Kornimate/medical-research-clean huggingface dataset:
investigation of bone defects and microcirculation with computed tomography and magnetic resonance imaging

Conditions: Osteoporosis; Multiple Myeloma; Vertebral Fracture

Summary: subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and localized microcirculation in test animals with osteoporosis, fractures and after placement of bone substitute material with volume computed tomography (vct) (animals only) and functional magnetic resonance imaging (mri). in vivo imaging by means of functional mri and vct is carried out in osteoporotic rats, both after the induction of fracture as well as after the placement of bone substitute material. furthermore, patients with asymptomatic mm are investigated with functional mr-imaging (dynamic contrast enhancement- mri and intravoxel incoherent motion (ivim)-imaging) longitudinally to predict the occurrence of osteolysis and the time to progression regarding slim-crab-criteria (rajkumar et al., lancet oncology, 2014). hypothesis: 1. affection of microcirculation at the junction of bone and bone substitute material can be displayed by vct and functional mri 2. functional mri has prognostic value regarding occurrence of osteolysis and progression to mm regarding slim-crab-criteria

in an experimental study, rat models were used for imaging studies employing mri (morphological, dce- and dwi) and vct. mice were not used for imaging purposes due to the small size. rats were shown to be of optimal size for small imaging studies. 144 patients with (suspected) asymptomatic mm were recruited for dynamic contrast-enhanced mri (dce-mri) and diffusion weighted imaging (dwi) of the vertebral column as well as whole-body mri using t1tse and stir images every 6 months until progression and/ or occurrence of first osteolysis. while during planning and initiation of this prospective trial mm was defined by crab-criteria only, in 2014 the slim-crab-criteria were proposed by the international myeloma working group (rajkumar et al., lancet oncology, 2014) with the goal to treat patients before development of osteolysis or other crab-criteria. these criteria were consequently introduced in clinical practice at our institution during the observation period of this study, which affects both inclusion and progression criteria of this study. in order to obtain a conclusive cohort with homogenous inclusion and progression criteria, slim-crab-criteria where retrospectively applied to restage all patients regarding inclusion and progression to mm defined by slim-crab-criteria.

Eligibility criteria:
inclusion criteria: * benign osteoporosis exclusion criteria: * contra-indications for mri
prospective study on the efficacy and safety of 2 week or 3 week xelox regimen for adjuvant chemotherapy in crc

Conditions: Colorectal Cancer

Summary: this study select the diagnosis of postoperative colorectal cancer patients with stage ii/iii to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. to analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.


Eligibility criteria:
inclusion criteria: * carcinoma of the intestine confirmed histologically or cytologically * radical surgical resection was performed after diagnosis and the post operative stages were high-risk ii or iii patients * the ecog ps score less than or equal to 2 points * no chemotherapy of any kind has been performed in the past * neutrophils acuity 1.5x10e9/l, platelets more than 100x10e9/l, college blood red protein more than 9g/dl * liver function transaminase is less than or equal to 2.5 uln, alkaline phosphatase is less than 2.5 uln, and total bilirubin is less than 1.5 uln exclusion criteria: * patients with unresectable crc * patients who have any form of chemotherapy before * participating in or having participated in clinical studies of other drug * patients have second primary malignant tumors of have other malignant tumors in the past five years * there is evidence of allergic reaction to drugs in this study * a history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias * severe active inflammation, including tuberculosis and hiv * long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose * drug or alcohol addiction * get pregnant or breastfeed * the investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems
ultra-high-resolution mapping guided partial antral ablation for af

Conditions: Atrial Fibrillation

Summary: the electrical isolation of the pulmonary veins (pvi) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (af) because the pv is the most common trigger of af. wide bi-antral circumferential ablation (waca) is more effective than segmental pv isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. therefore, it is widely accepted as initial ablation strategy. however, the waca technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the pv antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human pv-left atrium (la) junction are previously reported, and electrical pv isolation can usually be achieved without complete circumferential ablation. however, the current electroanatomical mapping (eam) system has a limitation to understand the complex relationship of pv-la junction mainly due to relatively low resolution. the rhythmia mapping system (bostonscientific, inc, cambridge, ma) is a new system provides ultra-high-resolution eam using a small basket array of 64 electrodes (intellamap orion, boston scientific). owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction. in this context, we hypothesized that rapid and precise identification of activation pattern of pv-la junction by rhythmia system could allow complete, durable electrical isolation of pvs without circumferential antral ablation.


Eligibility criteria:
inclusion criteria: 1. age over 20 years old and under 80 years old 2. patients with non-valvular paroxysmal atrial fibrillation 3. patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. patients who could have informed consent 5. patients who are available for a follow-up of more than at least three months after the catheter ablation exclusion criteria: 1. patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease 2. patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation 3. patients in the subject group vulnerable to a clinical study 4. patients who had undergone a prior catheter ablation for atrial fibrillation

Keywords: atrial fibrillation ablation pulmonary vein ultra high resolution mapping
determining the safety and effectiveness of olanzapine in children and adolescents

Conditions: Bipolar Disorder; Psychotic Disorders

Summary: this study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.

numerous advancements in mental health treatment have been made over the past decade. unfortunately, these advancements have focused on adults and have not been fully extended to children and adolescents. with limited pediatric information on the pharmacokinetics and pharmacodynamics for drugs used to treat mental health problems, psychiatrists are prescribing drugs for children using data extrapolated from adults, which may lead to potentially life-threatening results. olanzapine is widely prescribed to treat both children and adults. this study will determine the safety and effectiveness of olanzapine in children and adolescents with mental health disorders. the study will also compare the effects of gender, development, body composition, and metabolic genotype and phenotype on how olanzapine works. all participants will receive olanzapine for up to 8 weeks. blood collection will occur at each weekly study visit. on visit 1, participants will receive their first dose of olanzapine and repeated blood collection will occur every hour for 24 hours. blood collection will be used to determine the time it takes for olanzapine to be absorbed into the body, its duration of action, the extent of its distribution in the body, the manner in which it is excreted from the body, and its effects on organs of the body.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder with mania, mixed mania, or psychosis not otherwise specified * meet certain laboratory result requirements * have taken either lithium or valproate for 4 weeks or longer with no or only partial response * parent or guardian willing to provide informed consent exclusion criteria: * history of other serious unstable illness requiring medication * diabetes mellitus * abnormal physical examination and electrocardiogram (ekg) results * at risk for suicide or homicide (based on an assessment of suicidal history, intent or plan, mental state, mood, and substance use) * iq less than 65 * history of organic brain disease or seizure disorder * recent exposure to an infectious disease, such as tuberculosis (tb) or meningitis * current use of drugs that may interfere with the metabolism of olanzapine and unwilling to discontinue use during the study * body mass index (bmi) less than the 5th or greater than the 95th percentile for age and gender * history of smoking within 1 year prior to study entry * pregnancy or breastfeeding

Keywords: child adolescent mental health olanzapine pharmacokinetics pharmacology
exercise testing protocols for females and males with cad

Conditions: Coronary Artery Disease

Summary: the aim of this study is to determine if the test that allows males to achieve a higher vo2 (a measure of oxygen use during exercise) is different for females. the purpose of this study is to test 4 different exercise testing protocols to compare measured oxygen consumption in females and males with cad (disease caused by the buildup of plaque in the artery walls which can lead to insufficient amounts of blood, nutrients and oxygen being supplied to the heart). the 4 exercise tests that will be completed on the treadmill are the modified balke, modified bruce, modified naughton and university of ottawa heart institute slow ramp protocols. each test has a different stage duration (the amount of time that the test remains at a pre-determined speed and incline), and incremental increase in speed and incline. the main purpose of this study is to compare vo2 peak (the maximal amount of oxygen utilized during the exercise test) of females and males with cad in 4 different exercise protocols. for example, the investigators will find out: 1. which exercise protocol is more likely to achieve a higher peak v̇o2 in females and which protocol is more likely to achieve a higher peak v̇o2 in males, 2. if enjoyment affects the duration of the test, and 3. how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.


Eligibility criteria:
inclusion criteria: 1. 18 years and older; 2. previous cad diagnosis by a physician; 3. can perform a cpet until volitional exhaustion; 4. are able to self-ambulate on a treadmill; 5. are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (pci), coronary artery bypass graft (cabg)); and, 6. are able to provide written informed consent. exclusion criteria: 1. cannot speak, read, write, or understand english or french; 2. currently not enrolled in a cr program; 3. have recently changed (or planning to change) pa levels within the previous 4 weeks (as this may impact the ability to compare outcomes between exercise testing protocols); 4. have heart failure with an ejection fraction \<45% (indication of possible cardiomyopathy);6 5. have an arrythmia (relative contraindication for exercise testing),6 peripheral artery disease, valvular disease, severe aortic stenosis, cardiomyopathy, scad and/or copd (contraindications for maximal exercise testing); 6. has an icd; 7. is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia) 8. is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).
personalized shared eye-care identification of age-related macular degeneration using artificial intelligence and telemedicine by matching optometrist office-based sites with clinical supervision

Conditions: Age-Related Macular Degeneration

Summary: office-based optometrist centres equipped with low-cost oct devices can be used for screening of age-related macular degeneration. matching next-door optometrist centres with clinical sites introduces a shared care service in an unprecedented and broad manner and offers timely and inclusive access to eye care for all citizens affected by the most frequent blinding disease in western countries. the aim of the study is to detect amd in a next-door office-based setting on an individual level using low-cost oct, through a telemedicine feedback loop. the specific aims of this study are: * setting up a network of optometrist centres matched to clinical sites to perform shared care to protect eyesight in the elderly population. * identify imaging biomarkers of age-related macular degeneration from oct imaging. * give a risk estimation of progression using a one-time low-cost oct scan


Eligibility criteria:
inclusion criteria: * age: 55-99 years old * preserved visual function, defined as visual acuity better than or equal to 0.3logmar in one or both eyes exclusion criteria: * refractive errors with mean spherical equivalent (mse) greater than +/-6.00, with no limit to astigmatic component.

Keywords: telemedicine ophthalmic coherence tomography shared-care
determination of blood loss after cs

Conditions: Effect of Drug

Summary: comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following cs

tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following cs

Eligibility criteria:
inclusion criteria: 1. age : 20-40 year * 2- gestational age is between 37-41weeks 3- delivery by uncomplicated elective cs exclusion criteria: * 1- risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- grandmultiparity 3- past history of postpartum hemorrhage either atonic or traumatic 4- previous history of retained placenta 5- pre-eclampsia or gestational hypertension/ maternal dm 6- abnormal placentation 7- contraindications to the use of tranexamic acid 8- hypersensitivity to tranexamic acid. 9- women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),
treatment of knee osteoarthritis with allogenic mesenchymal stem cells

Conditions: Osteoarthritis, Knee; Arthritis of Knee; Knee Osteoarthritis

Summary: in this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (msc), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. the trial is based in our own previous results with autologous msc (ongoing nct01183728 trial). we propose here a multicenter, phase i-ii clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees ii and iii and iv). the assay consists of two arms with 15 patients each one. patients in the experimental arm will be given an intra-articular transplantation of allogenic msc, expanded "ex vivo" with our gmp-compliant procedure (msv, pei no. 10-134, authorized by the competent authority; same as in nct01183728). in the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. we shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by t2-weighted mri relaxation (cartigram) for one year.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis grade ii, iii and iv of kellgren and lawrence assessed by two observers. * chronic knee pain with mechanical characteristics. * no local or systemic septic process. * haematological and biochemical analysis without significant alterations that contraindicate treatment. * informed written consent of the patient. * the patient is able to understand the nature of the study exclusion criteria: * age over 75 or under 18 years or legally dependent * present infection (to be included in the study no signs of infection must be evidenced) * congenital or acquired malformation resulting in significant deformity of the knee (varus\<10º; valgus\<20º) and leading to problems in application or evaluation of results. * overweight expressed as body mass index (bmi) greater than 30.5 (obesity grade ii). bmi estimated as mass (kg) / corporal surface (m2). * women who are pregnant or intend to become pregnant or breast-feeding * neoplasia * immunosuppressive states * intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion * participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study. * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Keywords: knee degenerative disease osteoarthritis gonarthrosis stem cell cellular therapy regenerative therapy mesenchymal stem cells bone marrow musculoskeletal diseases mesenchymal stromal cells (allogenic)
study to determine the effect of food on the absorption of an oral testosterone undecanoate formulation

Conditions: Male Hypogonadism

Summary: the purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. subjects will have one dose of tu administered 30 minutes after the initiation of the meal.

Eligibility criteria:
inclusion criteria: * male * age 18-65 * morning serum testosterone (t) \<300 ng/dl on two occasions exclusion criteria: * significant intercurrent disease * abnormal prostate digital rectal exam, elevated psa, aua symptom score \>15 or history of prostate cancer. * serum transaminases \>2 times upper limit of normal * serum bilirubin \>2.0 mg/dl * hematocrit \ 50% * bmi \>36 * untreated, obstructive sleep apnea.

Keywords: primary hypogonadism secondary hypogonadism
glucagon modulation of ghrelin secretion

Conditions: Healthy Subjects; Obesity; Diabetes Mellitus, Type 1

Summary: as a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining glucose homeostasis in vivo. it is well known that intramuscular glucagon administration stimulates growth hormone (gh), adrenocorticotropic hormone (acth) and cortisol release in humans. recently, it has been shown that glucagon induces a remarkable decrease in ghrelin levels. the mechanisms underlying this effect are unclear and the role of changes in glucose, insulin, glucagon-like peptide-1 (glp-1) and catecholamines are widely discussed. the aim of the present study is to further evaluate the effect of glucagon on ghrelin secretion and the possible role of the above mentioned factors in mediating this effect.


Eligibility criteria:
inclusion criteria: * subjects \> 18 and \< 60 years old. * patients with diabetes type 1 should fulfill the following criteria: * ict insulin therapy was necessary within the first 3 months after diagnosis; * hba1c-wert \< 7%. exclusion criteria: * diabetes type 1 or 2 (for the healthy group). * biochemical evidence of impaired hepatic or renal function. * history of cardiovascular disease. * uncontrolled hypertension. * current inflammatory, malignant or psychiatric disease. * pregnancy

Keywords: obesity food intake glucagon ghrelin glucose insulin
investigation of the accuracy of a low-cost, portable, autorefractor to provide well-tolerated eyeglass prescriptions

Conditions: Refractive Errors

Summary: at the aravind eye hospital (aeh) in madurai, india, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the quicksee autorefractor. patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. after one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. after a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. patients may then decide which pair patient like best. this is a double blind, case-crossover clinical trial.


Eligibility criteria:
inclusion criteria: participants- 1. who visit a vision center for their eye check-up 2. who are aged between 18 years and 40 years exclusion criteria: participants- 1. whose refractive error is not within the detection range of the quicksee device: -10 to +10 d 2. who have a cylindrical power greater than 3 d 3. who have to travel long distances (beyond 10kms) to the hospital 4. who choose to buy spectacles that are priced more than rs. 2000/- per pair 5. who have speech or hearing impairment 6. who do not speak the local language, tamil 7. who do not want to purchase spectacles from aeh