Kornimate/medical-research-clean huggingface dataset:
hyperthermic intraperitoneal chemotherapy with paclitaxel in advanced ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage figo ii, iii and iv) or tumor recurrence. a cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization: * hipec-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic iv chemotherapy with carboplatin (auc=6) and paclitaxel (175 mg/m2) for 6 cycles. * no hipec-arm: cytoreductive surgery followed by postoperative systemic iv chemotherapy with carboplatin (auc=6) and paclitaxel (175 mg/m2) for 6 cycles.

Eligibility criteria:
inclusion criteria: * women with histologically confirmed epithelial ovarian cancer (stage ii / iii / iv disease of figo) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test) * complete cytoreduction: index cc0/cc1 cytoreduction (residual tumor size after surgery, no visible (cc0) or less than 0.25 cm (cc1)) * no extra-abdominal tumor disease * absence of heart failure. adequate renal and hepatic functions * eastern cooperative oncology group performance status 0-2 or karnofsky performance status ≥ 70% exclusion criteria: * patients with unresectable tumor or incomplete cytoreduction. * contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count \<1.500/mm3 (\<1.000/mm3 for patients with kaposi sarcoma). paclitaxel is also contraindicated in patients who have concurrent and severe infections. * extra-abdominal metastases or unresectable liver metastases * presence of other malignant tumor disease. * multisegmental complete bowel obstruction. * patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk * patients who refuse treatment or consent to participate in study

Keywords: hipec ovarian cancer peritoneal carcinomatosis
physical activity, function and quality of life in patients after endovascular treatment

Conditions: Peripheral Vascular Disease

Summary: the purpose of this study is to investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events.


Eligibility criteria:
inclusion criteria: * 55 years old or older * successful endovascular * living in oslo or in the close area being able to come to physical training classes at the hospital exclusion criteria: * endovascular treatment on study-leg last 2 years * other reasons for reduced walking function than peripheral arterial disease
modufolin (arfolitixorin) in combination with 5-fluorouracil alone or together with oxaliplatin or irinotecan in colorectal cancer

Conditions: Colorectal Neoplasm

Summary: the purpose is to characterise the tolerability of modufolin (arfolitixorin) in combination with 5-fu alone, in combination with 5-fu and oxaliplatin, in combination with 5-fu and irinotecan and in combination with 5-fu, oxaliplatin and bevacizumab. another purpose is to investigate 4 doses of modufolin to identify the best dose for further assessment.

the study will investigate the tolerability of modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-fu, oxaliplatin +/- bevcizumab, and irinotecan. when the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of modufolin at this dose level. twenty (20) of these additional patients will be treated in with oxaliplatin, 20 with irinotecan.

Eligibility criteria:
inclusion criteria: advanced metastatic colorectal (stage iv) cancer verified by biopsy

Keywords: colorectal cancer colorectal carcinoma colorectal tumors intestinal neoplasm gastrointestinal neoplasm gastrointestinal disease 5,10-methylenetetrahydrofolate tetrahydrofolates therapeutic uses pharmacokinetics pharmacodynamics safety assessments
prevalence of obstructive sleep apnea syndrome in sarcoidosis and impact of cpap treatment on associated fatigue status

Conditions: Sarcoidosis; Sleep Apnea, Obstructive; Fatigue

Summary: sarcoidosis is a multisystemic granulomatous disease that affects individuals worldwide without known pathogenesis, and the role of comorbidities has not been fully assessed in the scientific literature. an increased incidence of obstructive sleep apnea syndrome (osas) has been described in sarcoidosis although this association has not been explained yet and no data is available about the effect of treatment with continuous positive airway pressure (cpap) in sarcoidosis. also, patients affected by sarcoidosis usually experience a state of physical and mental weariness called fatigue and reported in approximately 60-80% sarcoid patients and thought to be a consequence of inflammatory mediators but the high prevalence of osas could be a remarkable bias in clinical evaluation because fatigue is also strongly associated with sleep disorders. thus, there is a real need for assessing not only the real prevalence of osas in sarcoidosis but also the effect of cpap treatment on fatigue status experienced by sarcoidotic patients.


Eligibility criteria:
inclusion criteria: * subjects with a definite diagnosis of sarcoidosis according to international ats and wasog guideline exclusion criteria: * ongoing cpap treatment * psychiatric disorders

Keywords: cpap
spiolto® respimat® (tiotropium/olodaterol) versus triple combination therapy in everyday clinical treatment practice for chronic obstructive pulmonary disease (evelut®)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: open-label comparative multicentric cohort study in copd patients with laba/ics, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

copd patients on laba/ics maintenance therapy with dyspnea (mmrc ≥ 1) and other symptoms (cattm ≥ 10), who are switched to either spiolto® respimat® in the new reusable inhaler or any triple therapy (lama + laba + ics) as an open or fixed combination according to approved smpcs at baseline at the discretion of their attending physician.

Eligibility criteria:
inclusion criteria: patients can be included if all of the following criteria are met: * diagnosis of copd * symptomatic (with regard to dyspnea (mmrc dyspnea score ≥1) and with regard to symptoms (cat score ≥10) at the same time) * patients on laba/ics maintenance therapy who are switched to spiolto® respimat® in the new reusable inhaler or a free/fixed triple combination of laba + lama + ics at visit 1 at the discretion of the treating physician. * adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel * male or female * patients aged ≥40 years of age * written informed consent prior to study participation * the patient is willing and able to follow the procedures outlined in the protocol exclusion criteria: * patients with contraindications acc. to smpc * patients not on laba/ics maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ics only, or a triple combination of lama + laba + ics (either as a fixed combination product or as separate components) * lack of informed consent * pregnant and/or lactating females * acute exacerbation of copd (within 4 weeks prior to visit 1) * frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months * acute respiratory failure (ph \ 30/min within 3 months prior to visit 1) * history or current diagnosis of asthma * history or current diagnosis of asthma-copd overlap * history or current diagnosis of allergic rhinitis within the last 5 years * history or current diagnosis of lung cancer within the last 5 years * participation in a parallel interventional clinical trial * mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician * moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic * severe exacerbation: exacerbation leading to hospitalization
developing a mhealth simulation platform for youth

Conditions: Engagement, Patient

Summary: the investigators will conduct a 12-week single group feasibility pilot field study among youth who will use a diabetes technology education application in their natural home environment.

the investigators will purposively select n=20 youth with at least 6 youth from each of 3 age ranges (10-12, 13-15, and 16-18) from eligible participants. youth will use the software in their home environment for 12-weeks. youth's diabetes device data will be used to select simulation content, targeted to meet each participant's educational needs. youth will meet with research staff via video chat at the onset of testing where a url link to the platform will be shared. youth will be assigned 3 scenarios/week. at the end of each scenario youth are guided to additional resources in the platform that they may choose to access. youth will meet with a member of the research team via video chat or phone call weekly to discuss platform issues or confusion as well as any questions regarding self-management content. platform performance will be monitored by researchers and performance data will be collected and stored within the application database. feasibility measures will include recruitment, weekly research sessions attendance, and global attrition data. sustained engagement measures will be collected from the application database and will include the frequency platform was accessed, number of assigned simulations completed (3 per week), and additional, optional, content accessed. glycemic control measures including a1c will be obtained from the youth's ehr. youth's diabetes devices will be downloaded at baseline and at 4, 6 and 12 weeks. glucose values from device downloads will be aggregated into derived measures of glucose control consistent with american diabetes association guidelines on glucose targets. self-management patterns and responsiveness will be assessed using pre- and post- diabetes device downloads at baseline, 4, 8, and 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes \>1 year * 10-18 years of age * currently uses insulin pump or hcl therapy * duration of 6 months of pump therapy exclusion criteria: * significant learning disability * self-reported pregnancy * inability to read and write english
interpreters as advocates for hypertensive patients

Conditions: Hypertension

Summary: the purpose of the study is to determine if medical interpreters trained to advocate on behalf of their patients deliver improved care compared to standard medical interpreters

over 21 million americans have limited english proficiency. about two-thirds of these individuals speak spanish. limited english proficiency has major adverse impacts on health and health care. using trained medical interpreters may help overcome this language barrier. compared to patients who need but don't get an interpreter, patients who use trained medical interpreters have better satisfaction, quality of care, and health outcomes. however, the outcomes of patients using interpreters is often poorer than that of english-speaking patients. this randomized controlled trial will test the utility of using interpreters as advocates for spanish-speaking inner city patients with hypertension.

Eligibility criteria:
inclusion criteria: * spanish speaking * limited english proficiency * uncontrolled hypertension * regular visit with primary care provider who is not proficient in spanish exclusion criteria: -

Keywords: hypertension spanish
the electroretinogram in healthy and glucose intolerant young men

Conditions: Electroretinography

Summary: the purpose is to investigate the electroretinogram (erg) in young, healthy men in the normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids treatment, high calorie diet and exercise restraint.

the subjects will be fasting from midnight the day before the experiment. standard procedures (including pupil dilation, dark adaptation, and local anaesthetics) are carried out to allow the erg to be obtained. after electrophysiology, the subject will be clamped at a plasma glucose level of 10 mm (\~180 mg/dl) and after a stabilisation period the erg protocol is repeated. each subject is examined twice on two different days. the first day the subjects are normoglycaemic in the morning (first examination) and hyperglycaemic (clamped to 10 mm) throughout the second examination. the second day subjects are also normoglycaemic and hyperglycaemic but shows up after 7-12 days of daily intake of prednisolone, high calorie diet, and exercise restraint.

Eligibility criteria:
inclusion criteria: * caucasians without type 2 diabetes mellitus * normal ogtt (75 g glucose dissolved in 250 ml water) according to who's criteria * bmi 20-30 * haemoglobin \> 8,0 mm exclusion criteria: * nephropathy (s-creatinin \> 130 µm or albuminuria) * relatives (parents or sibling with t2dm) * medical treatment which cannot be paused for 12 hours

Keywords: retina electroretinography diabetes mellitus glucose intolerance physiology
bacterial gene profiling to predict antibiotic resistance during cystic fibrosis pulmonary exacerbations

Conditions: Cystic Fibrosis

Summary: pulmonary exacerbations (pex) are key events that lead to a decline in health status among cf patients, with many never recovering to baseline health. with the advancement of new cftr modulators and other therapies increasing the lifespan of those living with cf, it will become increasingly important to have better strategies to manage pex in order to have better outcomes following treatment. pex treatment decisions will need to take into consideration the increasing frequency of antimicrobial resistance bacteria and the need to treat multiple types of bacteria at once. the purpose of this study is to analyze sputum samples from cf subjects at the time of pex in order to identify markers of antimicrobial resistant bacteria and see how those relate to treatment responses. cf patients will be recruited from patients followed by the adult cf program at national jewish health. within 48 hours of admission to the hospital for treatment of a pex, subjects will be enrolled and sputum will be collected. the sputum will be processed and analyzed for the presence of antimicrobial resistant bacteria. these results will be compared to clinical data, such as spirometry and frequency of hospitalizations.


Eligibility criteria:
inclusion criteria: * cf patients 18 years or older who are hospitalized for iv treatment of an acute pex * chronically infected with pseudomonas aeruginosa and/or staphylococcus aureus * can produce sputum * can provide written consent * willing to comply with study procedure exclusion criteria: * subjects who are not colonized with pseudomonas aeruginosa and/or staphylococcus aureus * the presence of a condition or abnormality that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
single ascending dose study of msd-001 in healthy participants

Conditions: Mental Health Disorders

Summary: the purpose of this phase 1 single ascending dose (sad) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of msd-001 when administered orally to healthy adult participants.

this is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of msd-001. the study will include two parallel parts, part 1 and part 2, stratified by cyp2d6 phenotype.

Eligibility criteria:
key inclusion criteria: * male or female healthy consented participants 18 to 55 years of age * cyp2d6 phenotype established based on pharmacogenetic testing. * free from psychoactive drug use from 4 weeks before dosing and until the last follow up visit. key exclusion criteria: * any current clinically relevant, or history of, acute or chronic diseases inclusive of psychiatric disorders and relevant family history, which could interfere with the participant's safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. * moderate to severe congestive heart failure, history of heart surgery, pulmonary hypertension, systemic hypertension (i.e., systolic bp \>139 mm hg, diastolic blood pressure \> 89 mm hg), pulse rate \> 90 bpm, clinically significant ecg abnormality, qtc \> 450 msec, myocardial infarction in the past year, or any other active or severe cardiovascular condition. * clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure. * use of any psychedelic drug in the three months prior to planned dosing or the occurrence of persistent psychological effects following the previous use of psychedelic drugs. * subject experiences severe anticipatory anxiety or is otherwise considered unfit for study. * history of moderate or severe illicit substance abuse or dependence, or a positive test result(s) for alcohol and/or drugs of abuse at screening or admission to the clinical unit. * subject has received a prior investigational intervention, has had a history of relevant hypersensitivity or allergic reactions, and has donated and/or received any blood or blood products or experienced blood loss, that may interfere with the objectives of the study. * subject has a significant negative life event (e.g. loss of a loved one) in the past 6 months.
hemocc study. hemostasis in cirrhotic children.

Conditions: Esophageal and Gastric Varices; Child, Only

Summary: prospective investigations into the role of hemostatic factors in the risk of variceal bleeding among children with chronic liver disease (thromboelastometry e.g) is still required. a better understanding of these factors would permit better risk stratification and targeted prophylaxis or therapy.

the investigators aim to start a prospective and observational study over a 2 years period. first, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at saint-luc university clinics. any patient with a congenital or acquired thrombophilia/haemorrhagic disorder will be excluded. the investigators expect to include 20 to 30 children in the study. the investigators will meet the parents to give them explanations about this study and its implications. then the investigators will get the free and informed consent about the participation to this clinical study. parents are obviously free to refuse to take part in this clinical study and to retire from it at any moment.

Eligibility criteria:
inclusion criteria: * children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation * children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g) * each patient will have a comprehensive assessment of portal hypertension (abdominal us-doppler and upper gastrointestinal endoscopy) and hemostasis exclusion criteria: * no underlying disease which can alter hemostasis (hemophilia, sepsis...) * no medication which can alter hemostasis (aspirin, anti-inflammatory drugs,...)
changes in muscle strength, inflammatory markers, and body composition in response to alternate day fasting combined with krill oil supplementation in adults with overweight and obesity

Conditions: Obesity Associated Disorder

Summary: the goal of this double-blind, randomised, controlled trial is to determine the effects of lc n-3 pufas supplementation on changes in body composition and muscle strength during body weight loss and body weight maintenance among healthy adults living with overweight and obesity. the main research questions: * is supplementation with lc n-3 pufas during dietary weight loss intervention (alternative-day fasting) attenuate the reduction in fat-free mass and muscle strength? * is supplementation with lc n-3 pufas during dietary weight loss intervention (alternative-day fasting) provide additional impact on appetite related hormones (acylated ghrelin, glp-1, and pyy) and cardiometabolic risk factors (post prandial inflammatory markers and triglycerides)? participants will be randomly assigned to a placebo (mix-vegetables oil) or lc n-3 pufas group (krill oil) (1:1 basis). both groups will follow a dietary weight loss intervention (alternate-day fasting). the study will last for 20 weeks that divided into 3 phases: four weeks of the preparation phase, eight weeks of body weight loss phase (alternate day fasting), followed by eight weeks of body weight maintenance phase (regular diet).

during the preparation phase, participants will be asked to take 4g/d krill oil capsules or placebo oil (mixed vegetable oil) with their healthy diet (their usual diet) for a period of 4 weeks. after the completion of the four weeks of the preparation phase, the weight loss intervention (alternate day fasting) will start, and it last for eight weeks. then, after the weight loss intervention, the weight maintenance phase will start, and it takes a period of 8 weeks until the end of the trial (20 weeks - study completion).

Eligibility criteria:
inclusion criteria: * healthy (male/female) * body mass index (bmi) of 25 - 39.9 kg/m2 * aged between 25 and 65 years * stable body weight for at least three months exclusion criteria: * smokers * food allergy * on any dietary supplements or dietary regimes at the time of the study * participants with systolic/diastolic \ 140/90 mmhg

Keywords: obesity cardiometabolic risk factors fat mass fat free mass body composition muscle strength lcn-3pufa