Kornimate/medical-research-clean huggingface dataset:
examining the effect of prolotherapy on quality of life and painkiller use in patients with knee pain

Conditions: The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain

Summary: 92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. when creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. however, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. in the control group, existing medical treatments were continued and no injection procedure was performed. before the research, all participants were evaluated with case report form, visual analog scale (vas) and quality of life scale short form (sf-36). the cases in the experimental and control groups were re-evaluated with the vas and sf-36 scales at the first month.


Eligibility criteria:
inclusion criteria: * patients who suffer from primary knee osteoarthritis exclusion criteria: * inflammatory knee pain * cellulitis * septic arthritis * local abscess * bleeding disorders * patient on anticoagulant medication * patients allergic to dextrose * diabetes mellitus * breathing problems * electrolyte imbalance * kidney or liver disease
a research study of the new medicine nnc0519-0130 in male chinese participants living with excess body weight

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: novo nordisk is developing a new study medicine nnc0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight. in this study, the concentration of nnc0519-0130 in the blood will be measured and its safety will be evaluated. the participants will either get nnc0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. this study will test up to 7 different doses of nnc0519-0130 and will last for about 28 weeks.


Eligibility criteria:
inclusion criteria: * male chinese participant. * body mass index (bmi) between 24.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * glycated haemoglobin (hba1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole \[mmol/mol\]) at screening. * use of prescription medicinal products or non-prescription drugs (including chinese traditional medicine or local medicine) within 14 days before screening, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (asa), domperidone or topical medication.
sigi insulin management system - a first-in-human study in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this early feasibility first-in-human study is a prospective single-arm single-center study of sigi insulin patch pump. after a 1st day and night under medical surveillance during a hotel stay, sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.

sigi insulin management system (sigi) is a novel insulin patch pump intended for subcutaneous delivery if insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. sigi is offering superior delivery accuracy and precision, accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and smartphone control. glycemia is cgm controlled and for safety purposes, cgm data are shared with study medical team during the whole study. sigi fih study is conducted in a single clinical site in lausanne university hospital (chuv) in switzerland.

Eligibility criteria:
inclusion criteria: * informed consent signed * patients with t1d since more than 1 year * adults 18+years * patients under sensor augmented pump for at least 6 months * hybrid closed-loop users willing to switch to manual mode 15 days before study * patients with calculated insulin-to-carb ratio and correction factor * patients with total daily insulin above 30 insulin units * patients with correction factor below 3.5 mmol/l * no severe hypoglycemic or ketoacidosis episode requiring third-party intervention within the past 12 months * active users of teflon infusion sets * patients willing to use a smartphone interface to use their pump and to answer study questionnaires exclusion criteria: * patients with t2d * patients with t1d under multiple daily injections * patients using apidra and not willing to switch to novorapid / fiasp / humalog * patients with history of skin diseases (e.g. generalized eczema, plan lichen, psoriasis) * patients with known allergy to some insulins * clarke's score ≥ 4 (hypoglycemia unawareness) * severe late complications of diabetes, like severe neuropathy, non-stabilized proliferative retinopathy, egf \< 30 ml/min, myocardial infarction or stroke within the last 3 months * glycated hemoglobin hba1c \> 8.5 % at screening visit * medications interacting with glucose homeostasis (e.g. steroids) * pregnant of breastfeeding women * planned operation / mri / ct requiring removal of infusion pad over the 15 days of the study * planned travel over the 15 days of the study * persons under guardianship or incapable of judgement

Keywords: insulin patch pump cgm control smartphone control pre-filled insulin cartridges occlusion detection
effect of exercise on biomarkers in sct

Conditions: Sickle Cell Trait

Summary: this study measures the effect of exercise on a variety of biomarkers in blood and urine selected to evaluate the physiological pathways of hemolysis, myolysis, thrombosis, inflammation, and renal function in subjects with sickle cell trait. these pathways have been shown to be associated with adverse events in athletes and warfighters with sct upon protracted, repeated, strenuous exertion. changes in biomarkers post-exercise compared to pre-exercise (and compared to healthy controls) suggest activation of the associated pathway(s) which may contribute to exercise-related events in athletes and warfighters and subclinical complications in non-athletes.

subjects with sickle cell trait and healthy controls will be subjected to a single bout of moderate, controlled exercise on a treadmill. blood and urine samples will be collected before exercise, immediately after exercise, and 24 hours after exercise. fifteen biomarkers, three selected to evaluate each of the five physiologic pathways previously listed, will be tested at each of the three time points. abnormal biomarkers before exercise suggest chronic pathway activation while exacerbated levels after exercise suggest further activation stimulated by exercise. biomarker levels 24 hours post-exercise will be used to evaluate continued pathway activation or pathway recovery. by definition, 95% of health controls will show normal biomarker levels pre-exercise and biomarker patterns post-exercise will serve as the expected standard by which to compare the test subjects.

Eligibility criteria:
inclusion criteria: sickle cell trait group (as) * health subjects with sickle cell trait (as) * ages 18-70 years inclusion criteria: control group (aa) * healthy subjects without sickle cell trait (aa) * ages 18-70 years exclusion criteria: sickle cell trait group (as) and healthy controls (aa). subjects will be excluded if they: * weigh less than 110 pounds, * are pregnant, * have hemoglobinopathies (other than sickle cell trait) as determined by hb electrophoresis, * have other self-reported conditions known to cause blood coagulation activation, myocyte destruction, hemolysis, chronic inflammation, or renal disease * any condition that places subjects at risk during exercise.

Keywords: sickle cell trait
pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5mg and glimepiride 4mg

Conditions: Type2 Diabetes

Summary: a randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

a randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

Eligibility criteria:
inclusion criteria: * healthy male volunteers (age: 19\~45years) * 55\<body weight\<90, 18\<bmi\<27 * fpg: 70-125 mg/dl exclusion criteria: * galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * clinically significant medical history * allergy or drug hypersensitivity * ast(sgot), alt(sgpt) \> upper normal range\*1.5, egfr\<80 ml/min * drink during clinical trial period * smoking during clinical trial period * grapefruit/caffeine intake during clinical trial period * no contraception
carvedilol and micro t-wave alternans in hypertensives with chronic kidney disease

Conditions: Vascular Disease; Kidney Disease

Summary: evaluate effectiveness of carvedilol cr on micro t-wave alternans in high risk hypertensives

the effect of carvedilol cr on micro t-wave alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.

Eligibility criteria:
inclusion criteria: * adults age 18 and older * chronic kidney disease * must be able to do stress test exclusion criteria: * must not be mentally disabled * unable to provide informed consent * unable or unwilling to comply with study protocol or procedures * pregnancy or unknown pregnancy status in female of childbearing potential * participation in any drug trial during the study period * prior enrollment in this study * active liver disease * currently on β-blocker medication at the time of enrollment * known history of asthma exacerbation with β-blocker therapy * second or third degree av nodal block or bradycardia with resting heart rate \<50 bpm * prior allograft organ transplantation * planned allograft transplantation reasonably foreseen within the active treatment period * electrocardiographic left or right bundle branch block * permanent implanted pacemaker * atrial fibrillation * ongoing treatment with any of the following medications: sotalol (betapace), azimilide (stedicor), quinidine (quinidex), disopyramide (norpace), dofetilide (tikosyn), ibutilide (corvert), procainamide (procanbid), bepridil (vascor), amiodarone (cordarone), clarithromycin (biaxin), erythromycin (eryc), halofantrine (halfan), pentamidine (pentam), sparfloxacin (zagam), domperidone (motilium), droperidol (inapsine), chlorpromazine (thorazine), haloperidol (haldol), mesoridazine (serentil), thioridazine (mellaril), pimozide (orap), arsenic trioxide (trisenox), cisapride (propulsid), lidoflazine (clinium), and methadone (dolophine)

Keywords: carvedilol heart disease vascular disease kidney
effectiveness of acupuncture for depressed patients not taking antidepressant medications

Conditions: Depression

Summary: acupuncture is a popular complementary/alternative therapy that has been in use for thousands of years for the treatment of various medical and psychiatric conditions, including major depressive disorder (mdd). in this study, the investigators applied the investigators acupuncture-treatment-for-depression protocol, based on traditional chinese medicine (tcm) principles for treating mdd, to depressed patients not taking any antidepressant medications (a protocol that the investigators previously piloted as a medication augmentation therapy for partial responders with mdd). the investigators specifically investigated the efficacy, safety, and tolerability of this tcm-based protocol for such patients, as well as potential differences in outcomes between weekly vs. twice-weekly treatment. the investigators hypothesized that acupuncture monotherapy would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). the investigators also hypothesized that acupuncture would be associated with minimal side effects.


Eligibility criteria:
inclusion criteria: * has current or past dsm-iv mdd diagnosis based on scid; and current 17-hamilton rating scale for depression (brsd) score of 14 or above * age between 18-65 * no treatment with antidepressant(s) in the past 3 months * if patient has received psychotherapy, no initiation or termination of therapy in the past 3 months. exclusion criteria: * patients with primary diagnosis other than major depressive disorder, or any history of psychosis or mania. * conditions that could make it difficult to conclusively determine that depressive symptoms were the result of mdd and not some other condition, including substance abuse or dependence within the last 6 months, medical conditions that could produce depression, including epilepsy, history of an abnormal eeg, severe head trauma, or stroke. * serious uncontrolled medical conditions \[e.g. poorly controlled diabetes, severe congestive heart failure\], or other medical conditions that have not been stable for at least 3 months. * electroconvulsive therapy (ect) during the last year. * current active suicidal or self-injurious potential necessitating immediate treatment. * currently receiving concomitant acupuncture treatment, or any acupuncture treatment in the past three months.

Keywords: acupuncture antidepressant monotherapy depression alternative treatments
blood glucose monitoring on behavior change in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with type 2 diabetes. a prospective, randomized, double-blind experimental study is designed with 60 diabetic patients randomly assigned to the experimental group receiving continuous blood glucose monitoring and self-regulation mode of health education and the control group receiving self-monitoring of blood glucose and routine health education. data will be collected three times, including blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.

this purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with type 2 diabetes. this study is a prospective, randomized, double-blind experimental study. a total of 60 diabetic patients who are willing to participate in the outpatient clinic of the hospital will be recruited. they are randomly assigned to the experimental group and the control group with 30 patients each. the experimental group will adopt continuous blood glucose monitoring for 7 days and self-regulation mode of health education, while the control group is self-monitoring of blood glucose and routine health education. data will be collected three times: pre-test, eighth day after intervention, and three-month after intervention. the data included blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.

Eligibility criteria:
inclusion criteria: 1. diagnosed with diabetes by a doctor, and the patient is over 20 years old 2. hemoglobin a1c (hba1c)\> 8 % or more 3. possessed self-monitoring equipment for blood glucose 4. ability to use a mobile phone 5. before participation, the subject fully understand the purpose and process of the research and obtain their consent. exclusion criteria: 1. diabetes health literacy lower than 9 points 2. those who have difficulty in visual, hearing and speech. 3. use of diuretics and steroids

Keywords: diabetes continuous blood glucose monitoring self-regulation blood glucose diabetes health promotion behavior diabetes self-efficacy medication compliance
implication of human papillomavirus (hpv) in lichen physiopathology in human (hpvlichen)

Conditions: Lichen Planus

Summary: lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (cd) cd8 t lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of t lymphocytes toward keratinocyte antigen(s), so far unidentified. in a recent study, the research team at institut pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of cd8 t lymphocytes could be the immunodominant peptide of human papilloma virus (hpv) 16. in line with this recent work which shows for the first time a link between hpv-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that hpv could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.

lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (cd) cd8 t lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of t lymphocytes toward keratinocyte antigen(s), so far unidentified. in a recent study, the research team at institut pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of cd8 t lymphocytes could be the immunodominant peptide of human papilloma virus (hpv) 16. in line with this recent work which shows for the first time a link between hpv-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to to test the hypothesis that hpv could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus. regarding erosive lichen planus, the aim is to test the cytotoxic function of the previously identified cd8 t lymphocytes specific for hpv16 e711-20.

Eligibility criteria:
inclusion criteria: * at least 18 year-old * clinically or histologically confirmed lichen : non-erosive lichen planus, erosive lichen planus, or sclerosus lichen * at diagnosis of desease before treatment, or during flares of the disease, with or without intake or topical application of immunosuppressants * affiliated or beneficiary of a social security system * informed and written consent exclusion criteria: * under 18 year-old, * legal protection measures, * inability to consent * pregnant or breastfeeding women.
study evaluating rhil-11 in left-sided ulcerative colitis

Conditions: Ulcerative Colitis; Inflammatory Bowel Disease

Summary: to explore the safety of orally delivered rhil-11 in patients with mild to moderate left-sided ulcerative colitis. to explore the effects of orally administered rhil-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.


Eligibility criteria:
inclusion criteria: * documented, signed informed consent to participate in this study * age greater than or equal to 18 years * documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy exclusion criteria: * crohn's disease * ulcerative proctitis * ulcerative colitis extending beyond the splenic flexure

Keywords: left-sided ulcerative colitis
a phase i study of ixabepilone in combination with capecitabine in japanese patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the dose-limiting toxicity (dlt), maximum tolerated dose (mtd) and recommended phase ii dose of ixabepilone in combination with capecitabine in japanese participants with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * women ≥ 20 years * histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast exclusion criteria: * number of prior chemotherapy lines of treatment in the metastatic setting ≥3
evaluation of a home-based parenting support program: parenting young children

Conditions: Intellectual Disability; Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder

Summary: background: parents with intellectual and developmental disabilities (idds) have a tendency to provide insufficient caregiving and often need parenting support to prevent neglect and child removal. however, parents with idds are not provided with appropriate support, and there is a lack of evidence-based programmes tailored to these parents' needs. parenting young children (pyc) is a home-based parenting programme developed for parents with idds. pyc has shown promising clinical results in interview-based studies, but there is no evidence of its effectiveness. the purpose of the proposed study is to evaluate the pyc programme for improving parenting in parents with idds where there is risk of child neglect. the study will include a quantitative evaluation, a process evaluation, and a qualitative evaluation of the children's and parents' perspectives on participating in pyc. methods: the quantitative evaluation will have a multi-centre, non-randomised, comparative study design. eligible for participation are parents with idds who have children aged 0-9 years living at home and who are assessed as needing tailored parenting support. thirty parents receiving pyc and thirty parents receiving treatment as usual (tau) will be recruited from swedish municipal social services. outcome variables will be examined before and after the intervention, with a follow-up 6 months after completing the intervention. the primary outcome will be goal-attainment in parenting skills, and secondary outcomes will be parental self-efficacy and children's wellbeing. interview methods will be used to explore the perspectives of parents and children in the pyc group. discussion: this study is motivated by the need for evidence-based support for parents with idds, and it focuses on upholding the centrality of child-caregiver relationships and family preservation, as well as children's rights and the rights of people with disabilities. social services have expressed ethical concerns with employing a randomized design for this vulnerable group, and this study will therefore evaluate pyc in a non-randomized comparative study.


Eligibility criteria:
inclusion criteria: * parents with idds, including id and other cognitive disabilities (e.g., adhd and asd). parents must have children aged 0-9 years living at home and be assessed by the social services to be eligible for tailored parenting support. exclusion criteria: * ongoing substance abuse, ongoing child abuse, and/or mental illness of such nature and degree that it may affect parent management training.

Keywords: intellectual and developmental disabilities parents parenting skills support programme