Kornimate/medical-research-clean huggingface dataset:
data collection during ct for axial flow vads

Conditions: Heart Failure

Summary: at present, there is not accurate way to determine specific flow rates for axial flow ventricular assist devices (vads). if a right heart cath is needed for these patients for clinical purposes, they will also undergo a cardiac ct scan while the pulmonary artery catheter is in place. it is possible to visualize the flow rates of axial flow vad's and determine a more accurate rate per specific patient. data analyzed with following results: article in press for cardiopulmonary support and physiology, results state "pairwise comparison of calculated output from left ventricular assist devices is feasible using first pass dynamic computed tomography test bolus technique versus thermodilution output measurements yielded good agreement (p=.03). the output calculated using dynamic ct underestimated the thermodilution output measurement by 0.54+ 0.37 l/min (95% confidence interval 0.66-0.94).

description as listed in summary. the hemodynamic data collected along with pump parameters may help determine more accurate flow rates specific to each patient.

Eligibility criteria:
inclusion criteria: * signed informed consent

Keywords: axial flow ventricular assist device cardiac ct stage iv heart failure
bioequivalence study of the fixed dose combination of 5 mg saxagliptin and 500 mg metformin xr tablet (manufactured in mt vernon, in) relative to 5 mg saxagliptin tablet and 500 mg metformin xr tablet (manufactured in evansville, in)

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to demonstrate bioequivalence (be) of a 5 mg saxagliptin/500 mg metformin extended release (xr) fixed-dose combination (fdc) tablet (manufactured in mt vernon, indiana \[in\]) to coadministered 5 mg saxagliptin and 500 mg metformin xr tablet (manufactured in evansville, in) in fed healthy subjects.

this study is designed to evaluate if the fdc tablet of 5 mg saxagliptin/500 mg metformin extended release (manufactured in mt vernon, indiana) is bioequivalent to the coadministered 5 mg saxagliptin and 500 mg metformin xr tablet (manufactured in evansville, indiana)

Eligibility criteria:
inclusion criteria: * healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ecg), and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive * ages 18 to 45, inclusive exclusion criteria: * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population * major surgical procedure within 4 weeks prior to randomization * positive serology test for human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) * clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease * history of gastrointestinal disease within the past 3 months * any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator * donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization * unable to tolerate oral and/or intravenous (iv) medications * unable to tolerate the puncturing of veins for drawing of blood * known allergy or hypersensitivity to any component of the study medication * history of any significant drug allergies (such as anaphylaxis or hepatotoxicity) * used any prescription drugs or over the counter products to control acid (for example, prevacid, mylanta or rolaids) within 4 weeks prior to randomization * used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization * taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization
efficacy and safety of the combination of valsartan plus amlodipine in hypertensive patients not adequately responding to the combination therapy with ramipril plus felodipine

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ace inhibitor plus calcium channel blocker


Eligibility criteria:
inclusion criteria: * male or female patients (18 years or older) * females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). * patients with moderate essential hypertension (who ii) exclusion criteria: * severe hypertension * pregnant or nursing women * treated hypertensive patients with controlled hypertension under current therapy (msdbp \< 90 mmhg and mssbp \< 140 mmhg) * a history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure nyha ii - iv * other protocol-defined exclusion criteria may apply

Keywords: hypertension
detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using oct angiography

Conditions: Diabetic Retinopathy

Summary: detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using oct angiography.

patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo oct angiography examination prior to their cataract surgery. average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, faz area (mm2) in the superficial capillary plexus, faz circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis. patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation. all patients will undergo oct angiography examination four weeks after their cataract surgery.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery. * patients who need cataract surgery without any intravitreal injections. * absence of any ocular disease other than diabetes mellitus. * cataract density allowing good visualization of the fundus by oct angiography. * patients with uneventful cataract surgery with phacoemulsification. exclusion criteria: * patients who fail to comply with the follow-up schedule. * very dense cataract not allowing good visualization of the fundus by oct angiography. * patients with complicated cataract surgery with phacoemulsification. * patients who need cataract surgery with any intravitreal injection.

Keywords: oct angiography diabetic retinopathy cataract surgery
trial to compare nnc0123-0000-0338 in a tablet formulation and insulin glargine in subjects with type 2 diabetes currently treated with oral antidiabetic therapy

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare nnc0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without dpp-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy


Eligibility criteria:
inclusion criteria: * age of 18-70 years (both inclusive) at the time of signing informed consent * body mass index of 25.0-40.0 kg/m\^2 (both inclusive) * subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening * insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes exclusion criteria: * known or suspected hypersensitivity to the trial products or related products * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
lateralization of the inferior alveolar nerve after repositioning of the bone window versus sticky bone augmentation

Conditions: Posterior Atrophic Mandible; Inferior Alveolar Nerve; Nerve Lateralization

Summary: rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using implants is subject to anatomical, surgical, and biological difficulties. in many cases, the bone is severely atrophied that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve (ian). ianl is defined as the lateralization of inferior alveolar neurovascular bundle posterior to the mental foramen, with preservation of the incisive nerve; exposure and traction are used to deflect the ian laterally while the implants are placed.

this prospective randomized clinical trial will enroll 20 patients with posterior mandibular ridge atrophy. ten of which will undergo computer guided nerve lateralization with subsequent implant placement and repositioning of the osteomotized bone window and ten patients will undergo computer guided nerve lateralization with subsequent implant placement and sticky bone grafting.

Eligibility criteria:
inclusion criteria: * patients suffering from unilateral posterior mandibular edentulism and having \< 8 mm of bone above the mandibular canal. * the width of the ridge should be \> 4mm. * the patient should be psychologically accepting the implant and the involved procedures. * the patients should have adequate oral hygiene and adequate bone quality. exclusion criteria: * any absolute contraindication for implant surgery such as uncontrolled diabetes mellitus, blood and/or bleeding disorders, serious osseous defects...etc. * any relevant systemic disease directly affecting bone metabolism and healing. * any habits that might reduce the blood flow and retard healing such as heavy smoking and alcoholism. * a history of any grafting procedure at the designated area. * patient with thick cortical bone buccally and a thin neurovascular bundle.

Keywords: inferior alveolar nerve lateralization neurosensory disturbance guided surgery posterior atrophic mandibular ridge
a randomized prospective trail of hipec in recurrent ovarian cancer patients with hrr mutation

Conditions: Ovarian Cancer; Epithelial Ovarian Cancer; Ovarian Cancer, Epithelial; Hyperthermic Intraperitoneal Chemotherapy(HIPEC); Homologous Recombination Repair Gene Mutation

Summary: a phase iii prospective study with the primary objective to investigate the benefit of hyperthermic intraperitoneal chemotherapy (hipec) in ovarian cancer patients with mutations in homologous recombination repair (hrr) genes. the target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing cytoreductive surgery (crs). patients will be divided into two groups according to hrr genes mutation, each group will be further divided into two sub-groups with different intervention. patients in group a are hrr mutated type, sub-group 1 will undergo crs plus hipec and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo crs and then go on to intravenous chemotherapy. patients in group b are hrr wild type, sub-group 3 will undergo crs plus hipec and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo crs and then go on to intravenous chemotherapy. all patients will receive maintenance therapy with niraparib after primary treatment. prognostic information will be collected for investigation of survival benefits of patients.


Eligibility criteria:
inclusion criteria: * age 18-75 * karnofsky performance status \>50 or world health organization performance score \< 2 * primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal) * preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan) * lesion can be removed completely or residual disease \< 0.5 cm * last chemotherapy finished no more than 12 weeks after surgery * no hepatic function damage * white blood cell count ≥3.5\*10\^9/l; platelet count ≥80\*10\^9/l; hemoglobin ≥90g/l * no contraindication of surgery and anesthesia * life expectancy ≥ 3 months * informed consent form signed exclusion criteria: * age \ 75 * no history of other cancer * platinum allergy * distant metastasis * used anti-angiogenic drug within 8 weeks * possibility of more than two resection of alimentary canal * recurrence \< 6 months after primary treatment * histologic type: non epithelial origin * infection out of control * follow-up unable to carry on (geographic or psychic) * cardiac insufficiency or respiratory insufficiency * has received hipec already * being in other clinical study * pregnancy or lactation period

Keywords: homologous recombination repair gene mutation hyperthermic intraperitoneal chemotherapy epithelial ovarian cancer
comparison of saliva biomarkers in two different geographical regions of turkey

Conditions: Saliva; Cortisol; Smoking, Tobacco; Periodontal Bone Loss; Periodontal Disease; Periodontal Therapy

Summary: periodontitis is a multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of inflammatory mediators such as il-1β. it is thought that il-10 has a regulatory role by limiting the initiation and progression of the acute inflammatory response with its anti-inflammatory effect. the high detection of rankl and rankl/opg ratios in periodontitis indicates that these markers play a role in bone destruction. elucidating the connections between the immune system and bone-related cytokines will contribute significantly to the resolution of these complex mechanisms underlying periodontal diseases. risk factors for periodontal diseases include gender, age, smoking and some hereditary factors. cortisol is an important marker of psychological stress. it is emphasized that stress and depression reduce immune system function and cause chronic inflammation. thus, it indirectly provokes periodontal tissue destruction.

this study consists of patients and healthy volunteers. saliva will be collected only once from healthy volunteers; from patients at the beginning and after non-surgical periodontal treatments are performed by the researchers. in the collected saliva; clinical parameters and salivary rankl, opg, il-10, il-1β, cortisol levels will be determined in periodontitis and periodontally healthy individuals living in two different geographical regions in turkey (ankara -erzurum); it will be determined whether non-surgical periodontal treatment has an effect on cytokines determined in saliva and clinical status at the end of 1-month follow-up period; periodontal pathogenesis and host response will be evaluated in smoker and non-smoker groups. analyses will be performed by elisa method. the study is based on the hypothesis that "different regional and geographical conditions determining climate, culture, environment, life, stress situations affect the course of periodontitis disease and host response". a regional comparison will be made between markers that affect the course of periodontitis disease and play a role in its pathogenesis in patients with different climate, living and cultural conditions, according to location.

Eligibility criteria:
inclusion criteria: * 35-60 years of age * good cooperation * a minimum of 20 permanent teeth, excluding third molars exclusion criteria: * systemic diseases * taking any medications * received antibiotic treatment in the last three months * those who had undergone periodontal treatment six months ago * pregnant or breastfeeding patients * prosthetic restorations * undergoing orthodontic treatment

Keywords: rankl osteoprotegerin interleukin-10 non-surgical periodontal therapy periodontitis saliva enviromental geographical locations
optimum immunosuppression in renal transplant recipients.new onset diabetes after transplantation

Conditions: Diabetes Mellitus, Adult-Onset

Summary: new onset diabetes after renal transplantation (nodat) is a common and severe complication negatively influencing graft and patient survival. cyclosporine (csa) and tacrolimus are the basis of modern immunosuppression. tacrolimus is superior to csa in terms of acute rejection and graft function. however, tacrolimus increases 2 times the risk of nodat as compared to csa.

new onset diabetes after renal transplantation (nodat) is a common and severe complication negatively influencing graft and patient survival. csa and tacrolimus are the basis of modern immunosuppression. tacrolimus is superior to csa in terms of acute rejection and graft function. however, increases 2 times the risk of nodat as compared to csa. objectives: a) to compare the incidence of nodat and glucose intolerance with 3 different regimes: tacrolimus with rapid steroid withdrawal; tacrolimus with steroids minimization; and csa with steroid minimization; b) to compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. a total of 210 patients will be randomized. the primary efficacy variable will be nodat or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.

Eligibility criteria:
inclusion criteria: * primary renal transplant recipients with end stage renal disease * no prior history of diabetes mellitus before transplant * absence of immunologic risk defined by the investigator criterion and panel reactive antibody (pra) \< 50% * absence of severe infection and hepatitis c or b infection * efficient contraception in women during the study additionally must meet one of these "metabolic criteria * recipient age \>or =60 or * recipient age between 45 and 59 years and at least one of the following metabolic criteria: prior to transplantation triglycerides (tgs) \>200mg/dl or the combination of a body mass index (bmi)\> 27 and triglycerides\>150 mg/dl or the combination of hdl-cholesterol\ 150 mg/dl. exclusion criteria: * patients with type i or ii diabetes prior to transplantation defined by the american diabetes association (ada) criteria * recipient age under 45 * patients receiving a second renal transplant * patients with high immunological risk or pra (panel reactive antibody level) \>or =50% * severe infection or hepatitis c or b infection. * dual renal transplant or double transplant with any other organ.
investigating motor cortex processing for pain modulation

Conditions: Motor Activity

Summary: the purpose of this study is to investigate the effects of different types of interventions (motor learning, somatosensory learning, observation task, mental imagery and tdcs) on the perception of pain and motor cortex excitability in healthy male subjects. this is an exploratory study of healthy subjects only.

there are 5 experiments: exp1: motor learning (3 groups, crossover) - motor leaning with and without visual feedback and a control group. exp2: sensory learning (4 groups, parallel) - sensory learning with and without feedback, an simple activation task and a control group. exp3: observational task (2 groups, parallel) - an motor observational task and a control group. exp4: mental imagery (2 groups, parallel) - a motor mental imagery and a control group. exp5: tdcs over the motor cortex (2 groups, crossover) - active and sham tdcs. note that this study has never been completed.

Eligibility criteria:
inclusion criteria 1. provide informed consent to participate in the study 2. 18 to 64 years old 3. no presence of rheumatologic disease as self reported 4. no clinically significant or unstable medical or psychiatric disorder as self reported 5. no history of alcohol or substance abuse within the last 6 months as self reported 6. no neuropsychiatric co-morbidity as self reported 7. no contraindications to single pulse tms (tms will be used to measure cortical excitability) * history of seizures * unexplained loss of consciousness * metal in the head * frequent or severe headaches or neck pain * implanted brain medical devices 8. no contraindications to tdcs * metal in the head * implanted brain medical devices

Keywords: learning pain perception
evaluation of safety and immunogenicity of meningococcal b and meningococcal acwy vaccine in at risk population

Conditions: Hiv; Meningitis, Meningococcal; HIV Infections

Summary: this study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis b (bexsero®) and meningitis acwy (menveo®) in adults and children aged 10-45 years living with hiv. all participants will be vaccinated with both menveo® and bexsero® on days 0 and 30. immunogenicity will be determined on venous blood sampled at days 0 and 60. adverse effects will be recorded to evaluate safety.


Eligibility criteria:
inclusion criteria: * any 10-45-year old male or female patients with confirmed hiv infection where they (or someone with parental responsibility) can sign fully informed consent and are able to comply with study requirements. exclusion criteria: * pregnancy or breast feeding, * history of menacwy (menveo® or nimenrix®) and 4cmenb (bexsero®) vaccination in the previous 2 years, * receipt of other non-live vaccines within 2 weeks and live vaccines within 4 weeks of first dose, planned receipt of vaccine within 2 weeks of study visits, * current active malignancy, * known latex allergy * known or suspected hypersensitivity to any components of the vaccines or history of severe allergic reaction after previous vaccination * bleeding disorder preventing im vaccination, * any acute or chronic illness which according to the investigators judgement would prevent patients to receive the vaccines or participate in the study * participation in clinical trials concerning investigational medical product within 0 days or before completion of the study * children in care

Keywords: vaccination hiv meningitis vaccine immunogenicity safety bexsero menveo co-administration