is determined to be inappropriate for the study 2. has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program additional inclusion/exclusion criteria apply. patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
rate control in patients with atrial fibrillation

Conditions: Atrial Fibrillation; Rate Control; Cardiopulmonary Exercise Test

Summary: to search for the best marker for the patients in atrial fibrillation with rate control

in an aging society, the prevalence of atrial fibrillation is increasing. the main treatment strategy is to reduce the complications of embolic stroke and heart failure. among these patients, a group of them will choose to have "rate control" based on the heart conditions and the preference of the patients. the strategy is to control the ventricular rate by drugs to prevent the heart from failure. however, when the physicians attempt to do so, they encounter two questions: how much is the optimal drug dose? and what is the best marker we are looking to? to answer these questions, the investigators design a prospective, cross-over study to explore this issue. the participants will do cardiopulmonary exercise test (cpet) before and after treatment. they will receive another cpet if drug dose is titrated up. with the study, the investigators will understand whether a resting heart rate can be a good marker for optimal drug dosage, and what is the optimal range of heart rate the physicians should target.

Eligibility criteria:
inclusion criteria: 1. 20\~90 years old 2. rate control is preferred after shared decision making exclusion criteria: 1. cannot cooperate with or complete cpet 2. has contraindication for cpet, such as uncontrolled heart failure, hypertension, angina, valvular heart disease, lung function impariment that sao2\<90% at room air. 3. ventricular rate below 80/min before any medication 4. permanent pacemaker implanted

Keywords: atrial fibrillation rate control cardiopulmonary exercise test
minimally invasive colon cancer surgery through immunomics and optical mapping of the sentinel lymph node.

Conditions: Colon Cancer; Sentinel Lymph Node

Summary: the project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (sln) in colon cancer patients. in addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (ln's) will be correlated to the ln location (anatomical mapping).


Eligibility criteria:
inclusion criteria: * tumor type: proven adenocarcinoma of the colon * extent of disease (ajcc 7th edition): clinically node negative (stage ii) non-metastatic colon cancer * locally resectable disease * adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent * laboratory data * serum creatinine ≤ 1.5 mg/dl or a calculated gfr ≥ 60 ml/min/1.73 m2 * serum total bilirubin ≤ 1.5 mg/dl, except for known gilbert's disease * platelet count \> 100,000/µl * hemoglobin \> 9g/dl * neutrophil granulocytes \> 1,500/ml * international normalized ratio (inr) ≤ 2 * absence of alcohol and/or drug abuse * no inclusion in other clinical trials interfering with the study protocol * no concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy * absence of any severe organ insufficiency * no pregnancy or breast feeding * adequate contraception in fertile patients * written informed consent exclusion criteria: * node positive and/or metastatic disease * locally unresectable disease * medically unfit patients (karnofsky index \< 70%) * allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)