Kornimate/medical-research-clean huggingface dataset:
phase 1b/2 study of carfilzomib, carboplatin, and etoposide in patients with previously untreated extensive stage small-cell lung cancer

Conditions: Extensive-Stage Small-Cell Lung Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for patients with extensive-stage small-cell lung cancer (es sclc).


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed diagnosis of extensive-stage small-cell lung cancer (es-sclc) with measurable disease per response evaluation criteria in solid tumors (recist) version 1.1; es-sclc is defined as: small-cell lung cancer (sclc) that has spread beyond one hemithorax and regional lymph nodes on the same side (e.g., supraclavicular) to the contralateral hemithorax, lymph nodes, or more distant locations in the body 2. subjects with asymptomatic brain metastases or other central nervous system (cns) disease at screening/diagnosis are eligible 3. males and females ≥ 18 years of age 4. eastern cooperative oncology group (ecog) performance status 0-1 key exclusion criteria: 1. previous systemic therapy to treat small-cell lung cancer (sclc). subjects with recurrent or progressive limited-stage sclc after previous systemic treatment are not eligible for study participation. 2. whole brain or focal radiation therapy within 14 days prior to cycle 1 day 1 (c1d1) for phase 1b or prior to randomization for phase 2 3. congestive heart failure (new york heart association \[nyha\] class iii to iv), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to prior to c1d1 for phase 1b or prior to randomization for phase 2
breath analysis in healthy controls

Conditions: Exhaled Breath; Mass Spectrometry; Healthy Subjects

Summary: the purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria:
inclusion criteria: 1. normal spirometry (forced expiratory volume in 1 second (fev1) \> 80%, forced vital capacity (fvc) \> 80%, fev1/fvc \> 70%.). 2. age between 18 and 90 years at study entry. exclusion criteria: 1. presence of an active malignancy. 2. presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (copd), sarcoidosis) 3. acute inflammatory disease (e.g. common cold) within the last 6 weeks. 4. acute or chronic hepatic disease. 5. renal failure or renal replacement therapy.
validation of subjective rating scales used to assess surgical conditions in abdominal surgery

Conditions: Surgical Conditions; Rating Scales; Laparoscopy; Neuromuscular Blockade; Pneumoperitoneum

Summary: use of neuromuscular blockade (nmb) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. however, no good subjective rating scale have been developed or validated. neither have possible inter-individual differences in use of such subjective scales been described. purpose: the aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * elective gynecologic laparoscopic operation * can read and understand danish * informed consent exclusion criteria: * bmi \> 30 kg/cm2 * known allergy to medications that are included in the project * severe renal disease, defined by s-creatinine\> 0,200 mmol/l, gfr \< 30ml/min or hemodialysis) * neuromuscular disease that may interfere with neuromuscular data * lactating or pregnant * impaired liver function * converting to laparotomy * perioperative use of neuromuscular blocking agents before randomization * pneumoperitoneum set to \>12 mmhg on the insufflator
primary care - continuous glucose monitoring

Conditions: Type 2 Diabetes Mellitus; Continuous Glucose Monitoring

Summary: introduction and objective: the key to optimal diabetes management is tight glucose control. hemoglobin a1c is the gold standard to assess glycemic control but in cases of unrecognized hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a haemoglobin a1c can not detect specific movement of blood glucose. continuous glucose monitoring (cgm) provides informations of glucose levels in a real-time format and may be helpful for making the personalized therapy decisions desired in the era of precision medicine. our aim is to analyse the benefit of tracking patterns of glucose values by using continuous glucose monitoring (cgm) in patients with t2dm in family medicine office.

study design: an observational, multicenter, cross-sectional study. a total of 20 gps from four croatian regions will recruit up to five subjects of both sexes from august 2017 till the end of september 2017, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with no insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycemia na haemoglobin a1c findings. sociodemographic, laboratory (hba1c, fasting and postprandial glucose, total cholesterol, high density cholesterol, low density cholesterol, triglyceride and serum creatinine) and habits data will be collected. setting: totally 100 of patients will be included. at primary care office each patient wear the device (ipro™2 medtronic) subcutaneously for up to 7-days and return it to the office for download. patients do not receive glucose alerts and only see the cgm data after it's been analyzed by the healthcare professional. a cgm device is to be set and take of by the gp. before the study start all gps will have a short education on cgm device by the diabetologist who use cgm on a daily base. study period is seven days and includes screening before study entry and two visits. on day 1, after screening and signing the informed consent, the cgm device is applied. patient is instructed to keep a 7 day diary with four daily standard home blood glucose monitoring (shbgm) along with the data on eating, physical exercise, drugs. bayer's contour® glucometer is used for the shbgm. on day 7, cgm device is took of and the data from ipro2 is uploaded to pc. at the end, each patient fill a short query on satisfaction while wearing cgm.

Eligibility criteria:
inclusion criteria: * t2dm diagnosed at least one year prior to study entry * no insulin in therapy * patients' ability to understand and answer the questionnaire by themselves * signed informed consent exclusion criteria: * known coagulopathy * oral anticoagulants in therapy * skin disease that enables continuous glucose monitor device application * febrile illness * patient's inability to physically visit a general practitioners office * patient's inability to answer the questionnaire by themselves

Keywords: glycemic variability hypoglycemia
effect of core stability exercises and balance training in postural control among down syndrome

Conditions: Down Syndrome

Summary: children with down syndrome often present with problems of posture \& balance and mobility. balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for children with ds. objective: to determine the effect core stability exercises and balance training in postural control among down syndrome.

this study was a randomized clinical trail. children with down syndrome were determined on inclusion \& exclusion criteria. children with down syndrome were arbitrarily allocated into two groups with ages ranged from 5 to 17 years. the sample size was 20 patients. they were assigned randomly into two groups. group 1 received balance training and group 2 received core stability exercises. the duration of treatment was 6 weeks. data is collected from comprehensive rehabilitation center chakwal postural stability was evaluated pre and post treatment by pediatric berg balance scale. values which were obtained after this intervention were analyzed for any change using spss

Eligibility criteria:
inclusion criteria: * trisomy 21 by genetic karyotype * a confirmed diagnosis of down syndrome by a paediatric neurologist, having no neurological or mobility disorders, * independent standing and walking abilities, * joint laxity , low muscle tone and psychomotor development deficits * normal vision and hearing exclusion criteria: * a history of congenital heart defects and orthopedic * surgery in the past year and severe mental retardation. * seizure * severe visual or auditory disturbances, * weight less than the 3rd percentile of down syndrome * multiple sclerosis or epilepsy

Keywords: down syndrome core stability postural control pediatric berg balance scale
home screening for chlamydia surveillance

Conditions: Chlamydia Trachomatis; Gonorrhea

Summary: this is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexually transmitted diseases.

this is a phase iii randomized controlled trial. we enrolled 403 young women from a variety of clinical settings and neighborhoods in the pittsburgh, pa region. women completed a baseline questionnaire and then were randomized to either an intervention group (receive home testing kit every six months) or to a control group (receive a letter suggesting a clinic visit for screening). participants were followed for 2 years, and medical chart abstraction was done to document tests done in clinical settings. the final study end points were number of tests completed, number of screening tests completed, number of stds detected, and incident cases of pelvic inflammatory disease.

Eligibility criteria:
inclusion criteria: age 15 to 29, 2 or more risk factors for stds, sexually active - exclusion criteria: currently pregnant, homeless -
community approach to reduce the risks of diabetes after gestational diabetes mellitus

Conditions: Diabetes

Summary: objective: the current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (dpp) curriculum in reducing type 2 diabetes risk in latinas with a history of gestational diabetes mellitus (gdm). research design and methods: seventy-six latinas aged 18-45 years with gdm in the past 3 years participated in an 8-week group-based, peer-educator led lifestyle intervention based on the dpp, with adaptations appropriate to latino culture and recent mothers. clinical and self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up (month-6). hypothesis-the modified culturally tailored dpp will improve risk factors associated with the development of type 2 dm.


Eligibility criteria:
inclusion criteria: * 18-45 years old * latina * gdm within the last 3 years * able and willing to participate in physical activity sessions exclusion criteria: * current diabetes * severe illness that would preclude them from coming to the sessions

Keywords: latinas gestational diabetes prevention
study of pain processing in subjects suffering from obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: we would like to test the effect of opioid medication on pain sensitivity in subjects who have been diagnosed with a sleep disorder called obstructive sleep apnea (osa) compared to other subjects without osa. patients with osa may have an altered sensitivity to the sedative, analgesic, and respiratory depressant effects of opioids.

the purpose of the study is to test the hypothesis that patients who suffer from moderate-to-severe osa have increased pain thresholds and are more sensitive to the analgesic effects of opioids compared to patients with normal sleep-related breathing physiology. we will evaluate the effect of remifentanil, a short acting mu-opioid receptor agonist, on pain using an experimental heat and cold-induced pain tests, and compare it between volunteers with and without a polysomnography (psg)-based diagnosis of obstructive sleep apnea.

Eligibility criteria:
inclusion criteria:1. male 2 .18 - 55 years of age 3. body mass index (bmi) lower or equal to 30 kg/m2 4. absence of severe systemic disease that results in functional limitations (i.e. poorly controlled hypertension, angina pectoris, prior myocardial infarction, pulmonary disease that limits activity) 5.subjects must be able to comprehend spoken and written english exclusion criteria:1. major psychiatric, neurological, or neuromuscular disorder 2. known diabetes mellitus or thyroid disease 3. allergy to study medication (remifentanil) 4. history of addiction 5. alcohol consumption which exceeds 2 drinks per day and /or drug abuse. 6. chronic or acute use of opioids, or other medications affecting the cns.
a study of ly3023414 and necitumumab in squamous lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: the main purpose of this study is to evaluate the safety and activity of the study drug known as ly3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous advanced nsclc (stage iv). * participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting. * measurable disease as measured by response evaluation criteria in solid tumors (recist) criteria v 1.1. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * able to swallow the study drugs whole. * adequate organ function. * women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment. exclusion criteria: * participants who have received \> 1 prior line of chemotherapy in the advanced or metastatic setting. (immunotherapy will not be considered a line of chemotherapy.) * prior treatment with a pi3k/mtor inhibitor, epidermal growth factor receptor (egfr) inhibitor, and/or necitumumab. * history of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment and stable without requirement of corticosteroids. * have serious pre-existing medical conditions. * have insulin-dependent diabetes mellitus. participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics. * women who are pregnant or breast-feeding. * clinically significant electrolyte imbalance ≥ grade 2. * currently receiving treatment with therapeutic doses of warfarin sodium. low molecular weight heparin and oral xa inhibitors are allowed. * have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-b ligand (rank-l) targeted agents (e.g. denosumab) ≤ 28 days prior to day 1 of cycle 1. * concurrent serious infection requiring parenteral antibiotic therapy. * have a second primary malignancy that in the judgment of the investigator and medical monitor may affect the interpretation of results. * have an active, known fungal, bacterial, and/or known viral infection. * history of arterial or venous embolism within 3 months prior to study enrollment. if the embolism occurred \>3 and \<6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.
comparative efficacy of liver fibrosis and steatosis assessment with fibroscan and ilivtouch

Conditions: Chronic Liver Disease; Liver Fibrosis; Liver Steatoses

Summary: this study is aimed to compare the results and operating characteristics of liver stiffness measurement with the use of fibroscan (echosens, france) and ilivtouch (wuxi hisky medical technologies co., china) in patients with chronic liver diseases.

this is prospective comparative trial to assess diagnostic characteristics of non-invasive methods of liver fibrosis and steatosis assessment based on the measurement of liver stiffness. the null hypothesis is that novel device, ilivtouch ft100/ft200 and standard probe allows to obtain similar results of liver stiffness and controlled attenuation parameter compared to fibroscan 530 and probes m+ and xl+ in patients with chronic liver diseases. according to the study protocol, standard examination will be performed to eligible subjects on the same day with the use of both devices. at least 10 measurements will be performed with the use of each device to each subject after overnight fasting. the medians of liver stiffness and controlled attenuation parameter measurements, their interquartile range, success rate of measurements and related interpretations of the results (grades of liver fibrosis and steatosis) will be compared. to assess the variability of the results, demographic data (age, biological sex, ethnicity) will be collected; weight and height of the subjects will be measured on the day of examination. medical history of the subjects will be examined to extract data, confirming the presence of chronic liver diseases and ensure eligibility.

Eligibility criteria:
inclusion criteria: * willingness to participate on the basis of the signed informed consent form; * availability of the medical records exclusion criteria: * pregnancy and breastfeeding; * narrow intercostal spaces making standard examination of the liver stiffness possible; * extreme obesity, in cases when amount of the fat tissue in right lower part of chest makes impossible to perform measurements; * ascites; * focal lesions of the liver (including, but not limited to liver cancer or metastases of cancer regardless of their origin, parasitic invasions, cysts) in projection of the measurements; * impossibility to perform evaluation with both devices due to any reasons; * any health-related conditions of a subject that put him/her at risk in case the procedures required per study protocol are performed or making him/her ineligible on the discretion of the investigator

Keywords: ilivtouch fibroscan liver stiffness measurement controlled attenuation parameter non-alcoholic fatty liver disease liver steatosis
russian clinical trial of mesenchymal cells in patients with septic shock and severe neutropenia

Conditions: Septic Shock; Nonchemotherapy Drug-induced Neutropenia; Neutropenia After Chemotherapy in Oncohematological Patients; Neutropenia in Patients With Aplastic Anemia

Summary: septic shock remains a significant clinical problem associated with high rates of mortality among neutropenic patient despite antimicrobial therapy and supportive care. recently, mesenchymal stromal cells (msc) have demonstrated remarkable potential effect in sepsis. msc treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial therapy. mscs reduced systemic inflammatory cytokine levels in mice, down-regulated of inflammation and inflammation-related genes (such as interleukin-10, interleukin-6). bacterial clearance was greater in msc-treated mice. thus, mscs have beneficial effects on experimental sepsis and suggest that msсs-therapy may be an effective adjunctive treatment to reduce sepsis-related mortality. the safety of mscs is proved by graft-versus-host disease treatment mscs in patients after bone marrow transplantation. this study hypothesis is that mscs reduce organ dysfunction/injury, systemic inflammation and mortality in patients with septic shock and severe neutropenia. the main goal of the study is to evaluate the impact of mscs therapy on organ dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock and severe neutropenia. all patients will be randomized in two groups: control group (standard treatment of septic shock) and mscs-group (standard treatment of septic shock + mscs infusion of 1-2 millions/kg/ day).

all activities related to this human subjects research have been guided by ethical principles and have been reviewed and approved federalwide assurance national ctr for hematology, fwa00006482. the goal of the trial is to evaluate plasma concentration of proinflammatory cytokine interleukin-6 and the antiinflammatory cytokine interleukin-10, plasma levels of blood creatinine, bilirubin, procalcitonin, c-reactive protein. then we will evaluate requirement for renal replacement therapy, requirement for mechanical ventilation or non-invasive mechanical ventilation, pulmonary function-coefficient, partial oxygen pressure arterial blood level, electrocardiograms, kaplan - meier curve,28-days mortality.

Eligibility criteria:
inclusion criteria: septic shock ≤10 hs after onset of septic shock severe neutropenia(≤ 1 10\^9/l) patients ≥17 years signed informed consent to treatment exclusion criteria: oncohematological patients with resistance to chemotherapy unsigned informed consent to treatment age \>75 years; pregnancy

Keywords: mesenchymal stromal cells septic shock neutropenia procalcitonin interleukin-6 interleukin-10 c-reactive protein survival organ dysfunction
role of alpha-lipoic acid in diabetes melitus type 1

Conditions: Diabetes MellitusType 1

Summary: this study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.

endothelial dysfunction and alterations in vascular structure are early indicators of future cardiovascular events. the atherosclerotic changes begin much earlier than the appearance of clinical disease. endothelial dysfunction in diabetes may be the result of a combination of multiple stressors. in the patients with type 1 diabetes, a significant increase in the concentrations of endothelial markers was already observed at the early stages of the disease including vascular cell adhesion molecules (vcam-1), intercellular adhesion molecules (sicam-1), soluble e- selectin e (se-selektin), asymmetric dimethylarginine (adma), plasminogen activator inhibitor 1 (pai-1) because their concentrations increase rapidly in states of cellular stress. increased carotid intima-media thickness (cimt) is a structural marker for early atherosclerosis that correlates with cardio-vascular risk factors. alpha -lipoic acid supplementation may have role in improving endothelial dysfunction and early atherosclerosis due to its oxidative and anti-inflammatory effect.

Eligibility criteria:
inclusion criteria: * children with t1dm on insulin therapy ≥ 0.5 iu/kg/day. * age range between 12 and \< 18 years old. * both sex. * duration of diabetes ≥ 3 years. * glycated hemoglobin of ≥ 7.5% * patients who are previously evaluated for endothelial dysfunction and atherosclerosis. exclusion criteria: * clinical evidence of heart failure, coronary artery disease, systemic hypertension, rheumatic fever, cardiomyopathy. * concurrent use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker, etc...). * concurrent use of hyperlipidemia agents (statin, fibrate). * concurrent use of antioxidants as selenium, vitamin c, vitamin e, etc.. * patients with inflammatory conditions. * patients with conditions predispose to oxidative stress (obesity, copd, etc...). * patients with liver disease. * patients with thyroid disease. * patients with seizures.