Kornimate/medical-research-clean huggingface dataset:
a 16 weeks study on efficacy and safety of two doses of empagliflozin (bi 10773) (once daily versus twice daily) in patients with type 2 diabetes mellitus and preexisting metformin therapy

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (t2dm) and insufficient glycaemic control. both doses may be given once daily or split to a twice daily dosage. this results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). this is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of t2dm 2. glycated hemoglobin (hba1c) \>=7.0 and \<=10/0% at visit 1 3. metformin therapy (at least 1500 mg/day, bid) 4. age\>=18 at visit 1 5. body mass index \<=45 kg/m2 exclusion criteria: 1. estimated creatinine clearance rate (eccr) \<60 ml/min (cockcroft-gault formula) screening and/or run-in 2. a confirmed glucose level \>240 mg/dl (\>13.3 mmol/l) after an overnight fast during placebo run-in
efficacy and safety of hydromorphone-ropivacaine versus sufentanil-ropivacaine for epidural labor analgesia

Conditions: Analgesia; Labor Pain

Summary: the purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone. participants will be randomly allocated to four groups : group 1, group 2, group 3 and group 4. for those in group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, for those in group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, for those in group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, for those in group 4 : they will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia. the goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ii * a single fetus * competent to provide informed consent exclusion criteria: * severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia * severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy * placenta previa
prospective treatment algorithm guiding repair of severe ischemic mitral regurgitation

Conditions: Mitral Regurgitation

Summary: ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease ischemic mitral regurgitation, or imr, is normally treated by repairing or replacing the mitral valve. currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. some surgeons, including dr. vincent chan, the principal investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. this study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. this algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.


Eligibility criteria:
inclusion criteria: * severe ischemic mitral valve regurgitation * 18 years of age, and able to provide informed consent. exclusion criteria: * mixed mitral valve pathology * acute ischemic mitral regurgitation
impact of social media on the development of anorexia nervosa

Conditions: The Focus of Study Were the Medical Students Whose Eating Behaviors Were Studied

Summary: the study involves the recruitment of medical students from all government medical colleges of karachi,pakistan. the sample size was 214. the study is a cross sectional study that requires the participants to fill out an online questionnaire after giving an informed consent online.

the study involves the recruitment of medical students from all government medical colleges of karachi, pakistan. the sample size was 214. the study is a cross sectional study that requires the participants to fill out an online questionnaire after giving an informed consent online.the questionnaire contained 15 items related to their social media use and its impact on their body image and eating behaviours.

Eligibility criteria:
inclusion criteria: * medical students of karachi * all should be aged 18 to 25 years * both genders included exclusion criteria: * non consenting participants * those who donot have access to social media
treovance stent-graft with navitel delivery system for patients with infrarenal abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysms

Summary: the primary goal of the study is to assess the safety and performance of the treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. the results of this study will permit the establishment of endpoints and clinical design for a subsequent u.s. trial.


Eligibility criteria:
inclusion criteria: * subjects with diagnosed with an infrarenal abdominal aortic aneurysm (aaa), with or without iliac artery involvement * subjects with an infrarenal aaa that is \>/= 4.5 cm in diameter for males, or \>/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months * subjects who consent to participate * subjects who agree to comply with the follow-up schedule exclusion criteria: * subjects with dissections, ruptured aneurysms, or symptomatic aneurysms * subjects with prior aaa repair * subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., marfan's syndrome, morbid obesity, severe coronary artery disease) * subjects who are pregnant or lactating * subjects participating in other investigational studies * subjects with less than 2 years life expectancy

Keywords: treovance aneurysm aaa
drug eluting balloon angioplasty for recurrent cephalic arch stenosis in dialysis fistulas

Conditions: Dialysis Access Dysfunction

Summary: this study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (deb) versus conventional percutaneous transluminal angioplasty (pta) for the treatment of hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in hemodialysis patients.

the cephalic vein constitutes the major outflow conduit for radial- cephalic autogenous accesses and is the sole outflow conduit for brachial- cephalic autogenous accesses. the portion of the cephalic vein that becomes perpendicular in the region of the deltopectoral groove before its confluence with the axillary or subclavian vein,the cephalic arch, is prone to the development of hemodynamically significant stenosis which is usually treated with balloon angioplasty. unfortunately restenosis due to angioplasty induced intimal hyperplasia is common and periodic repeated angioplasty is necessary to maintain patency. paclitaxel is a mitotic inhibitor used in cancer chemotherapy which is used as an antiproliferative agent for the prevention of restenosis (recurrent narrowing) of blood vessels after balloon angioplasty caused by excessive intimal proliferation. it is locally delivered to the wall of the blood vessel during the dilatation using a paclitaxel eluting balloon. initial trials with these balloons have shown promising results in peripheral arteries and early encouraging results in dialysis access.

Eligibility criteria:
inclusion criteria: * upper limb dialysis access fistula * angiographically demonstrated cephalic arch stenosis \>50% within 6 months of last angioplasty using a non drug eluting balloon * clinical evidence of hemodynamically significant stenosis: strong pulse and weak thrill on physical exam, prolonged bleeding from puncture sites, raised kt/v, raised dialysis venous pressure exclusion criteria: * contrast allergy * unable to give informed consent * cephalic arch stent or stent graft * life expectancy less then 6 months

Keywords: dialysis fistula cephalic arch stenosis balloon angioplasty drug eluting balloon
tio2-scaffolds for alveolar ridge preservation

Conditions: Alveolar Bone Resorption

Summary: the goal of this clinical trial is to evaluate the safety of placing tio2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction.

the primary objective of the clinical trial is to evaluate the safety of placing tio2 scaffolds in alveolar ridge. the secondary objectives are; (1) to assess anatomical changes as measured by intraoral digital scanning at the time of extraction, after 6 months. (2) to evaluate soft tissue inflammation at 1, 2, 4, 12 and 24 weeks post-surgery, (3) to assess the preservation of the alveolar ridge following placement of tio2 scaffold in the alveolae after tooth extraction, (4) to assess bone mineralization and quantitative healing in bone biopsies obtained at implant installation in the preserved site 6 months following treatment.

Eligibility criteria:
inclusion criteria: * subject must be ≥ 20 years, and present with a molar or premolar planned for extraction exclusion criteria: * individuals with medical conditions that may affect soft tissue or bone metabolism * previous local radiotherapy * current use of chemotherapy * systemic long-term corticosteroid treatment. * diabetes * smokers (\> 10 cigarettes/day). * patients with active of untreated periodontal disease. * present or past use of bisphosphonate treatment * pregnant or nursing subjects * \> class 2 according to the asa (american society of anesthesiologists) physical status classification * acute infection or no apical periodontitis visible on radiograph of tooth planned for extraction.

Keywords: scaffold bone resorption
hbsab response after hbv vaccination in chronic hepatitis b patients who have lost hbsag

Conditions: Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Summary: chronic hbv infection is major problem in asian countries. years after chronic infection, in some cases serum hbsag level declines to unmeasurable level. some of patients develop anti-hbsab but there is no standard treatment to accelerate hbsag seroconversion. there is a study to determine efficacy and safety of hbv vaccine in who is chronic hbv infection and lost their hbsag without seroconversion to anti-hbsab.


Eligibility criteria:
inclusion criteria: chronic hepatitis b infection group * 18-80 year-old * compensated liver disease * chronic hbv infection with or without nucs treatment * history of hbsag positive \> 6 months * hbsag negative with qualitative elecsys (roche) twice at least 6 months apart * hbsab negative * hbv dna \< 20 iu/ml healthy group * healthy person without history of hbv vaccination (hbsag, anti-hbc and hbsab negative) exclusion criteria: * history of previous hbv vaccination * anti-hcv and/or anti-hiv positive * decompensated cirrhosis * history of previous malignancies * history or currently receive immunotherapy, cytotoxic or immunosuppressive agents * patient with immunodeficiency disease * creatinine \> 1.5 mg/dl * pregnancy or lactating woman * unable to consent
smart cupboard-based system for memory assessment in alzheimer's patients

Conditions: Alzheimer Disease; Cognitive Decline

Summary: the main objective of the research is to create a tool that can make a good diagnosis of cognitive abilities in alzheimer's patients. as a secondary objective, the investigators intend to examine both the percentage of correct answers and the response times and see their relationship with age, gender, sex, months since the onset of the disease and years of training.


Eligibility criteria:
inclusion criteria: 1. being over 18 years. 2. provide signed informed consent. 3. have the ability to understand the study. exclusion criteria: having any physical or medical problem that prevents or advises them not to stand upright, in a bipedal position.
role of interleukin-1β and prostaglandin e2 in prediction and outcome of apnea in neonates

Conditions: Premature Newborns; Premature Newborns With Gestational Age 28 to 33 Weeks

Summary: our thesis proposed that il-1β may affect brainstem respiratory control via prostaglandin-dependant mechanism so we investigated the mediator roles of il-1β and pge2 levels in predicting apnea in pretertm newborn and their relation to clinical outcomes.


Eligibility criteria:
inclusion criteria: * preterm infants born at less than 37 weeks of gestation. * neonates aged from birth up to 28 days. * neonates diagnosed with apnea of prematurity or exhibiting apneic episodes exclusion criteria: * full-term neonates. * neonates with major congenital malformations or genetic syndromes. * neonates with severe neurological impairments (e.g., intraventricular hemorrhage grade iii or iv). * neonates with confirmed or suspected sepsis or active infections. * neonates receiving steroids, nonsteroidal anti-inflammatory drugs (nsaids), or other medications known to alter interleukin-1β or prostaglandin e2 levels. * neonates with congenital heart diseases. * neonates with a history of significant birth asphyxia requiring extensive resuscitation. * neonates whose parents or guardians refuse to provide informed consent.

Keywords: apnea of prematurity interleukin-1β prostaglandin e2 outcome
duloxetine stress urinary incontinence efficacy and safety study

Conditions: Urinary Incontinence, Stress

Summary: study f1j-mc-sbbu will examine the effect of duloxetine treatment in women with sui. the inclusion and exclusion criteria of this phase 3 study will ensure that all subjects have a clinical diagnosis of sui.


Eligibility criteria:
inclusion criteria: * present with sui based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of sui for a minimum of 3 months prior to study entry. * are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[iud\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study. * are free of uti symptoms and have a negative urine dipstick for nitrates and leukocyte esterase. * have discrete episodes of incontinence (that is, are dry between episodes and not continuously leaking urine, synchronous with increased intra-abdominal pressure from coughing, sneezing, exercising, etc.). * have seven (7) or more incontinence episodes per week, urinary diurnal frequency of eight (8) or less per day and nocturia of two (2) or less per day with denial of urge incontinence as a predominant symptom per micturition history collected at visit 1. an incontinence episode is defined as an easily noticeable leakage of urine that would wet a pad, containment garment, or article of clothing. diurnal refers to the voiding episodes that occur during the normal awake hours. nocturia refers to the voiding episodes that occur during the normal sleeping hours and that wake the subject. exclusion criteria: * suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation). * has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject. * are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study. * have had any major inpatient surgery within 3 months prior to study entry. * have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: 1. ureteric, bladder, urethral, or rectal fistula 2. uncorrected congenital abnormality leading to urinary incontinence 3. detrusor instability or noncompliant bladder 4. adult enuresis 5. voiding difficulty (i.e., subject complains of difficulty emptying their bladder).
high-voltage pulsed radiofrequency of the lumbar dorsal root ganglion for the treatment of chronic lumbar radicular and neuropathic pain; a prospective, doble-blinded and randomized controlled trial

Conditions: Pulsed Radiofrequency; Lumbar Radiculopathy

Summary: the management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. pulsed radiofrequency (prf) has been described in these cases. in order to determine whether high-voltage prf show better results than prf a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes. * correlation between clinical symptoms and lesion observed by magnetic resonance imaging (mri). * radicular syndrome of three months or more of evolution. * normal or pathological electromyogram (emg). * pain with neuropathic characteristics confirmed by the dn4 neuropathic pain questionnaire. * patients with a previous positive block diagnosis. * patients who have signed the informed consent document. exclusion criteria: * patients under 18 years of age. * patients with non-radicular low back pain. * mri not consistent with the patient\&#39;s symptoms. * patients with peripheral neuropathy of the lower extremities. * patients with a history or current diagnosis of serious mental disorder. * patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome. * infection at the puncture site. * coagulation disorders. * pregnant patients. * patients who refuse to sign the informed consent document. * patients allergic to radiological contrast.
comparison of two liraglutide formulations in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to test for bioequivalence of two formulations of liraglutide.


Eligibility criteria:
inclusion criteria: * good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs and blood and urinary laboratory assessments * body mass index (bmi) of 18-27 kg/m\^2 incl. exclusion criteria: * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the study, as judged by the investigator * impaired renal function * uncontrolled treated/untreated hypertension * any clinically significant abnormal ecg * active hepatitis b and/or active hepatitis c * positive hiv (human immunodeficiency virus) antibodies * history of alcoholism or drug abuse during the last 12 months * smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator * excessive consumption of a diet deviating from a normal diet as judged by the investigator
a study to test long-term safety of iclepertin in people with schizophrenia who took part in a previous connex study

Conditions: Schizophrenia

Summary: this study is open to adults with schizophrenia who took part in a previous connex study (study 1346-0011, 1346-0012, or 1346-0013). the purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called iclepertin in the long term. participants take iclepertin as tablets once a day for 1 year. in addition, all participants take their normal medication for schizophrenia. participants are in the study for a little more than 1 year. during this time, they visit the study site about 13 times and get about 9 phone calls from the study team. the doctors collect information on any health problems of the participants. doctors also regularly check the participants' symptoms of schizophrenia.


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent. * clinically stable outpatients who have been diagnosed with schizophrenia (as per diagnostic and statistical manual of mental disorders 5th edition (dsm-5)). * patients, who completed participation in the parent trial. * women of childbearing potential must use highly effective methods of birth control. * have a study partner who interacts with the patient on a regular basis. further inclusion criteria apply. exclusion criteria: * participant who developed dsm-5 diagnosis other than schizophrenia or any condition that would prevent the patient from participating in the extension trial since enrolment into the parent phase iii trial. * any suicidal behavior and/or suicidal ideation of type 5 based on the columbia suicidality severity rating scale (c-ssrs) in parent trial and up to and including visit 1 of this study. * positive urine drug screen ≥ 3 times during the treatment period of parent trial. * patients who are currently or wish to participate in another investigational drug trial. * any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial. further exclusion criteria apply.