Kornimate/medical-research-clean huggingface dataset:
low-dose glucagon for prevention of exercise-induced hypoglycemia in people with type 1 diabetes

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: the primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (mdi). the secondary aim is to compare the accuracy of three continuous glucose monitors (cgm) during and after exercise in inpatient and outpatient settings.

a randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. at every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo. during the visits and in an outpatient period the participants will have 3 different cgm devices installed and the values will be compared with self-monitored blood glucose values.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * t1d ≥ 2 years * use of insulin pump or mdi therapy for ≥ 6 months * current use of insulin aspart * hba1c ≤ 70mmol/mol (8.5%) * body mass index (bmi) ≤ 30 kg/m2 * performs exercise ≥1 time per week exclusion criteria: * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start * professional athletes or highly active individuals ( ≥ 5 hours of exercise per week) * known or suspected allergies to glucagon or related products * history of hypersensitivity or allergic reaction to glucagon or lactose * allergy to the patch of the cgm devices * patients with pheochromocytoma, insulinoma or gastroparesis * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. contraception is required throughout the study duration. sterilized or postmenopausal women (\>12 months since last period) are not required to use contraception) * inability to understand the individual information and to give informed consent * current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject * concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Keywords: type 1 diabetes exercise hypoglycemia glucagon continuous glucose monitoring
impact of combining incontinence-associated dermatitis prevention and management course and directive wheel chart

Conditions: Dermatitis; Knowledge, Attitudes, Practice

Summary: background: knowledge, attitudes, and behaviors regarding the prevention and care of incontinence-associated dermatitis (iad) need to be enhanced through educational training. there is a lack of innovative courses and convenient tools to assist nursing staff in learning and teaching in clinical settings. purpose: this study aims to investigate the learning outcomes of nursing staff in adult wards regarding the prevention and care of iad, comparing the effectiveness of a course combined with an directive wheel chart versus a course alone. additionally, the study examines the effectiveness of nursing staff applying the course and directive wheel chart in peer teaching.

design: this study was a two-phase randomized controlled trial conducted at a regional teaching hospital in taiwan. materials and methods: the study involved eight wards, comprising a total of 106 nurses, who were initially randomly assigned to either an experimental group (eg) or a control group (cg). subsequently, the nurses within each ward were randomly allocated to two phases. the researcher delivered a 50-minute lecture to both groups, providing the iad directive wheel chart only to the nurses in the eg. after a two-weeks period, one or two nurses from each ward in the first phase utilized the same course and directive wheel chart to peer-teach the nurses in the second phase within the same wards. the chinese version of the knowledge, attitudes and practices of incontinence-associated dermatitis questionnaire (kap-iad-q-c) and the chinese version of the attitude towards the prevention of incontinence-associated dermatitis instrument (apriad-c) were employed to evaluate effectiveness. the generalized estimating equation (gee) was utilized to analyze the effectiveness of the educational intervention for each phase.

Eligibility criteria:
inclusion criteria: (1)nurses in the eight adult wards. exclusion criteria: 1. new nurses had not completed the three-month probation period; 2. nurses are holding administrative management positions 3. nurse practitioners; 4. nurses who expected to be employed within six months due to job transitions.

Keywords: attitude course directive wheel chart incontinence-associated dermatitis knowledge practice
adoptive cell transfer combined with peptide vaccination in transiently immunosuppressed melanoma patients

Conditions: Melanoma

Summary: patients with advanced stage melanoma who underwent vaccination with the melan-a/mart-1 peptide and who display detectable levels of melan-a specific cd8+ t cells in peripheral blood are eligible for this trial. after collecting and freezing of these tumor specific t cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3 days after, cells are reinfused and peptide vaccination continued. the aim of this immunotherapy protocol is to boost tumor specific t cells during the immune recovery period in order to reinforce the patients' immune response against the tumor.

patients who have previously been vaccinated with melan-a/mart-1 peptide are eligible. whole pbmc's containing melan-a specific cd8+ lymphocytes are collected via lymphocytapheresis and freezed. lymphodepleting chemotherapy consists of 2 days of busulfan 2mg/kg at days -7,-6, followed by fludarabine 30mg/m2 at days -5,-4,-3. at day 0, whole untreated pbmc's are reinfused to the patient and vaccination with melan-a analog peptide is restarted and repeated every 4 weeks. immunomonitoring with detailed facs analysis using tetramers is performed at day 0,8,15,30, and then monthly. the aim is to boost melan-a specific cd8 t cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven proliferation due to peptide vaccination.

Eligibility criteria:
inclusion criteria: * stage iv melanoma * tumor expressing melan-a * patient of hla-a2 subtype * detectable immune response after peptide vaccination with melan-a * disease progression during peptide vaccination exclusion criteria: * cerebral metastases * rapidly progressive disease, that necessitates systemic chemotherapy

Keywords: adoptive cell transfer peptide vaccination melanoma immunosuppression and homeostatic proliferation
comparison of biphasic insulin aspart 30 versus insulin glargine both in combination with metformin and glimepiride in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe, oceania and south america. this trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * treatment with oads (oral anti-diabetic drugs) for more than 6 months * ongoing stable treatment with metformin for at least 2 months * ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months * insulin naive * hba1c (glycosylated haemoglobin a1c) between 7.0% and 11.0% (inclusive of both values) exclusion criteria: * metformin contraindication according to local practice * tzd (thiazolidinedione) treatment for the last 5 months before trial start * systemic treatment with any corticosteroid 3 months before trial start * any disease or condition which according to the investigator would interfere with the trial
effects of cardiorespiratory rehabilitation on the right ventricle in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients with pulmonary hypertension. rehabilitation is therefore now part of the recommendations for good practice. however, no data is available to elucidate the mechanism of this improvement: an improvement in myocardial reserve or an improvement in peripheral muscular capacity? the main objective of this study is to evaluate the difference in right ventricular contractile reserve before and after cardiorespiratory rehabilitation during stress ultrasound in pulmonary hypertension in 10 patients with pulmonary hypertension.


Eligibility criteria:
inclusion criteria: * major patients * proven pulmonary hypertension: papm ≥ 25mmhg, known ph * group 1,3,4 or 5 of the pulmonary hypertension classification * clinical stability \> 1 month clinically determined by clinician * nyha ii or iii class * signature of informed consent form following appropriate information * patient affiliated to the social security system exclusion criteria: * associated left heart disease * complex congenital heart disease * acoustic window which does not allow the echocardiography to be performed correctly * permanent cardiac arrhythmia * nyha iv class and nyha i class * inability to perform at least a minimal effort on an ergometer * unstabilized acute coronary syndrome * compensatory heart failure * disturbances of ventricular rhythm veins, may not be narrowed. * prevalence of high-risk embolic intracardiac thrombus * prevalence of high-risk embolic intracardiac thrombus * preference of a medium to high abundance peericard-like thinning. * venous thromboembolic venous thromboembolic disease (\> 3 months) * left ventricular ejector obstruction (severe and/or symptomatic) * persons under guardianship, under curatorship, protected by law * persons deprived of their liberty * pregnant and parturient women * major not able or unable to express consent * minors * inability to perform cardiac rehabilitation * modynamic instability * follow-up impossible for geographical or psychological reasons * inadequate command of the french language
alk37-007: evaluation of safety and efficacy of alks 37 (rdc-1036) in adults with opioid-induced constipation (oic)

Conditions: OIC

Summary: the purpose of this study is to evaluate the safety and efficacy of alks 37 when administered daily to adults with oic.


Eligibility criteria:
inclusion criteria: * are at least 18 years of age at time of consent * have a body mass index (bmi)of 19 to 35 kg/m2 at screening * are receiving prescribed opioid medication for the management of chronic, non-cancer pain * meet the criteria of oic * agree to use an acceptable method of contraception for the duration of the study exclusion criteria: * pregnancy and/or currently breastfeeding * clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) * receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction * any gastrointestinal (gi) disorder (other than opioid-induced constipation) or gi structural abnormality known to affect bowel transit, produce gi obstruction, or contribute to bowel dysfunction * use of naloxone, subutex or suboxone, revia, vivitrol, relistor, or entereg starting 15 days before the first study visit following screening until the end of the study * participation in a clinical trial of a pharmacological agent within 30 days before screening
study of ly2140023 in schizophrenia comparing ly2140023, olanzapine, and placebo

Conditions: Schizophrenia

Summary: assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia. the primary objective of this study is to determine if a mglu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the positive and negative symptom scales (panss) total score.

the primary objective of this study was to determine if ly2140023 dosed at 40 mg twice daily (bid) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the positive and negative syndrome scale (panss) total score. the secondary objectives of the study were to assess the safety and tolerability of ly2140023 compared with placebo and olanzapine; efficacy of ly2140023 compared with placebo in change from baseline to visit 8 in the panss positive symptom subset score; efficacy of ly2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to visit 8) in the panss total score; efficacy of ly2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to visit 8) in the panss positive symptom subset score; efficacy of ly2140023 compared with placebo in change from baseline to visit 8 in the panss negative symptom subset score; efficacy of ly2140023 compared with placebo in change from baseline to visit 8 in mood and anxiety as measured by the hamilton anxiety scale (hama) total score; efficacy of ly2140023 compared with placebo in change from baseline to visit 8 in the clinical global impression-severity (cgi-s); effect of ly2140023 on prolactin levels of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on the panss total score; pharmacokinetics of ly2140023 and ly404039 in patients, and to explore the relationship between exposure and efficacy.

Eligibility criteria:
inclusion criteria: * meet the dsm-iv criteria for schizophrenia as confirmed by modified scid exclusion criteria: * meet the full syndromal criteria for other axis i disorder * have taken any depot antipsychotic within 4 weeks before screening * are taking mood-stabilizing agents
digital mental health and wellness intervention for adults: a randomized control trial of comet

Conditions: Depressive Symptoms; Anxiety

Summary: the investigators are evaluating the acceptability and effectiveness of brief online wellness modules. participants will be randomly assigned to the intervention condition, an active control condition, or a wait-list control condition. the investigators are using a factorial design, such that each participant in the intervention condition will be randomly assigned to receive three of four wellness modules. the investigators will analyze the intervention's effectiveness as a universal intervention (using the full sample) and a targeted intervention (using the subset of the sample that reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility criteria:
adult participants (at least 18 years old) will be eligible for this study.
japanese study of bms-901608 (elotuzumab) in combination with lenalidomide and low dose dexamethasone

Conditions: Multiple Myeloma

Summary: the purpose of this study is to assess the safety and tolerability of elotuzumab when given in combination with lenalidomide and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma (mm) in japan.


Eligibility criteria:
for additional information, please contact the bms oncology clinical trial information service at 855-216-0126 or email mycancerstudyconnect@emergingmed.com. please visit www.bmsstudyconnect.com for more information on clinical trial participation. inclusion criteria: * received between 1 to 4 prior lines of therapy * measureable disease * men and women of childbearing potential (wocbp) must be using two acceptable methods of contraception * men must agree to use a latex condom and a second form of birth control during sexual contact with wocbp and must agree to not donate semen during study drug therapy * subjects must be willing to refrain from blood donations during study drug therapy exclusion criteria: * subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect poems syndrome * solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia * unable to take aspirin daily as prophylactic anticoagulation therapy. prior history of inability to tolerate weekly 40 mg dexamethasone * history of renal failure * history of clinical significant thrombosis, such as treatment for thrombosis was required
hypoxia-based dose escalation with radiochemotherapy in head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (fmiso)-pet-ct. patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (imrt) with 70 gy plus either 5-fluorouracil/mitomycin c or cisplatinum (arm a) or a dose escalation of 10% (77gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (arm b).


Eligibility criteria:
inclusion criteria: * histologically verified squamous cell carcinoma of the head and neck region stage iii and iv eligible for primary radiochemotherapy * measurabel disease by ct and/or mrt and/or fdg-pet-ct * fit for chemotherapy * no prior radiotherapy or major surgery in the head/neck region * karnofsky index \> 60% * informed consent exclusion criteria: * uncontrolled secondary cancer * distant metastases * pregnancy * expected malcompliance

Keywords: local control
denovo nt ankle ldc study

Conditions: Defect of Articular Cartilage; Osteochondral Lesion of Talus; Osteochondritis Dissecans

Summary: the purpose of this post-market clinical study is to collect long-term outcomes for denovo nt graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. outcomes to be assessed include pain, function, activity levels and healthcare resource use.

articular cartilage lesions in the ankle can cause significant pain and loss of function for young to middle age adults. there are several treatment options for symptomatic articular cartilage injuries depending on a patient's age, symptoms and duration of complaints in addition to the size and condition of the lesion. denovo nt natural tissue graft is comprised of fresh particulated juvenile cartilage pieces that are secured inside articular cartilage lesions using fibrin adhesive. denovo nt graft was developed due to the current need for expanded treatment options for the treatment of cartilage lesions, especially large lesions. this post-market, multicenter, longitudinal data collection study was established to collect clinical outcomes of subjects implanted with denovo nt graft. data may be obtained either retrospectively or prospectively from patients implanted or to be implanted with denovo nt graft for the treatment of lesion in the ankle. data to be collected include details of the operative procedure as well as subject pain, function, activity levels, and healthcare resource use through a five year post-operative follow-up period.

Eligibility criteria:
potential subjects are screened for study entry based on a preliminary review of the inclusion and exclusion criteria as it applies to their pre-operative status (unless otherwise noted). inclusion criteria: * has an articular cartilage lesion(s) in the ankle for which arthroscopic or surgical intervention with denovo nt graft is warranted or has had prior treatment with denovo nt graft for an articular cartilage lesion(s) in the ankle * has voluntarily signed the irb approved informed consent * is of stable health and is able to undergo surgery * is male or female over the age of 18 at the time of consent * is physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical visits. exclusion criteria: * displays a high surgical risk as determined by the investigative surgeon * is pregnant or breast-feeding * has a clinically diagnosed autoimmune disease * has an active joint infection or history of chronic joint infection at the surgical site * has medical history that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject

Keywords: talar injury ankle lesion defect cartilage repair
short-term outcomes of full bowel preparation (mbp+oa) for colon cancer resections versus no bowel preparation

Conditions: Colon Cancer

Summary: the purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.

the design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. after that colon resection is performed in both groups. short-term outcomes are assessed in 30 day period after surgery. this is a superiority trial evaluating statistical superiority. rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. for power of 80% enrolment of 586 patients is required. the intent-to-treat principle is used for the data analysis.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid) * clinical stage t1-4an0-2m0-1 (distant metastases must be resectable) * indications for surgical colonic resection * ecog status 0-2 * at least 18 years of age * written informed consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * pregnancy or breast feeding * medical contraindications for surgical treatment * any use of antibiotics 30 days prior to inclusion * functioning stoma * contraindications for use of mbp or oa drugs or their components * indications for mandatory mbp (planned intraoperative colonoscopy etc) * indications for obstructive resection * acute bowel obstruction, bleeding or perforation * other malignancies not in remission

Keywords: colon cancer mbp bowel preparation oral antibiotics