Kornimate/medical-research-clean huggingface dataset:
renin-angiotensin-aldosterone system polymorphisms in resistant hypertension and adverse cardiovascular events

Conditions: Systemic Arterial Hypertension; Hypertension Resistant to Conventional Therapy; Myocardial Infarction; Stroke

Summary: renin-angiotensin-aldosterone system (raas) polymorphisms influence 24h arterial pressure fluctuation. resistant systemic arterial hypertension (rsah) has an increased risk of end organ damage and unfavourable prognosis, whereas pseudo-rsah usually respond favourably to drug therapy. to prospectively investigate, in subjects with rsah in a tropical south american city: 1) adverse cardiovascular events defined as fatal and non-fatal stroke or acute myocardial infarction (ami); and 2) the association of raas polymorphisms and adverse cardiovascular events in this population. study population: 212 hypertensives recruited from primary care assistance (time since first diagnosis of hypertension: 16.5±8.1 years) and without appropriate pressure control, between 2001 and 2006, corresponding to 0.48% of all hypertensives under care (18 new cases/year), 57±10 years old, 66% females. under drug treatment schedule: three or more drugs including a diuretic. ninety two randomly selected hypertensives basis had renin-angiotensin-aldosterone system genetic profile determined. genetic assessment was carried out using a polymerase chain reaction assay amplification technique. the following single nucleotide polymorphisms were analyzed: renin (g1051a), angiotensinogen (m235t), angiotensin converting enzyme-ace (i/d), angiotensin ii type 1 receptor (a1166c), aldosterone synthase (c344t) and mineralocorticoid receptor (g3514c).


Eligibility criteria:
inclusion criteria: * subjects with uncontrolled systemic arterial hypertension despite use of three anti-hypertensive drugs, including one diuretic exclusion criteria: * secondary causes of systemic arterial hypertension

Keywords: systemic arterial hypertension hypertension resistant to conventional therapy genetic polymorphisms renin-angiotensin-aldosterone system genetic polymorphism risk markers adverse events acute myocardial infarction stroke
magnetic resonance imaging study on young and middle-aged patients with cervical spondylotic pain

Conditions: Neck Pain

Summary: cervical and shoulder pain in young adults is commonly caused by intervertebral disc degeneration, bulge or herniation. disc degeneration includes the synthetic and degradative imbalance of myxoid matrix, degeneration of annulus collagen, and decrease of water content in nucleus pulposus. a few patients with cervical degeneration had moderate to severe pain, but there are no obvious abnormalities in the shape and signal of the disc with routine mri, which may be related to the early discal degeneration. in most cases, the pain could be relieved by non-surgical treatment due to mild decreased proteoglycan and slight abnormality of water diffusion, but these changes cannot be clearly demonstrated by routine mri. therefore, it is necessary to rely on sensitive mri techniques to reflect the abnormal microstructure in the nucleus pulposus and annulus fibrosus, so as to assist the early detection of the main reason in patients with neck and shoulder pain and the evaluation of the efficacy of treatment.

this is an observational, longitudinal, and single-center study. confirmed patients with cervical and shoulder pain will complete several clinical and imaging programs before and after 3 and 12 months of non-surgical treatment for exploring the main reason of the symptom and the imaging predictors of treatment effect in the disease. the collected materials are listed below: (1) 3 times cervical mri scans, including t2-mapping, t1ρ and dki sequences, (2) visual analog scale (for pain assessment) and disease duration. then the t2 value, t1ρ, and dki derived parameters will be measured in the nucleus pulposus and annulus fibrosus.

Eligibility criteria:
inclusion criteria: 1. neck and shoulder pain, with or without upper limb pain and numbness; 2. disease duration longer than 2 months 3. visual analogue score (vas) ≥ 3 4. cervical mri showing cervical disc degeneration, bulge, protrusion, etc. 5. patients will undergo non-surgical treatment (maxillary occipital traction, massage, etc.) exclusion criteria: 1. severe trauma and surgery in neck and shoulder region. 2. x-ray or ct showing the severe cervical spine hyperplasia, infection (suppurative, tuberculous), neoplasm (various primary and secondary tumors), rheumatic (rheumatoid arthritis, ankylosing spondylitis), and nuclei pulposus calcification. 3. cervical mri revealed organic lesions such as inflammation of the spinal cord, tumors, syringomyelia, etc. 4. chronic pain in other regions.

Keywords: neck pain young adults t2-mapping t1ρ dki
comparison of sar342434 to humalog as the rapid acting insulin in adult patients with type 1 diabetes mellitus also using insulin glargine

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: to demonstrate non-inferiority of sar342434 versus humalog in glycated haemoglobin a1c (hba1c) change from baseline to week 26 in participants with type 1 diabetes mellitus (t1dm) also using insulin glargine. secondary objectives: to assess the immunogenicity of sar342434 and humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. to assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. to assess the efficacy of sar342434 and humalog in terms of proportion of participants reaching target hba1c (\<7%), fasting plasma glucose (fpg), self-measured plasma glucose (smpg) profiles, and insulin dose. to assess safety of sar342434 and humalog.

the study consisted of a: * up to 2 weeks screening period * 26-week treatment period * 26-week comparative safety extension period * 1-day follow-up period * the maximum study duration would be 54 weeks per participant and a 1-day safety follow-up

Eligibility criteria:
inclusion criteria: * participants with t1dm diagnosed for at least 12 months and had been treated with insulin glargine and humalog or novolog®/novo rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit. * written informed consent. exclusion criteria: * at screening visit, age under legal age of adulthood. * hba1c \ 10% at screening. * diabetes other than t1dm. * status post pancreatectomy. * status post pancreas and/or islet cell transplantation. * pregnancy and lactation. * women of childbearing potential not protected by highly effective contraceptive method of birth control. * less than 1 year on continuous insulin treatment. * use of insulin pump in the last 6 months before screening visit. * use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit. * use of insulin other than insulin glargine and humalog or novolog/novo rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. liprolog® is a european union approved insulin lispro and is allowed in those countries where it is marketed. * hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
efficacy and safety of perindopril 5 mg / indapamide 1.25 mg / amlodipine 5 mg fixed combination in hypertension

Conditions: Hypertension

Summary: the purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.


Eligibility criteria:
main inclusion criteria: * men or women of asian origin * ≥18 years old * treated for essential hypertension * having the day of the selection visit an uncontrolled hypertension treated with any anti-hypertensive monotherapy at maximal dose or any dual therapy at starting dose according to investigator's routine practice or at least 1 month prior to the visit * having at the selection visit a sitting sbp≥140 and \<180 mmhg and dbp≥90 and \<110 mmhg main exclusion criteria: * known or suspected symptomatic orthostatic hypotension or positive orthostatic test at the selection visit * treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit
phenotypic expressions in a french pseudoxanthoma-elasticum cohort

Conditions: Pseudoxanthoma Elasticum

Summary: the cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum (pxe) disease in various tissues (eye, skin, arteries, etc).

this national french cohort is intended to improve our knowledge on the pxe disease. the study of phenotypic expression of the diseases is focused on cutaneous, opthalmologic and vascular tissues. all investigations are included in a yearly follow-up for these patients and collected in a database. plasma are also collected for all patients and stored in our clinical research biological center in angers, including genetic (dna) material extracted from diagnostic skin biopsy. french ministry of teaching and research authorisation number for the pxe collection is ac 2008 871. declarative number is dc 2008 870.

Eligibility criteria:
inclusion criteria: * patients with pxe disease * informed consent obtained * patient affiliated to health care system (french social security) exclusion criteria: * no informed consent * no affiliation to a health care system
fatty acid synthase inhibition in castration refractory prostate cancer

Conditions: Prostate Cancer; Refractory Cancer; Castration Resistant Prostatic Cancer

Summary: the purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. investigators believe omeprazole may help the other medications work.

primary objective(s): obtain overall response rate (orr) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of subjects using prostate cancer clinical trials working group 3 (pcwg3) criteria, defined by partial response (pr) or complete response (cr) secondary objectives (only at patients treated at wake forest baptist comprehensive cancer center main campus): * pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by 11c-acetate pet/ct (3-6) non-invasive approach to demonstrate the fatty acid synthase inhibitor (omeprazole) is hitting its target * obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to the current "failing" taxane regimen. (16) * measure pain using the patient-reported outcomes measurement information system (promis) at baseline, cycle 5, cycle 12, and every cycle thereafter.

Eligibility criteria:
inclusion criteria: * patients must have castrate refractory prostate cancer with prior taxane treatment (docetaxel or cabazitaxel) which was used in the castrate refractory setting * cancer progression as defined by pcwg3 * age 18 or older. * ecog 0, 1, or 2 * life expectancy of greater than 2 months * men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * ability to understand and the willingness to sign an irb-approved informed consent document (either directly or via a legally authorized representative). * organ \& marrow function as defined below: absolute neutrophil count \>1,200/mcl platelets \>75,000/mcl; total bilirubin= within normal institutional limits; ast(sgot)/alt(sgpt) \<2.5 x institutional upper limit of normal; creatinine \<2.5 x institutional upper limit of normal exclusion criteria: * patients may not be receiving any other investigational agents. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy. * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
does endometrial injury improve intrauterine insemination outcome?

Conditions: Infertility

Summary: the investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

in a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve icsi outcome. little is known about the efficacy of this procedure in improving intrauterine insemination outcome. also little is known about the effect of this procedure if done in the stimulation cycle weather in icsi or intrauterine insemination cycles.

Eligibility criteria:
inclusion criteria: * 18 - 38 years. * patent fallopian tunes. * mild male factor. * anovulation. * unexplained infertility. exclusion criteria: * indications for icsi. * evidence of pelvic inflammatory disease.
safety and pharmacokinetics of repeat doses of csl324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis

Conditions: Hidradenitis Suppurativa; Palmoplantar Pustulosis

Summary: study csl324_1002 will investigate the safety and pharmacokinetics of repeat doses of csl324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. csl324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 75 years of age, inclusive * confirmed clinical diagnosis of moderate to severe hs as per international hidradenitis suppurativa severity score system (ihs4) guidelines (ie, ihs4 ≥ 4) * ppp differentiated from other forms of pustulosis * psoriasis with a palmoplantar pustulosis psoriasis area and severity index (pppasi) score of ≥ 12. * subjects with hs only: inadequate response to at least a 3-month (90 days) trial of oral antibiotics for treatment of hs * subjects with ppp only: confirmed clinical diagnosis of ppp at least 6 months before screening and inadequate response to topical therapy, phototherapy, and / or previous systemic therapy for the treatment of ppp exclusion criteria: * treatment with any medications and therapies not permitted during the study. * history of myeloproliferative disease. * malignancy within 5 years at screening with the exception of nonmelanoma skin cancer, carcinoma in situ, or prostate cancer not requiring treatment. * current, or a recent clinically significant history of, uncontrolled renal, hepatic(including currently active hepatitis b virus and / or hepatitis c virus), hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as potentially having an effect on study outcomes as determined by the investigator and / or sponsor. * congenital or acquired immunosuppressive condition(s), including human immunodeficiency virus infection. * clinical signs of active infection and / or fever \> 38°c during the 7 days before day 1. * clinically significant abnormalities on physical examination, ecg, or laboratory assessments, or neutropenia (defined as absolute neutrophil count \< 2.0 × 109/l) at screening. * subjects with ppp only: concurrent psoriasis vulgaris (not including scaly scalp and / or ears). * subjects with hs only: \> 20 draining fistulas."
effect of goal-directed fluid therapy based on stroke volume variation on metabolic acidosis in patients undergoing brain tumor surgery

Conditions: Brain Tumor

Summary: in patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to reduce cerebral edema. excessive administration of 0.9% normal saline has been to reported to cause hyperchloremic metabolic acidosis. on the other hand, hypovolemia due to insufficient fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid accumulation. however, the guideline for perioperative fluid management has not been yet established. the investigators hypothesized that intraoperative fluid management according to svv(stroke volume variation)could reduce perioperative metabolic acidosis compared to those by cvp(central venous pressure). therefore, the study is trying to determine if intraoperative fluid administration based on svv could reduce metabolic acidosis when compared with cvp in patients undergoing craniotomy due to brain tumor who receive 0.9% normal saline as main fluid regimen.


Eligibility criteria:
inclusion criteria: * patients undergoing craniotomy due to brain tumor * american society of anesthesiologists physical status i or ii * aged from 20 to 65 exclusion criteria: * compromised cardiopulmonary function * diabetes mellitus * symptom or sign with increased intracranial pressure * liver or renal disease * pre-existing metabolic acidosis * pregnant or breast-feeding * patients who cannot understand the statements for subjects
an observational, retrospective, uk & ireland audit of patient adherence to rebif® injections using the rebismart™ injection device

Conditions: Relapsing Multiple Sclerosis

Summary: this is an observational, retrospective, uk \& ireland audit measuring patient adherence to rebif® injections with the rebismart™ injection device. data will be collected from multiple sclerosis (ms) patients who have been prescribed rebif® and have been using the rebismart™ device for injection for a minimum of 24 months.


Eligibility criteria:
inclusion criteria: * relapsing multiple sclerosis (relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses) according to the association of british neurologists criteria (30) in the uk and the revised 2005 mcdonald criteria (31) in ireland * prescribed rebif® (22mcg or 44mcg) using the rebismart™ injection device * have been using rebismart™ for 24 months and be due a device replacement as part of their standard routine of care * registered with bupa home healthcare (uk) or sense nurse (ireland) * be willing to give consent for their adherence data to be captured in the audit exclusion criteria: patients who do not fulfill entirely the inclusion criteria as well as the following: * discontinued rebif before 24 months of treatment * unable or unwilling to give consent for their adherence data to be captured in the audit

Keywords: adherence multiple sclerosis
a phase 3b study evaluating the 24-hour intraocular pressure lowering effect of bimatoprost sr in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of bimatoprost sr in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * diagnosis of either oag or oht study eye, requiring iop-lowering treatment * participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months exclusion criteria: * current or anticipated enrollment in another investigational drug or device study * females who are pregnant, nursing, or planning a pregnancy during the study
effect of pulse rate changes on clinical outcome

Conditions: Overactive Bladder Syndrome; Chronic Urinary Retention

Summary: objectives: to evaluate the effect of pulse rate changes on the clinical response and stimulation related pain symptoms in sacral neuromodulation (snm) treatment. materials and methods: this pilot study evaluated the effect of 4 different pulse rates (5.2hz-10hz-21hz-40hz) in patients with suboptimal response to snm. the effect of each frequency was evaluated over test period of 6 days. to avoid carry over effect, stimulation was kept off for 24 hours between consecutive test periods. the last 3 days of every test period, a voiding diary (vd) and questionnaire was filled in. the changes on clinical response and pain symptoms were compared between the four pulse-rates using multivariate analysis. results: fifty patients were included of which 40 (80%) were female. mean age was 55.5yr (sd 12.3). forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic non-obstructive urinary retention. no significant difference was found regarding clinical outcome (vd and questionnaire) between the different pulse rates. furthermore, none of the four pulse rates was significantly related to the occurrence of snm-related pain. however, on individual basis, patients appear to benefit from changing the pulse rate concerning both treatment efficacy and stimulation related pain. conclusions: on group level, none of the four pulse rates in this study appears to have a significantly different effect on clinical outcome or snm-related pain. however, a tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be useful.


Eligibility criteria:
inclusion criteria: * patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention * patients with suboptimal effect of their neurostimulator exclusion criteria: * patients with 100% effect of their neurostimulator