Kornimate/medical-research-clean huggingface dataset:
study of difluprednate in the treatment of inflammation following ocular surgery (st-601a-002a)

Conditions: Inflammation

Summary: the purpose of this phase iii study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility criteria:
inclusion criteria: * unilateral ocular surgery in the day prior to study enrollment. * anterior chamber cell grade ≥ "2" on the day after surgery (day 1). * aged 2 years or older on the day of consent. * negative urine pregnancy test on day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion. * provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate. presurgical exclusion criteria: * systemic administration of any corticosteroid in the 2 weeks prior to study enrollment. * periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug. * instillation of any topical ocular corticosteroid or nsaid within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical nsaid to prevent miosis. * any history of glaucoma or ocular hypertension in the study eye. * history or presence of endogenous uveitis. * any current corneal abrasion or ulceration. * any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease. * allergy to similar drugs, such as other corticosteroids. * history of steroid-related iop increase. * scheduled surgery on the contralateral eye during the treatment period. * unwilling to discontinue use of contact lenses during the study period. * pregnancy or lactation. * participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study. * prior participation in the study described in this protocol. * unable or unwilling to give signed informed consent prior to participation in any study related procedures. postsurgical exclusion criteria: * ocular hemorrhage which interferes with evaluation of postsurgery inflammation. * injection of gas into the vitreous body during surgery. * presence of iop ≥24 mm hg on day 1 after surgery.
variability of physical assessments in an older population that is overweight or obese

Conditions: Obesity; Aging

Summary: variability of physical assessments in an older population that is overweight or obese.

the purpose of this study is to understand difficulty in obtaining physical assessment measurements and assess the variability of these assessments when performed by people who are overweight or obese. data collected in this protocol will be used to inform the design of future clinical studies.

Eligibility criteria:
inclusion criteria: * a written informed consent must be obtained before any study-related assessment is conducted. * men and women aged ≥ 45. * bmi ≥ 30 or bmi ≥ 27 with one or more obesity-associated comorbidities (e.g. hypertension, cardiovascular disease, hyperlipidemia, elevated fasting blood sugar levels, sleep apnea). * participants must be able to communicate well with the investigator and comply with the study requirements. exclusion criteria: * participant weight \> 150 kg. * systolic blood pressure \ 180 or diastolic blood pressure \ 100. * heart rate ≤ 50 or ≥ 100. * unstable medical condition that would put the participant at risk by performing the study assessments. * chronic medical condition rendering participants unable to perform the assessment, e.g., severe knee osteoarthritis.
structural characteristics of trunk and limb muscles in cachectic colorectal cancer patients

Conditions: Colorectal Cancer; Cancer Cachexia

Summary: until now, cancer is still associated with high morbidity and mortality, and is therefore a big issue for the public health. colorectal cancer is the second leading cause of cancer death in developed countries. in advanced colorectal cancer, 60% of these patients develop cachexia. the presence of cachexia plays an important role in the high mortality rate of cancer. cachexia is characterized by involuntary weight loss with loss of skeletal muscle with or without loss of fat mass. the aim of this study is to determine the feasibility of taking muscle biopsies of cachectic colorectal cancer patients. skeletal muscle characteristics will be compared between biopsies of the m. erector spinae and the m. vastus lateralis from cachectic colorectal cancer patients, non-cachectic colorectal cancer patients and healthy controls. 10 cachectic, 25 non-cachectic, and 25 healthy controls will be recruited for this study. it is an observational study, so measurements will be taken at one time point. interventions/measurements: * muscle biopsies * blood samples * 3d freehand ultrasound * short physical performance battery test * handgrip strength * questionnaires (activity pattern, quality of life)


Eligibility criteria:
cachectic colorectal cancer patients. inclusion criteria: * minimum age of 18 years old * unwanted weight loss \> 5% in the last 6 months or \> 2% unwanted weight loss in combination with a bmi \ 2% unwanted weight loss in combination with sarcopenia * cachexia staging score (css): 5-12 exclusion criteria: * mental of psychological condition * insufficient knowledge of the dutch language * muscle diseases affecting the spine and lower limbs * bedridden non-cachectic cancer patients. inclusion criteria: * minimum age of 18 years old * no unwanted weight loss \> 5% in the last 6 months or \> 2% unwanted weight loss in combination with a bmi \ 2% unwanted weight loss in combination with sarcopenia * cachexia staging score (css): 0-2 exclusion criteria: * mental of psychological condition * insufficient knowledge of the dutch language * muscle diseases affecting the spine and lower limbs * bedridden healthy controls. inclusion criteria: - minimum age of 18 years old exclusion criteria: * mental of psychological condition * insufficient knowledge of the dutch language * muscle diseases affecting the spine and lower limbs * bedridden

Keywords: colorectal cancer cachexia skeletal muscle skeletal muscle fibers capillarization
the influence of placental drainage of management of the third stage of labor:a randomized controlled study

Conditions: Postpartum Haemorrhage

Summary: to determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.


Eligibility criteria:
inclusion criteria: 1. greater than 37 gestational weeks 2. single pregnancy 3. vaginal delivery 4. estimated fetal weight 2500-4500 gr. exclusion criteria: 1. pprom 2. 37 or lower gestational week 3. multiple pregnancy 4. grand multiparıty (greater than 5) 5. coagulation defects (hellp, ablation placenta, previa, pre-eclampsia) 6. a history of any bleeding during pregnancy 7. caesarean delivery or any uterine scar 8. a history of postpartum haemorrhage 9. hydramnios 10. known uterine anomalies 11. suspected abnormal placentation (accreta, increta, or percreta) 12. prepartum hemoglobin concentration less than 8 g/dl 13. history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours
atrial fibrillation characterization on paroxysmal and persistent patients

Conditions: Atrial Fibrillation

Summary: background and hypothesis: atrial fibrillation (af) treatment strategies have limitations. the efficacy of the procedure depends in several factors such as age, af duration, atrial diameter and atrial electrophysiological behavior, determining what has been termed as atrial substrate. therefore, the effectiveness of one specific treatment such as the ablation procedure, will be determined by the areas responsible for the maintenance of the fibrillation and its modification and/or elimination. the identification of these areas with a clear description of the arrhythmic substrate is one of the most important factors to determine new biomarkers that explain, at electrophysiological level, the properties of the substrate and therefore, increase the acute efficacy and long-term effectiveness of the treatment.

the main objective of this project is to develop and validate new biomarkers based on a pre-existing methodology for the non-invasive identification of the mechanisms that are responsible for the maintenance of af. this will be achieved by using a body surface potential mapping recording and using the signal to develop a new algorithm that is able to, from the acquired signals acquired during sinus rhythm, extract relevant features for an accurate prediction of long-term ablation outcome for patients with af.

Eligibility criteria:
inclusion criteria: * patients with paroxysmal or persistent af symptomatic and refractory to at least one antiarrhythmic medication arriving in sinus rhythm to the electrophysiology laboratory. * patients must be able and willing to provide written informed consent to participate in the study. * prior anticoagulation for\> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi. exclusion criteria: * patients with inadequate anticoagulation levels, left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on tee prior to the procedure. * patients with moderate-to-severe mitral regurgitation. * patients with contraindications to systemic anticoagulation with heparin or coumadin. * patients who are or may potentially be pregnant. * current enrollment in another investigational drug or device study.
cd19-baff car-t cells therapy for patients with autoimmune diseases

Conditions: Autoimmune Diseases

Summary: clinical trial for the safety and efficacy of cd19-baff car-t cells therapy for autoimmune diseases.

in this study, 45 patients with autoimmune diseases include systemic lupus erythematosus、systemic sclerosis、dermatomyositis、immune nephritis and neuromyelitis optica were proposed to undergo cd19-baff car-t cell therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of cd19-baff car-t cell therapy for autoimmune diseases; at the same time, on the basis of expanding the sample size, more safety data on cd19-baff car-t cell treatment for autoimmune diseases were accumulated, including rare and delayed complications.

Eligibility criteria:
inclusion criteria: * 1. gender unlimited，18\<age; * 2. diagnosed as autoimmune diseases（systemic lupus erythematosus，immune nephritis, systemic sclerosis，dermatomyositis，neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and immunosuppressants，immunomodulator or biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission * 3. estimated life expectancy of minimum of 12 weeks; * 4. the blood routine meets the following standards: 1. lymphocyte count\>0.3×10e9/l; 2. neutrophils ≥0.5×10e9/l; 3. hemoglobin ≥60g/l; 4. platelet ≥30×10e9/l * 5. pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 6.those who voluntarily participated in this trial and provided informed consent; exclusion criteria: * 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; * 3.pregnant or lactating women (the safety of this therapy for unborn children is still unknown) * 4. patients with hiv infection * 5. active infection of hepatitis b virus or hepatitis c virus; * 6. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 7. creatinine\>176.8 umol/l, or alt / ast \> 3 times of normal amounts, or bilirubin\>51 umol/l; * 8. any unsuitable to participate in this trial judged by the investigator; * 9. individuals who have received car-t therapy, car-nk therapy, or any other gene modified cell therapy product within 3 months; * 10. received immunosuppressive therapy within one week prior to mononuclear cell collection； * 11. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)； * 12. any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Keywords: cd19-baff car-t
follow up after tace by elastography and color doppler.

Conditions: Hepatocellular Carcinoma

Summary: to determine accuracy of elastography and color doppler in follow up of patients with hcc after tace comparing with modified recist criteria.

the incidence of liver cancer is one of the highest in the world. in egypt hcc is the forth common cancer and represents up to 90% of all liver malignancies. where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively. transarterial chemoembolization (tace) is recommended as the first-line treatment in early stage patients with hepatocellular carcinoma (hcc) or as a palliative treatment modality in advanced patients with unresctable tumor which was known to increase survival rate. however, tumor control usually requires multiple tace interventions due to the presence of residual and recurrent lesions. currently the response evaluation criteria in solid tumors (recist) guideline was proposed as a method for measuring treatment response based on tumor shrinkage, which is a valuable measure of antitumor activity of cytotoxic drugs, which adapted the concept of viable tumor-tumoral tissue showing uptake in arterial phase of contrast-enhanced msct abdomen. elastography can provide information about tumor stiffness to predict tumor response after tace and detect any residual or recurrence. we also use color doppler in follow up to detect changes in portal pressure and hepatic artries hemodynamics of hcc patients after tace. mainly we search for changes in portal vein velocity {pvvel}, hepatic artery resistive index {hari} and hepatic artery pulsitality index {hapi}.

Eligibility criteria:
inclusion criteria: * all patients with hepatocellular carcinoma underwent tace in south egypt cancer institute. exclusion criteria: * patients with liver metastases. * patients with hepatic or perihepatic inflammations.

Keywords: tace
imbalances of regional pulmonary ventilation in patients with post-acute-covid-19

Conditions: COVID-19 Pneumonia; Post-acute COVID-19 Syndrome; Electric Impedance

Summary: investigation of the correlation of ct-morphological changes of the lung compared to regional ventilation distribution on electrical impedance tomography in patients with post-acute-covid-19 symptoms.

prospective non-interventional, monocentric observational study on imbalances in regional lung ventilation compared to chest ct in post-acute-covid-19. the aim is to verify the agreement between computerized tomography derived imaging variables and electrical impedance tomography in detecting lung ventilation imbalances. the primary study objective is to match ct morphological changes in regional ventilation in post-acute-covid-19 patients and/or changes in lung function examination, with changes that can be visualized by electroimpedance tomography.

Eligibility criteria:
inclusion criteria: * all patients undergoing a chest ct due to suspected post-acute-covid-19-syndrome * \>18 years * informed consent. exclusion criteria: * trauma patients and patients with unstable spinal injuries or fractures * patients with an bmi over 50 * patients with uncontrolled body movements * patients with a pacemaker

Keywords: electric impedance ct tomography regional ventilation post-acute-covid-19 syndrome post-covid-19 eit electroimpedance tomography long-covid
impact (improving plasma collection) clinical trial

Conditions: Apheresis Related Hypotension

Summary: prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.

prospective, multi-center, randomized, controlled clinical trial that will be conducted at three source plasma collection centers throughout the united states. the objective of the trial is to study the safety and effectiveness of a novel plasma collection nomogram run on the bi-directionally integrated haemonetics nexsys pcs® and haemonetics nexlynk dms® plasma collection system. subjects will be randomized into an intervention and control arm. the control arm will donate plasma using the current software. the intervention arm will donate plasma using a novel software that supports a more individualized collection approach.

Eligibility criteria:
inclusion criteria: * donors must be qualified to donate plasma per individual site's screening procedures which are in compliance with iqpp standards. if donors do not meet inclusion criteria at subsequent donations but have already been enrolled in the clinical trial, they are eligible to remain in the clinical trial and to donate plasma within the clinical trial once they meet eligibility criteria again, except if they fulfill any of the exclusion criteria listed below. exclusion criteria: * all subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial. * subject not able or willing to give consent to participate in the clinical trial. * subject donated plasma outside of the present clinical trial after enrolling in this clinical trial. * subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers. * in addition, all donors for whom a bmi for use in the ppn feature cannot be reliably calculated will be excluded

Keywords: plasmapheresis (source plasma collection)
the effect of routine video-recording on colonoscopy quality indicators.

Conditions: Colorectal Cancer

Summary: routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy. the purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy. the study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in poland (the polish colonoscopy screening platform; pcsp). individuals aged 55-64 years are eligible to participate in the pcsp. in the run-in period colonoscopy quality measures will be monitored through a dedicated joint database. then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group. screening centres assigned to the video recording group will receive videorecorders and dvds and will be asked to video record all screening colonoscopies (only withdrawal). control group will be allowed to record colonoscopies on demand only. then , the colonoscopy quality measures will again be monitored through a dedicated joint database. all the recorded dvds will be reviewed to verify ceacal intubation and withdrawal time by the pcsp team.


Eligibility criteria:
inclusion criteria: * screening centres participating in the polish colonoscopy screening platform (pcsp) between 2012 and 2013, in which no routine video recording of screening colonoscopies is performed * screening centres which will sign informed consent

Keywords: colonoscopy videorecording quality indicators screening colorectal cancer
compare the efficacy of levocetirizine to montelukast in reducing symptoms of sar in sensitive subjects exposed to ragweed pollen

Conditions: Rhinitis, Allergic, Seasonal

Summary: to compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.


Eligibility criteria:
inclusion criteria: * have had seasonal allergic rhinitis due to ragweed for the last 2 consecutive years * subjects who obtain a minimum sum score, considering sar related symptoms (mean value), as defined by the protocol exclusion criteria: * any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety * have used forbidden concomitant medications as defined by the protocol

Keywords: levocetirizine xyzal rhinitis allergic seasonal ragweed
cardiac output autonomic stimulation therapy for heart failure - hemodynamic effects

Conditions: Heart Failure Acute; Heart Failure

Summary: a single-arm study to observe neurotronik cardiac autonomic nerve stimulation (cans) therapy system hemodynamic and other physiologic effects.


Eligibility criteria:
inclusion criteria: * normal sinus rhythm by ecg * men and women 21-75 years old * patients with stable symptomatic heart failure, new york heart association (nyha) class ii, iii, or iv. exclusion criteria: * systolic blood pressure \ 160 mmhg * current amiodarone therapy or any other antiarrhythmic therapy * coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month * enzyme-positive mi within prior 1 month * patients who have been hospitalized for heart failure and who required the use of hf iv therapy within 30 days before enrollment (measured from release) * history of recent severe ventricular arrhythmias * pre-existing carotid artery or cerebral disease * patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) * patients with prior vagalotomy * patients with current or prior vagal nerve stimulators * subjects with narrow angle glaucoma * renal failure - on dialysis or serum creatinine \> 2.0 mg/dl * hepatic failure - bilirubin, sgot, or sgpt \> 4x upper limit of normal * patients with a life expectance \< 12 months per physician judgment * women who are pregnant * allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products * subjects unwilling or unable to provide consent for the protocol

Keywords: electrical stimulation therapy; electrodes; parasympathetic nervous system; sympathetic fibers, post ganglionic; congestive heart failure; heart failure