Kornimate/medical-research-clean huggingface dataset:
food as medicine: an rct to study the effect of home delivered, medically tailored meals on patients with metastatic cancer

Conditions: Quality of Life

Summary: the purpose of this study is to determine whether medically tailored meals (hdtm) can improve quality of life for patients with metastatic cancer.

the current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. the goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass. all patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. however, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.

Eligibility criteria:
inclusion criteria: * diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (m1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present. * pain score (ps) 0-3 * age\>18 * both male and female subjects eligible * all ethnicities eligible * access to refrigerator or freezer exclusion criteria: * diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment * currently receiving home delivered meals from other sources * evidence of any alimentary tract obstruction or other condition preventing oral alimentation * requirement for enteral or parenteral nutrition at time of diagnosis * incarcerated individuals
intra-abdominal hypertension in critically ill patients

Conditions: Intra-Abdominal Hypertension; Abdominal Compartment Syndrome

Summary: the aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.

increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. the quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. the prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.

Eligibility criteria:
inclusion criteria: * foley catheter in-situ on admission exclusion criteria: * contra-indication to bladder pressure measurement * home service asked that patient is not included * death within 24 priors of admission before bladder pressure measured * no bladder pressure performed within 24 hours of admission * consent refused or unable to be obtained (lack of sdm, patient unable to provide)
acute neural and immune effects of alcohol in people living with hiv infection

Conditions: HIV-1-infection; Alcohol Drinking

Summary: this study will examine whether moderate alcohol use in the context of hiv infection exacerbates inflammatory signaling in the immune system and brain. the study will recruit healthy individuals and people living with hiv infection who are otherwise in good health to participate. participants will complete an experimental protocol that involves controlled alcohol administration and magnetic resonance imaging (mri). primary outcomes are plasma biomarkers of inflammation and mri markers correlated with neuroinflammation. results will advance understanding of the effects of alcohol use in people living with hiv infection.

a sample of 56 participants, to include equal numbers of plwh and uninfected controls, will be recruited to complete the experimental protocol. participants will be randomized to one of the two beverage conditions (0.60 g/kg alcohol beverage, 0.00 g/kg placebo beverage). blood samples will be collected at baseline (prior to beverage administration) and for three hours afterward. cognitive performance and subjective intoxication will be assessed using standardized measures. mri scans will be collected 4-5 hours after beverage consumption to capture neurobiological outcomes on the descending limb of blood alcohol.

Eligibility criteria:
inclusion criteria: * 21 to 60 years of age * able to speak and read english at least at 8th grade level * alcohol use as defined by study protocol * body mass index of 18.5-30 kg/m2 * lab tests obtained in past year showing no evidence of acute/chronic hepatitis b or c infection * hiv-1 serostatus confirmed by standard clinical testing * hiv-specific criteria for antiretroviral medication use and lab parameters * able to consume soy and nuts safely exclusion criteria: * heavy drinking as defined by study protocol * treatment for alcohol/drug use, with exception of smoking cessation * use of specific medications in the past month * daily use of specific over-the-counter drugs * disorder of the lower gi tract * positive urine drug test or screening for drug use disorder * current major psychiatric disorder * history of significant problems from blood draw * safety contraindication for mri * head trauma with loss of consciousness \> 10 min * inability to abstain from nicotine during study session * inability to abstain from cannabis before and during study session * pregnant, breastfeeding, or not using effective birth control * any other clinical condition or therapy that, in the physician's opinion, would make the individual unsuitable for study or unable to comply with dosing requirement

Keywords: hiv infection alcohol brain inflammation
r-ceop-90/r-ceop-70 versus r-chop-50 in the treatment of diffuse large b-cell lymphoma and follicular lymphoma grade 3b

Conditions: Diffuse Large B-cell Lymphoma; Follicular Lymphoma Grade 3B

Summary: the main purpose of this study is to evaluate the safety and efficacy of r-ceop-90/r-ceop-70 versus r-chop-50 in the treatment of diffuse large b-cell lymphoma and follicular lymphoma grade 3b patients.

the study aims to evaluate the safety and efficacy of r-ceop-90/r-ceop-70 versus r-chop-50 in the treatment of diffuse large b-cell lymphoma and follicular lymphoma grade 3b patients.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed de novo diffuse large b-cell lymphoma or follicular lymphoma grade 3b 2. age\>=16 y.o.,\<=80 y.o. 3. ecog \< 3 4. no past history of malignancy 5. radiologically measurable disease, ct imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter \> 1.5 cm, or 1 clearly demarcated lesion with a largest diameter \> 2.0 cm. 6. life expectancy\>6 months 7. informed consented exclusion criteria: 1. chemotherapy before 2. bone marrow transplantation before 3. history of malignancy 4. active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy 5. uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease 6. primary cutaneous, cns, mediastinal dlbcl 7. lvef≤50% 8. other uncontrollable medical condition that may that may interfere the participation of the study 9. lab at enrollment(unless caused by lymphoma) * neutrophile\<1.5\*10\^9/l * platelet\<80\*10\^9/l * hemoglobulin\<100g/l * alt or ast \>2\*uln,akp or bilirubin \>1.5\*uln * creatinine\>1.5\*uln 10. not able to comply to the protocol for mental or other unknown reasons 11. pregnant or lactation 12. active liver or biliary disease 13. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled. 14. hiv infection

Keywords: diffuse large b-cell lymphoma follicular lymphoma grade 3b
nhfov as primary support in very preterm infants with rds

Conditions: to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates

Summary: this will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in china. the investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that nhfov is more effective than ncpap in the treatment of respiratory distress syndrome (rds) in infants with a gestational age of less than 28 weeks when used as a primary noninvasive ventilation (niv) mode.

preterm infants are eligible to the study if they they match the following inclusion criteria: (1) gestational age between 240/7 and 286/7 weeks; (2) diagnosis of rds. the diagnosis of rds will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (fio2) greater than 0.25 for target saturation of peripheral oxygen (spo2) 89% to 94%;; (3) age less than 2 hours; (4)informed parental consent has been obtained. neonates will be randomized and assigned either to ncpap or nhfov arms with a 1:1ratio, when patients fulfill all inclusion criteria. randomization cannot be done earlier. simple randomization will be done according to a computer-generated random number table and will be posted in a specific secured website 24/7 available. twins will be allocated in the same treatment group. infants randomized to one arm cannot crossover to the other or vice- versa during the study. for all the groups, if the fraction of inspired oxygen (fio2) requirement is persistently higher than 0.30 per target spo2 89-94% after starting the respiratory support, newborns receive surfactant by "lisa" technique, administration of surfactant (curosurf,chiesi pharmaceutics, parma, italy) 200 mg/kg. after the administration of surfactant, if fio2 requirement is persistently \>0.4 to keep spo2 89-94% or severe apnea episodes are present (defined as recurrent apnea with \>3 episodes/h associated with heart rate \ 60 mmhg and potential of hydrogen (ph)\<7.20 obtained at least 1 hour after commencement of the assigned treatment, newborns are intubated and mechanically ventilated. for all the newborns enrolled in the study, arterial or free-flowing capillary blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. further controls follow the routine of the ward.

Eligibility criteria:
inclusion criteria: (1) gestational age between 240/7 and 286/7 weeks; (2) diagnosis of rds. the diagnosis of rds will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (fio2) greater than 0.25 for target saturation of peripheral oxygen (spo2) 89% to 94%；（3） age less than 2 hours exclusion criteria: * intubated forany reasons at birth * major congenital malformations or known complex congenital heart disease * no parental consent

Keywords: nasal high frequency oscillation ventilation(nhfov); nasal continuous positive airway pressure(ncpap); preterm infants
love4mum: virtual engagement for preventing postpartum depression

Conditions: Postpartum Depression; Maternal Behavior; mHealth Intervention; Mental Health Issue

Summary: postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. this pilot study evaluates the effectiveness of a novel mobile app called love4mum, developed based on cognitive behavioral therapy and psychoeducation principles, in preventing postpartum depression. the pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the love4mum. primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. this research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.

postpartum depression (ppd) is a significant mental health issue. traditional support systems remains challenging and mhealth intervention provides an opportunity to access for support. the primary objective of this study is to preliminarily assess the effectiveness of a developed mobile application called love4mum in prevention of postpartum depression. the study will employ a single-blinded, pilot randomized controlled trial (rct) design involving a sample of 64 mothers. participants will be randomly assigned in a 1:1 ratio to one of two groups: the intervention group, which will receive standard postpartum care plus love4mum mobile application, or the control group, which will receive standard postpartum care alone. the primary outcome measure will be the effectiveness of the mobile application in improving symptoms of postpartum depression among mothers. secondary outcome measures will include changes in postpartum mental health literacy scores and negative automatic thoughts frequencies. through the systematic evaluation of the love4mum mobile application in conjunction with standard postpartum care, this pilot rct aims to generate preliminary evidence regarding the efficacy and feasibility of using mhealth tools for preventing postpartum depression.

Eligibility criteria:
inclusion criteria: * mothers with epds score 9-\<12 * mothers with access to smartphone and internet connectivity * continue routine postpartum care at the government health facilities * literate in english and malay exclusion criteria: * history of drug abuse * diagnosis of depressive illness or any other mental health illness * undergoing treatment for mental health * infant born with intrauterine death or died immediately after birth

Keywords: postpartum depression mhealth intervention self-guided postpartum mental health literacy
effect of ring on gastroesophageal reflux (gerd) after rygbp

Conditions: Morbid Obesity; Gastroesophageal Reflux Disease; Vomiting

Summary: silastic rings have been used around the gastric pouch in order to promote better weight loss after roux-and-y gastric bypass surgery ( rygbp). however the investigators have shown that some patients developed gastroesophageal reflux disease after rygbp in a previous study. the investigators hypothesized that the use of a silastic ring may play a role in promoting gerd after this operation.

this is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or gerd symptoms.

Eligibility criteria:
inclusion criteria: * indications for bariatric surgery (bmi over 40kg/m2 or over 35kg/m2 associated to a life-treating morbid conditions. * acceptance to be submitted to a 24h ph-monitoring and esophageal manometry * no contra-indication for gastric bypass * absence of previous gastric surgery * option for open gastric bypass exclusion criteria: * inferior and superior total teeth prosthesis * poor surgical conditions

Keywords: obesity gastroesophageal reflux disease morbid obesity esophagitis gerd silastic ring gastric bypass
a retrospective non-interventional study to evaluate the use of seroquel extended release (xr) and immediate release (ir) in the clinical practice of inpatients with schizophrenia

Conditions: Schizophrenia

Summary: the primary objective of this non-interventional study is to investigate how seroquel xr and seroquel ir are used in the clinical practice of inpatients with schizophrenia. this will be done by a retrospective review of medical records to evaluate patients treated with seroquel xr or seroquel ir as primary antipsychotic treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia. * at least one dose of seroquel xr or seroquel ir during the study period (1st of july 2009 - 30th of september 2010). * hospitalization due to psychotic symptoms at any time during the study period (1st of july 2009 - 30th of september 2010) and with admission and discharge dates available. exclusion criteria: * participation in a clinical trial during the study period. * treatment in forensic care according to lrv ("lagen om rättspsykiatrisk vård").

Keywords: mental disorder antipsychotic treatment
effects of an infant formula and follow-on formula containing bio-active ingredients on growth, tolerance and infections

Conditions: Growth; Infections

Summary: in this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an if and fof containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard if and fof

in this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an if and fof containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard if and fof, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included \<2mo of age.

Eligibility criteria:
inclusion criteria: * full-term infants * healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g * boys and girls * apparently healthy at birth and screening * weight-for-age z-score (waz) at screening within the normal range according to who child growth standards * age at enrolment: ≤60 days of age * if age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion * if 1 month \< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2 * being available for follow up until the age of 12 months * written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years exclusion criteria: * severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (cma), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (fgid)) * incapability of parents to comply with the study protocol * illiterate parents (i.e. not able to read and write in local language) * participation in another clinical trial * unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months * infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion

Keywords: infant nutrition growth gut comfort product tolerance infections
comparing hand-sewn (end-to-end or kono-s) to stapled anastomosis in ileocolic resection for crohn's disease

Conditions: Crohn Disease

Summary: the aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and kono-s) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.

within the surgical ibd society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent crohn's disease after surgery. despite optimal surgical and medical management, recurrent disease after surgery is common. different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and kono-s) and stapled (side-to-side). the various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. it is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.

Eligibility criteria:
inclusion criteria: * males and females aged \>16 years * ileocolic disease or disease of the neoterminal ileum with an indication for resection * concurrent therapies with corticosteroids, 5-asa drugs, thiopurines, mtx, antibiotics, and anti-tnf therapy are permitted. * all patients should have undergone a colonoscopy and a recent update of imaging (e.g. ultrasound, mr enterography (or ct enterography if mr is contraindicated))- ability to comply with protocol. * competent and able to provide written informed consent. * patient must have been discussed in the local mdt exclusion criteria: * inability to give informed consent. * patients less than 16 years of age. * clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. * history of cancer \< 5 years which might influence patients prognosis * emergent operation. * pregnant or breast feeding. * inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Keywords: crohn's disease ileocolic endoscopic recurrence ileocolic anastomosis
detection of autologous dehp (diethylhexyl phthalate)-free blood transfusion in anti-doping

Conditions: Transfusion Reaction

Summary: the aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in dehp-free blood bags.


Eligibility criteria:
inclusion criteria: * have to fill the swiss blood donation formulary exclusion criteria: * anemia * cardiovascular disease * neurologic disease * not performed a blood donation for 5 weeks ago the start of the study. * immunological disease