Kornimate/medical-research-clean huggingface dataset:
the feasibility of a facebook group-based program for foot self-management support of adults with diabetes in canada

Conditions: Diabetic Foot Ulcer

Summary: the primary objective of this study is to examine the feasibility of a facebook group-based program to support adults with diabetes in their foot self-care and prevention of foot ulcers. the sub-objectives are: 1. to determine the recruitment and retention rate of participants in the study. 2. to assess the acceptability of the facebook group program among participants. 3. to determine the level and pattern of engagement by the participants within the facebook group platform. 4. to determine the efficacy of the facebook group program and how it works to improve diabetic foot care-related outcomes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type i or ii diabetes; * 18 years of age or older * reside in canada * proficiency in the english language - understanding, speaking, reading, and writing. * have an active facebook account or willing to create one * have access to the internet and computer or smartphone exclusion criteria: * declined consent * did not provide follow-up contact information * completed less than 60% of the baseline survey

Keywords: patient education foot self-care foot self-care adherence social media self-management support
a study evaluating s 95005 plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated colorectal cancer who are non-eligible for intensive therapy

Conditions: Metastatic Colorectal Cancer

Summary: the main purpose of this study is to evaluate the progression-free survival (pfs) in patients receiving s 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.


Eligibility criteria:
inclusion criteria: * written informed consent obtained. * has ecog (eastern cooperative oncology group) performance status of 0, 1 or 2 at the time of the randomisation. * has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum. * ras status must have been determined (mutant or wild). * has at least one measurable metastatic lesion. * no previous systemic anticancer therapy for unresectable metastatic colorectal cancer. * previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment. * patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions. * is able to take medication orally (i.e., no feeding tube). * has adequate organ function. * coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs). * women of childbearing potential must have been tested negative in a serum pregnancy test. female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. women and female partners using hormonal contraceptive must also use a barrier method. exclusion criteria: * is a pregnant or lactating female. * has certain serious illness or serious medical condition(s) as described in the protocol. * has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation. * has previously received trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to trifluridine/tipiracil or any of its excipients. * has rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption. * has contra-indication to bevacizumab or capecitabine.

Keywords: metastatic colorectal cancer untreated first-line s95005 (trifluridine/tipiracil) bevacizumab capecitabine
is the distance of patients from rouen university hospital influencing the time between colectomy and first chemotherapy cure for colon cancer?

Conditions: Cancer Colon; Colectomy; Chemotherapy

Summary: this project has for objective to demonstrate that the increase of the distance "patient home - center of treatment" may be associated with significant, other noticeable, noted events. this distance may also be available in the rouen university hospital. the study of the association in this distance and the delay in initiating chemotherapy after surgery in patients treated at the chu correspond to a pilot study prior to the completion of the analysis at the regional scale.


Eligibility criteria:
inclusion criteria: - patients who had colectomy for colon cancer and at least one chemotherapy treatment at chu rouen, between 2009 and the first half of 2015. exclusion criteria: * patients who died in hospital before receiving a chemotherapy treatment * patients with a cim code of metastasis during the stay of the colectomy or the first chemotherapy treatment * patients who received a chemotherapy treatment before colectomy * patients who have undergone several colectomies.

Keywords: distance
comparison between combined scoring of bethesda cytology and tirads ultrasound with histopathology in thyroid nodule

Conditions: Thyroid Nodule

Summary: a thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. most thyroid nodules are benign, with only 10% to 15% harboring cancer. this is a prospective study conducted at the department of ear, nose and throat - head and neck surgery (ent-hns) of shree birendra hospital , a tertiary heath care centre of nepal. individuals visiting ent-hns outpatient department with thyroid nodules had undergone ultrasonography (usg) of neck followed by fine-needle aspiration cytology (fnac) from the thyroid nodules. usg was reported by thyroid imaging reporting and data system(tirads) and fnac by bethesda system. thereafter patients were planned either for surgery either total thyroidectomy or hemithyroidectomy. post operative histopathology was correlated with preoperative fnac and usg reports.

the main objective of this prospective cohort study is to know the correlation between pre- operative bethesda with post- operative histopathology , pre - operative tirads with post operative histopathology and comparison of combined scoring of bethesda and tirads with histopathology report. it is of utmost importance to deep dive into thyroid nodules workup to detect malignant nodules, as the management aspect of benign and malignant nodules has a vast difference. thyroid ultrasonography is useful for risk stratification of nodules, and american college of radiology thyroid imaging reporting and data system (acr ti-rads) classification provides recommendations for fine-needle aspiration cytology (fnac) based on objective ultrasonography features of these nodules. to maintain uniformity in reporting system fna sample are categorized according to the bethesda system. total 42 participants who met the inclusion criteria were included in the study. statistical analysis was done using statistical package for the social science (spss) version 25. analysis was done in the form of percentage and proportion and represented as table wherever necessary. spearman's correlation coefficient was used to evaluate the correlation between bethesda and tirads. bethesda and histopathology and tirads and bethesda system. the p value was set at \< 0.05 for statistical significance.

Eligibility criteria:
inclusion criteria: * 1.patients presenting to ear nose and throat, head and neck surgery department with thyroid nodules undergoing hemithyroidectomy or total thyroidectomy within the study period exclusion criteria: * 1.patients refusing to give consent for the study. 2.patients with already known case of thyroid malignancies proven by histopathological reports.

Keywords: fnac tirads bethesda histopathology
treatment of deficient subclass or anti-polysaccharide antibody response

Conditions: IgG Deficiency; Infections

Summary: there is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin g (igg)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. therefore, the dutch inter university working party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.

there is no consensus on the treatment of patients with recurrent infections and isolated igg-subclass deficiency and/or selective antipolysaccharide antibody deficiency. at present, there are no robust criteria to predict which patient will or will not respond adequately to antibiotic treatment or to ivig. furthermore, it is unknown whether ivig treatment improves the quality of life in these patients. therefore, the dutch interuniversity working party intends to start a study in this patient group. in this study, treatment for a year with antibiotics will be compared with a year intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder. the patient will visit the clinic every 3 months during which laboratory tests and physiological measurements will be performed. moreover the occurrence of infections and fever, the use of antibiotics, hospital admissions, and quality of life will be documented. the study should result in a national harmonization in the treatment of this patient group. to this end, the results of the study will be used to compile a treatment protocol for this group of patients in the netherlands and if applicable also in other countries worldwide.

Eligibility criteria:
inclusion criteria: * igg subclass deficiency and/or (selective) antipolysaccharide antibody deficiency * at least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients. * total serum igg \> 4 g/l * ≥ 5 years of age * informed consent exclusion criteria: * treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study * allergic reactions against human plasma/plasma products, or co-trimoxazole * an ongoing progressive terminal disease * pregnancy or lactation * history of (transient) cerebrovascular accident or coronary insufficiency * renal insufficiency (plasma creatinin \> 115 µmol/l; or creatinin clearance \<20 ml/min) * an ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints * detectable anti-iga antibodies * active systemic lupus erythematosus (sle) * glucose-6-phosphate hydrogenase deficiency

Keywords: igg subclass deficiency anti-polysaccharide deficiency therapy immunoglobulins, intravenous co-trimoxazole
sprint interval training on the endurance, strength and velocity capacities of healthy sedentary subjects

Conditions: Sedentary Behavior

Summary: the present study aims to analyse first, the acute effects generated by a single bout of sprint interval training (sit) and, secondly, the effects of a long-term intervention on sedentary participants.

the main goal is to determine the optimal dose of high-intensity exercise that enhances the best physiological adaptations. the cumulative effects of sit, will be assessed by a series of measures placed throughout the time-course (before, after the 1st , the 2nd and the 3rd block of sit). those measures consist of physiological measurements (vo2max), neuromuscular capacities (force-velocity profile) the autonomic nervous system responses (heart rate variability) and blood markers (lactate, creatine phosphokinase (ck), cytokinases, µrna). acute effects will be measured in the familiarisation sessions (after short (8 sprints) and long (14 sprints) sets) by performing a battery of neuromuscular, perceptual, and autonomic nervous system tests before and after the single session of sit.

Eligibility criteria:
inclusion criteria: * untrained healthy (less than 2 hours of sport per week) * free from muscular, bone or joint injuries * free from neurologic disease exclusion criteria: * taking neuroactive substances that can alter corticospinal excitability * heart or respiratory failure. * subjects who have taken corticosteroids within 3 months (inhalation, infiltration or history of corticosteroid therapy). * pregnant woman * subject under guardianship

Keywords: sprint interval training vo2max acute fatigue chronic fatigue force-velocity profile
impact of mallinckrodt electronic device on continuous control of tracheal cuff pressure

Conditions: Critical Illness

Summary: despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. the aim of this study is to determine the efficiency of mallinckrodt electronic device (mallinckrodt electronic cuff pressure controller, vbm medizintechnik gmbh, sulz an) in continuous control of tracheal cuff pressure.


Eligibility criteria:
inclusion criteria: : * patients intubated in the icu with a high volume / low pressure pvc-cuffed tracheal tube * predicted duration of mechanical ventilation \> or = 48h * age \> or = 18 years * signed informed consent exclusion criteria: * contraindication for semirecumbent position * contraindication for enteral nutrition * pregnancy * refuse to participate to the study

Keywords: tracheal cuff pressure continuous control microaspiration
safety, immunogenicity study of gsk biologicals' pandemic influenza candidate vaccine (h1n1) (gsk2340272a)

Conditions: Influenza

Summary: this trial is designed to assess the safety and immunogenicity of a prime-boost schedule of gsk biologicals' investigational vaccine gsk2340272a in children aged between 6 and 35 months. this protocol posting has been updated following protocol amendment 4, march 2010. the protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol * children, male or female, aged between 6 and 35 months at the time of first study vaccination. * written informed consent obtained from the parent(s) or lar(s) of the subject. * healthy children, as established by medical history and clinical examination when entering the study. * parent/lar with access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user device. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * clinically or virologically confirmed influenza infection within six months preceding the study start. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * history of hypersensitivity to vaccines. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines * history of any neurological disorders or seizures. * acute disease and/or fever at the time of enrolment * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. * child in care.

Keywords: influenza infection gsk bio's influenza vaccine gsk2340272a
adce-t02, a tissue factor targeted antibody-drug conjugate, in patients with selected advanced solid tumours

Conditions: Advanced Solid Tumor

Summary: adcendo aps is conducting a phase 1 study of an investigational drug called adce-t02 (previously known as amt-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. the main purpose of the study is to determine the maximum tolerated dose (mtd), the recommended dose and the safety and tolerability of adce-t02 when given as a single therapy over a range of different dose levels.


Eligibility criteria:
key inclusion criteria: 1. patients must have pathologically confirmed unresectable advanced solid tumor. 2. patients who have undergone at least one systemic therapy and have progressive disease 3. patients must have at least one measurable lesion as per recist version 1.1. 4. eastern cooperative oncology group (ecog) performance status of 0-1. 5. life expectancy ≥ 3 months. 6. patients must have adequate organ function as indicated by laboratory values 7. women of childbearing potential (wcbp), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of adce t02. 8. male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of adce t02. key exclusion criteria: 1. prior treatment with any agent targeting tissue factor 2. central nervous system (cns) metastasis. 3. active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants. 4. persistent toxicities from previous systemic anti-neoplastic treatments 5. known past or current coagulation defects leading to an increased risk of bleeding 6. significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure , uncontrolled hypertension, uncontrolled cardiac arrhythmias 7. history of (non-infectious) interstitial lung disease (ild)/pneumonitis that required steroids, or current ild/pneumonitis, or suspected ild/pneumonitis 8. prior history of malignancy other than inclusion diagnosis within five years prior to first dose of adce t02.
study of efficacy and safety of vildagliptin as add-on insulin therapy in t2dm patients

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: the purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with t2dm inadequately controlled by insulin, with or without concomitant metformin treatment. it was agreed with pmda to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in japanese patients when it iwas used on top of insulin.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of t2dm by standard criteria. * hba1c ≥ 7.0 to ≤ 10% at visit 1. * age: ≥ 20 to \< 75 years old at visit 1. * bmi ≥ 20 to ≤ 35 kg/m2 at visit 1. exclusion criteria: * fpg ≥ 270 mg/dl (≥15 mmol/l) at visit 1. * type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. * significant heart diseases * hepatic disorder other protocol defined inclusion/exclusion criteria may apply

Keywords: diabetes mellitus (dm) , diabetes, noninsulin-dependent diabetes mellitus (niddm), adult-onset diabetes, high blood sugar, t2dm
effect of saccharomyces boulardii on necrotizing enterocolitis in very low birth weight infants

Conditions: Necrotizing Enterocolitis; Very Low Birth Weight Infants

Summary: probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of nec in clinical trials, saccharomyces boulardii has not been used in the prevention of nec in very low birth weight infants yet. the objective of this study is to evaluate the efficacy of orally administered s boulardii in reducing the incidence and severity of nec in very low birth weight infants.

the primary outcome of this study is to evaluate the efficacy of orally administered s boulardii in reducing the incidence and severity of nec in very low birth weight infants.

Eligibility criteria:
inclusion criteria: * very low birth weight infants \< 1500 gr exclusion criteria: * genetic anomalies * not willing to participate * allergy to s. boulardii components

Keywords: saccharomyces boulardii necrotizing enterocolitis
safety, tolerability, and pharmacokinetics (pk) of ctp-499

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of ctp-499 following single dose administration.

this is a double-blind, single ascending dose administration study of four doses of ctp-499. following dosing safety and tolerability will be assessed. blood and urine samples will be taken for pharmacokinetics (pk) and bioavailability. safety assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ecgs, and physical examination findings. the plasma concentration time data for ctp-499 and its metabolites will be analyzed using noncompartmental methods. actual dosing and sampling times will be used for analysis. the primary pharmacokinetics parameters are: cmax, tmax, t1/2, auclast and aucinf for plasma; relative bioavailability; and ae and clr for urine.

Eligibility criteria:
inclusion criteria: * healthy volunteers * ages 18 to 55 years old * nonsmokers * bmi of 18 to 30 kg/m2 exclusion criteria: * significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders of drug hypersensitivity * systolic blood pressure \ 140, diastolic bp \> 90

Keywords: safety tolerability pharmacokinetics healthy volunteers