Kornimate/medical-research-clean huggingface dataset:
intervention of biventricular pacemaker function on ventricular function among patients with lvad's

Conditions: Heart Diseases; Left Ventricular Dysfunction

Summary: the primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (lvads, or "mechanical hearts"). second, the investigators are interested in understanding how different pacemaker settings influence function of the heart at rest and activity.

healthy individuals, as well as patients with advanced heart failure supported by lvads, completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided heart function at rest and with exercise during invasive cardiopulmonary exercise testing on upright cycle ergometry.

Eligibility criteria:
15 patients with advanced heart failure (hf) who have already undergone implantation of a continuous-flow left ventricular assist device (cf-lvad) implantation. inclusion criteria: 1. have already received cf-lvads and are clinically stable, 2. ambulatory outpatients and are fully recovered (at least 3 months) from lvad implantation; exclusion criteria: 1. individuals with clinical right ventricular (rv) failure under resting conditions, defined as moderate-severely reduced rv systolic function on echocardiography, or 2. clinical evidence of rv failure (elevated jugular venous pressures, 3 or 4+ \[significant\] peripheral edema); 3. disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease); and 10 healthy individuals will serve as a control group to define normal rv function during exercise. inclusion criteria: 1) persons without a past medical history of cardiovascular disease or related disease such as: 1. hypertension, 2. diabetes, 3. peripheral vascular disease, 4. arrhythmias, f. are not taking any cardiac-related medications (e.g. antihypertensive medications). exclusion criteria: 1. individuals requiring systemic anticoagulation with vitamin-k antagonists or new/direct oral anticoagulants ("noac"/"doac"); 2. disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease).
cone beam computed tomography (ct) bladder

Conditions: Bladder Cancer

Summary: this study is designed to investigate whether daily images of the pelvis and bladder using a device called a cone beam ct scanner will help to increase the accuracy of radiotherapy treatment. the cone beam ct scanner is a part of the radiotherapy treatment unit. the results of the study may allow patients in the future who are undergoing radiotherapy treatment for bladder cancer to 1) have more accurately directed treatment, 2) have higher doses of radiation delivered to the tumour while keeping doses to the surrounding normal tissues as low as possible. this may allow eradication of the cancer while minimizing side effects of treatment. this study consists of two phases: phase a and phase b. in phase a, images were collected and analyzed and it was confirmed that it was useful to use the cone beam machine for daily cone beam ct bladder (phase b)treatment adjustments. in phase b, we hope to be able to use cone beam ct scans to more accurately direct the radiotherapy treatments on a daily basis.

cone beam computed tomography (ct) is new technology that allows the acquisition of 3-dimensional cross-sectional imaging while the patient is positioned on a linear accelerator couch. cone beam ct also provides 3d soft tissue volumetric data and therefore important information on daily interfraction movement and deformation of normal critical structures within the pelvis. visualization of the tumor using this technology may also be enhanced by the additional placement of fiducial markers around the tumor bed to ensure even more accurate targeting. the aim of this study is to assess the feasibility of daily cone beam ct for image guidance in patients receiving radiation therapy (rt) for bladder cancer as well document changes in size and location of the bladder and rectum during an entire course of rt. this will enable us to explore techniques for radiation therapy based on normal tissue avoidance models to reduce treatment toxicity and potentially dose escalation in the future.

Eligibility criteria:
inclusion criteria: diagnosis of carcinoma of the bladder * patients undergoing radical external beam radiotherapy * age \>18 years * ecog performance status 0-1 * informed consent exclusion criteria: * inflammatory bowel disease or collagen vascular disease * patients undergoing palliative radiotherapy to the bladder

Keywords: bladder cancer cone beam ct on-line image guidance radiation therapy in bladder cancer patients
ambulatory versus home blood pressure monitoring in obstructive sleep apnea

Conditions: Obstructive Sleep Apnoea; Hypertension

Summary: subjects referred to a sleep clinic had polysomnography (psg), clinic bp measurements, 24-hour abp monitoring and hbp monitoring using a device (microlife watchbp homen) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime bp measurement (3 nights, 3 readings/night).


Eligibility criteria:
inclusion criteria: * age ≤ 65 years * suspected osa * treated or untreated for hypertension exclusion criteria: * history of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke) * history of asthma or chronic obstructive pulmonary disease (fev1/fvc \<70%) * history of diabetes mellitus, collagen diseases and sarcoidosis * serum creatinine \>1.6 mg/dl, proteinuria * previous treatment with cpap * pregnancy or menstruation during the study * treatment with steroids, lithium or any other drugs affecting bp * change in antihypertensive treatment(if any) in the last 8 weeks before study entry
a comparison study of oxybutynin and botulinum toxin for neurogenic detrusor overactivity

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type a on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.


Eligibility criteria:
inclusion criteria: * spinal cord injury * detrusor overactivity * age over 18 years * spinal cord injury at least 12 months duration * undergoing regular clean intermittent catheterisation exclusion criteria: * pregnancy * desire to become pregnant during the study period * breastfeeding * blood coagulation disorder * neuromuscular transmission disorder * use of any intravesical pharmacologic agents * previous use of botulinum toxin a

Keywords: neurogenic bladder urodynamic quality of life
dosing and tolerability of deoxycholic acid vs. polidocanol in the treatment of neurofibromatosis type 1 cutaneous neurofibromas

Conditions: Neurofibromatosis 1

Summary: this study will evaluate the tolerability and effectiveness of two treatments in neurofibromatosis type 1 cutaneous neurofibromas. these treatments are: kybella and asclera injection. each patient will have a treatment and a control site.


Eligibility criteria:
inclusion criteria: 1. adult males and females ≥18 years of age 2. have a diagnosis of nf1 based on germline genetic testing or by meeting ≥ 2 the following criteria: 1. family history of nf1 2. six or more light brown ("cafe-au-lait") spots on the skin 3. presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas 4. freckling under the arms or in the groin area 5. two or more pigmented, benign bumps on the eye's iris (lisch nodules) 6. a distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg 7. tumor on the optic nerve that may interfere with vision 3. patients must be seeking treatment for cnf 4. patients must have ≥ 6 paired cnf per modality (3 treated and 3 untreated). cnf should be visible and measure between 2-8mm in size. these must be in areas amenable to treatment and surveillance with digital photography. 5. cnf must be located on the trunk, arms or legs of the patient 6. able and willing to comply with all visit, treatment and evaluation schedules and requirements 7. able to understand and provide written informed consent exclusion criteria: 1. patients who are undergoing other treatment modalities or investigational agents for their cnf lesions 2. individuals who cannot give informed consent or adhere to study schedule 3. actively tanning during the course of the study 4. adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists; 5. known allergy to injectable anesthetics, polidocanol or deoxycholic acid 6. those with acute thromboembolic diseases 7. those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy 8. those with dysphagia 9. women who are pregnant 10. any condition which, in the investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study
a natural history study of adult onset pompe disease using muscle mri

Conditions: Pompe Disease

Summary: this project is an observational prospective study in which patients affected by an adult onset pompe disease will be followed-up during three years using different clinical, analytical and radiological tests in order to know which is the natural history of the disease and which is the impact that treatment with recombinant enzyme has in the progression of the disease.

study aim: the principal objective of the study is to find biomarkers that quantify the natural progression of the disease and to know if they are useful to determine the improvement or lack of impairment of the disease in response to enzyme replacement therapy (ert). study design: a single center observational prospective study. patients: patients with adult onset pompe disease (onset of symptoms after two years old) and molecular diagnosis confirming the disease are eligible methods: clinical information will be obtained according to a pre-defined protocol including six visits: screening visit, baseline, 6 month, 12 month, 24 month and 36 month. in each visit we will perform the following tests: clinical assessment (including interview with patients, quality of live questionnaires, timed tests and assessment of muscle balance using a myometer), analytical tests (blood and urine tests), cardiac test (electrocardiogram (ecg) and cardiac echography), respiratory assessment (using spirometer) and skeletal muscle imaging (muscle mri). all data collect will be introduced in a database and afterwards statistically analyzed. expected results: we expect to find a biomarker useful to follow-up the progression of pompe disease. this biomarker has to be sensitive to the changes that muscle function may have after treatment with ert. funding: this project is funded by genzyme, a sanofi company

Eligibility criteria:
inclusion criteria: * pompe disease confirmed using genetic study * onset of symptoms more than 2 years old * to be able to come to the hospital and follow all the visits * patients with respiratory involvement are welcomed exclusion criteria: * patients unable to perform a mri (respiratory problems can be solved using mechanical ventilation)

Keywords: pompe glycogenosis type ii acid maltase deficiency
huaier granule for prevention of recurrence and metastasis of hepatocarcinoma following local ablation

Conditions: Hepatocarcinoma

Summary: to evaluate the efficacy and safety of huaier granule for prevention of recurrence and metastasis of hepatocarcinoma following local ablation

a multicenter, prospective cohort study investigating huaier granule for prevention of recurrence and metastasis of hepatocarcinoma following local ablation，to evaluate the efficacy and safety

Eligibility criteria:
inclusion criteria: 1. 18 years ≤ age ≤ 75 years, both male and female 2. patients are diagnosed with hcc via examination of tissues according to guidelines for diagnosis and treatment of hepatocellular carcinoma (version 2017) by nhfpc (national health and family planning commission of the people's republic of china) and/or hcc imaging criteria of american association for the study of liver diseases (aasld) for the diagnosis of hcc; 3. radiographic testing shows cancer cells have been eliminated after four weeks of local ablation;complete response (cr): dynamic contrast-enhanced ct scans and follow-up mr images show low-density area of hepatocellular carcinoma and no enhancement during the arterial phase of contrast-enhanced ct; also patients with 0.5-1 cm beyond the limits of the tumor margins (considered as safe surgical margins) are eligible; 4. according to contrast-enhanced ct and mri, with solitary tumor smaller than 5 cm in diameter; with multiple tumors (no more than 3 masses), the largest dimension is less than 3 cm; 5. patients are eligible if hemoglobin (hb) count ≥90g/l, platelets count (plt) ≥60×109/l, absolute neutrophil count (anc) count \>1.0×109/l, prothrombin activity (pta)\>50%, serum creatinine is less than 1.5 times uln (upper limit of normal) and total bilirubin (tbil) \<51.3μmol/l (3 mg/dl); 6. ecog score of 0-1; 7. liver function is child - pugh grade a or b. 8. history of tace for treatment of hcc is less than or equal to twice - 9. the patients are volunteered for the study, sign informed consent form and cooperate with investigator to collect data. exclusion criteria: 1. radiographic testing shows cancer cells have not been eliminated after four weeks of local ablation; 2. the occurrence of embolism occurs in large blood vessels on liver, patients with extrahepatic metastatic of hcc or liver transplantation; 3. patients who are about to receive or already received chemotherapy or molecular targeted therapy; 4. patients who are about to receive tace treatment for hcc; 5. patients without previous treatment of huaier granules. 6. history of diabetes; 7. hcc patients with uncontrollable ascites at the beginning of enrollment of the study or are very likely to have ascites during the next four weeks at the time of enrollment; patients with hepatic encephalopathy or upper gastrointestinal bleeding; 8. patients have basic diseases including severe cardiopulmonary insufficiency, renal insufficiency, or severe mental illness; 9. patients with other infectious disease (excluding viral hepatitis) 10. patients who cannot take oral medication; 11. conditions that are considered not suitable for this study investigators.
become-9: a clinical study of be-101 for the treatment of adults with moderately severe or severe hemophilia b

Conditions: Hemophilia B, Severe; Hemophilia B

Summary: the become-9 study (be-101-01) is a phase 1/2, first in human, multi-center, open-label, dose-escalation study to evaluate the safety and clinical activity of a single intravenous (iv) dose of be-101 in adults with moderately severe or severe hemophilia b. once infused, be-101 is designed to engraft and continuously secrete fix into the circulation to restore clinically meaningful levels of active fix. be-101 is an autologous (person's own cells) b cell medicine (bcm) which uses crispr/cas9 gene editing to precisely insert human fix gene into those cells.

the study includes 2 distinct parts: part 1 and part 2. in part 1, an ascending-dose design will be utilized to enable evaluation of increasing doses in a stepwise manner. the objective for this dose escalation is to identify the dose of be-101 required to achieve desired fix activity 28 days after infusion. upon identification of a safe and efficacious dose in part 1, an expansion phase (part 2) will initiate. the initial cohort in the part 2 expansion (part 2a) phase will include up to 6 adult participants to further characterize the safety and activity of be-101 at the selected dose. additional cohorts for adolescents and redosing for participants in part 1 of the study will occur following data availability of part 1. up to 24 participants will be enrolled across part 1 (up to 18) and part 2a (up to 6). consented participants will complete a screening period to assess eligibility and upon enrollment will undergo leukapheresis collection to support be-101 manufacturing. following administration, participants will be monitored for safety and clinical activity. the total duration of study participation is approximately 52 weeks post iv administration of be-101.

Eligibility criteria:
inclusion criteria: * adult males (≥18) with moderately severe to severe hemophilia b (fix deficiency) * received ≥50 exposure days to factor ix products preceding enrollment. * currently receiving prophylaxis treatment * adequate organ function and clinical labs * able to tolerate study procedures including leukapheresis. exclusion criteria: * pre-existing or history of specific diseases * b-cell malignancy, ebv lymphoproliferative disease * primary immunodeficiency disease or disorder (pidd) or systemic immuno-suppression * arterial and/or venous thromboembolic events within 2 years prior to dosing * history of anaphylaxis or nephrotic syndrome * active infection (hiv, hep b or c) * history of inhibitor to fix or inhibitor * history of an allergic reaction or anaphylaxis to fix products * within 6 months from be-101 administration: * planned surgical procedure * previously dosed with gene therapy or participated in an interventional clinical study * planned participation in clinical trial within one year after be-101 * administration of a vaccine within 28 days of dosing other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hemophilia b dose escalation
microcurrent stimulation for dry age-related macular degeneration

Conditions: Dry Age-related Macular Degeneration

Summary: evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.

multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

Eligibility criteria:
key inclusion criteria - study eye: * dry amd diagnosis. key exclusion criteria - study eye: * wet amd

Keywords: amd dry amd
clinical characteristics of lung cancer in china

Conditions: Lung Cancer

Summary: this study is a single-center, real-world and large-population-based retrospective study. in the current study, the investigators not only describe the changes of demographic and basic clinicopathological characteristics of lung cancer during recent years but delineate the correlation between clinicopathological features and common clinical blood tests in such a large population.

in this study, the investigators will collected all lung cancer patients diagnosed in shanghai pulmonary hospital from 2012 to 2020. by conducting this population based study, the investigators would like to delineate changes of characteristics of lung cancer in chinese patients during these years. meanwhile, the investigators will compare clinicopathological features, routine blood tests, blood biochemical tests and coagulation status among participants at different stages. this comparing will assist the investigators to understand systemic changes during lung cancer progression. the same comparison will also be conducted among participants having different driver mutation through which the investigators will further understand the characteristics of different patients and treat patients more precisely.

Eligibility criteria:
inclusion criteria: 1. patients have medical records in our hospital. 2. patients were diagnosed as lung cancer by pathological examination. exclusion criteria: 1. patients were lack of accurate pathological diagnoses. 2. pathological diagnosis was benign disease or metastatic cancer from other organs.

Keywords: cross-sectional study clinical characteristics
aerobic exercise and oxygen uptake efficiency slope in coronary artery disease

Conditions: Coronary Artery Disease

Summary: thus, the purpose of the present study was to evaluate the effects of continuos exercise training (cet) and interval exercise trainining (iet) on oxygen uptake efficiency slope (oues) in patients with coronary artery disease.

the oxygen uptake efficiency slope (oues) is a submaximal index that incorporates cardiovascular, peripheral and pulmonary factors that determine ventilatory response to exercise. there is scarce information about the effects of the mode and intensity of exercise training on oues in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * stable coronary artery disease diagnosed by coronary angiography exclusion criteria: * unstable angina pectoris, * complex ventricular arrhythmias, * pulmonary congestion and * orthopaedic or neurological limitations to exercise

Keywords: exercise training
early salvage stereotactic radiotherapy for biochemical failure after rp

Conditions: Prostatic Neoplasm

Summary: after radical prostatectomy, 30-60% of patients will develop recurrent disease. salvage radiotherapy, usually at 2 gy per fraction, is the main treatment option for these patients. the aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.

the present study aims at delivering 30 gy to the prostatic bed in 5 fractions. at the same time, the pelvic nodes will be covered to 25 gy, but in those patients considered at low risk of nodal involvement. in patients with evidence of macroscopic disease at the tumor bed through dce-mri, 40 gy will be delivered in 5 fractions. selected patients will receive 6-month lhrh analogue preceded by bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.

Eligibility criteria:
inclusion criteria: * - able and willing to provide informed consent; * pathologically proven diagnosis of prostatic adenocarcinoma; * biochemical failure (2 consecutive psa rises above 0.2 ng/ml) after radical prostatectomy; * no regional or distant metastases; * eastern cooperative oncology group performance status 0-1 exclusion criteria: * - previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy; * previous radiotherapy to the pelvis; * previous or current symptomatic vesicourethral anastomotic stenosis post-rp (weak stream, straining to void, hesitancy and incomplete bladder emptying); * psa level at srt\> 2 ng/ml; * (each single) lesion volume within the prostatic fossa at mpmr \>5 cc; * previous chemotherapy for malignancy in past 5 years; * previous androgen deprivation for biochemical failure after rp; * contraindication to short term ad (in case of px) * presence of nodal or distant metastasis, as confirmed by magnetic resonance (mr) or pet/ct * pathologically positive lymph nodes (pn+) at rp; * serious medical comorbidities or other contraindications to radiotherapy * presence of active inflammatory bowel disease; * presence of active connective tissue disease; * unable or unwilling to complete quality of life questionnaires

Keywords: prostate cancer; biochemical recurrence; salvage radiotherapy; sbrt;
alcohol diet and drug use preceding alcoholic hepatitis

Conditions: Hepatitis, Alcoholic

Summary: addup is an observational study of patients with alcoholic hepatitis. a structured interview is used to quantitatively estimate: 1. alcohol use 2. dietary intake 3. drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. after interview patients are followed up for 12 months with regard to response to therapy and survival. the study is intended to explore potential precipitants of alcoholic hepatitis.


Eligibility criteria:
inclusion criteria: * acute alcoholic hepatitis * aged over 18 years * able to give informed consent exclusion criteria: * evidence of other acute or chronic liver disease * episode of alcoholic hepatitis in 6 months before admission * severe hepatic encephalopathy * delirium