Kornimate/medical-research-clean huggingface dataset:
adg126 in combination with pembrolizumab in patients with advanced/metastatic solid tumors

Conditions: Advanced/Metastatic Solid Tumors

Summary: this is a phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, pk, and immunogenicity of adg126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

this is a phase 1b/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pk, and preliminary efficacy of adg126-pembrolizumab alone or adg126-pembrolizumab in combination with trifluridine/tipiracil-bevacizumab or fruquintinib in patients with advanced/metastatic solid tumors, with a focus on mss crc. the study drug adg126 is an anti-ctla-4 fully human monoclonal antibody that specifically binds to human ctla-4. pembrolizumab is a pd-1 receptor-blocking antibody (a humanized igg4 monoclonal antibody).

Eligibility criteria:
inclusion criteria: 1. ≥18 years of age at the time of informed consent. 2. eastern cooperative oncology group (ecog) performance status 0 or 1. 3. wash out period from previous antitumor therapies 4. at least 1 measurable lesion at baseline according to the definition of recist v1.1. 5. adequate organ function. 6. an archival tumor biopsy is required and should be taken within 2 years of enrollment. if not available, a fresh tumor biopsy is acceptable. 7. for dose escalation phase only: patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists. 8. dose expansion phase only: tumor tissues (archived or fresh biopsy) before treatment are required for all patients. exclusion criteria: 1. pregnant or breastfeeding females. 2. childbearing potential who does not agree to the use of contraception during the treatment period. 3. treatment with any investigational drug within washout period. 4. prior treatment with an anti-ctla-4 therapy. 5. history of significant iraes or irae. 6. central nervous system (cns) disease involvement. 7. history or risk of autoimmune disease. 8. patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent). 9. any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (copd). 10. major surgery within 4 weeks prior to the first dose of the study drug. 11. has had an allogeneic tissue/solid organ transplant. 12. has received a covid-19 vaccine within 7 days prior to the first dose of study treatment. has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. note: administration of killed vaccines are allowed. 13. a positive covid-19 test within 14 days of cycle 1 day 1. 14. history of severe hypersensitivity (grade ≥3)or known to be allergic to protein drugs or recombinant protein.

Keywords: adg126-p001
efficacy of kcl plus 0.9%nacl compare with kcl plus 0.45%nacl

Conditions: Hypokalemia

Summary: evaluate efficacy and safety of iv administration of potassium chloride (kcl) plus 0.9%nacl compare with kcl plus half-strength normal saline solution (0.45%nacl) in correcting hypokalemia

hypokalemia is frequently encountered in hospitalized patients. intravenous (iv) potassium repletion with saline is preferred used for initial therapy. however, administration of normal saline (0.9%nacl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia. object of this study : to evaluate efficacy and safety of iv administration of potassium chloride (kcl) plus 0.9%nacl compare with kcl plus half-strength normal saline solution (0.45%nacl) in correcting hypokalemia.

Eligibility criteria:
inclusion criteria: * serum k+ 2.5-3.49 mmol/l * no life threatening condition from hypokalemia exclusion criteria: * pregnancy * volume overload, heart failure * hypotension * acute kidney injury * dysnatremia * k+ shift * salt wasting nephropathy
influence of epidural analgesia in elective laparoscopic colorectal resections

Conditions: Pain

Summary: epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. in laparoscopic surgery, the role of epidural surgery is not established. this prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.

all patients with elective, laparoscopic colorectal resection between november 2004 and january 2007 were included in the trial. the decision for epidural analgesia was made by the anaesthetist and the patient. contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications. primary outcome was subjective feeling postoperatively, assessed with a vas for pain and cramps and amount of analgesics used. secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.

Eligibility criteria:
inclusion criteria: * elective laparoscopic colorectal resection exclusion criteria: * emergency surgery * preoperatively planned stoma formation

Keywords: laparoscopic colorectal surgery epidural analgesia pain score postoperative ileus
hyperspectral imaging pre and post endovascular intervention

Conditions: Chronic Limb Ischemia; Non-Healing Ulcers

Summary: this trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

this will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., abpi, pvr with oxyhemoglobin (oxyhb) and deoxyhemoglobin (deoxyhb) measurements obtained with a new imaging device manufactured by hypermed inc (oxyvu) that uses hyperspectral technology.

Eligibility criteria:
inclusion criteria: 1. patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization. 2. age group between 50-85 3. gender - male or female 4. race - all race and ethnicities exclusion criteria: 1. patients with known cardiac disease - new mi (within 3 months). 2. patients with hypertension with the systolic bp \>200 or diastolic bp\>110 on the day of testing 3. patients on supplemental o2 for chronic obstructive lung disease 4. bed-ridden subjects - either due to chronic disability or neurological problems

Keywords: revascularization claudication hyperspectral oxygenation limb ischemia
the effect of exercise on pain sensitivity in a population with ongoing neck pain compared to healthy controls

Conditions: Neck Pain; Healthy

Summary: this study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.

increased pain sensitivity is a common finding in neck pain patients when compared to healthy controls. although most studies favor exercise as an intervention, the specific effect on pain sensitivity is still debated. this study will investigate the effect of exercise on pain sensitivity in neck pain patients compared to healthy controls

Eligibility criteria:
inclusion criteria: - healthy participants * pain free healthy participants * able to speak, read and understand danish and english exclusion criteria: - healthy participants * pain from the neck or shoulder area during the past 6 months * experience of delayed onset muscle soreness (doms) during the week leading up to the test session * former surgery in neck or shoulder * current or previous chronic or recurrent pain condition * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses * regular use of analgesics * abnormally disrupted sleep in the last 24 hours preceding the experiment * lack of ability to cooperate inclusion criteria: - neck pain population * self reported neck pain lasting three months or longer. * able to speak, read and understand danish and english * reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion exclusion criteria: - neck pain population * shoulder pain during arm movements * experience of doms during the week leading up to the test session * former surgery in neck or shoulder * current or previous chronic or recurrent pain condition other than neck pain * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses * abnormally disrupted sleep in the 24 hours preceding the experiment * lack of ability to cooperate

Keywords: exercise neck pain pain sensitivity
a study of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy

Conditions: Chemotherapy Induced Anemia

Summary: the purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.


Eligibility criteria:
inclusion criteria: * cancer patients exclusion criteria: * a history of myocardial, cerebral or pulmonary infarction * severe hypertension beyond control by drugs
free gingival graft adjunct with low level laser therapy

Conditions: Wounds and Injuries; Transplants; Gingival Recession, Localized; Low-Level Light Therapy

Summary: the present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.

background: shrinkage of the free gingival graft (fgg) and patient's discomfort during healing period are important concerns. therefore, this study aimed to evaluate the effect of low level laser therapy (lllt) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain. methods: thirty patients were randomly assigned to receive either fgg+ lllt (test, n = 15) or fgg + placebo lllt (control, n = 15). in the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 w, continuous mode, time of irradiation:60 s, energy density: 6 j/cm2, spot size:0.5 cm) was applied immediately after the fgg surgery and 1,3,7, and 14 days later. the control group received the same sequence of irradiation with the laser-off. comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. complete wound epithelization, visual analogue scale (vas) pain score of recipient site and the number of analgesic used were evaluated after the surgery.

Eligibility criteria:
inclusion criteria: * patients \>18 years old * patients presenting class i or ii miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration * the included teeth had also keratinized gingiva \<2 mm; pi and gi\<1. * the patients had to be systemically healthy and non-smokers. exclusion criteria: * patients presenting active periodontal disease and probing depth \>3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure; * pregnant or lactating women; * patients who underwent periodontal surgery in the study area; * patients with orthodontic therapy in progress were excluded.

Keywords: free gingival graft, low level laser therapy, shrinkage
"studio nava" - national study on quality of life in adolescents affected by allergic rhinitis with or without asthma

Conditions: Allergic Rhinitis; Asthma

Summary: "studio nava" is a national study aiming to assess allergic rhinitis and asthma outcomes on quality of life and quality of sleep in adolescent patients by means of web survey. "studio nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, act, asthma control test; psqi, pittsburgh sleep quality index; t5ss, total symptom score; modified sidria for adolescents; rhinasthma; vas scale), that will be available for the doctors after the registration to the web platform. downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.


Eligibility criteria:
inclusion criteria: * clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age. * controls n°: 600 subject (5 for each participant pediatrician) of the same age range, without respiratory pathology. exclusion criteria: * subjects that have not allergic rhinitis with/without asthma diagnosis or are \ 17 years old

Keywords: adolescents respiratory pathology
a study of the effect of nebivolol to evaluate its vasodilatory effects in hypertensive patients

Conditions: Hypertension

Summary: the study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.


Eligibility criteria:
inclusion criteria: * male or female, ambulatory outpatients 18-79 years old at screening * minimum 2-year history of stage i/ii hypertension * qualifying blood pressure criteria for study entry and for randomization * willing to adhere to the dietary compliance and undergo protocol procedures * have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days exclusion criteria: * have any form of secondary hypertension * have clinically significant respiratory or cardiovascular disease * presence/history of coronary artery disease or peripheral vascular disease * have diabetes mellitus, type i or ii * have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker

Keywords: hypertension blood pressure nebivolol bystolic (tm) metoprolol er (tm)
the german patient blood management network

Conditions: Clinical Safety of a PBM Program

Summary: * this epidemiological trial will determine whether the implementation of a pbm program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort * primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the pbm program. * secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic rbc units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay. * the primary aim is to prove non-inferiority of the intervention (pbm) group when compared with the control group stratified by center.

background: the transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. however, transfusion practice currently varies significantly between hospitals and even between physicians and patient blood management programs have not been implemented nationwide in germany yet. patient blood management (pbm) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. a rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. the purpose of the german pbm network is to evaluate the safety of a standardized, evidence-based patient blood management concept. study design and methods: this epidemiological study is a follow-up of a study that is already being carried out in four german university hospitals. this new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. a patient-centred, evidence-based patient blood management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. this pbm program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic rbc concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).

Eligibility criteria:
inclusion criteria: * all surgeries with a general or local anaesthetic * minimum hospital stay of 24 h * ≥ 18 years exclusion criteria: * \< 18 years * ophthalmologic or dermatologic or outpatient surgery * all non-surgical anesthetic procedures

Keywords: patient blood management red blood cell transfusion practice patient safety anemia clinical outcome perioperative care
phase ii proof of concept study in uncomplicated uti

Conditions: Urinary Tract Infections

Summary: a study of the efficacy and safety of mpc-shrc for the relief of symptoms associated with uncomplicated urinary tract infections.


Eligibility criteria:
inclusion criteria: * non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection * on adequate birth control * normal ecg exclusion criteria: * participated in any other trial within 30 days of visit 1 * known or suspected allergy to investigational drug * narrow angle glaucoma * recovering from chicken pox or flu-like symptoms * history of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption * taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections * currently taking prohibited drugs * taken an antibiotic within 7 days of visit 1 * are ineligible to receive an antibiotic * history of urinary retention * history of interstitial cystitis * history of impaired renal function * history of impaired hepatic function * diagnosis or suspicion of complicated urinary tract infection or systemic infection * history of substance abuse
multi-center database registry to study thalamus changes using ai in ms

Conditions: Multiple Sclerosis

Summary: in this study the investigator's propose to validate a newly developed approach, deepgrai (deep gray rating via artificial intelligence), to simplify the calculation of thalamic atrophy in a clinical routine and allow academic and community neurologists to plan, perform, and publish novel and influential clinical research using data from clinical routine, by employing deep machine learning (dml) pattern recognition (pr) information through use of artificial intelligence (ai).

this is a multicenter, observational, retrospective, cross-sectional and longitudinal population study of brain volume changes in ms patients. the retrospective electronic medical record (emr) and brain mri image data will be collected at participating ms centers and de-identified data will be integrated into a central research database. all the data to be integrated into the database has already been collected by physicians at the centers as part of their routine clinical practice and is thus non-interventional and retrospective in nature. this new approach will be compared to existing approaches of brain volume measurement that are currently widely available. this breakthrough approach would lead to potentially abandoning classis measurement of the specific brain volume structures and would be applicable in real-time in clinical routine.

Eligibility criteria:
inclusion criteria: 1. patient diagnosed with relapsing-remitting (rr) ms 2. access to raw mri index scan images that meet all of the below criteria 1. mri scan image acquired at index 2. the scan was performed on 1.5t or 3t scanners 3. the scan must have a t2-flair sequence 3. access to raw mri post-index scan images that meet all of the below listed criteria 1. mri scan image acquired at post-index 2. the scan was performed on 1.5t or 3t scanners 3. the scan must have a t2-flair sequence 4. age 18-85 at index 5. fulfilling the mri scan and clinical data requirements outlined in table 2 6. none of the exclusion criteria exclusion criteria: 1. have received an investigational drug or experimental procedure during the study period 2. women who were pregnant, or lactating at index or during the post-index period 3. patients who had a relapse 30 days prior to the selected mri scan date 4. patients who received steroid treatment 30 days prior to the selected mri scan date 5. presence of other neurologic diseases affecting cns
post marketing surveillance study of sifrol® in patients with idiopathic parkinson's disease

Conditions: Parkinson Disease

Summary: study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of parkinson's disease (pd) symptoms, assessment of the reasons for add-on treatment with l-dopa and dosing of pramipexole and l-dopa when given concomitantly.


Eligibility criteria:
inclusion criteria: * diagnosis of early stage idiopathic parkinson's disease * no pre-treatment with any dopaminergic treatment (de novo patients), or pre-treatment with l-dopa at doses of \< 200 mg/d exclusion criteria: * treating physicians are asked to consider the regulation described in the summary of product characteristics (smpc) for the treatment with pramipexole