Kornimate/medical-research-clean huggingface dataset:
a multiple increasing dose safety and tolerability study after inhalation administration of biix 1 xx in healthy male volunteers

Conditions: Healthy

Summary: the objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of biix 1 xx and to obtain preliminary pharmacokinetic data


Eligibility criteria:
inclusion criteria: * healthy male volunteers who have broca-indices within +-20% * participants in the age range between 21 to 50 years * in accordance with good clinical practice (gcp) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study. subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead electrocardiogram (ecg) * haematopoietic, hepatic and renal function test will be carried out in the laboratory * the subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. the above mentioned examinations will be performed within 14 days before the first administration of the test substance exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate or ecg) or laboratory tests deviating form normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy) or psychiatric disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of a drug with a long half-life (\>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study * use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial * participation in another trial with an investigational drug within the last two months prior to the start of the study * smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) * inability to refrain from smoking on study days * history of alcohol abuse and/or alcohol abuse * drug abuse * blood donation (\>100 ml) within four weeks prior to administration * other disease or abnormality of clinical relevance * excessive physical activities within two weeks prior to administration or during the trial
diagnosis of hemangiomas and vascular malformations

Conditions: Hemangiomas; Vascular Malformations; Venular Malformations; Venous Malformations; Lymphatic Malformations; Arteriovenous Malformations

Summary: to develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of vms. the purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions. the instrument must be simple and affordable so it can be used by primary car physicians in the doctor office. the procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.


Eligibility criteria:
inclusion criteria: * suspected hemangioma, vascular malformations (vms) including venular malformations (port-wine stain, pws), venous malformations, lymphatic malformations, arteriovenous malformations or mixed malformations. exclusion criteria: * all pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.

Keywords: diagnosis hemangiomas vascular malformations venular malformations venous malformations lymphatic malformations arteriovenous malformations
prospective study of the health benefits of ultra-violet filtering contact lenses

Conditions: Refractive Errors

Summary: the purpose of this study is to examine the short-term protective effect of ultra-violet filtering contact lenses on macular pigment ocular density.


Eligibility criteria:
inclusion criteria: * the subject is an adapted soft contact lens wearer * the subject's spherical error equivalent (best sphere corrected for back vertex distance) must be from -0.50 diopters (d) to -6.00d or from +0.50d to +4.00d in each eye * the subject must have a refractive astigmatism in each eye of -0.75d or less * the subject must have a best corrected visual acuity of 6/9 or better in each eye. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol * the subject must read and sign the statement of informed consent * the subject must be at least 18 years of age exclusion criteria: * systemic or ocular allergies which might interfere with contact lens wear * systemic disease which might interfere with contact lens wear * ocular disease which might interfere with contact lens wear * grade 3 or 4 slit lamp findings * greater than 0.1 difference in macular pigment optical density (mpod) findings between right and left eye at baseline visit * on changing stable medication or taking any medication known to affect tear film * active ocular surface pathology * use ocular medication * had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study * significant ocular tissue anomaly * presence of two or more corneal scars in either eye * pregnancy or lactation, or intends to become pregnant during the time period of the study * any medical condition that may be prejudicial to the study * diabetes * infectious diseases (e.g. hepatitis, tuberculosis) * contagious immunosuppressive diseases (e.g. hiv)
effect on parkinson's disease after therapeutic induction of craniosacral integrated therapy

Conditions: Parkinson's Disease

Summary: we are studying \& researching the effect of craniosacral integrative therapy on parkinson's diseased patients for 3 months. with a therapeutic induction via manual craniosacral integrative therapy for 90 minutes per session with a total of 2 session divided equally in a month (biweekly intervention). at the end of 3 months each patient will have total of 9 hours of craniosacral integrative therapy induced, we will document the symptoms and shortcomings of the patients at evaluation, before and after therapeutic treatment on a measured scale ranging from 1-10. finally graphically and statistically measure the quality of change in the symptoms at the end of 3 months and provide executive summary of the research finding, which the investigators expect to be a positive one.

we are studying \& researching the effect of craniosacral i therapy on parkinson's disease

Eligibility criteria:
inclusion criteria: * must be diagnosed with parkinson's disease exclusion criteria: * anyone without parkinson's disease

Keywords: parkinson's disease craniosacral therapy cranial osteopathy
s9313b study of tumor tissue samples from women with early-stage breast cancer enrolled on clinical trial swog-9313

Conditions: Breast Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients enrolled on clinical trial swog-9313 will respond to doxorubicin and cyclophosphamide. purpose: this laboratory study is looking at tumor tissue samples from women with early-stage breast cancer enrolled on clinical trial swog-9313.

objectives: primary * to determine if aldh1 positivity, as determined by ihc staining, identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with adjuvant doxorubicin and cyclophosphamide on clinical trial swog-9313. secondary * to determine associations of aldh1 expression with other known factors that have been determined on clinical trial swog-9313, such as estrogen receptor (er) status, her2 status, topoii, cyclin e, and p27. * to determine if aldh1 positivity, as determined by ihc staining, identifies a poor prognostic subgroup within er and her2 subgroups in patients treated on clinical trial swog-9313. outline: this is a multicenter study. tumor tissue samples from clinical trial swog-9313 are analyzed for aldh1 expression by ihc.

Eligibility criteria:
disease characteristics: * tumor samples collected from women diagnosed with early-stage breast cancer on clinical trial swog-9313 available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer
single-dose study of pf-04603629 in type 2 diabetic subjects

Conditions: Diabetes Mellitus, Type 2

Summary: pf 04603629 is a long acting exendin proposed for the treatment of type 2 diabetes mellitus. the purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * hb a1c lower or equal to 11% exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * evidence of diabetic complications with significant end-organ damage

Keywords: glp-1
diet and meal timing in patients with non-alcoholic fatty liver disease: a pilot study

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.

time-restricted eating (tre) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. non-alcoholic fatty liver disease (nafld) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. the only current treatment for nafld is weight loss. in the proposed study, the investigators aim to test the hypothesis that tre will add additional benefit in the treatment of nafld on top of standard of care diet and lifestyle modifications.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and \< 65 years old * must provide signed written informed consent and agree to comply with the study protocol * bmi \>25 kg/m² * baseline liver fat content of at least 10% as measured by mri-pdff exclusion criteria: * unclear etiology of liver disease * competing etiologies for hepatic steatosis * co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to: * positive hepatitis b surface antigen * positive hepatitis c virus rna * suspicion of drug-induced liver disease * alcoholic liver disease * autoimmune hepatitis * wilson's disease * hemochromatosis * primary biliary cholangitis or primary sclerosing cholangitis * known or suspected hepatocellular carcinoma * current or recent history (\ 30g of alcohol per day. for women, it is defined as \>20g of alcohol per day. * compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). nash patients with fibrosis stage = 4 according to the nash crn fibrosis staging system are excluded. * reduction in weight by ≥ 5% within the prior 90 days * current fasting for ≥ 12 hours per day on the majority of days each week * pregnant females * mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain * inability to perform mri-pdff and/or study as defined below * inability to medically perform prolonged fasting (i.e. insulin regimen)
efficacy and safety of terlipressin with albumin versus midodrine with albumin versus albumin alone in prevention of paracentesis induced circulatory dysfunction in cirrhosis

Conditions: Cirrhosis

Summary: * study population: patients admitted or seen in out patient department, department of hepatology, institute of liver and biliary sciences. * study design: prospective open labeled randomized controlled trial. * study period: january 2017 to december 2017 * intervention- subjects will be randomized to 3 groups * all patients will receive standard medical therapy - albumin-8g/l of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. group a - subjects will receive terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) group b - midodrine 7.5 mg tds x 3 days group c - standard medical therapy only * monitoring and assessment: clinical evaluation will be done at regular intervals. * adverse effects: rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted. * stopping rule: development of picd, hypertension ( bp\>160/90mmhg-jnc class ii)


Eligibility criteria:
inclusion criteria: 1. patients with cirrhosis who undergo large volume paracentesis (\> 5l) 2. patients with age from 18-75 years exclusion criteria: 1. renal failure ( creatinine\>1.5mg/dl) 2. recent gastrointestinal bleeding within 7 days 3. spontaneous bacterial peritonitis 4. patients with cardiovascular disease (electrocardiogram, 2d echo) 5. systemic arterial hypertension ( \>160/90mmhg) presence of hepatocellular carcinoma or portal vein thrombosis, budd chiari syndrome 6. patients with active untreated sepsis 7. pregnancy 8. patients with hepatic encephalopathy 9. no use of drugs affecting systemic hemodynamic 3 days prior to enrollment 10. refusal to participate
a study to evaluate safety and effectiveness in patients of all age groups excluding less than 12 months old infants with diabetes mellitus in routine clinical practice in korea

Conditions: Diabetes

Summary: this study is conducted in asia. the aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in korea.


Eligibility criteria:
inclusion criteria: - signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - the decision to initiate treatment with commercially available tresiba® flextouch® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study - male or female, age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with tresiba® flextouch® based on the clinical judgment of their treating physician as specified in the korean-prescribing information (kpi) exclusion criteria: - previous participation in this study. participation is defined as having given informed consent in this study - patients who are or have previously treated with tresiba® flextouch® - mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. however, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (lar) are capable of giving study specific signed informed consent. any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
comparison between two surgical methods for eyelid ectropion: tarsal strip alone versus tarsal strip with punctoplasty (three snips with or without diamond-shaped resection)

Conditions: Ectropion

Summary: ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of lacrimal point. the objective of the study is to compare two surgical strategies for eyelid ectropion combined with ectropion of the lacrimal point

were included patients underwent eyelid ectropion surgery in ophthalmology department from oct 2014 to oct 2015. the first procedure is lateral tarsal strip alone (group 1); the second one is lateral tarsal strip with three snips with or without diamond-shaped resection (group 2). the authors focused on the alteration of the quality of life related to watering, before and after operation. quality of life related to discomfort due to watering was evaluated before and after surgery using a questionnaire. informations have been gathered via phone with a ten items questionnaire, each item is worth 0 (no or minim discomfort due to watering) or 1 (discomfort due to more than moderated watering)

Eligibility criteria:
inclusion criteria: * patients underwent eyelid ectropion surgery exclusion criteria: -
sleep apnea in tia/stroke: reducing cardiovascular risk with positive airway pressure

Conditions: Transient Ischemic Attack; Stroke

Summary: the goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(pap) therapy reduces cardiovascular risk. patients with transient ischemic attack(tia) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.

the proposed study is a randomized controlled trial among patients with transient ischemic attack (tia) and minor stroke, comparing strategies for the diagnosis and treatment of sleep apnea with usual care over 6-12 months at 2 sites (yale university school of medicine and indiana university school of medicine). patients with tia and minor stroke will be randomly assigned to either usual care or a diagnosis and treatment approach that includes ambulatory polysomnography and initiation of autotitrating cpap for sleep apnea in a 1:2 (control:intervention) randomization scheme. intervention patients with sleep apnea will receive either a standard cpap treatment intervention or an enhanced protocol designed to increase long-term cpap adherence. the primary outcomes will include: (a) the impact of cpap on pathophysiologic markers in the following domains of cardiovascular risk: inflammation (crp, il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma catecholamines and heart rate variability (hrv)), insulin resistance (homa-ir, hba1c), endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media thickness); and (b) long-term (6-12 month) cpap adherence.

Eligibility criteria:
inclusion criteria: * 18 years and older * tia or ischemic stroke * within 1 week of neurological symptom onset * brain imaging within 24 hours exclusion criteria: * known to have sleep apnea * suspected sleep disorder other than sleep apnea * hospice patients or patients receiving comfort only measures * patients unable to use a nasal or face mask * patients who require mechanical ventilation * non english language patients * inability to provide informed consent * active suicidal ideation * live outside the recruitment area * provider does not allow researcher to contact patient

Keywords: sleep apnea cpap adherence behavioral adherence stroke
gabapentin in phantom and stump pain

Conditions: Amputation of Lower Limb

Summary: to investigate whether gabapentin can prevent phantom and stump pain after amputation.


Eligibility criteria:
inclusion criteria: 1. amputation of crus or femur exclusion criteria: 1. patients who cannot cooperate 2. fertile women without sufficient contraceptives 3. allergy to gabapentin 4. earlier amputation of the same limb except toes 5. serious lever, kidney, cardiac, respiratory, haematological disease.-
correlating early fdg pet/ct and ctdna in immune checkpoint inhibitor (ici)-treated melanoma patients

Conditions: Melanoma; Melanoma Stage III; Melanoma Stage IV; Unresectable Melanoma

Summary: the purpose of this research study is to determine if analysis of pet/ct scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of immune checkpoint inhibitor therapy.

this is a pilot, prospective, observational study to estimate the degree to which baseline and early interval 18f-fdg pet/ct imaging within 3-4 weeks of ici therapy initiation can accurately correlate with ctdna level trends, predict clinical response, onset of immune-related adverse events, and survival outcomes in advanced stage melanoma patients. primary objective • to determine if early interval response assessment with 18f-fdg pet/ct during initial treatment with ici therapy at 3-4 weeks correlates with ctdna level changes in advanced melanoma patients. secondary objectives * to determine if early interval response assessment with 18f-fdg pet/ct during initial treatment with ici therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients. * to assess if early interval response assessment with 18f-fdg pet/ct predicts development of clinical iraes in advanced melanoma patients. * to assess if early interval response assessment with 18f-fdg pet/ct and ctdna level predicts progression-free survival (pfs) in advanced melanoma patients. * to assess if early interval response assessment with 18f-fdg pet/ct and ctdna level predicts overall survival (os) in advanced melanoma patients.

Eligibility criteria:
inclusion criteria: * willing to provide informed consent. * must have an advanced stage iii or stage iv melanoma diagnosis for which treatment with ipilimumab, nivolumab, and/or pembrolizumab, either alone or in combination with other ici therapy, is planned. * must be planning to participate in signatera™ (ctdna level) monitoring with standard of care laboratory testing routinely obtained for treatment with ici therapy. * individuals at least 18 years of age. * women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study. * willing to comply with all study procedures and be available for the duration of the study. exclusion criteria: * not able to receive treatment with ici therapy * use of investigational drugs, biologics, or devices within 30 days prior to enrollment. * women who are pregnant, lactating, or planning on becoming pregnant during the study. * not suitable for study participation due to other reasons at the discretion of the investigators.

Keywords: circulating tumor dna fdg ici