Kornimate/medical-research-clean huggingface dataset:
a trial comparing the safety and efficacy of semaglutide once weekly versus sitagliptin once daily in japanese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in japanese subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, age 20 years or older at the time of signing informed consent * glycated hemoglobin (hba1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (oad) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening * japanese subjects diagnosed with type 2 diabetes who are: a) on stable oad monotherapy at a half-maximum dose or below according to the approved japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (for metformin only: the maximum dose of 750 mg/day is allowed except for metgluco®. for metgluco®, the allowable half-max dose of 1125 mg/day must be applied.). 'stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period * treatment with once-weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days prior to screening * treatment with any glucose lowering agent(s) (except for pre-trial oad for subject treated with oad monotherapy) in a period of 60 days prior to screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness * any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol * history of chronic or idiopathic acute pancreatitis * screening calcitonin value of 50 ng/l (pg/ml) or greater * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2) * impaired renal function defined as estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula (4 variable version) * acute coronary or cerebrovascular event within 90 days before randomisation * heart failure, new york heart association (nyha) class iv
dynamic changes of circulating tumor dna in surgical lung cancer patients

Conditions: Carcinoma; Non-small-cell Lung Cancer; Lung Neoplasms

Summary: previous study showed circulating tumor dna levels reflect the total systemic tumor burden. circulating tumor dna levels should decrease after complete surgery and could be increase as tumor recurrence. few study investigated the half time of circulating tumor dna in lung cancer patients that no criterion has been established of how to use it for surveillance.

for lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. a series of mutations will be detected in plasma before surgery based on next generation sequencing. the positive mutation will be traced after surgery and in follow up.

Eligibility criteria:
inclusion criteria: * suspected lung cancer before surgery * no malignant tumor history within the past 5 years * the pulmonary nodule is not pure ground glass opacity * patients must have given written informed consent exclusion criteria: * multiple primary lung cancer * r1,r2 resection * histology confirmed not non-small cell lung cancer * unqualified blood samples

Keywords: circulating tumor dna half time lung cancer surgery surveillance
circulating tumor cells in mcrc for liver resection

Conditions: Metastatic Colorectal Cancer; Circulating Tumor Cell

Summary: resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. however, early recurrence occurs in up to 30% in 3 months after liver resection. to optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

this is a single-center prospective study to evaluate the predictive value of circulating tumor cells (ctc) in patients with metastatic colorectal cancer who are planned to have curative resection of liver metastasis. blood will be taken from patients within 7 days before liver resection. ctc enumeration is done by a highly-sensitive microfluidic platform for which ctc can be subsequently enumerated with or without sequencing performed. patients are then followed up regularly with contrast ct scan for recurrence. the primary study endpoint is to define the cutoff value of ctc count in patients with early relapse \< 6months after liver resection. seventy-seven patients will be recruited in 24 months.

Eligibility criteria:
inclusion criteria: 1. age\>=18 years 2. signed informed consent 3. histologically or cytologically confirmed colorectal adenocarcinoma 4. both primary tumor and liver metastases are amenable to curative resection. exclusion criteria: 1. presence of extrahepatic metastasis 2. history of other malignancies in the last 5 years 3. patients unable to comply with the protocol

Keywords: metastatic colorectal cancer liver resection circulating tumor cells
clove in the treatment of relapsed or resistant acute leukemia in children

Conditions: Acute Leukemia

Summary: study hypothesis. combination chemotherapy with clofarabine vp16 and cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric. forty children with relapsed or refractory acute lymphoblastic leukemia (all) or acute myeloid leukemia (aml) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles end point were complete remission (cr)or cr without platelet recovery (crp) and toxicity


Eligibility criteria:
inclusion criteria: * presence of \> 25% of blast in bone marrow * treatment with second line therapies * patients with resistant disease i.e. with \>25% of blasts 21 days after the last cytostatic agent administration * children with persistent high mrd level (\> 10-3) after first or further line chemotherapy, were considered eligible to the treatment * relapsed after \> months after sct * karnofsky score \>50 * a forced espiratory volume \>30% * sufficient hepatic and renal function defined as creatinine levels \<2 × uln, bilirubin \<1.5 × uln * aspartate and alanine aminotransferases \<10 × uln. exclusion criteria: * isolated extra-medullary relapse, and active infections
effectiveness of card for improving school-based immunizations

Conditions: Vaccination; Complications; Vaccine Adverse Reaction; Fear

Summary: vaccination is estimated to have saved more lives in canada than any other single intervention and is considered one of the most important advances in the prevention of disease. the process of vaccination, however, is stressful for individuals. school-based vaccinations in particular, are associated with high levels of fear and anxiety among students. this randomized cluster trial will implement a multi-faceted knowledge translation intervention called the card (c-comfort a-ask r-relax d-distract) system in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.

the investigators developed a multi-faceted knowledge translation intervention called the card system to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. card addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. in a small controlled clinical trial in a public health unit in niagara, ontario, the investigators demonstrated benefits of card on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with card by all stakeholder groups (students, public health staff, school staff and parents). this study will evaluate card in a large cluster trial in calgary, alberta. this trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation. eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to card or control (usual practices). data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.

Eligibility criteria:
inclusion criteria: * grade 6 and 9 students eligible for vaccination at school * public health staff in community health centre involved in the study * school staff in a participating school involved in school vaccination * parent of a student eligible for vaccination at school exclusion criteria: - unable to understand and read english

Keywords: school vaccinations pain management knowledge translation cluster trial
a study of japanese rheumatoid arthritis participants

Conditions: Rheumatoid Arthritis

Summary: the objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (sc) dosing with ly2127399 for participants who have participated in a prior ly2127399 clinical study. at the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. additional follow up after week 72 may continue to assess b-cell recovery.


Eligibility criteria:
inclusion criteria * have given written informed consent * women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation * must have completed treatment and 12 week follow up period in prior ly2127399 study nct01253226 \[study h9b-je-bcdk (bcdk)\] exclusion criteria * have had any safety event during the previous ly2127399 (bcdk) study that participants participated in * have received, during previous study (bcdk), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (dmard) except for, methotrexate (mtx), hydroxychloroquine, sulfasalazine or bucillamine
comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder

Conditions: Opioid Use Disorder

Summary: the current first-line treatment for opioid use disorder (oud) in canada is buprenorphine/naloxone (bup/nx). the standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. this study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with oud.

this is a randomized, controlled, open-label superiority trial involving 50 individuals with oud. participants will be randomized into two arms: rapid micro-induction and standard induction (based on the american society of addiction medicine practice guidelines and product monograph) of bup/nx.

Eligibility criteria:
inclusion criteria: 1. opioid use disorder (oud) as defined by the diagnostic and statistical manual of mental disorders-5 diagnostic criteria; 2. individuals seeking opioid agonist treatment (oat); 3. be 19 years of age or older; 4. be willing and able to adhere to the study protocol and follow-up schedule; 5. be able to provide written informed consent to participate in the clinical trial. 6. if female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study. exclusion criteria: 1. diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment; 2. anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone; 3. positive pregnancy test for women of childbearing potential; 4. methadone use in the past 5 days; 5. buprenorphine use in the past 5 days; 6. known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone; 7. anticipation that the patient may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion; 8. unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study.

Keywords: buprenorphine/naloxone suboxone opioid agonist treatment micro-induction microdosing withdrawal management
dose-escalation study of t cell vaccine in multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive

Summary: the purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive t cells in ms patients and 2) to study the clinical effectiveness of t cell vaccine ion the clinical course of ms.

the principle of tcv is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. because pathogentic autoreactive t cells are viewed as pathogens in t cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.

Eligibility criteria:
inclusion criteria: * stable ms disease within 30 days prior to enrollment * edss score between 2 and 8 inclusively * failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for ms. exclusion criteria: * women who are pregnant or breast-feeding or who plan to become pregnant during the study * has taken immunomodulating drugs within 60 days prior to screening * hiv positive

Keywords: tovaxin tcv autologous
a research study looking at how oral semaglutide works in people with type 2 diabetes in finland, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how rybelsus® works in people with type 2 diabetes and to see if rybelsus® can lower their blood sugar levels. participants will get rybelsus® as prescribed to them by the study doctor. the study will last for about 8-10 months. participants will be asked to complete a questionnaire about how they take their rybelsus® tablets. participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * available hba1c value less than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (v1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit' (v1) if in line with local clinical practice * treatment naive to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of less than 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
a study of ribavirin to treat m4 and m5 acute myelocytic leukemia

Conditions: Acute Myelocytic Leukemia

Summary: the purpose of this study is to determine if ribavirin (a drug commonly used to treat hepatitis c) also has activity in the treatment of patients with refractory or relapsed acute myeloid leukemia (aml) of the m4 and m5 subtype.

the eukaryotic translation initiation factor eif4e is dysregulated in many human malignancies, including a subset of myeloid leukemia (m4/m5 aml and blast crisis cml). eif4e overexpression leads to oncogenic transformation. ribavirin impedes eif4e mediated transformation in vitro, in primary human specimens and in animal models. while ribavirin has been used extensively for the treatment of viral hepatitis c and its safety profile has been well defined, it has never been used in patients with aml. this study will establish the efficacy and safety of ribavirin in m4/m5 aml patients. in addition, this study will also include correlative studies to determine the effect of ribavirin on eif4e activity and eif4e related pathways in m4/m5 aml patients.

Eligibility criteria:
inclusion criteria: * a diagnosis of acute myeloid leukemia (aml), either m4 or m5 subtype de novo or resulting from a transformation from mds or a myeloproliferative disorder. * patients with aml who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. or * patients with aml blast crisis from cml if they are not suitable candidates for intensive induction chemotherapy or have failed imatinib mesylate or * patients with secondary aml after mds if they are not suitable candidates for intensive induction chemotherapy. * ecog 0,1,2, or 3 * life expectancy \> 12 weeks. * adequate renal and hepatic function exclusion criteria: * uncontrolled central nervous system involvement by aml * active cardiovascular disease as defined by nyha class iii-iv categorization. * intercurrent illness or medical condition precluding safe administration of ribavirin. * received any previous therapy within 28 days prior to study entry.hydrea is permitted but must be stopped 7 days prior to starting study drug. * known infection with hiv.

Keywords: aml acute myelocytic leukemia leukemia relapsed refractory m4 m5
an investigation of performance and safety of the wound dressing fibdex in patients with superficial dermal burns

Conditions: Burns

Summary: this is a prospective, randomised, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (nfc) wound dressing fibdex® for treatment of superficial dermal burns in paediatric and adult patients. the clinical performance and safety of fibdex® will be compared to epicitehydro (qrskin gmbh, würzburg, germany) and epiprotect® (s2medical ab, linköping, sweden). epicitehydro is considered to be the primary comparator. the investigation will be conducted at 2 clinical research sites in sweden.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent (by the patient and/or the patient's parent\[s\]/legal guardian\[s\] as applicable). 2. patient with superficial dermal burn wound(s) (class ii/a) ≤36h as assessed by the investigator. 3. patient at least 1 year old. 4. patient who has at least 3 superficial dermal burn wounds on anatomically equivalent areas or a superficial dermal burn large enough to allow a lateral comparison. 5. wound area at least 50 cm2 (per wound, if 3 separate wounds) or at least 150 cm2 (if single wound) as judged by the investigator. exclusion criteria: 1. patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergic reaction to, any of the dressing components. 2. pregnant or breast-feeding female. 3. patient with chemically or electrically induced burns. 4. other non-burn wound in target wound area. 5. not suitable for inclusion according to the investigator. 6. cognitive dysfunction or psychiatric history (investigator's discretion). 7. chronic or presently active skin condition that is judged as interfering with normal wound healing process (investigator's discretion) 8. target burns on sensitive skin areas, such as the facial or genital area. 9. inability or unwillingness of participant or parent(s)/legal guardian(s) to give written informed consent.
effects of faba bean fractions as ingredients in novel food products on glycemia, appetite and metabolic control

Conditions: Obesity; Diabetes

Summary: the investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake at a meal


Eligibility criteria:
inclusion criteria: * non-smoking * no metabolic disease * bmi 20 - 25 kg/m\^2 * male * age 18-30 exclusion criteria: * intolerance to treatments * currently taking appetite-modifying medications * restrictive eating * smoking * over- or underweight * breakfast-skipping

Keywords: food intake satiety appetite glycemia faba bean protein snack
visiodol: validation of the visiodol® scale

Conditions: Visual Deficiency; Congenital Blindness; Acquired Blindness

Summary: the aim of this study is to validate the visiodol® scale for screening of pain in people with visual impairment.

the visiodol® monocentric study conducted at clermont-ferrand university hospital is a cross-disciplinary diagnostic tool validation performed in patients with acquired or congenital visual impairment and healthy sighted volunteers. different evaluations by thermal (pathway médoc®) and mechanical (electronic von frey®) tests will allow to compare the new visiodol® scale with the numerical scale, which is a commonly used tool. the ergonomic quality, the satisfaction of use and the quality of life, stress, anxiety and catastrophism of the patients will also be studied.

Eligibility criteria:
inclusion criteria: * healthy volunteers * subjects aged over 18 / under 60 * male or female * subjects fasting from coffee, tea, coca-cola and others stimulants * sufficient understanding and cooperation to comply with the study requirements * agreed to provide written consent * affiliated to the social security * subjects with visual impairment (congenital or acquired) * subjects with no visual impairment (healthy group) exclusion criteria: * subjects under 18 years old * administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)

Keywords: blinded population pain evaluation diagnostic tool