Kornimate/medical-research-clean huggingface dataset:
renal effects of two iodinated contrast media in patients at risk undergoing coronary angiography

Conditions: Coronary Artery Disease; Renal Impairment

Summary: the main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. a standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. serum creatinine (scr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

gehc has decided not to provide this detail

Eligibility criteria:
inclusion criteria: * subjects with a combination of diabetes mellitus (type i or ii) and renal impairment, defined as serum creatinine (scr ) ≥150 µmol/l (1.7 mg/dl) for men and ≥133 µmol/l (1.5 mg/dl) for women or creatinine clearance (crcl) ≤ 50 ml/min calculated according to cockroft-gault formula, referred for coronary angiography with or without pci. exclusion criteria: * concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. subjects undergoing dialysis or kidney transplant will not be included.

Keywords: iodixanol iopamidol coronary angiography contrast media-induced nephropathy
plerixafor/g-csf as additional agents for conditioning before hsct in cgd patients

Conditions: Chronic Granulomatous Disease

Summary: treatment study to assess of safety and efficiency of conditioning with plerixafor and g-csf as additional agents for prevention of graft failure after transplantation in patients with chronic granulomatous disease

severe primary or secondary graft dysfunction is one of major problem in patients with chronic granulomatous disease (cgd). in this study the hypothesis is that the use of plerixafor and g-csf as additional agents in conditioning regimen would offers advantages. the effect is based on mobilizing bone marrow stem cells into the peripheral blood and blocking cxcr4 chemokine receptors to prevent stem cell homing. thus, some have hypothesized that plerixafor and g-csf make free stromal space of the bone marrow available for donor stem cell engraftment. moreover, stem cell release probably leads to liberation of host stem cells from the anti-apoptotic effects of the bm stroma for the more powerful effect of chemotherapy. thus, the purpose of this study is to evaluate the safety and efficiency of myeloablative conditioning with plerixafor and g-csf as additional agents for prevention of graft failure after stem cell transplantation in patients with chronic granulomatous disease.

Eligibility criteria:
inclusion criteria: patients aged ≥ 1 months and \< 25 years patients diagnosed with cgd eligible for an allogeneic transplantation signed written informed consent exclusion criteria: lack of informed consent.

Keywords: chronic granulomatous disease graft failure stem cell transplantation plerixafor conditioning regimen
stress response using thin and standard size endoscopy.

Conditions: Upper Gastrointestinal Disease,Ulcers

Summary: sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups. 1. transnasal gastroscopy with thin endoscope 2. transoral with thin endoscope 3. standard size trans-oral endoscopy stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.

a substantial number of descriptive studies and clinical trials have made it evident that upper gastrointestinal endoscopy elicits cardiovascular and respiratory changes. recent publications have indicated less marked cardiovascular changes when using thinner endoscopes or transnasal endoscopy .hormonal stress response during upper gastrointestinal endoscopy has also been described, but never related to the different methods of upper gastrointestinal endoscopy. furthermore the patient tolerance is markedly improved compared to the standard transoral route. the aim of the present randomised study was to evaluate the ecg-, blood pressure- and pulse rate changes and the endocrine stress response (norepinephrine, epinephrine and cortisol) elicited by upper gastrointestinal endoscopy using a thin endoscope either transnasally or orally or a standard endoscope orally. method and material sixty patients were included consecutively after written and informed consent and were all over 18 years. patients receiving digitalis, ß-blocking agents or calcium antagonists were excluded, as well as patients receiving drugs for thyroid dysfunction or patients receiving steroids. patients with known disease or trauma of the nasal cavity were not included. only intended diagnostic upper gastrointestinal endoscopies were included. the patients received standard medication during the endoscopy if required. immediately prior to the endoscopy each of the 60 patients chose an envelope with the allocation to one of three groups a) endoscopy with a thin endoscope (4.5 mm olympus prototype fiberendoscope) introduced transnasally (t group), b) endoscopy with a thin endoscope (4.5 mm olympus prototype fiberendoscope) introduced orally (o group) or c) endoscopy with a standard gastroscope (6 mm olympus gif xv10) (s group). all patients received the same amount of a local anesthetic spray (lidocaine 10 mg/dose, astra zeneca) (twice in each nostril and twice in the oropharynx, given by one of two particular persons to ensure application of comparable doses of local anesthetic).

Eligibility criteria:
inclusion criteria: * diagnostic gastroscopy, age over 18, danish speaking, exclusion criteria: * use of beta blocking or any other heart rate modulating drug, antithyroid drugs

Keywords: transnasal gastroscopy, stress response, ischaemia
safety and efficacy of rlx030 in pregnant women with pre- eclampsia

Conditions: Pre-eclampsia

Summary: this study is designed in two parts. part 1 will assess the safety and tolerability of different doses of rlx030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). part 2 will assess whether an optimal dose of rlx030 can prolong pregnancy in women with pre-eclampsia.


Eligibility criteria:
key inclusion criteria: * written informed consent was obtained before any assessment was performed. * women at 18 to 40 years of age with a pregnancy 28 weeks (0 days) and 33 weeks (+4 days) gestational age. gestational age was based on mother's last menstruation; if last menstruation was unknown, an alternative method was used as applicable and was documented in the (electronic) case report/record form \[(e)crf\]. * women with a diagnosis of pre-eclampsia or superimposed pre-eclampsia requiring hospitalization. pre-eclampsia was defined as new onset of hypertension (sbp ≥ 140 or dbp ≥ 90 mmhg) or gestational hypertension accompanied by proteinuria (\>= 0.3 g/24h) after 20 weeks of gestation. superimposed pre-eclampsia was defined as chronic hypertension with new onset of proteinuria after 20 weeks of gestation. * reassuring fetal testing (cardiotocography and biophysical profile) key exclusion criteria: * severe hypertension (sbp ≥ 160 mmhg or dbp ≥ 110 mmhg) and /or those receiving anti-hypertensive treatment at time of randomization. * clinically relevant electrocardiogram (ecg) abnormalities at screening excluding those abnormalities commonly seen in pregnancy according to the investigator. * symptoms indicative of severe pre-eclampsia or hellp syndrome (hemolysis, elevated liver enzymes, and low platelet count) for which immediate delivery of the baby may be indicated. symptoms include persistent cns symptoms (severe headaches, visual changes, altered mentation), persistent right upper quadrant or epigastric pain, nausea or vomiting, severe thrombocytopenia (\ 2x upper limit of normal) liver enzymes (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\]). * eclampsia during current pregnancy, vaginal bleeding present at screening, abruptio placentae, oligohydramnios * current diagnosis of a seizure disorder that requires chronic medication. * pre-gestational diabetes (type 1 or type 2) with or without diabetic retinopathy. diagnosis (previous or current) of gestational diabetes, regardless of treatment, was allowed * known allergy to magnesium sulfate or steroids. * multifetal gestation, known major fetal anomaly, intrauterine growth restriction (\<5th percentile).

Keywords: human recombinant rlx030 pre-eclampsia hemodynamics pharmacokinetics
a study of tirzepatide (ly3298176) in participants with obesity or overweight with weight related comorbidities

Conditions: Obesity; Overweight

Summary: the main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without type 2 diabetes. the study will last around 74 weeks.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * have a history of at least 1 unsuccessful dietary effort to lose body weight exclusion criteria: * diabetes mellitus * change in body weight greater than 5 kg within 3 months prior to starting study * obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * history of pancreatitis * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * history of significant active or unstable major depressive disorder (mdd) or other severe psychiatric disorder within the last 2 years

Keywords: metabolism and nutrition disorder prediabetes diet exercise
light therapy to improve symptoms in pregnant women with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.

depression during pregnancy is a common and high impact disease.children who are exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as low birth weight, and more often show cognitive, emotional and behavioral problems.therefore, early detection and prompt treatment of depression during pregnancy can benefit both mother and child.however, the window of opportunity in pregnancy is small and from the perspective of the child postponement is in fact non-treatment. psychotherapy might take a long time to be effective and do not work for all people. further, the safety of pharmacological treatment for pregnant women with depression is still a big concern .psychiatric medication use for depression in pregnancy may also pose a risk of fetal growth retardation and preterm delivery, as well as withdrawal symptoms in the new born. therefore, investigating non-pharmacological approaches to treating depression during pregnancy is urgent and relevant, for both mother and child. preliminary evidence shows that bright light therapy (blt) is an effective treatment for pregnant women with depression based on several theoretical and clinical considerations, with effect size around 0.45 and without adverse effects to the new born. in this study we aim to investigate the effectiveness of blt on pregnant women with major depression.

Eligibility criteria:
inclusion criteria: women; 18\~45 years of age; medically healthy, with normal ocular function; 13\~28 weeks pregnancy; dsm-v diagnosis of major depressive disorder hamd score ≥18 exclusion criteria: dsm-v defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders; substance use disorders; substance use within the last 6 months; suicidal ideation, suicidal attempt, suicide behavior, and attempted suicide; being treated by the light therapy; with antidepressant in recent 2 months; multiple pregnancy; any obstetrical care or medications for physical disorders that might confound treatment results; current use of β-adrenergic blockers, melatonin, or st. john's wort; thyroid function test results inconsistent with normal pregnancy

Keywords: light therapy; major depressive disorder; pregnancy
the effect of sildenafil citrate on the success rate of ovulation induction using clomiphene

Conditions: Anovulatory

Summary: the aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.


Eligibility criteria:
inclusion criteria: * women age 21-35 years. * anovulatory cycles due to polycystic ovaries syndrome. * non-smokers. * free of major medical illness exclusion criteria: * women with myoma or adenomyosis * women with congenital uterine anomaly. * chronic use of any medications including non-steroidal anti-inflammatory drugs. * associated cases of infertility other than pcos (male factor, tubal factor,....). * asherman syndrome. * cases with endometrial hyperplasia. * cases with endometrial polyp
efficacy study of pembrolizumab with entinostat to treat metastatic melanoma of the eye

Conditions: Metastatic Uveal Melanoma

Summary: the purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease). pembrolizumab is an antibody that helps the immune system to attack cancer cells. although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established. entinostat is a histone deacetylase (hdac) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy.


Eligibility criteria:
inclusion criteria: * age above 18 years. * signed and dated written informed consent before the start of specific protocol procedures. * ecog ps 0-1 * histologically/cytologically confirmed stage iv uveal melanoma * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per recist 1.1 criteria * any number of prior therapies (including none), with the exception of anticancer immunotherapy exclusion criteria: * active brain metastases (symptomatic and/or requiring corticosteroids) or leptomeningeal metastases * previous treatment with anticancer immunotherapy * pregnant or nursing (lactating) women * medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study * active autoimmune disease * immune deficiency or treatment with systemic corticosteroids * use of other investigational drugs (drugs not marketed for any indication) within 28 days before study drug administration * life expectancy of less than 3 months

Keywords: uveal melanoma
study of human brain-gut axis and gut microbiome in patients with brain lesions - repository for neuroscience research

Conditions: Malignant Central Nervous System Neoplasm

Summary: this study explores how microorganisms in the gut can affect the growth and progression of brain tumors.

primary objectives: i. to establish a mayo clinic florida brain tumor-gut axis human biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information. ii. to use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer. iii. to study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy. outline: this is an observational study. participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

Eligibility criteria:
inclusion criteria: * all patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study. exclusion criteria: * excluded samples will be from patients younger than 18 years old. there are no exclusions due to race/sex.
role of il-5r signaling in non-eosinophil upper airway cells in crswnp

Conditions: Nasal Polyps; Aspirin-exacerbated Respiratory Disease

Summary: the overarching hypothesis of this proposal is that il-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of il-5 affects several relevant effector pathways that lead to clinical benefit.

further characterization of the role of il-5rα expression and function on human plasma cells will determine whether inhibiting il-5 signaling on these cells offers therapeutic promise in other diseases related to plasma cell proliferation. further characterization of human upper airway epithelial cell il-5rα expression and function will determine whether or not inhibiting il-5 signaling on these cells offers therapeutic promise in other diseases related to epithelial dysfunction. il-5rα expression has been identified on several relevant sinus tissue effector cells, including on nasal polyp plasma cells and epithelial cells, and the aim of this study is to further the field by determining the consequences of il-5 signaling on those cells.

Eligibility criteria:
inclusion criteria: * aerd, crswnp, healthy controls exclusion criteria: * not on any systemic steroids or respiratory biologics at time of surgery
quantification of breast radiotherapy associated late toxicity using novel ultrasound techniques

Conditions: Breast Radiotherapy Toxicity

Summary: around 20% of women who receive breast radiotherapy (rt) experience moderate to severe breast hardening and shrinkage. these side-effects have been shown to be important factors influencing quality of life after breast radiotherapy. it is thought that the likelihood of developing these side-effects is related to the presence of underlying genetic differences in patients. in order to identify these genetic differences, the severity of side-effects needs to be accurately measured. currently, clinical assessments are conducted by a clinician but this is not specific enough to be able to relate development of breast shrinkage and hardening to genetic differences. for example, clinical assessment often fails to distinguish between hardness due to swelling (known as oedema) and hardness due to generalised radiation-induced scarring (known as fibrosis). ultrasound techniques, however, may be able to help quantify and characterise radiotherapy-associated changes in breast tissue allowing for better correlation with genetic abnormalities. once genetic changes can be identified, adjustment of breast rt treatments (or add drugs) to help reduce side-effects in women at higher genetic risk of side-effects may be possible. this study tests the ability of two forms of ultrasound, shear-wave elastography (use) and ultrasound backscatter spectroscopy (ubs), to quantify and characterise breast shrinkage and firmness with a view to using these techniques to measure the late side-effects of breast rt to study the underlying causes of radiotherapy toxicity. principle research question: can a new ultrasound technique (shear wave elastography) measure radiation-induced side-effects in women who have received breast radiotherapy?


Eligibility criteria:
inclusion criteria: two patient groups will be included: 1. import or fast trial patients who received breast rt previously and have received four (or more) year follow-up assessment which found moderate or severe induration. 2. patients who are (1) undergoing, or undergone recently, breast rt (general population) and have undergone a clinical assessment that found moderate or severe oedema, or (2) import high patients who have received rt and have received one or two year follow-up which found moderate or severe oedema. exclusion criteria: * patients with bi-lateral breast cancer. * patients who have undergone surgery to the contralateral breast for either benign or malignant conditions.

Keywords: breast cancer elastography ultrasound imaging quantification of toxicity side-effects
healthcare utilization and outcomes of finess treatment in the office

Conditions: Rhinosinusitis

Summary: a prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using finess sinus treatment in the physician's office.

a prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using finess sinus treatment in the physician's office. also to demonstrate the long-term durability of finess sinus treatment performed in an office setting.

Eligibility criteria:
inclusion criteria: * 18 years or older * male or female subjects * diagnosis of rhinosinusitis (ct radiographic evidence and medical evaluation) * willing to comply with protocol requirements * able to provide consent exclusion criteria: * hemophilia * cystic fibrosis * ciliary dysfunction * severe septal deviation causing obstruction of the ostiomeatal unit * pregnant females

Keywords: rhinosinusitis balloon catheters office treatment otorhinolaryngologic diseases respiratory tract infections respiratory tract diseases finess sinus treatment endoscopic sinus surgery
the study on the esketamine in the treatment of postherpetic neuralgia

Conditions: Postherpetic Neuralgia; Esketamine

Summary: herpes zoster (hz) is an acute herpetic skin disease caused by the reactivation of the varicella-zoster virus (vzv) latent in the sensory ganglia. postherpetic neuralgia (phn) often occurs after herpes zoster heals and persists for a long time. at present, clinically anticonvulsants (such as gabapentin, pregabalin) and antidepressants (such as amitriptyline) are clinically first-line drugs for the treatment of phn, which are not usually effective to treat phn well, as well as to alleviate patients' bad mental symptoms. esketamine, as a well-known n-methyl-d-aspartate receptor inhibitor, has both analgesic and antidepressant effects with extremely few incidence of respiratory depression, delirium, hallucinations, nausea and vomiting. therefore, we hypothesize that esketamine could relieve phn and anxiety and depression-like symptoms symptoms in patients with phn. this study intended to compare the efficacy of pregabalin, amitriptyline combined with esketamine therapy and pregabalin combined with amitriptyline therapy for alleviating phn, and to further explore the feasibility and safety of esketamine in the treatment of phn as well as underlying the mechanism of esketamine on the phn.


Eligibility criteria:
inclusion criteria: * 18-80 years old; patients with post-herpetic neuralgia with anxiety and depression; nrs ≧4 points; a and (or) d ≧8 points in the hospital anxiety and depression scale (hads) ; the course of disease ≧3 months; patients with invalid conventional treatment (pregabalin or gabapentin combined with anti-anxiety depression, anti-epileptic dugs). exclusion criteria: * present acute and chronic pain caused by other disease during treatment; serious systemic disease; severe infection, history of heart, lung, liver and kidney dysfunction, tumor, immunodeficiency and other serious diseases, or currently receiving or have recently received immunosuppression or cytotoxic drug treatment; a history of mental illness such as epilepsy, depression, alzheimer's, multiple sclerosis, parkinson, etc., and a history of head trauma; participating in another clinical trial.