Kornimate/medical-research-clean huggingface dataset:
a trial of fosfomycin vs ciprofloxacin for febrile neutropenia

Conditions: Febrile Neutropenia

Summary: randomized phase 3 trial to compare efficacy and safety of oral fosfomycin versus ciprofloxacin to prevent febrile neutropenia in patients with acute leukemia or recipients of hematopoietic stem cell transplant.

multicenter, prospective, randomized, open label phase iii trial to assess the efficacy and safety of oral fosfomycin vs. oral ciprofloxacin in the prevention of febrile neutropenia in patients with acute leukemia who are treated with intensive chemotherapy and/or are recipients of a hematopoietic stem cell transplant. non-inferiority design. 156 patients will be recruited: 78 in each arm

Eligibility criteria:
inclusion criteria: 1. subjects who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure. 2. adult subjects ≥ 18 years of age with acute leukemia diagnosis who are going to receive their first intensive chemotherapy cycle or adult subjects ≥ 18 years of age who are candidates to receive a first stem cell transplant. 3. expected neutropenia 100x109/l lasting at least seven days. in case of expected neutropenia range 100-500x109/l lasting seven days or more, at least one of the following risk factors for infection must be present: 1. performance status (eastern cooperative oncology group, ecog) ≥2. 2. expected mucositis grade 3-4. 3. age ≥65 years. 4. comorbidity index (hcti) ≥3. 5. serum albumin\< 35 g/l. 6. total dose of etoposide \> 500 mg/m2 7. total dose of cytarabine \> 1 g/m2 8. active or refractory neoplasia at the moment of stem cell transplant. 4. performance status (eastern cooperative oncology group, ecog) of 0 to 3. 5. adequate organ function defined as: liver: bilirubin, alkaline phosphatase, or sgot \< 3 times the upper normal limit (unless it is attributable to tumor activity). renal : creatinine ≤ 250 μmol/l (2.5 mg/dl) (unless it is attributable to aml activity). 6. life expectancy higher than 3 months. 7. women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completing treatment. exclusion criteria: 1. hypersensitivity to fluoroquinolones or fosfomycin. 2. treatment with broad spectrum antimicrobial therapy within 4 weeks of first study treatment. 3. prior intensive chemotherapy or stem cell transplant. treatment with hydroxyurea or corticosteroids used to control white blood cell counts are permitted. 4. fever of infectious origin or documented infection within 4 weeks of first study treatment. 5. presence of any severe psychiatric disease or physical condition that, according to the physicians criteria, contraindicates the inclusion of the patient into the clinical trial. 6. subjects that have participated previously in this study
stereotactic magnetic resonance guided radiation therapy

Conditions: Pancreas Cancer; Lung Cancer; Renal Cancer; Adrenal Metastases; Prostate Cancer; Liver Metastases; Oligoprogressive Nodal Metastases; Metachronous Nodal Metastases; Synchronous Nodal Metastases; Mesothelioma; Spine Metastases; Brain Metastases; Borderline Resectable Pancreatic Carcinoma

Summary: this is a master prospective phase i-ii trial evaluating feasibility and efficacy of stereotactic magnetic resonance (mr) guided adaptive radiation therapy (smart) in patients with cancer. * the phase 1 study will evaluate the feasibility and safety of delivering smart in patients with cancer. * phase 2 will evaluate efficacy of smart with specific reference to tumor control and improvement in patient reported outcome measures

this research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of mr-guided radiation to treat cancer. the u.s. food and drug administration (fda) has approved this device as a treatment option for cancer. in this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily mri has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Eligibility criteria:
inclusion criteria: * participants must have a confirmed malignancy requiring stereotactic body radiation therapy. see specific disease site cohorts for more details. * tumor size ≤ 7cm * age 18 years of older. * ecog performance status ≤2 (karnofsky ≥60%, see appendix a) * ability to understand and the willingness to sign a written informed consent document. * specific eligibility requirements for each disease site with be covered in each specific cohort. exclusion criteria: * specific exclusion requirements for each disease site with be covered in each specific cohort * history of allergic reactions attributed to gadolinium-based iv contrast. -- note: if a patient will not receive contrast, this is not applicable * pregnant women are excluded from this study. * severe claustrophobia or anxiety * participants who cannot undergo an mri

Keywords: magnetic resonance imaging (mri) mridian linear accelerator pancreas cancer lung cancer renal cancer adrenal metastases prostate cancer liver metastases oligoprogressive metachronous synchronous spine prostate boost pelvic re irradiation
gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab

Conditions: Colorectal Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors understand how patients respond to treatment. purpose: this laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.

objectives: * determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-vegf therapy. outline: tumor tissue samples collected on clinical trial e-3200 are analyzed for laboratory endpoints.

Eligibility criteria:
disease characteristics: * tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum * receiving bevacizumab on clinical trial e-3200 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adenocarcinoma of the colon adenocarcinoma of the rectum recurrent rectal cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer stage iii colon cancer stage iv colon cancer
acute nutritional ketosis in vlcad deficiency

Conditions: VLCAD Deficiency; Fatty Acid Oxidation Defects

Summary: to test if a ketone-ester based drink can boost muscle mitochondrial function in vivo in patients with vlcadd in order to establish a rational basis for therapeutic use in this disorder.

exertional rhabdomyolysis is a common symptom in very long-chain acylcoa dehydrogenase deficient (vlcadd) patients. failing muscle atp homeostasis, due to impaired fatty acid oxidation, is the most likely cause. therefore, supplementation with an alternative energy substrate to boost atp homeostasis, such as an exogenous ketone ester (ke) drink, could be a therapeutic option. previous results suggest that ke is preferentially oxidized in the tricyclic acid (tca) cycle and improves physical endurance in athletes. our primary objective is to test if ke boosts muscular atp homeostasis in vlcadd patients to establish a rational basis for therapeutic use. vlcadd patients will be included in a randomized, blinded, placebo controlled, 2-way cross-over trial. prior to each test, patients receive a ke drink or an isocaloric carbohydrate equivalent, and completed a 35 min cycling test on an upright bicycle, followed by 10 minutes of supine cycling inside a mr scanner. the protocol will be repeated after at least one week with the opposite drink.

Eligibility criteria:
inclusion criteria: - confirmed vlcadd by genetic profiling exclusion criteria: * contraindications for mri studies (assessed by standardised questionnaire as previously used in metc 08-267/k; see umcg section f metc documents) * inability to perform bicycle exercise. * recent episode of rhabdomyolysis, or treatment for acute renal failure in the past 2 months. * intercurrent illness which may influence exercise tolerance (anaemia, musculoskeletal injury, or other undiagnosed illness under investigation). * known coronary artery disease, positive history for angina, or changes on ecg suggestive of previous ischaemia without a negative stress test. * insulin-dependent diabetes mellitus. * loss of, or an inability to give informed consent. * pregnancy or current breastfeeding, or females not taking the oral contraceptive pill (this is due to the variability in hormonal patterns and substrate levels with different parts of the menstrual cycle). * any other cause which in the opinion of the investigators, may affect the volunteers ability to participate in the study.

Keywords: fatty acid oxidation disorders ketone ester vlcad deficiency
dietary carbohydrate consumption at breakfast on food intake, glycemic response, and subjective appetite

Conditions: Childhood Obesity; Breakfast

Summary: the purpose of this study is to determine the effect of carbohydrates of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (nw) and overweight or obese (ow/ob) children.

regular breakfast eating nw and ow/ob children, 9-14 years of age, will participate in the experiment. four isocaloric (450 kcal) breakfasts (eggs with a side of french fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. on five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.

Eligibility criteria:
inclusion criteria: * be between 9 and 14 years of age * be healthy, and have been born at term * not be taking any medications * not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans * nw (between the 5th and 85th bmi percentile for age and gender) * ow/ob (\>85th bmi percentile for age and gender) exclusion criteria: * food sensitivities, allergies, or dietary restrictions * health, learning, emotional, or behavioural problems * receiving any medications

Keywords: children dietary carbohydrates satiety appetite blood glucose solanum tuberosum obesity breakfast
a study to follow up recurrence rates of actinic keratoses one year after completion of study 1487-imiq

Conditions: Actinic Keratoses

Summary: the purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % imiquimod cream in a previous study.


Eligibility criteria:
inclusion criteria: * 100% clearance of actinic keratosis (ak) lesions in the 1487 imiq study exclusion criteria: * used any treatments in the previous treatment area within 24 hours prior to the follow-up visit

Keywords: 1 year follow up
role of adiposomes in endothelial dysfunction

Conditions: Obesity; Diabetes; Cardiovascular Diseases

Summary: the development of type ii diabetes (t2d) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (ob-t2d) patients, the investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. the investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. adiposomes are known to carry bioactive cargos such as proteins and micro rnas; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. in the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in ob-t2d subjects. on top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (gsls). these lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. preliminary findings showed that in endothelial cells, gsl-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. therefore, the central hypothesis is that adipose tissues in ob-t2d patients release gsl-loaded adiposomes that induce vascular endothelial dysfunction. the researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce gsl-loaded adiposomes, and subsequently alleviate vascular risk in ob-t2d patients. the investigators will test the hypotheses by pursuing the following aims: aim 1: investigate the role of gsl-rich adiposomes in the pathogenesis of endothelial dysfunction in ob-t2d adults; aim 2: test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.


Eligibility criteria:
inclusion criteria: * bmi ≥ 35 kg/m2 * between ages 18-50 years * not pregnant * diabetic (current use of diabetes medication or fasting glucose ≥126 mg/dl) * medical clearance to participate in a moderate-intensity exercise program exclusion criteria: * pregnant women * current smokers * currently abusing alcohol or drugs * chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer * non-english speakers * history of allergic reactions to lidocaine
pilot study using neoadj chemo-rad & egfr-tyrosine kinase inhibitor for potentially resectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: to determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an egfr tyrosine-kinase inhibitor (osi-774, tarceva) in the treatment of patients with resectable pancreatic cancer.

to determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an egfr tyrosine-kinase inhibitor (osi-774, tarceva) in the treatment of patients with resectable pancreatic cancer.

Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the pancreas * resectable disease * tumor \</= 6cm diameter * ecog performance 0-1 * organ system fxn: granulocytes (\>/=1800/ul); plt ct \>/=100k; bili\</=2mg; liver enzymes \<2.5uln; crt \</=1.5; * normal cxr * negative pregnancy test exclusion criteria: * metastatic disease or peritoneal seeding based on cross-sectional imaging * previous irradiation to the planned field * prior chemotherapy or immunotherapy * active infection * active pud

Keywords: pancreatic cancer resectable pancreatic cancer adenocarcinoma of the pancreas
respiratory complications after laparoscopic surgery

Conditions: Pulmonary Atelectasis; Respiratory Insufficiency; Pneumonia

Summary: the purpose of this study is to describe the magnitude of respiratory complications after laparoscopic hysterectomy and cholecystectomy.

the purpose of this study is to describe change in pulmonary function and incidence of respiratory complications after laparoscopic surgery. the investigators will include 60 women scheduled for laparoscopic hysterectomy or cholecystectomy. the investigators will measure the pulmonary function by different methods during and for 2 hours after surgery. moreover, the incidence of respiratory complications including pneumonia, respiratory failure and radiologically verified atelectasis will be registered.

Eligibility criteria:
inclusion criteria: * women * \> 45 years old * scheduled for laparoscopic cholecystectomy or laparoscopic hysterectomy exclusion criteria: * weight \< 50 kg * pregnant or nursing * cardiac failure * renal failure * inability to breath through a facial mask * inability to give informed consent * inability to keep arterial oxygen saturation above 90% without supplemental oxygen

Keywords: postoperative pulmonary complications laparoscopic surgery
reverse intestinal metaplasia in the stomach (revise)

Conditions: Gastric Intestinal Metaplasia; Gastric Precancer

Summary: this study is designed to test the use of pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment. a secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.

the proposed study is an early phase ii clinical trial designed to generate additional data regarding safety and efficacy for the use of pyrvinium, an fda-approved drug no longer in active use. the study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). this initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines for mapping and surveillance). the investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping, and then of these 60 participants, 32 eligible participants (after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia) will be included in the randomized control trial to receive either pyrvinium (n=16) or placebo (n=16). treatment is planned as followed: 2 weeks of pyrvinium vs placebo (within 3 months of initial research endoscopy). following the initial endoscopy, participants will receive placebo or pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. the drug (or placebo) will be verified and dispensed from the investigational drug pharmacy using an ind with attention to safety and blinding to research participants and clinical research staff. the drug and placebo will be administered as liquid suspensions. medication diary logs will be used and participants will be asked to return bottles that contained the medication. all participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity.

Eligibility criteria:
inclusion criteria: * adults (including men, women, and non-binary individuals) over age 18 with known gim with at least one high-risk feature (extensive vs limited, incomplete or mixed-type gim, family history of stomach cancer), * ability to provide informed consent, * evidence of prior but not active h. pylori infection exclusion criteria: * active gastric cancer diagnosis, * high-risk of bleeding complications due to anticoagulants or underlying medical condition, * pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)

Keywords: gastric intestinal metaplasia pyrvinium
internet-delivered therapy for alcohol misuse: investigating patient preference for self-guided or guided treatment

Conditions: Alcohol Use Disorder

Summary: internet-delivered cognitive behaviour therapy (icbt) shows promise as a method of treating alcohol misuse. in this form of treatment, patients complete online lessons over several weeks that assist patients in developing skills to address alcohol misuse. icbt can be offered to patients in a self-guided format or with guidance. self-guided icbt allows users to complete lessons by themselves without any contact with a guide. guided icbt involves having support from a guide in the form of emails, online messages and/or brief telephone calls. in some studies, guided-icbt has shown greater reductions in alcohol consumption than self-guided icbt. to date, there has been limited research on patient preferences for these varying levels of support when icbt is offered as part of routine health care. this represents an important research direction as there is some past research showing that patients' treatment preferences can affect study enrollment, attrition, adherence, satisfaction, and outcomes. this study will investigate patient preferences for self-guided icbt versus guided-icbt and compare enrollment, attrition, adherence, and outcomes of the two approaches when patients select their treatment preferences. the study will also explore the extent to which preferences are related to patient background variables (e.g., duration, severity of problems, treatment goals in terms of patients wanting to cut-down on alcohol use versus to abstain from alcohol use). furthermore, this study seeks to identify how ratings of effort and helpfulness throughout treatment vary depending on whether patients select self-guided versus guided icbt. this study represents a pragmatic observational trial conducted in routine care and aims to increase understanding of how to implement icbt within routine care.


Eligibility criteria:
inclusion criteria: * timeline followback (tlfb; preceding week alcohol consumption) \> 13 drinks * alcohol use disorders identification test (audit) \> 7 exclusion criteria: * suicidal ideation (measured by scoring \> 2 to question 9 of phq-9) * severe mental health or medical conditions * severe drug use problems (measured by scoring \> 24 on drug use disorders identification test \[dudit\] or clinical assessment) * low motivation to do, or concerns regarding, online treatment * ongoing or impending significant mental health treatment * not residing in saskatchewan canada for the duration of treatment * lack of or inconsistent access to a computer and internet at home or private place for the duration of treatment

Keywords: internet-delivered cognitive behaviour therapy guidance alcohol misuse
fst-100 in the treatment of acute viral conjunctivitis

Conditions: Acute Viral Conjunctivitis

Summary: this randomized, double masked, multi-center study is being conducted to support the safety and efficacy of fst-100 for the treatment of acute viral conjunctivitis. the study intends to show superiority of fst-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye exclusion criteria: * have a known sensitivity to any of the components of fst-100 or fst-100 vehicle