Kornimate/medical-research-clean huggingface dataset:
a trial investigating the pharmacodynamic and pharmacokinetic properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period * female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)
development of a novel signature integrating clinical, imaging and epigenetic information to tailor pelvic nodal treatment in prostate cancer

Conditions: Prostate Cancer (Adenocarcinoma)

Summary: radical prostatectomy (rp) represents one treatment option for clinically localized pca. the most updated guidelines of the european association of urology indicate the need to perform eplnd in patients with a lni risk \>5% according to the briganti nomogram. it allows for sparing eplnd in two thirds of contemporary surgically treated patients, but many patients still receive an eplnd in the absence of lymph node metastases. this is key, since eplnd is associated with significant risks of complications. improving our ability to detect lni in pca would be key for two main reasons: 1. to administer more timely treatments which in turn improve patient outcomes. 2. to avoid significant overtreatment and spare eplnd-related toxicity. our hypothesis is that lymphatic spread of pca cells might be predicted through integration of clinical variables, radiologic and epigenomic information. we aim at developing an accurate predictive model that includes radiological and epigenomic information.


Eligibility criteria:
inclusion criteria: * patients diagnosed with localized prostate cancer (ctanyn0m0) who underwent radical prostatectomy and extended plnd * all included patients presented one or multiple lesions at the mp-mri of the prostate, defined as pi-rads 3 to 5 * at least two biopsy cores were required: i) one positive core from the mp-mri pi-rads 3- 5 lesion/s (target lesion), ii) one positive core from the systematic sampling (outside the target lesion) exclusion criteria: * unavailable or negative mp-mri, unavailable or negative target or systematic biopsy, and refute to undergo radical prostatectomy with plnd at the ospedale san raffaele
comparative effects of virtual reality and frenkel's exercises in patients with stroke.

Conditions: Stroke

Summary: to compare the effects of virtual reality and frenkel's exercises on balance, gait and quality of life in patients with stroke.

this randomized control trial will be conducted at islam central hospital, sialkot over a duration of 7 months after approval of synopsis. 36 participants who meet the inclusion criteria will be further divided into 2 groups. the treatment will be given with the frequency of 3 times per week for 6 weeks. treatment sessions will be of 30 minutes with short resting intervals. data will be collected using various assessment tools including, berg balance scale, time-up and stroke-specific quality of life. pre-intervention assessment will be conducted before starting the treatment protocol and post assessment after 6 weeks of treatment. the data will be analyzed using spss version 28 for windows software. statistical significance will be set at p = 0.05. normality of data will be assessed through kolmogorov smirnov test. difference between pre-treatment and post-treatment readings will be calculated using paired sample t-test for parametric data. for non-parametric data wilcoxon test will be used. independent sample t-test will be used for parametric data and mann whitney test will be used for non-parametric data.

Eligibility criteria:
inclusion criteria: 1- age 40-65 years. 2. stroke patients with both genders. 3. subacute stroke patients will be included. 4. survivors of ischemic stroke. 5. no prior experience with vr-based rehabilitation. 6. patients with ≥24 mini-mental state exam score. exclusion criteria: 1. patient with serious behavioral problems or mental health. 2. patients with recent lower extremity deep vein thrombosis, quadriplegia, parkinson's disease, lower limb fractures, or recent myocardial infarction. 3. patients with malignant tumor, or other unstable condition. 4. participants with ent defect, hearing, majorly affected vision(blindness), cataract, glaucoma, loss of vision. 5. subjects with diagnosed vestibular disease.

Keywords: balance berg balance scale frenkel's exercises gait stroke
coherence training for military personnel

Conditions: Stress

Summary: military operations and training situations present many physical and psychological challenges for service members to adapt to and overcome. the challenges of these changing conditions necessitate having to cope with stress, which is seen as the negative perceptions, feelings, and emotions that manifest from the subjective physical and/or mental strain on life processes. in addition, service members are returning from deployments having gone through traumatic experiences that can develop into posttraumatic stress disorder (ptsd), depression or other serious conditions. the surface warfare independent duty corpsman (idc) school is an example of a training environment where some students may be entering the program with symptoms of ptsd, which may preclude or make it more difficult for them to perform well. autonomic nervous system (ans) dysregulation has been observed in patients with ptsd and those experiencing chronic stress, such that there is more arousing, sympathetic input to the heart than calming, parasympathetic input, which is usually the dominant division of the ans involved in controlling one's heart rate. the idc training program is an example of an environment where the service member is expected to excel while being subjected to multiple sources of stress. the fast tempo coupled with performance expectations may induce stress and actually inhibit learning. the institute of heartmath has developed the coherence advantage program which teaches one to self-regulate their emotions while focusing on breathing to compliment the active process of self-regulation. in conjunction, the emwave personal stress reliever allows the user to receive heart rate variability (hrv) biofeedback, hence giving the user the opportunity to self-regulate their ans through breathing and self-regulation techniques. the proposed study will test the effectiveness of the coherence advantage program versus progressive muscle relaxation (pmr) in reducing stress symptomatology among surface warfare idc students. the effectiveness of these two different interventions will be compared on outcomes of ptsd, depression, anxiety, sleep quality, perceived stress, attrition, and class performance.


Eligibility criteria:
inclusion criteria: * sailors * enrolled as students in the surface warfare medicine institute's independent duty corpsman school exclusion criteria: * administratively rolled over into another class * dropped out of the school (due to academic or medical reasons)

Keywords: perceived stress depression anxiety posttraumatic stress disorder military school training environment heart rate variability progressive muscle relaxation psychophysiological coherence coherence advantage stress reduction stress regulation independent duty corpsmen
a trial of shr-1210 in combination with shr6390 in patients with advanced crc, nsclc and hcc

Conditions: CRC; HCC; NSCLC

Summary: this is a phase ib/ii , open-label , investigator-initiated trail of shr-1210 (an anti-pd-1 inhibitor) in combination with shr6390 (a cdk4/6 inhibitor) in patients with advanced colorectal cancer, non-small cell lung cancer and hepatocellular carcinoma. the study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. the first part of the study is the dose-finding phase designed to establish the safety of shr-1210 combination with shr6390 at different dose levels(150mg qd or 100mg qd ). the second part of the study is the expansion phase designed to generate additional clinical data at specified doses . this study aims to evaluate the safety and efficacy of shr-1210 combination with shr6390 in the treatment of advanced crc,nsclc and hcc.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in this study and sign informed consent . * men or women aged 18-75 years * has confirmed by histology and cytology advanced and/or metastatic colorectal cancer patients, the advanced (ⅲ b/ⅳ period) in non-small cell lung cancer，or patients with advanced hepatocellular carcinoma confirmed histologically or cytologically or clinically，at least one measurable lesion that meets the recist v1.1 criteria without local treatment. * the patients can swallow pills normally. * ecog score was 0 or 1. * have a life expectancy of at least 12 weeks. * the functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : neutrophils≥1.5 x 109/l, hb≥9g/dl; plt≥90 x 109/l, alb≥3g/dl, tsh≤uln(upper limit of norma), tbil ≤ 1.25 x uln, alt and ast ≤ 1.5 x uln, akp≤ 2.5 x uln, cr≤ 1.5 x uln * female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment. exclusion criteria: * subjects had any active autoimmune disease or history of autoimmune disease. * subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. it is still in use within 2 weeks before enrollment. * subjects with severe allergic reactions to other monoclonal antibodies. * the subjects had a central nervous system metastases of clinical symptoms. * central lung squamous cell carcinoma, or nsclc with large vascular invasion confirmed by imaging. * a heart condition or disease that is not well controlled. * subjects had active infections. * other clinical trials of drugs were used within 4 weeks prior to the first administration. * the subjects have received other pd-1 antibody therapy or other immunotherapy for pd-1 / pd-l1 or cdk4/6 inhibitor treatment in the past. * there are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
magnesium lactate in the reduction of gestational diabetes incidence.

Conditions: Pregnancy Related

Summary: gestational diabetes, occurs during the second or third trimester of pregnancy, with no prior history of diabetes; this entity can be resolved at the end of pregnancy. magnesium is the fourth most abundant mineral in the body, it plays an essential role in the regulation of insulin metabolism, in the functions of adenosine triphosphate. in mexico, the prevalence of hypomagnesemia is 36.3% for women. findings suggesting that magnesium supplementation may be a beneficial indication in metabolic glucose disorders. the hypothesis of this study is: that magnesium lactate administration is safe and reduces the incidence of gestational diabetes.

objective: this study aims to evaluate the efficacy and safety of magnesium lactate oral administration in reducing the gestational diabetes incidence. design: randomized, double-blind, placebo-controlled clinical trial. study population: pregnant women aged 19 to 35 years, in the twelfth week of pregnancy, whit hypomagnesemia and without the concomitant disease. study groups: an intervention group and a control group. sample size: it was calculated using a statistical power of 80%, an alpha value of 0.05; 15% of the difference in the mean of gestational diabetes incidence control group and intervention groups was considered. the estimated sample size was 110 subjects for each group. process: all eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups. the intervention group will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement; the control group will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement. the blood concentrations of glucose, triglycerides, magnesium, creatinine, transaminases, and thyroid hormones will be measured, as well as the anthropometric measurements, at baseline and end conditions. also, an oral glucose tolerance curve will be realized at the 20th gestation week. statistical analysis: numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. differences between the groups were estimated by unpaired student t-test for numerical variables (mann-whitney u test for skewed data) or chi-square and fisher´s exact test for categorical variables. intragroup differences were estimated by paired student t-test.

Eligibility criteria:
inclusion criteria: * pregnant women aged 19 to 35 years. * 12th to 14th gestation weeks. * informed consent of the participant. exclusion criteria: * diabetes. * high blood pressure. * hypertriglyceridemia (\>250 g/dl) * neoplasia disease. * thyroid disease. * hepatic disease. * consumption of alcoholic beverages. * smoking. * medication use (thiazide diuretics, anti-blocking agents, calcium antagonists, statins, nicotinic acid, phenytoin, valproic acid, antidepressants, beta-adrenergic, theophylline, glucocorticoids, in the last year)
a companion sample collection protocol to support the discovery of breast cancer aberrations with treatment of cdk4/6 therapy/lee011/ribociclib

Conditions: Breast Cancer

Summary: this study was a companion study to clee011a2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

this was a multicenter, non-treatment based companion sample collection protocol conducted in the us only. this protocol sought to evaluate the aberrations of common pathways for newly diagnosed hr+/her2- advanced breast cancer tumors and responses to ribociclib in diverse patient populations. this companion sample collection protocol was available for all us patients enrolled on clee011a2404 (compleement-1) and did not alter the planned treatment. tumor collection required for this study occurred at two time points: at baseline/screening and upon the development of progressive disease as shown in the protocol. patients eligible for this companion study were required to sign an optional additional consent form at the time of enrolling into the core trial. after eight patients had consented and samples had been taken, it was determined that the companion study protocol had not been properly initiated or monitored at the sites. this was determined to be a significant gcp violation and the clinical team made the decision to terminate the trial. in addition to the gcp issues, enrollment had been closed to the core study so enrolling additional patients was no longer possible. the limited number of samples would not provide any meaningful analysis. the samples were never analyzed. the study was not terminated due to safety or efficacy concerns. samples collected were either destroyed or will be retained for up to 15 years based upon the decision of the patient.

Eligibility criteria:
inclusion criteria: * written informed consent was to have been obtained prior to any baseline/screening procedures. * patients eligible for this companion sample collection protocol sample collection protocol must have met all inclusion in clee011a2404. exclusion criteria: * patients eligible for this companion sample collection protocol must not have met any of the exclusion criteria in the clee011a2404 study, in addition to the following: * patients without either fresh or archival tumor tissue accessible.

Keywords: hr-positive her2-negative advanced breast cancer lee011 ribociclib letrozole femara cdk cdk4 cdk6 cdk4/6 cdk4/6 inhibitor phase iii phase iiib er-positive pr-positive postmenopausal premenopausal men
immunogenicity and safety of v70p5 revaccination subjects

Conditions: Influenza

Summary: this study will evaluate the safety and immunogenicity of children previously primed in the v70p5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.


Eligibility criteria:
inclusion criteria: * healthy male or female children that have previously participated in the v70p5 study in finland. exclusion criteria: * any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.

Keywords: influenza trivalent adjuvanted vaccine children
a study of uk-369,003 on the safety and efficacy in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a randomised, controlled study investigating the effect of uk-369,003 on exercise tolerance in patients with copd


Eligibility criteria:
inclusion criteria: * gold criteria 2 to 4 * 10 pack year history of smoking exclusion criteria: * women of child bearing potential
stress reduction for overweight or obese women either with polycystic ovary syndrome (pcos) or without pcos (non-pcos)

Conditions: Polycystic Ovary Syndrome; Overweight; Obesity; Stress, Physiological; Stress, Psychological

Summary: the purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with polycystic ovary syndrome (pcos) or without pcos (non-pcos). stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.


Eligibility criteria:
inclusion criteria: 1. women, age 18 years or older 2. body mass index (bmi) ≥ 25 kg/m2 (overweight or obese) exclusion criteria: 1. current pregnancy 2. secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, cushing's syndrome, or hyperprolactinemia (prolactin \>30) 3. untreated hypothyroidism or hyperthyroidism (defined as tsh \ 5.5 miu/ml) 4. severe active neuropsychological disorder such as psychosis or suicidal ideation 5. severe untreated depression or anxiety. women with severe depression or anxiety will be allowed to participate if they are under the care of a mental health specialist as long as they have permission to do so from their mental health specialist and will continue to follow-up with their mental health specialist during the study. 6. history of an inpatient admission for psychiatric disorder within the past two years 7. active alcohol or drug abuse 8. inability to read, speak or write english 9. inability to commit to the intervention and follow-up 10. current enrollment in a stress reduction program 11. mindfulness practice within the past 6 months (regular formal practice at least once a week) 12. current enrollment in other investigative studies 13. type 1 diabetes

Keywords: polycystic ovary syndrome stress mindfulness meditation health education women overweight obesity
intravenous fluids in pediatric migraine

Conditions: Migraine; Migraine in Children

Summary: the goal of this clinical trial is to compare intravenous (iv) fluids in pediatric patients with migraine. the main questions it aims to answer are: * does a large amount of fluids (bolus) improve pain * does a large amount of fluids (bolus) reduce admissions to the hospital for migraine participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours. researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.

patients will be randomized to one of two treatment groups. the intervention group will receive a 20 ml/kg bolus of normal saline (with a maximum of 1l), given over one hour. the control group will receive normal saline at half maintenance (with a maximum of 50ml/hr) over one hour. both groups will receive: * ketoralac (toradol), 0.5mg/kg, with a maximum of 30mg * diphenhydramine(benadryl), 0.5mg/kg, with a maximum of 25mg * prochlorperazine(compazine), 0.15mg/kg, with a maximum of 10mg pain score, heart rate, and blood pressure will be monitored every 30 minutes from the start of the medications/fluids being started, for a period of two hours. pain will be recorded using a 100mm visual analog scale.

Eligibility criteria:
inclusion criteria: * at least 1 prior headache * minimum pain score of 10mm * headache lasting 2-72 hours * at least two of the following four: 1 bifrontal/bitemporal or unilateral location, 2 pulsating quality, 3 moderate or severe pain intensity, 4 aggravation by or causing avoidance of routine physical activity * at least one of the following: 1 nausea and/or vomiting, 2photophobia and phonophobia, 3 not better accounted for by another ichd-3 diagnosis exclusion criteria: * shunted hydrocephalus * temperature equal to or greater than 38.5c * clinical suspicion of meningitis * known or suspected intracranial lesion * clinical evidence of significant dehydration (or signs of shock, or attending discretion) * head trauma in previous 7 days * pregnancy or breastfeeding * initial pain score less than 10mm * allergy to study medications * patients previously participating in the study

Keywords: migraine headache pediatric fluids bolus
the safety and tolerability of intra-abdominal t-pa and dnase on peritonitis in peritoneal dialysis patients

Conditions: Peritoneal Dialysis; Peritoneal Dialysis, Continuous Ambulatory

Summary: hypothesis: intraperitoneal tpa and dnase is well tolerated at a number of different doses. different doses of tpa and dnase will have a dose-related effect on inflammatory markers (crp and intraperitoneal white cell count). aims: 1. to examine the tolerability of different doses of intraperitoneal tpa and dnase compared to standard treatment. 2. to examine the changes in biochemical and clinical outcomes of pd peritonitis with the addition of intraperitoneal tpa and dnase to usual therapy.


Eligibility criteria:
inclusion criteria: 1. pd patient 2. proven peritonitis (as defined as at least 2 of: (i) symptoms and/or signs of peritonitis; (ii) cloudy dialysate or dialysate white cell count \> 100x 106/l with \>50% neutrophils; (iii) positive culture of dialysate 3. age \> 18 years old exclusion criteria: 1. more than one organism on culture 2. contra-indication for systemic thrombolysis (eg. current or recent stroke, major haemorrhage or major trauma; proliferative retinopathy; major surgery in the previous 5 days) 3. known sensitivity to dnase or t-pa 4. pregnancy or lactating mother 5. expected survival less than 3 months 6. clinical indication for pd catheter removal, as defined by treating team 7. inability to provide written informed consent 8. systemic anticoagulation 9. severe uncontrolled hypertension 10. documented ulcerative gastrointestinal disease during the last three months

Keywords: peritoneal dialysis peritoneal dialysis, continuous ambulatory peritonitis