Kornimate/medical-research-clean huggingface dataset:
cisplatin plus docetaxel versus cetuximab, cisplatin, and docetaxel in metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this is a phase ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mnpc) to determine whether the addition of cetuximab to induction chemotherapy and chemoradiation could improve therapeutic efficacy in mnpc, and investigate predictive and prognostic factors for mnpc.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nasopharyngeal carcinoma * untreated metastatic nasopharyngeal carcinoma (stage ⅳc according to the 7th american joint committee on cancer staging system and stage ⅳb according to the chinese 2008 staging system for nasopharyngeal carcinoma) * patients must have measurable disease based on response evaluation criteria in solid tumors (recist) version 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 6 months * absolute neutrophil count (anc) \>=1.5×10\^9/l * platelets \>= 80×10\^9/l * hemoglobin \>= 90 g/l * bilirubin \<= 1.5 × upper limit of normal (uln) * aminopherases ( alanine transaminase and aspartate aminotransferase) \<= 2.5 × uln (without liver metastasis) or \<= 5.0 × uln (with liver metastasis) * creatinine \<=uln * international normalized ratio (inr) of prothrombin time (pt) \<= 1.5 × uln * the pregnancy tests of women of childbearing potential should be negative before treatment * women of childbearing potential and sexually active males must adopt efficient contraception methods while on treatment and for six months after the completion of the treatment * patients should understand and are willing to participate in the study. inform consent form is supposed to obtained before treatment exclusion criteria: * prior radiotherapy of target lesions * prior systemic chemotherapy and/or targeted therapy * brain metastasis * concurrent other malignancies * severe or active infectious disease requiring systemic antibiotics or antiviral, antifungal treatment * active tuberculosis * severe cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction in the past 6 months, congestive heart failure with cardiac function grade ⅲ to ⅳ based on new york heart association cardiac functional grading, serious arrhythmia, or pericardial effusion * co-existing mental disease that would preclude full compliance with the study * females are pregnant or breast feeding
obesity and financial incentives

Conditions: Obesity

Summary: investigate whether economic incentives help obese individuals to lose weight.


Eligibility criteria:
inclusion criteria: * bmi above 30 * age between 18 anf 75 * registered residence in the german federal state of baden-württemberg exclusion criteria: * considerable language barriers * pregnancy * psychological disorders * eating disorders * tumor disease within last five years * abuse of alcohol * abuse of drugs * serious general diseases
pasireotide in the treatment of hypoglycemia following gastric bypass surgery

Conditions: Hypoglycemia, Reactive

Summary: postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of roux-en-y gastric bypass (rygb), and the treatment options are limited. pasireotide has shown to be effective in preventing hypoglycemia in rygb operated subjects, however treatment often leads to increased hyperglycemia. the purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in rygb operated subjects with postprandial hyperinsulinemic hypoglycemia.

with the growing number of rygb operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (phh) has increased. phh is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (glp-1) levels. symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. at present there are few treatment options available for rygb patients with phh and most of them rely on dietary changes that are difficult to adhere to. pasireotide has been shown to reduce hypoglycemia in rygb operated subjects with phh, but often leads to increased hyperglycemia as well. the purpose of the study is to investigate two doses of pasireotide in rygb operated subjects with phh. each subject will undergo two meal tolerance test (mtt) preceded by either 75 µg or 150 µg of pasireotide. blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, c-peptide, glp-1 and glucagon levels.

Eligibility criteria:
inclusion criteria: * rygb operated patients with documented hypoglycemia (blood glucose \<3.9 mmol/l) who have previously completed the study 'treatment of hypoglycemia following gastric bypass surgery' (hypogb2015) * hemoglobin \> 7,3 mmol/l * negative human chorionic gonadotropin (hcg) urine test * females of reproductive age: use of safe contraception exclusion criteria: * treatment for cardiovascular disease * treatment with antipsychotic medication * treatment for thyroid disease * prior medical treatment of postprandial hyperinsulinemic hypoglycemia * prior allergic reactions to the study medicine

Keywords: gastric bypass hypoglycemia hyperinsulinemia
colecalciferol as an add-on treatment to interferon-beta-1b for treatment of multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin d3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.


Eligibility criteria:
inclusion criteria: * age 18 to 55 years * remitting-relapsing multiple sclerosis according to mcdonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month * edss (expanded disability statsu scale) ≤ 5 * no neutralising antibodies to infb as measured by indirect mxa test * prepared and considered to follow the protocol * using appropriate contraceptive methods (women of childbearing potential) * has given informed consent exclusion criteria: * serum calcium \>2.6 mmol/l * serum 25(oh)d2 (kalsidiol) \> 85 nmol/l * presence of primary hyperparathyroidism (serum intact pth, parathyroid hormone)\>65 ng/l) * pregnancy or unwillingness to use contraception * alcohol or drug abuse * use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses * current use of other immunomodulatory therapy than interferon-beta-1b * known allergy to cholecalciferol or arachis oil (peanuts) * therapy with digitalis, calcitonin or active vitamin d3 analogues during the previous 12 months or multivitamins containing vitamin d during previous two weeks preceding study entry * any condition predisposing to hypercalcaemia (such as any type of cancer) * sarcoidosis * nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit * significant hypertension (blood pressure \<180/110 mmhg) * hyperthyroidism, or hypothyroidism in the year before the study began * a history of nephrolithiasis during the previous five years * cardiac insufficiency or significant cardiac dysrhythmia * unstable or advanced ischaemic heart disease * has suffered a major depression

Keywords: vitamin d multiple sclerosis mri randomised trial finland
the effect of a mindfulness-based stress reduction program in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Mindfulness; Upper Motor Neuron Lesion

Summary: the aim of this study is to investigate the effect of an mindfulness-based stress reduction (mbsr) program designed in accordance with the literature and the basic principles of the program on fatigue, self-efficacy and stress for individuals with multiple sclerosis (ms). thirty members of the multiple sclerosis society with multiple sclerosis were randomized as experimental and control groups. participants in the experimental group received an 8-week mbsr program by an mbsr instructor. the patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. outcome measurements consisted of fatigue impact scale (fis), self-efficacy scale and perceived stress scale.

the use of mindfulness-based interventions to reduce fatigue in individuals with ms is supported by meta-analytic evidence. a systematic review concluded that mindfulness-based interventions effectively improves the quality of life in ms patients. to characterize the best formatting, mechanisms of action, and outcomes in ms patients with a wider range of social, educational, and clinical backgrounds, more research is necessary. participants in the experimental group received an 8-week mbsr program by an mbsr instructor. each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. experiences after meditation were shared with the group. each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. home practice meditations were performed by listening to the guide audio recording with headphones. all home exercises in the training content were followed up on a daily basis and recorded. the patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. furthermore, the control group received an invitation to participate in an identical mbsr program session following the study's conclusion.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting ms or progressive ms * over 18 years of age, * neurologist confirmed diagnosis of ms, * a score of less than or equal to 7.0 on the expanded disability status scale (edss). exclusion criteria: * comorbidities with life-threatening physical or mental health (such as active psychosis, suicidal ideation, or terminal or life-threatening co-occurring medical diseases), or disorders that are predicted to severely restrict participation and adherence (e.g., dementia, pregnancy, ongoing substance abuse); * individuals who are presently undergoing non-pharmacological psychological treatments or prior formal training in mindfulness

Keywords: mindfulness multiple sclerosis fatigue self-efficacy
vitamin d intervention and associated changes in the gut microbiome and vitamin d levels in healthy adults

Conditions: Colorectal Cancer

Summary: although dietary vitamin d supplementation has been used in the clinical setting for decades, the effect of supplementary vitamin d consumption on the structure of the microbiome has not been studied in humans in fine scale or with concomitant adjustment for dietary intake. understanding the interaction of vitamin d with the microbiome in humans could lead to important advancements in the understanding of how vitamin d together with diet impacts the microbiome composition, and ultimately, risk of eocrc. this study has the potential to lay the ground work for an adjunctive therapy to manipulate the microbiome to reduce risk of eocrc. this proposed study is designed to evaluate the effect of vitamin d supplementation on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.


Eligibility criteria:
inclusion criteria: * adult 18 years or older exclusion criteria: * women who are currently pregnant or breastfeeding * use of antibiotics within the last 2 weeks * use of supplementary vitamin d within the last month * self-reported, pre-existing history of inflammatory bowel disease, heart disease or diabetes * students under 18 * tanning/sun exposure \> 60 min at a time in last 4 weeks * no phenobarbital, carbamazepine, spironolactone chronic therapy; or steroid use within the last 2 weeks * severe allergy to ingredients found in supplements
effect of soymilk replacement on anthropometric and blood pressure value

Conditions: Weight; Waist; Systolic Blood Pressure; Diastolic Blood Pressure

Summary: soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on weight control and blood pressure management. most studies in this regard have been conducted on postmenopausal or premenopausal women and there are few studies on female youths. therefore, we are going to determine the effects of soy consumption on the weight, waist circumference and blood pressure in overweight and obese female youths. this was a cross-over randomized clinical trial which was conducted in 2010 in isfahan on overweight or obese young female youths. after three weeks run-in, females were randomly assigned to consume a diet containing caw's milk or a diet in which only one glass of soy milk was substituted; each one for six weeks. random sequencing generated in spss was used for allocating females in different group randomly. patients were not blinded because they had to use soy milk in one period of trial and use caw's milk in another period.


Eligibility criteria:
inclusion criteria:being in the age range of 18 to 30 and having body mass index more than 30 kg/m2 were the inclusion criteria. - exclusion criteria:having allergy to soy product or caw's milk and not consuming the soy milk or caw's milk, incidence of chronic or acute diseases which make patients not to follow the research protocol or beginning to consume the medications were the exclusion criteria. -
coronary artery stent evaluation with 320-slice computed tomography - the cars 320 study

Conditions: Coronary Artery Stenosis

Summary: the investigators aim at analyzing the diagnostic accuracy of 320-row ct for coronary stents.


Eligibility criteria:
inclusion criteria: * suspected coronary artery in-stent restenoses based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days. * able to understand and willing to sign the informed cf. exclusion criteria: * creatinine of above 2.0 mg/dl * age below 40 years * women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before ct. * resting heart rate above 70 beats per minute and contraindications to beta blockers (e.g. moderate to severe bronchospastic disease, asthma) * atrial fibrillation, uncontrolled tachycardia, a-v block ii or iii degree or other non-sinus rhythms * inability to hold the breath for 10 seconds * hypotension \< 80 mmhg systolic * unstable angina pectoris, acute myocardial infarction \< 48h * continuous therapy with dipyridamol * severe aortic stenosis

Keywords: men or women of any ethnic group scheduled to undergo conventional coronary angiography for suspected coronary artery stent stenosis
efficacy and safety of octreotide in laparoscopic hepatectomy surgery: effect on blood loss, need for vasoactive drugs, transfusion requirements.

Conditions: Hepatic Carcinoma; Hepatic Metastasis

Summary: the goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases. the main questions it aims to answer are: * decrease in intraoperative bleeding measured in ml of blood lost. * decrease in the need for blood transfusion and use of intraoperative vasoactive drugs. participants will receive octreotide or placebo after signing the informed consent form.

the drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room. the patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. the monthly follow-up will coincide with the medical check-up and control analytical data will be taken. subsequently, an attempt will be made to contact with the patient 3 months after surgery. the duration of participation of each participant in the trial will therefore be about 3 months after surgery. the intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of ssf to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery. the pharmaceutical form to be used is sandostatin. the control group will receive ssf as a placebo in the same sequence, first a loading dose in half an hour and then a continuous infusion of 25 mcgr/h until the end of surgery. and then a continuous infusion until the end of the surgery.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hepatic lesions who are going to undergo hepatectomy via laparoscopy. * the patient must be between 18 and 80 years old. * the patient, or his/her representative, has given his/her consent to participate in the study. * the patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial. * the patient must not be allergic to the drug. exclusion criteria: * history of hypersensitivity to the drug to be administered. * children under 18 years of age. * urgent intervention. * intervention performed in an open manner (not laparoscopic). * patient's refusal to participate in the study. * contraindication to receive octreotide. * women of childbearing age (those women who are in the period between menarche and menopause). having to present a negative pregnancy test to take part in the study. * pregnant or lactating women, given the absence of studies of this drug in this patient profile.
adaptive treatment strategies for improving engagement with a web-based smoking intervention in socially anxious smokers

Conditions: Social Anxiety Disorder; Tobacco Use Disorder

Summary: this phase i trial will use a pilot sequential multiple assignment randomized trial (smart) to examine protocol feasibility and acceptability of new components of a web-based intervention for socially anxious smokers. this study will be used to help build an adaptive treatment strategy to improve engagement with and effectiveness of the web-based intervention. adaptive treatment strategies provide individualized sequences of intervention components to accommodate the changing needs of individuals based on their characteristics, treatment response, or engagement.

this study proposes to use a pilot smart to help build an adaptive treatment strategy to improve engagement with and effectiveness of a web-based intervention for socially anxious smokers. at the outset of the study (phase 1), participants will receive access to a new web-based smoking intervention (mywebquit) and will randomized to receive one of two text message services: 1) 1-way text messages, or 2) interactive, 2-way text messages. those who disengage with the website in the first 5 weeks will be re-randomized to one of three re-engagement strategies: 1) re-engagement emails, 2) re-engagement interactive text messages, or 3) no re-engagement strategy. outcomes include protocol feasibility, treatment acceptability, treatment utilization, and smoking cessation.

Eligibility criteria:
inclusion criteria: * resides in the us and anticipates remaining in the us for the duration of the study * smokes at least 5 cigarettes per day for at least 12 months prior to screening * desire to quit smoking within 30 days * has at least weekly internet access * current use of a personal email account * current use of text messaging * willing to receive text messages as part of this study * screen positive for social anxiety (lsas-sr ≥ 60) * interested in participating in the study for themselves (versus \[vs\] someone else) * not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program * no prior participation in one of the investigator's prior smoking cessation studies, * comfortable reading, writing, and speaking english * agree to the conditions of compensation * not currently incarcerated in a prison * willing to use the mywebquit program, complete study assessments, and sign an online consent form * no other member of their same household participating in the study
happy baby hearts study

Conditions: Coarctation of Aorta

Summary: the goal of this observational study is to determine the feasibility of renal near infrared spectroscopy (nirs) monitoring in the newborn nursery for newborns at low risk of coarctation of the aorta (coa). the main questions it aims to answer are: * whether continuous renal nirs monitoring is feasible; * whether nirs monitoring results in higher nursing and parent/caregiver satisfaction than current standard monitoring; and, * whether participants who develop coa will spend a smaller proportion of time within the normal range than patients who do not have coa. participants will be observed through continuous renal oxygenation monitoring with nirs.


Eligibility criteria:
neonate inclusion criteria: * delivered at ≥ 35 weeks of gestation * \<12 hours of age * inpatient at meriter hospital, inc. nicu or newborn nursery or afch picu or nicu * diagnosed as at risk for coa neonate exclusion criteria: * major congenital anomalies of the kidney * attending physician's discretion to not place sensors due to clinical concerns * in the researcher's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life primary caregiver inclusion criteria: * able to understand and the willing to sign a written informed consent document * willing to comply with all study procedures and be available for the duration of the study * birth parent (i.e., the parent who gave birth to the baby) who is the primary caregiver of a neonate who is eligible to participate in study * agrees to enroll neonate into study * aged 15 years or older * pregnant mother with a baby diagnosed prenatally as at risk for coa will be eligible for the study. they must also meet the following criteria: * require an "arch watch care plan" as a results of prenatal ultrasonography findings * agree to enroll offspring into the study at birth primary caregiver exclusion criteria: * subject is unable to provide informed consent, including subjects who are in foster care and subjects within state custody * pregnant woman who does not plan to maintain custody of the child after birth, such as instances of adoption or surrogacy newborn nursery nursing staff: * all newborn nursery nursing staff at meriter hospital, inc.'s newborn nursery are eligible to participate