Kornimate/medical-research-clean huggingface dataset:
reducing residual albuminuria in subjects with diabetes and nephropathy with atrasentan

Conditions: Chronic Kidney Disease; Diabetic Nephropathy

Summary: prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. the objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets compared to placebo in reducing residual albuminuria in japanese type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose for hypertension of a ras (renin angiotensin system) inhibitor.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the screening period. * patient is receiving a maximum tolerated labeled dose of an acei (angiotensin converting enzyme inhibitor) or arb (angiotensin ii receptor blocker)(renin angiotensin system (ras) inhibitor). estimated gfr (glomerular filtration rate) is greater than or equal to 30 and less than or equal to 75 ml/min/1.73m2 by the ckd (chronic kidney disease) * epidemiology collaboration (epi) formula. * uacr (urinary albumin to creatinine ratio) is greater than or equal to 200 mg/g as determined by the geometric mean of the three morning void urine specimens obtained at run-in period. * serum albumin is greater than or equal to 3.0 g/dl. bnp (b-type natriuretic peptide) is less than or equal to 200 pg/ml. * sbp (systolic blood pressure) is greater than or equal to 110 mmhg and less than or equal to 160 mmhg. hba1c (glucosylated hemoglobin a1c) is less than or equal to 12% and serum potassium is less than or equal to 5.5 meq/l. exclusion criteria: * patient has a history of moderate or severe edema, facial edema unrelated to trauma, or a history of myxedema in the prior 6 months to screening. * patient is receiving loop diuretics greater than or equal to 120 mg qd (once daily) of furosemide or greater than or equal to 3.0 mg qd (once daily) of bumetanide or greater than or equal to 150 mg qd (once daily) of ethacrynic acid or greater than or equal to 60 mg qd (once daily) of torasemide. * patient has a documented history of stage c or stage d heart failure, defined acc/aha (american college of cardiology/ american heart association practice guidelines). * patient is receiving any of a combination of an acei (angiotensin converting enzyme inhibitor) and arb (angiotensin ii receptor blocker) or rosiglitazone or aliskiren or an aldosterone antagonist and patient is receiving pioglitazone and edema is present.

Keywords: endothelin receptor antagonists proteinuria
effects of vitamin d3 versus 25ohd3 on mineral metabolism and immune function

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to compare the effects of two different forms of vitamin d supplements (vitamin d3 and 25-hyrdroxyvitamin d3 \[25(oh)d3\]) on vitamin d levels in the blood, and on markers of skeletal and immune health. this study is designed as a pilot study. a multi-ethnic cohort of 48 patients will be included (12 caucasian, 12 african american, 12 hispanic/latino, 12 asian/asian american). potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. the purpose of the screening visit is to identify vitamin d-deficient (25-hydroxyvitamin d \<20 ng/ml) individuals who are candidates for vitamin d supplementation. eligible patients will then be randomly assigned to receive either vitamin d3 (2400 iu/day) or 25(oh)d3 (20 mcg/day) for 16 weeks. after initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. at each visit, blood will be collected to assess vitamin d levels in the blood, as well as markers of skeletal and immune function. participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). after all data is collected, changes in vitamin d levels in the blood following supplementation with either vitamin d3 versus 25(oh)d3 will be determined, and correlated to markers of calcium balance and immune function. knowledge gained from this study may have a significant impact on how vitamin d status is defined, and how vitamin d repletion is administered.


Eligibility criteria:
inclusion criteria: * age \> 18 * 25d \< 20 mg/ml exclusion criteria: * age \< 18 * 25d \> 20 ng/ml at time of screening * clear signs of infection at time of screening (coughing, sneezing, wheezing, frequency, dysuria) * history of conditions that would influence intestinal absorption of vitamin d3 or 25ohd3 supplements * history of nephrolithiasis, primary hyperparathyroidism, or other metabolic bone disease * history of chronic kidney disease (defined as crcl \< 30 ml/min) * history of rheumatologic or autoimmune conditions * history of sarcoidosis * history of active or latent tuberculosis * history of hiv * history of hyperthyroidism * history of chronic glucocorticoid use defined as the equivalent of 5 mg of prednisone per day for more than 2 months within the last 6 months * history of use of medications known to affect calcium/vitamin d metabolism, bone metabolism, and immune response * hypercalcemia * hypercalcinuria

Keywords: hypovitaminosis d free 25-hydroxyvitamin d total 25-hydroxyvitamin d
complications and clinical response in cancer patients treated with anti-vegf-related therapies

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study collects information about complications and clinical response in cancer patients treated with anti-vegf-related therapies. this study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-vegf related therapy. this may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.

primary objective: i. to explore the incidence of clinical complications associated with anti-vegf-related therapies in cancer patients treated at emory university and the university of texas m.d. anderson cancer center (mdacc). secondary objectives: i. to explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-vegf-related therapies. ii. to explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-vegf-related therapies. iii. to investigate the validity of a novel multi-parameter-based blood pressure scoring system and to determine if the new scoring method is concordant with the current common terminology criteria for adverse events (ctcae) method. outline: patients' medical records are reviewed.

Eligibility criteria:
inclusion criteria: * patients must be able to understand and be willing to sign a written informed consent document * patients must be receiving any anti-vegf-related regimen in monotherapy or combination therapy
first-oslo long-term follow-up

Conditions: Stroke

Summary: the study aims to describe the functional level of the patients who received high intensity gait training during inpatient stroke rehabilitation at discharge, three, six and twelve months after stroke. these data will determine if the observed gains from the high-intensity gait training are retained after discharge from inpatient rehabilitation.

the study is a cohort-study that will have a prospective observational design. this design allows us to follow patients who presently have had a stroke and received high intensity stepping training over time. at this time little is known about the patient's functional trajectory the first 12 months after receiving high intensity stepping treatment as no study has examined long-term effects of high-intensity stepping training delivered in inpatient rehabilitation for stroke in norway nor internationally.

Eligibility criteria:
inclusion criteria: * adults (\>18 years old) who are receiving inpatient rehabilitation for stroke * \< six months post-stroke * have the goal to improve walking function * provide written consent will participate in the study. exclusion criteria: * inability to consent * use of bracing or instrumentation (e.g. ventilator) that limits walking * independence in walking outdoors and on stairs (functional ambulation category (fac) at admission = 5) * uncontrolled cardiopulmonary, metabolic, infectious or psychiatric disorders

Keywords: high intensity gait training
cervical radiculopathy trial

Conditions: Cervical Radiculopathy

Summary: the primary aim of the present project is to compare the effectiveness of surgery and nonsurgical treatment in patients with cervical radiculopathy caused by either disc herniation or spondylosis. secondary aims are to evaluate cost-effectiveness and predicting factors of success of the two treatments, and to explore the terms success rate and expectations by asking the patients to fill in their expected primary outcome score at baseline.

cervical radiculopathy is usually caused by disc herniation or spondylosis. prognosis is expected to be good in most patients but there is limited scientific evidence about the indication for non-surgical and surgical treatment. two randomised controlled trials comparing cervical decompression and non-operative treatment with cost-effectiveness analysis and assessment of expectations and predictors of outcome. the main research question will be evaluated at one-year follow-up. 1. to test the hypothesis that the effectiveness of surgery as measured by the change in neck disability index (ndi) at 1-year follow-up in patients with cervical radiculopathy is not different from non-surgical treatment in: 1. study 1: one level disc herniation (c5/6 or c6/7) 2. study 2: one or two level spondylosis (c5/6 and/or c6/7) 2. to test the hypothesis that surgery is more effective in patients with more clinical finding (dermatomal sensory loss, myotonal weakness and reflex disturbance) at baseline when adjusted for other possible predictors such as age, gender, baseline pain, duration, radiological findings, expectations, and psychological factors). 3. to estimate cost-effectiveness for health care costs and societal costs (including sickness absence) in surgical versus non-surgical patients. 4. to assess radiological (mri and ct) measurements of foraminal area and nerve compression and if changes can predict clinical changes (ndi and arm pain) at 1-year . 5. to evaluate treatment outcome expectations at baseline asking the patients to fill in their expected improvement.

Eligibility criteria:
inclusion criteria: * age 20 to 65 years. * study 1: neck and arm pain for at least 3 months with a corresponding herniation involving one cervical nerve root (c6 or c7) study 2: neck and arm pain for at least 3 months with a corresponding spondylosis involving c6 and/or c7) . * pain intensity of arm pain of at least 4 on a scale from 0 (no pain) to 10 (worst possible pain) * willing to accept either of the treatment alternatives * ndi \> 30 exclusion criteria: * patients with any previous cervical fractures or cervical spine surgery; * signs of myelopathy; * rapidly progressive paresis or paresis \< grade 4; * pregnancy; * arthritis involving the cervical spine; * infection or active cancer; * generalised pain syndrome; * serious psychiatric or somatic disease that exclude one of the treatment alternatives; * concomitant shoulder disorders that may interfere with outcome; * abuse of medication/narcotics, * not able to understand written norwegian, * not willing to accept one of the treatment alternatives.
primary sjögren syndrome

Conditions: Primary Sjögren's Syndrome

Summary: primary sjögren syndrome (pss) is an inflammatory, autoimmune, multiorgan disease often involving the central and peripheral nervous systems. fifteen to twenty percent of patients with the primary sjögren's syndrome have neurological complications involving the peripheral nervous system. although some patients have large fiber neuropathy, around forty percent of patients with sjögren's syndrome experience neuropathic pain with normal electrodiagnostic studies. although these patients may be diagnosed with fibromyalgia or depressive symptoms, some have been shown to have small fiber neuropathy (sfn). a recent study proved that more than 90% of pss patients with such neuropathic pain have sfn {fauchais, 2010 #188}. the aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pss and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or auto-antibody response. quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated. a skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation. moreover, pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy. recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pss-related sfn. dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies.


Eligibility criteria:
inclusion criteria: * patients with pss according to revised european criteria and exhibiting neuropathic pain without any electromyographic abnormality will be included (group i). * age of entry into the study ≥ 18 yrs (both groups). * affiliated or profit patient of a social security system (both groups). * informed consent signed up (both groups). exclusion criteria: * chronic alcoholism * type i or type ii diabetes * peripheral neuropathy unrelated to pss complications * coagulation disease * previous allergy to xylocaine, lidocaine, prilocaine or ricin oil * porphyria, methemoglobinemia * patients under measure of maintenance of justice. * patients unable to understand or to participate to the study. * child and major patients making the object of a measure of lawful protection. * patients deprived of freedom. * pregnant, nursing women. * participation in biomedical research within one month prior to inclusion.
increasing bone density by application of surface electrical stimulation

Conditions: Osteoporosis; Electrical Stimulation; Posture

Summary: bonestim system for osteoporosis treatment uses surface electrical stimulation of neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing contractions of the spinal column muscles. the primary aim of this clinical study is to determine if the bonestim therapy can improve bone density. a secondary aim is to determine whether the applied treatment increases postural stability and facilitation of daily life activities. inducing of contractions of the spinal column muscles in this manner could be new treatment options for the patients with reduced mobility and the patients with serious contraindications for drugs.


Eligibility criteria:
inclusion criteria: * t score at least 1,5 (ideal 2,-2,5) * stable bone turn over (lab.analyses.) exclusion criteria: * fracture,pace maker, malignancy and gastrointestinal problems * chronic corticosteroid therapy * spinal surgery in previous year
lifestyle in pregnancy and offspring

Conditions: Childhood Obesity; Adiposity; Body Composition; Metabolic Risk Factors

Summary: children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. we have conducted a follow-up study on an existing clinical trial, called the lip study (lifestyle in pregnancy), registration number nct00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. this present study follows the children until 3 years of age. we have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. clinical examination is taking place at age 2.5-3 years including anthropometric measurements, dual energy x-ray (dxa) scans and blood samples measuring metabolic markers.


Eligibility criteria:
inclusion criteria: * children born to women who were part of the preceding lip study and who completed the lip study until birth. inclusion criteria for the lip study: * singleton pregnant * bmi \>/= 30 and \</= 45 e xclusion criteria for preceding lip study: * chronic diseases * not danish speaking * abuse of alcohol or drugs * preterm delivery in earlier pregnancies
trigger-point blockade in persistent pain after open groin hernia repair

Conditions: Inguinal Hernia; Chronic Pain

Summary: groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life. this study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality. the hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.

this placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. in order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.

Eligibility criteria:
inclusion criteria: * patients with persistent pain (\< 6 mo) after open groin hernia repair * patients with maximal pain area 3 cm or less from the superficial inguinal ring * patients living in the capital region of denmark (region hovedstaden) or the region of zealand (region sjælland) exclusion criteria: * known allergy to bupivacaine or other local anesthetics of amide-type * declared incapable of making his/hers own affairs * does not comprehend danish in the written or spoken language * cognitive impairment to a degree influencing the testing reliability * known recurrence of the inguinal hernia * other surgical procedures performed in the groin or on the external genitals * neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc * abuse of alcohol or drugs * unable to cooperate with the sensory examinations

Keywords: chronic pain inguinal hernia outcome surgical procedure, operative
efficacy and tolerability study of progesterone vaginal tablets (endometrin®) in menopausal women treated by estrogen

Conditions: Endometrial Hyperplasia; Endometrial Cancer

Summary: the objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.

estrogen replacement therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.

Eligibility criteria:
inclusion criteria: * women who are candidates for hormone replacement therapy due to menopausal symptoms. * women with an intact uterus. * no menses within the 12 months preceding screening visit and /or fsh \>30 iu/l. * endometrial thickness ≤ 5 mm. exclusion criteria: * submucosal fibroid/s that applying pressure and affecting endometrial thickness * other medication that could affect estrogenic state.

Keywords: menopause endometrial thickness progesterone
brief cbt for the treatment of depression during inpatient hospitalization

Conditions: Depression

Summary: moderately to severely depressed subjects will be randomized to the "control group," who will receive care as usual, or the "cbt group," who will receive care as usual in addition to the manualized course of cognitive behavioral therapy (cbt).

participants assigned to the cbt condition will receive the usual standard of care during an inpatient psychiatric hospitalization. this includes but is not limited to medication management, group therapy, and individual therapy. if a patient is randomly assigned to the enhanced cbt group, manualized cbt, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.the training m.d., who is a treating physician on hcc-10, will also intermittently and randomly observe the cbt sessions to ensure the manual properly is being followed. although the control condition may contain elements of cbt as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the cbt condition. participants assigned to the control condition will receive the usual standard of care during an inpatient psychiatric hospitalization. this includes but is not limited to medication management, group therapy, and individual therapy.

Eligibility criteria:
inclusion criteria: * diagnosed with depression according to diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) criteria on initial assessment on the unit. * demonstrates at least moderate degree of depressive symptoms on madrs, ham-d, and cgi-s. * provides written informed consent. exclusion criteria: * a mental illness other than depression that is the primary cause of treatment, as determined by the principal investigator. * a cognitive or neurologic disorder that inhibits ability to engage in cbt.

Keywords: depression cognitive behavioral therapy (cbt)