Kornimate/medical-research-clean huggingface dataset:
safety and preliminary efficacy of jbh492 monotherapy in patients with cll and nhl

Conditions: Non-Hodgkins Lymphoma; Chronic Lymphocytic Leukemia

Summary: the purpose of the first-in-human study was to assess the safety, tolerability, pharmacokinetics (pk), immunogenicity and preliminary efficacy of jbh492 as single agent.

this was a fih, open-label, phase i/ib, multi-center study, which consisted of a dose escalation part of jbh492 as a single agent, followed by an expansion part. the escalation part was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r cll) and non-hodgkin's lymphoma (r/r nhl). once the maximum tolerated dose/recommended dose (mtd/rd) of single agent jbh492 was determined, the study continued with an expansion part with single agent jbh492 in defined patient populations.

Eligibility criteria:
inclusion criteria: for patients with cll: • confirmed diagnosis of chronic lymphocytic leukemia (cll) for patients with nhl: * histologically confirmed diagnosis of b- or t-cell non-hodgkins lymphoma (nhl). * must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy. exclusion criteria, applicable to both cll and nhl: * history of anaphylactic or other severe hypersensitivity/infusion reactions to adcs, monoclonal antibodies (mabs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration * any prior history of treatment with maytansine (dm1 or dm4)-based adc * known intolerance to a maytansinoid * patients with any active or chronic corneal disorders * patients who have any other condition that precludes monitoring of the retina or fundus * patients with active cns involvement are excluded, except if the cns involvement has been effectively treated and provided that local treatment was completed \>4 weeks before first dose of study treatment. patients that have been effectively treated for cns disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met. patients who received prophylactic intrathecal treatment are eligible, if treatment discontinued \>5 half-lives prior to the first dose of study treatment * impaired cardiac function or clinically significant cardiac disease * known history of human immunodeficiency virus (hiv) infection * active hbv or hcv infection. patients whose disease is controlled under antiviral therapy should not be excluded. patients who are anti-hbcab positive should be hbsag negative and hbv-dna negative to be eligible other inclusion and exclusion criteria may apply.

Keywords: cll nhl ccr7 jbh492 adc chronic lymphocytic leukemia non-hodgkins lymphoma
survival of patients with acute heart failure in need of intravenous inotropic support: a multicentre, parallel-group, randomised, double-blind, double-dummy study of levosimendan versus dobutamine in patients with acute heart failure.

Conditions: Acute Heart Failure

Summary: the primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.


Eligibility criteria:
inclusion criteria: * written, signed and dated informed consent * male and female patients over 18 years of age. females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. women who are postmenopausal \[two years since last menstrual cycle\], surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential * hospitalised patients with acutely decompensated heart failure * left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months * clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening: * oliguria (mean urine output \< 30 ml/h for at least 6 hours) and not a result of hypovolemia * dyspnoea at rest or mechanical ventilation for heart failure * haemodynamic impairment in those patients with swan-ganz catheter inserted (pcwp ≥ 18 mmhg and/or cardiac index ≤ 2.2 l/min/m2) exclusion criteria: * severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy * weight ≥ 160 kg * cardiac surgery within 30 days before screening * stroke within 3 months before screening * systolic blood pressure persistently less than 85 mmhg at screening or at baseline * heart rate persistently 130 bpm or greater at screening or at baseline * serum potassium less than 3.5 mmol/l at screening * administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation * hypersensitivity to levosimendan or dobutamine or any of their excipients * a history of torsades de pointes * severe renal insufficiency (serum creatinine \> 450 mmol/l \[5.0 mg/dl\]) or on dialysis * significant hepatic impairment at discretion of the investigator * acute bleeding * severe anemia (haemoglobin \< 8 g/dl) at screening * septicaemia or septic shock * other serious diseases limiting life expectancy considerably (e.g. end-stage cancer) * participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study * administration of levosimendan within 30 days prior to screening
automatic ventilation in prehospital resuscitation on ohca

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: the goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. the intervention group is automatic ventilation and the control group is manual ventilation. the main questions it aims to answer are: 1. how does automatic ventilation affect ohca patients' survival and prognosis comparing to manual ventilation. 2. what are the differences on resuscitation qualities between automatic ventilation and manual ventilation.


Eligibility criteria:
inclusion criteria: * age over 18 years old at the time of occurrence of out-of-hospital cardiac arrest (ohca). * attended by the hsinchu county fire department for emergency medical assistance. exclusion criteria: * pregnant women. * ohca caused by trauma. * return of spontaneous circulation (rosc) observed at the scene. * clearly deceased at the scene (reaching conditions such as decomposition, rigor mortis, severe burns, decapitation, evisceration, or trunk fracture). * refusal of medical transportation by family members. * no placement of an advanced airway throughout the procedure.

Keywords: automatic ventilation prehospital resuscitation emergency medical service
the accuracy of optic biopsies versus conventional biopsies for the diagnosis of superficial bladder neoplasia

Conditions: Bladder Cancer

Summary: this study evaluates the accuracy of confocal laser endomicroscopy (cle) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. cle results are compared to histopathology results.

confocal laser endomicroscopy (cle) is a technique which during endoscopic examination of the bladder (cystoscopy) gives magnified, microscopic-like images of tissues and cells, by inserting a laser fiber through the cystoscope. cle aims to target biopsies during cystoscopy and reduce the number of biopsies, and the need for additional cystoscopies i general anesthesia. this study evaluates the ability of cle to assess tissue in the bladder. the ability to diagnose normal mucosa, inflammation and tumors of the bladder by the cle is compared to the histopathological examination of selected tissues (biopsies). patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. after standard cystoscopy where suspicious mucosal areas are located and marked, a contrast agent (fluorescein) is administrated intravenously. cle fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. the pathologist assesses the cle video and registers the results. biopsies are then taken from the selected, suspicious areas. the results of cle assessment are compared with the histopathological results.

Eligibility criteria:
inclusion criteria: * first time transurethral resection of bladder (turb) for bladder tumors under 3 cm * suspicious mucosa / carcinoma in situ * recurrent pta * positive cytology with normal flexible cystoscopy * control after bacille calmette guérin (bcg) treatment exclusion criteria: * allergy to fluorescein * pregnant and lactating women. * renal failure (egfr \<20 ml / min)
gc-pro intervention

Conditions: Cancer; Cardiovascular Diseases; Prenatal Condition; Reproductive Condition; Genetic Condition

Summary: the goal of the gc-pro study is to try to make genetic counseling better for people of all backgrounds. we are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. the purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. the research team is also working with partners from the somali, latino/hispanic, black/african american, and hmong communities to make sure the research is being done in a way that will benefit underserved communities.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * individual or their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site * understand and be able to provide information for study forms and surveys in english. exclusion criteria: * unable to provide informed consent * for pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.

Keywords: genetic counseling cancer heart disease reproductive prenatal genetic
a multiple ascending dose study of r1450 in patients with alzheimer disease.

Conditions: Alzheimer's Disease

Summary: this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of r1450 in patients with mild to moderate alzheimer disease. patients will be randomized to receive either r1450 or placebo by intravenous infusion for a total of 7 doses. the starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 50-90 years of age; * diagnosis of probable alzheimer disease, with symptoms \>=1 year prior to screening; * meets dsm-iv criteria for alzheimer-type dementia; * stabilised on approved medications for treatment of alzheimer disease for \>=4 months prior to baseline. exclusion criteria: * active major depressive disorder, or a history of bipolar disorder; * history of schizophrenia; * concurrent participation in a non-pharmacological trial with a key objective of improving cognition; * prior randomisation in any r1450 trial.
virtual visitation in intensive care unit study

Conditions: Critically Ill Patients

Summary: the purpose of this study is to identify the efficacy of virtual visitation in intensive care unit on patients and their caregivers during covid-19 pandemic.

after being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (virtual visitation once a day) or control group (phone interviews once a day).

Eligibility criteria:
inclusion criteria: * patients who are expected to stay in the intensive care unit for more than 48 hours * patients with a rass score of -2 or higher exclusion criteria: * patients who discharge or die within 48 hours of admission to icu
comparison of brachial artery dilatation, uterine artery doppler, umbilical artery doppler and 1st-trimester visceral adipose tissue measurement in obese and normal pregnant women

Conditions: Obese; Vascular Diseases; Pregnancy Related; Visceral Obesity

Summary: brachial artery flow-mediated in obese and normal-weight pregnant women dilation of uterine artery doppler and umbilical artery doppler results comparison of

the systemic inflammatory effect caused by obesity and vascular disorder it has been reported that it creates studies. healthy vascular endothelial structure increases vascular tone by regulating nitric oxide (no) release. reduced nitric oxide production, reducing flexibility it has a facilitating effect on hypertensive diseases and other obstetric diseases. endothelial function, which is a non-invasive, easily applicable, and reproducible method it can be detected by endothelium-dependent vasodilation. a good indicator of endothelial function in studies in which the brachial artery flow-mediated dilation (fmd) shown. brachial artery blood pressure cuff at forearm level in normal healthy people with compression for 3-5 minutes 50 mmhg above systolic pressure, 60-120 seconds after loosening the cuff when measured later, individuals with healthy endovascular function and the brachial artery are also reactive hyperemia, and a 10% dilatation is expected. many obstetric effects such as obesity preeclampsia, preterm labor, gestational diabetes, preterm labor although it was found to be related to pathology, the relationship between them could not be determined exactly. our study aimed to increase brachial artery dilatation in obese and normal pregnant women. by comparing, determine the level of nitric oxide and endovascular function. also uterine vascular structures of obesity by comparing vascular structures with artery and umbilical uterine dops examine the effect on pregnant women between the ages of 18-40 who apply to the diseases and obstetrics outpatient clinic will be taken. 24-28. brachial artery dilatation, uterine, and umbilical artery doppler between 11-14, 37-40w weeks between gestational weeks, and visceral adipose tissue measurement at first trimester will be examined.

Eligibility criteria:
inclusion criteria: * obese and normal pregnant * 11-14 weeks * 24-28 weeks * 37-40 weeks exclusion criteria: * smoking * chronic vascular disease * diabetes mellitus * over 40 years old
ckd-391 pharmacokinetic study

Conditions: Healthy

Summary: a randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety ckd-391 to coadministration atorvastatin and ezetimibe in health volunteers.

to compare the ckd-391 (experimental product) to the dose atorvastatin calcium and ezetimibe combination in health male subjects is the purpose of this trial. following are evaluated in this trial; characteristics and safety/tolerability of ckd-391.

Eligibility criteria:
inclusion criteria: * bwt \>=50kg, bmi 18\~29 * signed the informed consent form prior to the study participation exclusion criteria: * clinically significant disease * subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug * clinically significant allergic disease * impossible to taking the institutional standard meal * previously donate whole blood within 60 days or component blood within 20 days * previously participated in other trial within 90 days * continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials * an impossible one who participates in clinical trial by investigator's decision including laboratory test result

Keywords: dyslipidemia ckd-391 atorvastatin ezetimibe
effects of adjunct antimicrobial photodynamic therapy in periodontal treatment of patients with obesity

Conditions: Periodontitis; Obesity

Summary: the goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (apdt) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. the main question it aims to answer are: does adjuvant apdt improves periodontal health? are there differences in the proteomic profile of gingival fluid after both treatments? participants will receive scaling and root planing complemented or not by apdt. results will be collected after 1, 3, and 6 months. researchers will compare adjuvant apdt treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.


Eligibility criteria:
inclusion criteria: * obesity (grade ii and iii classified according to body mass index) * periodontitis stage ii to iv * presence of at least 20 teeth excluding 3rd molars. exclusion criteria: * smokers * alcohol or drugs consumption * kidney disorders * pregnancy or lactation * use of antibiotics at the last 30 days * use of drugs that alter periodontal structures as phenytoin or ciclosporin * periodontal treatment at the last 6 months

Keywords: periodontitis obesity
vincat: vinorelbine, carboplatin and trastuzumab in advanced her-2 positive breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in her2-positive metastatic breast cancer.

the addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. in this phase ii single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.

Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of breast cancer * stage iv disease * none or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted) * overexpression of her-2 (immunohistochemistry 3+) or genetic amplification of c-erbb2/neu (fish+) * ecog performance status 0-2 * age \>18 and \< 75 years * left ventricular ejection fraction (lvef) \>50% * life expectancy \>3 months * signed informed consent exclusion criteria: * absence of measurable or evaluable disease * life expectancy \< 3 months * ecog performance status \> 2 * history of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ). * previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease) * previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted) * neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 9 g/dl * creatinine \> 1.5 x the upper normal limits * got and/or gpt \> 2.5 x the upper normal limits and/or bilirubin \> 1.5 x the upper normal limits in absence of hepatic metastases * got and/or gpt \> 5 x the upper normal limits and/or bilirubin \> 3 x the upper normal limits in presence of hepatic metastases * congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia * any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * male gender * pregnant or lactating women * refusal or incapacity to provide informed consent * inability to comply with follow up

Keywords: advanced her-2 positive
ossiris study - a post-market clinical follow-up investigation.

Conditions: Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

Summary: this is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.bone as recommended by the specialist and according to orthopaedic standard procedures. patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. the expected schedule is at month 3, month 6 and month 12. patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. all safety data will be collected from patient inclusion to the end of the clinical investigation. all study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties. it is planned to enroll 135-193 patients from approximately 15 eu and uk sites.


Eligibility criteria:
inclusion criteria: 1. patient is undergoing a standard of care bone grafting with b.bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved ifu. 2. male or female patient ≥ 18 years old. 3. patients willing and able to attend the standard of care follow-up visits and procedures. 4. patients who have provided consent to participate in the clinical investigation and to the processing of personal data. exclusion criteria: 1. patients with any conditions in which b.bone is not indicated according to the contraindications defined in the ifu of b.bone 2. patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments. 3. woman who is pregnant or breast-feeding. 4. patients who, in the opinion of the investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.
prevena vascular groin wound study

Conditions: Wound Infection; Peripheral Arterial Disease; Aneurysm; Surgical Wound Dehiscence

Summary: the purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (prevena; kci, inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

the study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. prevena vacuum dressing. the wounds will then be assessed for wound complications in the 30 days postoperatively. wound complications include breakdown, infection and lymph leak. patients not considered high risk will have standard post-op dressings and followed similarly to controls. the investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.

Eligibility criteria:
inclusion criteria: * all patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study exclusion criteria: * emergency procedure * unable to give informed consent