Kornimate/medical-research-clean huggingface dataset:
evaluation of safety and efficacy of the apyx™ device for the repair of pelvic organ prolapse (pop)

Conditions: Pelvic Organ Prolapse

Summary: the aim of this study is to further evaluate this minimally invasive sslf technique with respect to safety, clinical effectiveness, and patient satisfaction. the procedure will be performed in women electing to undergo surgical repair of their prolapse who wish to preserve their uterus, and will be evaluated using standardized measures and questionnaires.

this study will evaluate sacrospinous ligament fixation using an incision-free technique - a technique that was developed with the goal of offering a technically simple, safe, and effective alternative to surgical prolapse repair procedures. when compared to previously reported sslf methods, this technique has undergone novel modifications with the intent of maximizing efficacy and minimizing invasiveness. first, each sacrospinous ligament is approached trans-vaginally using a small diameter, low profile needle as the delivery platform for the anchoring unit. secondly, the suspension is bilateral, thus maintaining vaginal length and width without deviation or narrowing of the vagina as might occur with a traditional (unilateral) sacrospinous repair. and third, using bio-degradable sutures and a securing element that stabilizes the fixation as opposed to performing an incision in the vaginal wall for suturing enables an incision-free procedure leaving the vagina free of any device after a period of several weeks.

Eligibility criteria:
inclusion criteria: women with prolapse electing to undergo reconstructive vaginal surgery for primary uterovaginal prolapse, who wish to enroll in this trial of an incision-free prolapse repair technique, after being familiarized with the suspected benefits and risks of the procedure. * ages 18-90 years old * pop-q stage 2 or greater with an apical support defect, also defined as uterovaginal prolapse * desire of uterine preservation * patient is willing to return for follow-up evaluation and questionnaire completion at 3 months, 6 months, and 12 months, in addition to routine postoperative standard of care. * english fluency exclusion criteria: * previous vaginal, abdominal, or laparoscopic repair for pelvic organ prolapse * prior hysterectomy * known allergy to nitinol / stainless steel / polydioxanone. * suspected uterine pathology, including malignancy. * history of chronic pelvic pain, interstitial cystitis or fibromyalgia. * women diagnosed with symptomatic uterine fibroids, cervical elongation or hypertrophy, abnormal uterine or vaginal bleeding. * history of pelvic inflammatory disease (pid) * prior pelvic radiation therapy or malignancy. * diagnosis of reproductive tract anomalies. * pregnant or lactating women. * participation in another trial * inability to provide informed consent for study enrollment * pi's subjective assessment that study procedure will not plausibly correct patient pelvic organ prolapse symptoms due to anatomic considerations
thrombosomes® in bleeding thrombocytopenic patients

Conditions: Thrombocytopenia; Hematologic Diseases; Bone Marrow Aplasia

Summary: the study evaluates the safety and potential early signals of efficacy of allogeneic thrombosomes in bleeding thrombocytopenic patients

the primary objective of the present study was to assess the safety of increasing dose levels of thrombosomes in bleeding patients with thrombocytopenia. the secondary objective was to explore early signals of clinical efficacy of thrombosomes in this population. the secondary objectives included: 1) evaluation of the impact on who (world health organization) bleeding scores at various timepoints; 2) number and type of blood products infused through day 6 follow-up period; and 3) post hoc analysis of hematology, coagulation, and chemistry.

Eligibility criteria:
inclusion criteria: * adults up to 74 y/o with any of following: acute leukemia (all or aml), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤ 70,000/μl) for a minimum of 2 days. may include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with graft-vs-host disease. * hospitalized patients (or willing to be hospitalized for 24 hours after rx) with modified who grade 1 (subset) or grade 2 bleeding score or at risk for same within 4 weeks of screening. the grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites. * no platelet inhibitor drugs within 5 days prior to infusion and through day 6 follow-up period. exclusion criteria: * history or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: transient ischemic attack, stroke, myocardial infarction, stent placement, valve replacement and/or repair * currently with an active acute infection, or suspected infection, a single oral temperature of ≥ 101° f or a temperature of ≥ 100.4°f sustained over a 1 h period in past 24 h. subjects on prophylactic antibiotics are not excluded from study * coagulopathy or receiving anticoagulants that result in pt (prothrombin time) or aptt (activated partial thromboplastin time) values greater than 1.3 x upper limit of normal or elevated d-dimer of decreased fibrinogen * history of any inherited coagulation or platelet function, disorder or itp (idiopathic thrombocytopenic purpura), ttp (thrombotic thrombocytopenic purpura), or hus (hemolytic-uremic syndrome) * receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion * treatment with an investigational drug within 1 month of infusion, other than for treatment of their underlying disease

Keywords: thrombocytopenia bleeding
analysis of bioparametric measures for correlating daily habits and reducing blood pressure

Conditions: Hypertension; Diet, Mediterranean; Cardiovascular Diseases; Exercise; Machine Learning; Overweight and Obesity; Body Composition; Triglyceride-Storage; Disease

Summary: to study the effects of the use of a mobile application plus recommendations based on a mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in a spanish adult population.

in the valencian community, 93% of deaths appear to be related to (non-communicable) diseases such as: obesity, hypertension and diabetes. in 2013, cardiovascular diseases were the leading cause of death in women (34.4%) and the second in men (28.0%). there is a forecast that overweight and obesity will reach levels of 89% and 85% in men and women, respectively, by 2030. this will result in an increase in the obesity-related prevalence of coronary heart disease by 97%. the promotion of research on arterial hypertension and how it could be reduced is one of the basic pillars in decreasing the prevalence and incidence in the spanish population. research should anticipate and develop treatments and vaccines that prevent new scenarios of widespread infection. therefore, the main objective is to study the effects of the use of a mobile application plus recommendations based on a mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in the adult spanish population.

Eligibility criteria:
inclusion criteria: * over 40 years old * healthy. * blood pressure levels slightly elevated but less than 140 mm hg and/or diastolic pressure less than 90 mm hg. * smartphone access exclusion criteria: * subjects with diseases. * consumption of drugs and/or supplements. * subjects with food intolerances/allergies. * subjects with muscle or joint injury. * subjects with impossibility to follow up the intervention. * refusal of informed consent
fenofibrate and propranolol in burn patients

Conditions: Burn

Summary: the proposed study will test the hypothesis that propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and qol in burned patients.

determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. the investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.

Eligibility criteria:
inclusion criteria: * 0 through 80 years * ≥ 20% total body surface area burn injury exclusion criteria: pregnancy history or existence of pre-burn injury conditions * allergies to propranolol or fenofibrate * asthma requiring treatment * congestive heart failure (measured ejection fraction \< 20%) * renal or hepatic disease * medical condition requiring glucocorticoid treatment * history of aids, aids related complex or hiv * history of cancer within 5 years decision not to treat due to burn injury severity or futility as deemed by the clinical team
accuracy evaluation of the bd facs presto system

Conditions: Acquired Immunodeficiency Syndrome

Summary: the enumeration of t lymphocytes positive for the cd4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as aids. the bd facs presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumeration of cd4 absolute count, cd4 percentage of lymphocytes, and hemoglobin (hb) concentration in human whole blood. this is a prospective study to determine the relative bias between the investigational bd facs presto system and the predicate bd facs calibur with bd tritest system in their determination of absolute cd4, % cd4, and hb concentrations.


Eligibility criteria:
inclusion criteria: * subject has been infected with hiv and willing to provide informed consent to draw venous and capillary blood * specimen: venous blood must be collected in blood collection tube with edta anticoagulant and stored at room temperature (20-25 °c) according to tube manufacturer's instructions * specimen: post enrolment staining within 24 hours * venous blood of acceptable quality for flow cytometry, e.g. no hemolysis or clots and acceptable pre analytical handling) * venous blood sample \> 1 ml for sample preparation * capillary blood applied to the investigational cd4/%cd4/hb cartridge exclusion criteria: * subject unwilling to disclose medical information regarding previous cd4 test results * subject unwilling to discuss medical information regarding co-morbid conditions and current medications

Keywords: flow cytometry
a study of venetoclax and alvocidib in patients with relapsed/refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia (AML)

Summary: an open-label, dose-escalation study to assess the safety and pharmacokinetics (pk), to determine the dose limiting toxicity (dlt) and the recommended phase 2 dose (rptd), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (r/r) acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * must have adequate coagulation, hematology, kidney, and liver function, per protocol. * diagnosis of relapsed or refractory (r/r) acute myeloid leukemia (aml) * meet the following disease activity criteria: * an established, confirmed diagnosis of aml by world health organization criteria excluding acute promyelocytic leukemia (apl)-m3; and * an eastern cooperative oncology group (ecog) performance status less than or equal to 2. * if male participant is sexually active, he must agree from day 1 through 6 months after the last dose of alvocidib or 90 days after the last dose of venetoclax, whichever is longer, to practice the protocol-specified protection. exclusion criteria: * history of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ. * prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy. * history of previous enrollment in studies nct02993523 or nct03069352. * history of exposure to alvocidib or any other cyclin-dependent kinase 9 (cdk9) inhibitor. * history of tumor lysis syndrome (tls) due to previous exposure to venetoclax.

Keywords: cancer acute myeloid leukemia (aml) relapsed acute myeloid leukemia refractory acute myeloid leukemia
construction and application plan of home cardiac rehabilitation for patients undergoing tavr

Conditions: Aortic Stenosis

Summary: cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. the theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and motivation, promoting individual behavior change by selecting the best intervention function and maximizing the use of available resources. to improve the compliance of tavr patients with digital home cardiac rehabilitation, this study is based on the needs of tavr patients and their caregivers for digital home cardiac rehabilitation. based on the best evidence summary of tavr patients' home cardiac rehabilitation, a home cardiac rehabilitation plan for tavr patients is constructed using the theory of behavior change wheels. the delphi method is used to revise the plan, develop a tavr patient home cardiac rehabilitation management system, and conduct clinical application research on the plan to explore the intervention effect of tavr patients' home cardiac rehabilitation based on real-time information intervention.

conduct home cardiac rehabilitation assessment 1-6 days before discharge; in the first week after discharge, cultivate the patient's motivation for rehabilitation; in the second week after discharge, create a home rehabilitation environment; in the third week after discharge, health education on risk factor management; health education on anticoagulation management in the fourth week after discharge; 5 weeks after discharge, home symptom and follow-up management education; carry out home exercise and monitoring from 1 to 12 weeks after discharge.

Eligibility criteria:
inclusion criteria: patients undergoing tavr who were classified as grade i-iii by the new york heart association (nyha); patients are able to use mobile devices such as smartphones; patients who have obtained admission qualifications after undergoing digital home cardiac rehabilitation risk assessment by the rehabilitation team; the patient and their family members voluntarily participate in this study and are willing to provide an informed consent form; able to use remote rehabilitation diagnosis and treatment systems exclusion criteria: malignant tumors or those with serious complications; patients with hearing and visual impairments; patients with limited physical activity due to other diseases; patients with obvious cognitive or mental disorders; patients without internet connection after returning home from hospital; patients who have participated in or participated in other trials or rehabilitation plans within the past three months.

Keywords: cardiac rehabilitation extended care aortic stenosis tavr
effects of carboxymethylcellulose artificial tears on the eye microbiome

Conditions: Dry Eye Syndromes

Summary: carboxymethylcellulose (cmc), a common component in artificial tears, has been shown to modify the gut microbiome. the study is examining its effects on the eye microbiome, which may have implications on ocular disease and artificial tear choice. the study will administer artificial tears containing cmc to the treatment group and artificial tears without cmc to the control group. surveys and conjunctival swabs will be collected before and after treatment for bacterial genome sequencing and analyzed by r statistical packages.


Eligibility criteria:
inclusion criteria: * adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the uf oaks eye clinic. exclusion criteria: * individuals with active eye infections or have prosthetic eyes. * are immunocompromised, or are diagnosed with autoimmune diseases or malignant neoplasms about the eye. * individuals who take immunomodulatory therapy, steroids, antibiotics, medicated eyedrops, or are already using cmc eyedrops within 1 week of the study will also be excluded.
comparison of outcomes between low dose emicizumab and factor viii in clinically severe hemophilia a

Conditions: Severe Hemophilia A Without Inhibitor; Joint Bleed

Summary: * to outcome between low dose emicizumab and low dose prophylaxis with fviii concentration * to study pharmacokinetic, side effect of low dose emicizumab

* to compare outcome between low dose emicizumab and low dose prophylaxis with fviii concentration using abr, ajbr and hjhs, haemoqol * to study pharmacokinetic, side effect and effectiveness of low dose emicizumab

Eligibility criteria:
inclusion criteria: * severe or moderate hemophilia a with baseline fviii:c of \<3 iu/dl or severe bleeding phenotype * receiving low dose fviii prophylaxis for at least 6 months exclusion criteria: * detectable fviii inhibitor at screening * detectable fviii inhibitor at screening having other underlying diseases: juvenile rheumatoid arthritis, metabolic bone diseases, or other conditions mimicking or causing joint diseases

Keywords: emicizumab hemophilia a
mri perfusion imaging at 3tx compared to invasive ffr measurements

Conditions: Perfusion Imaging; MRI; Myocardial Fractional Flow Reserve; Myocardial Ischemia

Summary: coronary artery disease (cad) has a great significance concerning prevalence and mortality in the western world. it is usually diagnosed by catheterization and coronary arteries are visually assessed by the examiner. thus having a great spectrum of interobserver differences, especially when it comes to intermediate lesions. the gold standard to assess the haemodynamic significance is the measurement of the myocardial fractional flow reserve (ffr). the fame-study (tonino, de bruyne et al. 2009) was able o show that additional ffr- measurements in patients with intermediate lesions could significantly reduce stent implementation and consequently mortality. however this method is not used in daily routine and is available only in a fraction of catheter labs worldwide. taking this into account decision finding especially in intermediate lesions remains difficult. one major step to simplify the invasive approach concerning intermediate lesions would be to establish a non-invasive procedures which localizes the coronary vessel to intervene ahead catheterization. do to steady technical development cardiac mri has become a powerful tool which is able to determine myocardial vitality, perfusion and function. in particular the new generation of 3 tesla multi transmit mr with its higher field strength and better spatial resolution seems to be able to show first pass myocardial perfusion more precise. with this new technology prefixed to cardiac catheterization clinical relevant information can be made accessible and thus reduce the number of unnecessary implemented stents.


Eligibility criteria:
inclusion criteria: * intermediate lesion defined by myocardial fractional flow reserve measurement * age \> 18 years exclusion criteria: * pregnancy * contraindication with adenosin, contrast agents or mr-scaning * severe renal dysfunktion * instable patient(e.g. acute myocardial infarction)
eliquis safety surveillance in japanese patients with nonvalvular atrial fibrillation

Conditions: NonValvular Atrial Fibrillation

Summary: the primary objectives of this study are: * to estimate the incidence rate of unexpected adverse events * to characterize the bleeding events and assess risk factors of bleeding * to identify ancillary baseline variables that may also be associated with adverse outcomes


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study exclusion criteria: * patients who are receiving eliquis outside of its approved indication will be excluded from this study

Keywords: cardiovascular
voice and swallowing outcomes following revision anterior cervical spine surgery

Conditions: Dysphagia; Dysphonia

Summary: evaluate voice and swallowing outcomes post operatively.

anterior cervical decompression and fusion is one of the most common spinal surgical procedures performed in the united states. common complications of this type of surgery are difficulty swallowing and nerve dysfunction that can effect voice. the chance of having voice and swallowing disturbances increases if this type of surgery has to be repeated. the purpose of this study is to document the voice and swallowing function of patients undergoing this type of surgery in an effort to find better ways to identify and treat these common complications.

Eligibility criteria:
inclusion criteria: * patients undergoing revision anterior cervical spine surgery exclusion criteria: * primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.