Kornimate/medical-research-clean huggingface dataset:
basal bolus therapy in patients with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: primary objective: to evaluate the efficacy of the association lantus (once-a-day, od) apidra (thrice-a-day, tid) in terms of change hba1c from baseline to end of study (week 24), in patients with type 1 diabetes mellitus (t1dm). secondary objectives: to evaluate: * the change of hemoglobin a1c (hba1c) from baseline to week 12 * the percentage of patients with hba1c \< 7% at week 12 and week 24 * the fbg and the 7-point self monitoring of blood glucose (smbg) at baseline, week 12 and week 24 * the daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24 * the incidence of symptomatic hypoglycemias * adverse events

after a two-week run-in period patients will enter a six-month treatment period. estimated study duration per patient : 26 weeks (including a 2-week run-in period).

Eligibility criteria:
inclusion criteria: 1. known type 1 diabetic patients (male or female) treated with any type of insulin regimen, except: * continuous subcutaneous insulin infusion (csii, or pump), and * patients already treated with insulin glargine 2. age: 18-60 years inclusive 3. hba1c: 8% - 10% assessed over the past 6 month 4. at least 1 year of continuous insulin treatment 5. willingness to accept, and ability to follow: * a basal bolus regimen (glargine x1 and glulisine x3 per day), * self-monitoring blood glucose (smbg) * a fixed meal plan, or cho counting 6. signed informed consent obtained prior to any study procedure criteria for entry in the treatment period: 1. hba1c 8-10% assessed between week -2 and week 0 2. serum creatinine ≤135 micromol/l in men and ≤110 micromol/l in women 3. alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) lower or equal to three times the upper limit of normal 4. pregnancy test negative if women of childbearing potential exclusion criteria: 1. history of hypersensitivity to insulin glargine and/or insulin glulisine 2. pregnant, breast-feeding or women of childbearing potential not using efficient contraception 3. brittle diabetes 4. known impaired renal function defined as serum creatinine \> 135 micromol/l in men and \> 110 micromol/l in women at study entry 5. known impaired hepatic function defined as alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal at study entry 6. diabetes ketoacidosis 7. history of drug or alcohol abuse 8. psychiatric or mental disease 9. inclusion in another study in the past 6 months or previous inclusion in this study 10. patient unable or unwilling to manage properly the basal bolus regimen the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
evaluation of keyo in children with epilepsy

Conditions: Intractable Epilepsy; Glucose Transporter Type 1 Deficiency Syndrome; Ketogenic Dieting

Summary: to evaluate the tolerance, acceptability and compliance of keyo in 20 subjects aged 3 years and over, with intractable epilepsy or glut-1 ds on a kd.

qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product. collection of daily data about the gastro-intestinal tolerance of the study product. collection of daily data about compliance with the study product i.e. actual versus prescribed intake. improve quality of life by increasing range of foods available for use in a ketogenic diet.

Eligibility criteria:
inclusion criteria: * 3 years and over * confirmed diagnosis of intractable epilepsy or glut-1 ds * children must be currently established on a kd for at least 3 months, taken orally * written, informed consent by participant/carer exclusion criteria: -

Keywords: epilepsy glut ketogenic glucose
evaluation of omarigliptin (mk-3102) in obese participants and in participants with type 2 diabetes (mk-3102-004)

Conditions: Type 2 Diabetes (T2D)

Summary: this study will test the safety and tolerability of omarigliptin. it is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with type 2 diabetes (t2d) will be sufficiently safe and well tolerated to permit continued clinical investigation.


Eligibility criteria:
inclusion criteria: * obese (body mass index \[bmi\] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential * has been diagnosed with t2d (panel b) * is not actively participating in a weight loss program exclusion criteria: * has a history of clinically-significant disease (other than t2d) * has a history of cancer * has estimated creatinine clearance ≤60 ml/min * is unable to refrain from or anticipates the use of any prescription or non-prescription medication * consumes excessive amounts of alcohol or caffeine * has participated in a previous omarigliptin study

Keywords: type 2 diabetes (t2d)
reducing menopausal symptoms for women during menopause using group education in a primary health care setting

Conditions: Menopause

Summary: the aim of the study is to investigate if group education about the topic menopause to women in phc can improve women's menopausal symptoms and reduce depression.

one hundred twenty women will be included in the study. the survey population consists of swedish-speaking women aged 45-55 years and seek care at distriktsköterskemottagningen in skene and at the antenatal clinic in svenljunga. the selection is done consecutively. method: grouping:the women will be randomly allocated to intervention group and control group (60/60). the intervention: the project includes the implementation of a total of four equivalent group treatments. two of the group education will be at skene medical center and two svenljunga medical center. group treatments are carried out by the district nurse and midwife in common. each treatment group includes 15 women. a total of 60 women will thus participate in group education..each treatment group consists of two information sessions of 2 hours. the first information contains information about the menstrual cycle, hormonal shift, urogenital symptoms, and information on prevention and health promotion self-care. the other information currently contains information about cardiovascular risk factors during menopause, relations, mental health, information about depressive symptoms and for preventive measures and health-promoting self-care. the control group did not obtain any group education or any other intervention.

Eligibility criteria:
inclusion criteria: * female gender, 45 to 55 years of age, comprehension and fluency in the swedish language. exclusion criteria: * that the patient did not any longer want to participate in the study.

Keywords: climacteric education mental health menopause
a multiple dose study to assess the safety and tolerability of bms-986166 in healthy volunteers

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to understand if multiple oral doses of bms-986166 are safe and well tolerated in healthy patients.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy female patients of non-childbearing potential or male patients as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ecg), and clinical laboratory evaluations will be eligible to participate in the study * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive * this study permits the re-enrollment of a patient that has discontinued the study as a pre-treatment failure (i.e. patient has not been randomized / has not been treated). if re-enrolled, the patient must be re-consented exclusion criteria: * women who are of childbearing potential, lactating or breastfeeding * any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or sponsor medical monitor * patients with history of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ecg abnormalities, or any congenital heart disease * patients with any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening * patients who have received any live vaccines within 1 month of study drug administration, or who plan to have a live vaccine at any time during the study, including during the follow up period * positive test for tuberculosis at screening * past or current history of neurologic disorders, guillain-barré syndrome, central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesia's (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities other protocol defined inclusion/exclusion criteria could apply
anti-oxldl igm antibodies as a novel therapy for metabolic lipid diseases

Conditions: Lipid Metabolism, Inborn Errors

Summary: to test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

growing evidence describes the central role of oxidized low density lipoproteins (oxldl) in diseases related to lipid metabolism. moreover, oxldl has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. relevantly, it has been shown that immunizing mice with streptococcus pneumoniae results in higher serum titers of anti-oxldl igm antibodies due to molecular mimicry.

Eligibility criteria:
inclusion criteria: * patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology) * familial hypercholesterolemia, * npb, * npc * partial lipodystrophy (pparg mutations and laminin a/c mutations) * intention to be treated and participate to the treatment - written informed consent exclusion criteria: * medical conditions that may interfere with the study procedures: cancer hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome * alcohol abuse (quantitative limit \>20g/day for men and \>10g for women) * illiteracy * patients younger than 10 years. * any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.
study evaluating dvs-233 sr in adult outpatients with major depressive disorder

Conditions: Depression; Depressive Disorder; Major Depressive Disorder

Summary: the main objective of this study is to compare the antidepressant efficacy and safety of dvs-233 sr versus placebo in adult outpatients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * outpatients * men and women age 18 years of age and older * women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception exclusion criteria: * treatment with dvs-233 sr at any time in the past * treatment with venlafaxine (immediate release \[ir\] or extended release \[er\]) within 90 days of study day 1 * known hypersensitivity to venlafaxine (ir or er) * significant risk of suicide based on clinical judgment, including common
performance of eeg during emergence agitation in nasal surgery.

Conditions: Nasal Surgery

Summary: the purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. it is still not enough to explain the relationship between emergence agitation and electroencephalogram in adults. researchers will demonstrate the relationship between parameters related electroencephalogram and emergence agitation in adults undergoing nasal surgery.

researchers use sedline to perform perioperative eeg measurements of young adult patients undergoing nasal surgery under general anesthesia with sevoflurane. emergence agitation occurrence and eeg patterns are observed. the researchers record the patient's sex, type of surgery, pre-education on emergence agitation, preoperative hospital anxiety and depression scale (hads), postoperative pain, amount of analgesics administered in the surgery/recovery room, and pacu time. investigators check the correlation between eeg and perioperative variables. investigators also compare eeg and perioperative variables for those who were given an explanation of emergence agitation and those who were not.

Eligibility criteria:
inclusion criteria: * adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent exclusion criteria: * cns disease (ex.dementia, stroke, brain tumor, psychological disorder..) * unable to communicate * general anesthesia history within 6 months * disagree to participate in study

Keywords: general anesthesia electroencephalogram emergence agitation sevoflurane
crt( chemo-radiation therapy) patterns and short-term outcomes on unresectable nsclc and sclc in routine practices in russia

Conditions: Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)

Summary: this is a multi-center, non-interventional, study with the aim to access routine practice of diagnostic and treatment approaches in patients with nsclc and sclc in 50 largest oncology centers in russian federation. the data for all 2000 patients with la nsclc and ls-sclc who receiving crt will have been collected for 2 years from the primary medical records. demographic and clinical characteristics of the patients, information of routine diagnostics procedures and treatment approaches for patients with unresectable la nsclc and ls-sclc and the treatment results of the end of crt will be collected. information about any specific nsclc or sclc treatments following crt (e.g., durvalumab) will not be collected in the study. patients with nsclc and sclc meeting the inclusion criteria will be prospectively enrolled into the study. study procedures will comply with all the local regulatory requirements regarding ae reporting (pharmacovigilance). study design considers secondary data collection approach using existing patients' medical records, after patients' visits according to routine sites' practice. data for visit (record) 1 will be collected at the start of crt (concurrent or sequential), and data for visit (record) 2 will be collected after the last dose of rt and with ct control results available, but the time frame for this data collection is expected to be no later than 6 months after visit 1.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. provision of written informed consent 3. patient received at least one rt dose under prescribed crt (concurrent or sequential) for definitive treatment of locally advanced nsclc (stage ii-iii, unresectable or inoperable nsclc, including locoregional recurrence and patient's refusal to undergo surgery) or ls-sclc based on local mdt decision 4. patient is currently undergoing rt (preferably no more than 10 doses) exclusion criteria: 1. participation in another clinical study with an investigational product during the last 3 months 2. confirmation that the subject was already included in this study before 3. absence of written informed consent form 4. data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database.
the effect of acupressure on preoperative anxiety and postoperative pain and nausea-vomiting

Conditions: Anxiety State; Pain; Vomiting; Nausea

Summary: the study was conducted in the ent clinic of mersin şehir training and research hospital between june 1 and december 1, 2021, with a total of 60 adult patients, 30 in the study group and 30 in the control group, who met the inclusion and exclusion criteria.

in the study, 60 patients were randomly assigned to the study and control groups. the study group (n = 30) included shen men, the 7th acupuncture point (ht7) of the heart meridian located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris tendon, ex-hn3 (yintang) located in the middle of the beginning of both eyebrows and the thumb and the li4 points located in the space between the index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied for an average of 15 minutes. no intervention didn't made to the control group (n = 30). the primary outcome of the study is the effect of acupressure on the state and trait anxiety level of patients. the secondary outcome of the study is the effect of acupressure on pain and nausea and vomiting level in patients. anxiety levels of the patients were evaluated before and 15 minutes after acupressure application; pain levels were evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * emergency ent surgery, * refused to participate in the research, * did not sign the informed consent form, * have a physical problem that prevents the application of acupressure to ex-hn3 (yintang), li4 and ht7 points, * diagnosed with anxiety, panic attacks and taking medication for anxiety, * previous surgical experience, * under 18 and over 65, * people with vision, hearing and perception problems, * unable to read and write turkish, * have any problem that prevents them from communicating cognitively, emotionally and verbally, * experience in acupressure, * patients who have received sedative medication before surgical intervention didn't be included in the study. exclusion criteria: * emergency ent surgery, * refused to participate in the research, * did not sign the informed consent form, * diagnosed with anxiety, panic attacks and taking medication for anxiety, * previous surgical experience * under 18 and over 65, * people with vision, hearing and perception problems, * unable to read and write turkish, * have any problem that prevents them from communicating cognitively, emotionally and verbally, * experience in acupressure, * patients who have received sedative medication before surgical intervention didn't be included in the study.

Keywords: pain ent patients
a phase ii, dose ranging study of cp-690,550 eye drops in patients with dry eye disease

Conditions: Dry Eye Syndromes

Summary: the purpose of the study is to evaluate dose-response, efficacy and safety of cp-690,550 eye drops in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: * subjective symptoms of dry eye for at least 6 months * signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia) exclusion criteria: * women who are nursing, pregnant or planning pregnancy during the study * participation in other studies within 30 days of screening visit * ocular disorders that may confound interpretation of study results

Keywords: dry eye
implementation of the heliostartm in real-world clinical practice at a high-volume center

Conditions: Atrial Fibrillation

Summary: the heliostartm catheter (biosense webster) is a new technology for pulmonary vein isolation (pvi) in atrial fibrillation (af), combining radiofrequency (rf)-ablation and 3d-mapping visualization with the concept of "single-shot"-ablation device. this study evaluates the operator learning curve und procedural outcome during implementation of the heliostartm.

the first patients undergoing pvi by heliostartm at heidelberg university hospital are included in this prospective study. procedures are performed by an operator proficient in cb-ablation. procedural outcome was analyzed over the course of increasing experience with the device and in comparison to a previous cohort investigated during implementation of the arctic fronttm-cryoballoon (medtronic).

Eligibility criteria:
inclusion criteria: * age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent af exclusion criteria: * history of prior af ablation, left atrial thrombus, suspected irregular pv-anatomy in pre-procedural transesophageal echocardiography (toe) or contraindication for peri-procedural anticoagulation therapy
low vw activity in adolescent hmb

Conditions: Von Willebrand Factor Deficiency

Summary: this is a research study for patients diagnosed with heavy menstrual bleeding (hmb) and low von willebrand factor (vwf). menstruation, also known as a period, is the regular discharge of blood and tissues from the uterus. hmb is having a heavier amount of discharge during menstrual period. low von willebrand factor means that the participant has lower level of a blood protein that is important for clotting of blood and so, the participant is at a higher risk for bleeding. the purpose of this project is to study the genetic differences of adolescent females with hmb and low vwf activity and compare the genetic differences with their bleeding manifestations, response to medications and outcome.

one hundred and twenty subjects will be enrolled. adolescent females with heavy menstrual bleeding (hmb) and low von willebrand factor (vwf) will be recruited. data collection will occur from participant's medical records in regards to their low vwf activity and hmb medical history. participants will be asked to complete symptom questionnaires in regards to their hmb. a blood sample will be collected to analyze how many participants have the disease causing sequence variation in the vwf gene and other genes affecting bleeding, clotting and blood vessel biology and correlated with their bleeding history. the blood sample will be deidentified and stored indefinitely for future research.

Eligibility criteria:
inclusion criteria: * post-menarchal females less than 21 years of age * hmb defined as pbac score greater than 100 * vwf:activity more than or equal to 30 and less than or equal to 50 iu/dl x 2 * vwf: activity /vwf:ag ratio greater than or equal to 0.6 * normal vw multimers, if performed exclusion criteria: * post menarchal females age greater than or equal to 21 years * vwf: activity less than 30 or greater than 50 iu/dl consistently, type 2 or type 3 vwd * presence of other bleeding disorders (thrombocytopenia, platelet function defect, coagulation factor deficiency, fibrinogen defect or deficiency)

Keywords: bleeding disorders heavy menstrual bleeding