Kornimate/medical-research-clean huggingface dataset:
a study to compare the finger prick whole blood mitra assay method with the established venepuncture whole blood method for quantitative determination of tacrolimus blood concentrations in transplant patients

Conditions: Kidney Transplantation; Liver Transplantation

Summary: the purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood mitra assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.

this will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. participants will have been on a stable dose of advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial advagraf. participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick mitra sample at pre-dose and at approximately 1 and 3 hours post-dose. participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.

Eligibility criteria:
inclusion criteria: * subject will be a recipient of either a liver or kidney transplant and on a stable dose of commercial advagraf minimum of 3 months. * subjects will be with clinically stable graft function for at least 3 months. exclusion criteria: * subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.

Keywords: kidney transplantation a bioanalytical method cross-validation advagraf liver transplantation
broad band emission led phototherapy source versus narrow band

Conditions: Neonatal Hyperbilirubinemia; Jaundice, Neonatal

Summary: phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. light-emitting diodes (leds) are become routinely used for phototherapy in neonates with hyperbilirubinemia. blue led light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. however, the effectiveness of phototherapy with narrow-band led light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. it is still controversial whether the use of green light has any advantage over blue light. the most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.the aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green led with blue narrow spectral band phototherapy device.


Eligibility criteria:
inclusion criteria: * non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on nice criteria, gestational age ≥33 weeks, birth weight ≥1800 g, postnatal age \>24 hrs and ≤14 days exclusion criteria: * hemolytic jaundice, major congenital animalities and history of phototherapy. infants with indication of intensive treatment double phototherapy were not included.

Keywords: phototherapy blue light led green light led
benefit of coq-10 in patients on statins

Conditions: Pain; Soreness; Weakness; Fatigue

Summary: this study will investigate whether a supplement called co-enzyme q10 can help ease or eliminate some of the side effects that result from taking statin medications. these side effects include muscle pain, fatigue or muscle cramping.

specific aim 1: to demonstrate that supplementation with coq10 in patients treated with statins ameliorates symptoms of muscle pain and fatigue and improves energy metabolism and muscle function. this objective will be achieved in a randomized, placebo-controlled double blind trial by assessing the degree of muscle symptoms and interference of pain with daily activities, aerobic capacity, and muscle function before and after supplementation with either coq10 or placebo in groups of statin-treated subjects. specific aim 2: to examine changes at a molecular/cellular level that are associated with improved pain and muscle function in statin-treated subjects supplemented with coq10. this aim will be addressed by analyzing muscle biopsies taken from statin-treated patients before and after supplementation with coq10 or placebo.

Eligibility criteria:
inclusion criteria: 1. adult men and women 21 years and older taking statin medications for hyperlipidemia under the current national cholesterol education program guidelines (ncep iii) and complaining of myopathic symptoms. exclusion criteria: 1. diagnosis of cancer; 2. acute illness of any sort; 3. hemoglobin less than 12, 4. creatinine greater than 1.5 mg/dl; 5. liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal; 6. use of certain medications or nutritional supplements within the past month; 7. untreated hypertension (diastolic bp\> 100 mm hg); 8. diagnosis of diabetes mellitus (fasting blood glucose \> 126 mg/dl); 9. untreated hypothyroidism; 10. overt congestive heart failure (by physical exam); 11. active inflammatory diseases such as rheumatoid arthritis, lupus, etc., 12. bleeding disorders; 13. history of adverse reactions besides myopathy associated with the use of statins; 14. any previous adverse reaction to coq10 or to multivitamin supplements containing coq10; 15. plasma cpk levels \> 3 times the upper normal limit; or 16. congenital myopathies and/or neuromuscular degenerative diseases.

Keywords: coq-10 statin muscle pain cardiovascular
efficacy of seroquel sr in combination with an antidepressant in treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: to evaluate the efficacy and safety of quetiapine fumarate sustained release (seroquel sr) in the treatment of major depressive disorder. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * male or female aged 18 to 65 years * a documented diagnosis of major depressive disorder exclusion criteria: * patients with a dsm iv axis i disorder other than mdd within 6 months of enrolment * patients with a diagnosis of dsm iv axis ii disorder which has a major impact on the patient's current psychiatric status * patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment

Keywords: major depressive disorder mdd
tee/angio fusion study

Conditions: Structural Heart Disease

Summary: this is a pilot study of patients undergoing structural heart disease procedures that utilize tee and fluoroscopic guidance at the new york university (nyu) langone medical center. patients in this study will undergo their procedure utilizing the tee/angio fusion software prototype. this protocol is primarily intended to ascertain the potential utility of the software prototype in the study population and to provide data and feedback to improve the workflow and algorithms of the prototype. as such, a primary outcome variable and statistical analysis plan have not been identified. however, procedural time, measures of radiation exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual valvular regurgitation or paravalvular regurgitation as applicable, and complications will be recorded.

this study is for patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes tee and fluoroscopic guidance at the nyu langone medical center. it will evaluate the utility and workflow of the transesophageal echocardiography/angiography (tee/angio) fusion software prototype to provide visualization of anatomic landmarks and guidance during structural heart disease procedures. the purpose of this study is to evaluate software (tee/angio fusion) that merges images from two standard procedures (ultrasound and x-ray) used to look at the heart during a procedure for structural heart disease. typically, these 2-dimensional images are viewed separately, requiring the operator to mentally merge the two images together while deciding if he/she is in the correct location for the treatment strategy. tee/angio fusion is designed to make a single 3-dimensional image of the heart in real-time.

Eligibility criteria:
inclusion criteria: * subjects must be more than 18 years of age * subjects must have a plan to undergo a transcatheter-based structural heart disease procedure that utilize tee and fluoroscopic guidance exclusion criteria: * subjects with a known contraindication for insertion of the tee probe (e.g. history of esophageal stricture, scleroderma, etc.), which will be ascertained by a non-invasive imaging specialist (contraindications are routinely assessed in the course of the preoperative workup)subjects who have a known contraindication for insertion of the tee probe (e.g. history of esophageal stricture, scleroderma, etc.), which will be ascertained by a non-invasive imaging specialist (contraindications are routinely assessed in the course of the preoperative workup) * pregnant * participating in a competing study * unable or do not provide consent

Keywords: transesophageal echocardiography/angiography (tee/angio)
an observational study of inflammatory bowel disease (ibd) patients with non-alcoholic fatty liver disease (nafld)

Conditions: Inflammatory Bowel Disease (IBD); Metabolic Dysfunction Associated Fatty Liver Disease

Summary: inflammatory bowel diseases (ibd), including ulcerative colitis and crohn's disease, are currently of unknown etiology and incurable. in recent years, the incidence of ibd has increased dramatically in china, and it will become a common disease of digestive system in china. mesenteric adipose tissue hyperplasia indicates disease activity in ibd patients, and abnormal lipid metabolism plays an important role in the pathogenesis of ibd. in addition to intestinal symptoms, nonalcoholic fatty liver disease (nafld), also known as metabolic dysfunction associated fatty liver disease (masld), has become the most common extraintinal manifestation in ibd patients. what are the similarities and differences between ibd patients with and without masld? does the occurrence and severity of masld affect the clinical efficacy of ibd and increase the adverse outcome of ibd? there are no relevant studies to date. we have previously completed the construction of a cohort of 290 ibd patients using the ibd patient database and biobank of dongfang hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on ibd disease activity. based on this cohort, multi-center cooperation was carried out to establish an ibd research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. the clinical characteristics of ibd patients with masld were analyzed. logistic regression, cox regression, kaplan-meier survival curve and other methods were used. to investigate the effect of masld on the clinical efficacy and prognosis of inflammatory bowel disease (ibd). this project will provide efficient, full and reliable research-grade data with chinese characteristics for ibd clinical research, and improve the level of regional diagnosis and treatment.


Eligibility criteria:
inclusion criteria: 1. subjects aged over 18 years (including borderline values), of either sex. 2. subjects consistented with the chinese consensus on the diagnosis and treatment of ibd; 3. subjects able to cooperate with follow-up, participate in this study and sign the informed consent. exclusion criteria: 1. subjects with incomplete clinical data; 2. subjects can not to cooperate with follow-up, and refuse to sign the informed consent; 3. subjects can not to cooperate with the completion of relevant examinations; 4 pregnant women; 5.subjects with severe heart, lung, kidney and other organ diseases or cancer, and expected survival time less than 6 months.
intermittent androgen deprivation therapy with or without stereotactic body radiotherapy for molecularly identified hormone sensitive oligometastatic prostate cancer

Conditions: Prostate Cancer

Summary: this study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on psma pet scan


Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. able to provide informed consent. 3. histologic diagnosis of prostate adenocarcinoma. 4. ecog performance status 0-1. 5. stage iv hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by psma pet-ct scan with no metastases visible on conventional imaging (ct chest/abdomen/pelvis and bone scan +/- mri) performed within 3 months of starting adt. 6. up to a maximum of 3 psma avid areas of metastatic disease. 7. for patients with metachronous disease, there must be a documented psa rise. for those who had previous prostatectomy, psa must be \> 0.2 ng/ml. for those who had previous radical radiotherapy, psa must have risen to at least 2 ng/ml above the nadir (phoenix definition). the primary tumor must be controlled, with no psma avid progression within the primary prostate. 8. all sites of disease are amenable to and can be safely treated with sbrt. exclusion criteria: 1. significant comorbidities rendering patient not suitable for adt and/or sbrt. 2. history of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer. 3. prior use of salvage or palliative intent adt. prior adt use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed. 4. castrate resistant prostate cancer. 5. evidence of spinal cord compression.
influence of probiotics on atopy, immunological responses and gut microflora - follow-up to 5 years

Conditions: Eczema; Asthma; Allergic Rhinitis

Summary: the investigators had conducted a double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age. this follow-up study will extend a further 3 years to 5 years of age for assessing the longer term beneficial effects of this form of probiotics intervention on the incidence of allergic disease and sensitization at 5 years of age.

probiotics are helpful bacteria of healthy gut and have shown potential in reducing allergy. a double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age had been conducted. this study aims to assess the longer term beneficial effects of this form of intervention on the incidence of allergic disease and sensitization at 5 years of age by extending the follow-up period. all children (from original cohort of 253) who completed the initial 2-year visit has been invited to participate. they will be evaluated with monthly phone calls and yearly clinic visits. allergic sensitization will be assessed with skin prick tests to a panel of allergens. this project will provide insights into the role of early supplementation of probiotics on the development of the immune system and its effect on allergy. the additional follow-up period is critical for the evaluation of respiratory allergies in the form of clinical asthma, allergic rhinitis and sensitization to inhalant allergens, which tend to develop after 2 years of age.

Eligibility criteria:
inclusion criteria: * parents agree to the subject's participation in the study and informed consent has been obtained. * the subject has been a participant in the phase i double-blind, randomized placebo-controlled study and had taken either normal infant formula or formula supplemented with probiotics postnatally for 6 months. * the parents are willing to comply with study procedures and are able to keep to scheduled clinic visits. exclusion criteria: * the parent is unable /unwilling to comply with procedures.

Keywords: probiotics eczema asthma allergic rhinitis prevention immunological responses
dexmedetomidine in erector spinae block in postoperative analgesia

Conditions: Postoperative Pain

Summary: 60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. during anesthesia: total intraoperative fentanyl required will be recorded. after surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to pca device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. during anesthesia: total intraoperative fentanyl required will be recorded. after surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to pca device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. other secondary outcomes are numerical rating scales and incidence of opioid side effects.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * female, aged (18-70) years * belongs to american society of anaesthesiologists physical status class ii. * scheduled for breast cancer surgeries. exclusion criteria: * patient refusal. * local infection at the site of the block. * cardiac dysfunction (ejection fraction \<45%). * preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (pca) device. * allergy to one of the study drugs. * pregnancy. * coagulopathy (pc \<60% and platelet count\<100.000).

Keywords: erector spinae block. dexmedetomidine. postoperative analgesia
open label, adaptive, parallel group pet study using ro7017773 and [11c] ro15-4513

Conditions: Autism Spectrum Disorder

Summary: this is a single dose (sd), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing gabaa receptors by ro7017773 in healthy participants.


Eligibility criteria:
inclusion criteria: * healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemisty, serology, and urinalysis), as judged by the investigator. * males and women of non-childbearing potential (woncbp) exclusion criteria: * history of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or cns infections * clinically significant abnormal finding from the mri performed after the initial screening examination * abnormal blood pressure, i.e, systolic blood pressure (sbp) greater than 140 or less than 90 mm hg, and diastolic blood pressure (dbp) greater than 90 or less than 50 mm hg * abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm * history or presence of clinically significant ecg abnormalities before study drug administration or cardiovascular disease * show evidence of human immunodeficiency virus (hiv) infection and/or positive human hiv antibodies * positive result on hepatitis b (hbv) or hepatitis c (hcv), presence of hepatitis b surface antigen (hbsag) or positive hepatitis c antibody test result at screening or within 3 months prior to starting study treatment
acute cognitive and neurobehavioral intervention: efficacy evaluation

Conditions: Traumatic Brain Injury

Summary: to learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.

to evaluate the efficacy of the first steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about tbi and compensatory strategies. the first steps program was developed to address the neurobehavioral and emotional concerns of survivors of tbi during the course of inpatient rehabilitation. program format and content reflects clinical experience and extensive research review. input from survivors, family members, and rehabilitation staff trained in working with the tbi population has also helped shape the implementation protocol. the foundation of the protocol is a curriculum \[niemeier, j., kreutzer, j., \& taylor, l. (2005). acute cognitive and neurobehavioral intervention for individuals with acquired brain injury: preliminary outcome data. neuropsychological rehabilitation, 15(2), 129-146.\] the first steps curriculum consists of ten lessons and was developed to address the common needs, issues, and concerns of tbi survivors admitted acutely for inpatient rehabilitation.

Eligibility criteria:
inclusion criteria: * adults (18 years or older) who have experienced a tbi (damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia, or skull fracture, or objective neurological findings that can be reasonably attributed to tbi on physical examination or mental status examination). exclusion criteria: * imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others. * unable to tolerate treatment sessions due to physical, cognitive, behavioral, or other difficulties.

Keywords: brain injury, acute rehabilitation
impedance cardiographic (icg) assessment of pregnant women with severe hypertension to assess impact of standard therapy

Conditions: Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia); Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe); Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)

Summary: the utilization of external cardiohemodynamic patient assessment, applying non-invasive stick-on contact patches to the mother's neck on either side and chest wall on either side, enables the practitioner to have information about the patient's cardiac function and vascular status beyond simply blood pressure and pulse. this information, once collected, should open the practitioner's eyes to better assess the patient's disease status and her response to therapy. we will use this information to compare the effectiveness of the two standard medications used for treatment of maternal high blood pressure.

pregnant patients with severe acute hypertension due either to superimposed preeclampsia, severe preeclampsia or severe gestational hypertension will be randomized to receive either of two antihypertensive agents (hydralazine or labetalol). just before drug administration and immediately thereafter impedance cardiography of the patient will be undertaken and the results analyzed relative to the cardiac profile and the drug administered to reduce the severe hypertension.

Eligibility criteria:
inclusion criteria: * nulliparous or parous patients with severe hypertension * singleton gestation * gestational age greater than 20 weeks exclusion criteria: * multiple gestation * gestational age less than 20 weeks