Kornimate/medical-research-clean huggingface dataset:
the comunicare study: the effectiveness of a multimodal intervention based on person-centered communication

Conditions: Diabetes Mellitus, Type 2

Summary: pragmatic cluster-randomized clinical trial. an open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year.

pragmatic cluster-randomized clinical trial. an open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year. randomization unit: health care professionals. analysis unit: patients and health care workers. scope: primary care (pc) health centers in the community of madrid (spain). population sample: patients of 40 to 75 years of age with dm2, hba1c ≥7.5%, on oral antidiabetic drugs (oad) treatment, who had attended pc consultation during the last year. sample size: 250 patients (125 per group). main objective: assess the effectiveness of an intervention based on person-centered interviewing (pci) to improve metabolic control and increase oad treatment adherence in patients with dm2. intervention: four-component intervention including 1) training of health care professionals (doctors and nurses) on pci, 2) practice of pci techniques, 3) information card for patients and family members, 4) instructions sheet on drug prescription. control arm: usual clinical practice. variables: 1) patients: main: metabolic control (difference of hba1c ≥0.5%), and oad treatment adherence (average increase of 50-75%); secondary: cardiovascular risk, compliance with clinical practice guidelines, complications related to dm2, satisfaction with treatment, adverse effects of medication, usage of health care services. 2) healthcare workers: professional burnout. follow-up period: 1 year. analysis: multi-level models.

Eligibility criteria:
inclusion criteria: * age range between 40 and 75 years. * patients with dm2 undergoing regular treatment with at least one type of oad for the last 6 months. * hba1c ≥7.5% in the last laboratory test. * pc patients that have attended consultation in at least 2 occasions for reasons related to their diabetes. * patients that will remain in the hc area during the follow-up period. * patients willing to provide informed consent to participate in the study. exclusion criteria: * patients whose diabetes is monitored in specialized care consultations or private clinics, and attend the hc only for medical prescription. * patients diagnosed with a terminal disease and a survival prognosis of less than 1 year. * patients already taking part in another clinical trial. * patients on a surgery waiting list and/or not expecting to complete the follow-up period. * pregnant women. * patients with cognitive impairment. * patients suffering from severe chronic pathologies (kidney failure requiring hemodialysis; cardiac insufficiency of a degree equal to or higher than iii/iv according to the classification by the new york heart association; respiratory insufficiency requiring treatment with continuous oxygen therapy and/or chemotherapy). * patients suffering from a psychiatric disorder that requires neuroleptics treatment. * drug use or alcohol abuse (\>60 gr/day).
comparison of vascular findings between symptomatic and asymptomatic postmenopausal women before and during hormone therapy (hrt)

Conditions: Postmenopausal Vasomotor Symptoms; Cardiovascular Disease

Summary: recent large randomized, placebo-controlled studies assessing the health effects of ht question the overall benefits of long term ht, especially with respect to cardiovascular disease. however, recently menopausal women with severe hot flushes were mostly excluded from these trials. this was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to ht in women with and without hot flushes can differ. aims of the present project are 1. to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms 2. in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal ht.

we recruit 160 healthy postmenopausal women between ages 48-55. eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ecg and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. in the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. in the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. after the treatments the baseline assessments are repeated.

Eligibility criteria:
inclusion criteria: * postmenopausal women between ages 48-55 * minimum of 6 months and maximum of 36 months from last menstrual period * postmenopausal status of these women will be confirmed by level of fsh that should exceed 30 u/l * eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless exclusion criteria: * smoking * hysterectomy * dyslipidemia * overt hypertension (blood pressure \> 140/90) * diabetes * any regular medication * ht in the previous 3 months * body mass index over 27

Keywords: postmenopausal vasomotor symptoms hot flush vascular function cardiac function cardiovascular risk factor
imaging of unstable carotid plaque in patient referred to endarterectomy

Conditions: Carotid Artery Stenosis

Summary: this study will assess unstable plaque imaging features by using high resolution mr imaging and sodium fluoride f-18 pet. this is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components


Eligibility criteria:
inclusion criteria: * age over 18 years old * health care system affiliation * referred to carotid endarterectomy * symptomatic patients: * carotid stenosis between 70 and 99% (nascet criteria) * tia or minor stroke attack (rankin ≤ 3) * asymptomatic patients: * carotid stenosis between 70 and 99% (nascet criteria) * no symptoms * patient who has been informed of the study and has given his/her informed consent exclusion criteria: * contra indication to mri * renal failure (clearance \< 30ml/mn) * patient with active inflammatory disease * history of cancer * pregnancy or lactation * patient with carotid disease treated by fibrinolysis * patient under guardianship, or unable to understand the purpose of the study
a clinical trial to evaluate safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of kmrc011

Conditions: Acute Radiation Syndrome

Summary: this trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of kmrc011 injection in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * a male whose age is between 19 and 55 years of age * a person whose body mass index is between 18.5 and 27 kg/m2 at screening * a person who has the ability and willingness to participate in the clinical trial * a person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial exclusion criteria: * a person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology\*oncology system, cardiovascular system, etc.(in the case of liver disease items, it includes subjects who have hepatitis virus) * a person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment * a person with infectious disease or severe trauma within 21 days of the randomization date * a person whose serum ast, alt or γ-gt levels exceed 1.5 times the upper limit of the reference range at screening * a person whose qtcf on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening * a person with a glomerular filtration rate less than 60 ml/min/1.73 m2 calculated from serum creatinine at screening * a person with a systolic blood pressure less than 100 mmhg, greater than 150 mmhg, diastolic blood pressure less than 60 mmhg, or greater than 100 mmhg at screening * a person with thrombocytopenia or coagulopathy which should not be given intramuscular injection * a person whose weekly average drinking amount exceeds 140g of alcohol per week * a person whose daily average smoking amount exceeds 10 per day * a person who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the investigational product within 14 days of the injection * a person who has the history of substance abuse or positive urine screening test * a person who have received a investigational product or a bioequivalence study drug within at least 90 days prior to the randomization * a person who donated whole blood within 60 days before the randomization, or donated components of blood within 30 days * a person who dose not have a medically approved contraceptive during the trial and has a plan to provide sperm * a person who has clinically significant abnormalities from clinical laboratory test * a person who is deemed ineligible for clinical trials by the investigator
pediatric induction therapy in kidney transplantation

Conditions: Kidney Transplant Rejection; Pediatric Kidney Disease

Summary: the goal of this observational study is to compare the efficacy of two most commonly used induction therapy for the prevention of acute rejection (ar) after renal transplantation in children. the main question it aims to answer is: is basiliximab (anti-cd25 monoclonal antibody) induction therapy effective and safe in preventing ar after kidney transplantation in children compared with anti-thymoglobulin polyclonal antibodies induction therapy? the transplant and follow-up data of participants will be retrospectively collected. researchers will compare the rate of ar to see if basiliximab (anti-cd25 monoclonal antibody) induction therapy is a better option for certain pediatric kidney transplant recipients.


Eligibility criteria:
inclusion criteria: * receiving the kidney graft from a deceased donor * basiliximab or ratg induction therapy was used in perioperative period exclusion criteria: * recipients with pre-transplant calculated panel reactive antibodies (cpra) \>10% * recipients of combined liver, pancreas or heart transplantation * no induction or other induction therapy was used in perioperative period * recieving the kidney graft from a living donor
a phase ii study of maintenance with azacitidine in mds patients

Conditions: Leukemia, Myelocytic, Acute; Myelodysplastic Syndromes

Summary: a phase ii multicentre trial of maintenance with azacitidine in mds patients achieving complete or partial remission (cr or pr) after intensive chemoterapy. the primary objective is response duration (mds or aml)

a academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk mds patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation

Eligibility criteria:
inclusion criteria: * mds with int 2 or high ipss score eitherraeb 1 or 2 according to the who classification (see appendix 1) or cmml with wbc \< 13 109/l raeb-t according to the fab classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) aml secondary to mds (saml) with a confirmed mds phase of at least 2 months with available bone marrow cytogenetics at diagnosis of aml and in cr or pr according to iwg criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response aged 18 years of age or more written informed consent adequate contraception, if relevant negative pregnancy test if relevant. patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it exclusion criteria: * aml secondary to myeloproliferative or mds/mpd who subgroups except cmml with wbc\< 13 109/l * therapy related mds (after chemo or radiotherapy for a previous neoplasm or immune disorder) * patients eligible for allogeneic bone marrow transplantation (with a identified donor) * liver and/or kidney failures prohibiting the use of azacitidine. creatininemia \> 1.5 normal value alat and asat \> 3n * bilirubin \> 2 n, unless due to dyserythropoiesis * known hypersensitivity to azacitidine or mannitol * other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor * uncontrolled infection, * who performance status \> 2 * life expectancy less than 3 months

Keywords: mds myelodysplastic syndromes aml intensive chemotherapy azacitidine
a study of intravenous mircera in dialysis patients with chronic renal disease and anemia.

Conditions: Anemia

Summary: this single arm study will assess the efficacy, safety and tolerability of monthly intravenous mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. patients will receive monthly intravenous injections of mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period; * continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * hemolysis; * folic acid and vitamin b12 deficiency.
direct and reversed dorsal digito-metacarpal flaps: a review of 24 cases

Conditions: Finger Injuries; Soft Tissue Injuries

Summary: multiple digital injuries are often complex and severe, and the commonly used local and regional flaps may not be feasible. the authors reconstruct soft tissue defects of the fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.

at final follow-up, we measure the sensibility of the flaps using the static 2-point discrimination test. the static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. the modified american society for surgery of the hand guidalines are used to stratify discriminator measurements(excellent \ 15 mm). each area is tested 3 times with a discriminator (ali med, dedham, ma). two out of 3 correct answers are considered proof of perception before proceeding to another lower value. we stopp at 4mm as a limit of 2pd and consider this normal. the measurements are performed at a single time point at final follow up.

Eligibility criteria:
inclusion criteria: * the injured and adjacent fingers are unable to be used as the donor due to multiple digital injuries * a soft tissue defect \> 1.5 cm in length with exposed bone or tendon * the reverse dma flap may not be appropriate for tissue reconstruction due to the concomitant injuries or due to the limitation of the rotation arc * a patient between 15 and 60 years of age exclusion criteria: * concomitant injuries involved all the finger that precluded their use as donor sites * a defect less than 1.5 cm in length * injuries to the course of the vascular pedicle

Keywords: defect, dorsal branch of the digital artery, dorsal digital flap, dorsal metacarpal artery flap.
an adherence study of antipsychotic medication in outpatients with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this prospective study examines the differences among several measures of adherence to antipsychotic medications in outpatients with schizophrenia. adherence is assessed by using self-report, physician report, pill count and electronic monitoring. the rates of adherence/non-adherence with various tools will be manifested. the association between antipsychotic adherence/non-adherence and various clinical status, including psychotic symptoms, depressive symptoms, side effects, neurocognitive function and insight are analyzed. participants are assessed at baseline during a visit to their outpatient clinic and followed up for 8 weeks.


Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent 2. male or female, aged from 20 to 65 years 3. clinician rendered diagnosis of schizophrenia or schizoaffective disorder documented by a checklist of diagnostic and statistical manual of mental disorders- fourth edition (dsm-iv) criteria 4. currently taking a single oral antipsychotic (e.g., quetiapine, risperidone, olanzapine, or amisulpride). 5. female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropine (hcg) test at enrolment 6. outpatient status, with psychiatric hospitalization or psychiatric emergency room visit within the previous 2 years and no hospitalizations within 3 months 7. mild to moderate symptom checked by cgi-s (less than score 4) 8. able to understand and comply with the requirements of the study exclusion criteria: 1. any dsm-iv axis i disorder not defined in the inclusion criteria 2. presence of a co-morbid diagnosis that might influence outcome measures (e.g., mental retardation) 3. alcohol or substance dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria 4. patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 5. pregnancy or lactation 6. evidence of hypersensitivity to quetiapine or other antipsychotics used in the study 7. use of any cytochrome p450 inhibitors or inducers in the 14 days preceding enrolment 8. administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 9. use of pillbox 10. treatment with clozapine (because of its unique monitoring guidelines) 11. administration of electroconvulsive therapy (ect) in the last 6 months 12. unstable or inadequately treated medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder 13. involvement in the planning and conduct of the other study. 14. participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.

Keywords: schizophrenia adherence
a prospective, observational study to assess and evaluate the use of glucophage xr therapy in the management of patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this was an observational, prospective, multicentric study conducted in a cohort of subjects with type 2 diabetes and prescribed with glucophage xr therapy from hospitals or clinics in hong kong, indonesia, korea, malaysia, philippines and singapore. glucophage xr is being used in the asia pacific region for the treatment of subjects with type 2 diabetes. this study was designed to provide information on the day to-day experience of using glucophage xr in the management of subjects with type 2 diabetes and its use in routine clinical practice in asia pacific region.

glucophage (metformin) is the standard first line therapy for subjects with type 2 diabetes mellitus (dm). the consensus statement from the american diabetes association and the european association for the study of diabetes has recommended metformin therapy in concurrent with lifestyle intervention at diagnosis. it has been well accepted that subjects' compliance with therapy tends to decrease as the dosage frequency increases and hence the regimens should be simplified as far as possible to support good compliance with therapy. the use of an extended release formulation of metformin (glucophage xr) supports the simplification of treatment of subjects with type 2 diabetes by allowing a once daily administration of metformin. objectives primary objective: * to assess the tolerability of glucophage xr therapy when used in routine clinical practice in subjects with type 2 diabetes secondary objective: * to assess the effectiveness of glucophage xr therapy on the maintenance of glycaemic control the study does not involve any active involvement of the subjects and does not require any change from the standard medical management of the subjects. each subject will be followed upon starting glucophage xr therapy and until at least 12 weeks of treatment or discontinuation of treatment, whichever being earlier.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with type 2 diabetes * subjects who have been given glucophage xr for the treatment of the type 2 diabetes exclusion criteria: * subjects treated with glucophage xr before the study initiation * contraindicated use of glucophage xr based on local label * subjects who plan to continue on another oral anti diabetic therapy during the course of the study

Keywords: type 2 diabetes diabetes mellitus glucophage metformin
a study of naldemedine (s-297995) for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.


Eligibility criteria:
inclusion criteria: * subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation * subjects with \< 3 spontaneous bowel movements a week and experiencing bowel symptoms * subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months exclusion criteria: * evidence of clinically significant gastrointestinal disease * history of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation * severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation

Keywords: opioid therapy non-malignant chronic pain opioid-induced constipation