Kornimate/medical-research-clean huggingface dataset:
body-fluid balance and drinking habits in patients with retinal vascular occlusion

Conditions: Dehydration; Retinal Vascular Occlusion

Summary: the purpose of this study is to examine the body-fluid balance in patients with retinal vascular occlusion and the influence of drinking habits and hemodilution on the degree of body hydration.

patients with retinal vascular occlusion who are hospitalized for hemodilution and cardiovascular risk assessment are asked to report their drinking habits. hydration status before and during hemodilution is assessed with a body-fluid analyzing scale.

Eligibility criteria:
inclusion criteria: * informed consent * age over 18 years exclusion criteria: * age under 18 years * hypertensive urgency * myocardial infarction \< 4 weeks ago, chest pain * heart rhythm disorders, high degree valvular defects * pacemaker, defibrillator * peripheral arterial occlusive disease * end stage renal disease * acute hepatitis, chronic inflammatory intestinal disease * pregnancy

Keywords: retinal vascular occlusion drinking habits body hydration body-fluid balance
safety, tolerability, pharmacokinetics and preliminary antitumor activity of escalating doses of sim0348 as a single agent in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multicenter, open label, phase i trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of sim0348 as monotherapy in adult subjects with advanced and metastatic solid tumors. the trial starts with a dose escalation and dose expansion part (part 1) followed by a cohort expansion part (part 2).


Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * must have failed at least one established standard anti-cancer therapies * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy at least 12 weeks * adequate hematologic and end organ function * histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care * confirmed availability of representative tumor specimens * measurable disease according to recist version 1.1 exclusion criteria: * malignancies other than disease under study within 2 years prior to day 1 of cycle 1 * primary central nervous system (cns) malignancy, or untreated/active cns metastases * history of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted), and active pneumonia that are considered inappropriate by the investigator * history of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * history of autoimmune disease * positive human immunodeficiency virus (hiv) test * severe infection within 2 weeks prior to the first dose of study treatment * significant cardiovascular disease * history of allogeneic tissue/solid organ transplant or graft-versus-host disease * known clinically significant liver disease
observation of treatment with certolizumab pegol in daily practice

Conditions: Rheumatoid Arthritis

Summary: this is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of cimzia in adult patients with ra in need of treatment with a biological product.

the purpose of this study is to assess the clinical efficacy of cimzia in achieving clinical remission after two years of therapy. the observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.

Eligibility criteria:
inclusion criteria: * patients eligible for treatment with cimzia as defined in eu approved smpc exclusion criteria: * patient previously treated with cimzia. patient with known hypersensitivity to any component of cimzia

Keywords: certolizumab pegol cimzia
long-term safety and efficacy study of peginterferon beta-1a

Conditions: Relapsing Multiple Sclerosis

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (biib017) in participants originally treated in study 105ms301 (nct00906399) who continue peginterferon beta-1a treatment. the secondary objective of this study is to describe long-term multiple sclerosis (ms) outcomes in participants originally treated in study 105ms301 (nct00906399) who continue peginterferon beta-1a treatment.


Eligibility criteria:
key inclusion criteria: * must have completed the study treatment and visit schedule through week 96 in study 105ms301 (nct00906399). key exclusion criteria: * subjects exceeding more than 6 weeks since completion of the week 96 visit of study 105ms301 (nct00906399). * subjects with any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease * pregnant or nursing women. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: subcutaneous extension interferon ms pegylated injectable sc peg peginterferon beta-1a relapsing
intensity of exercise and glucose metabolism

Conditions: Prediabetes

Summary: our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.

study type: interventional study design: randomized endpoint classification: changes in fasting and 2 h glucose, insulin and lipid concentrations intervention model: parallel assignment masking: open label primary purpose: prevention and dose response assessment of exercise on glucose and lipid metabolism condition: prediabetes intervention: supervised exercise - the training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. after 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min. no intervention: control group; couseling at baseline. participants of the control group are advised to continue their usual physical and dietary habits. experimental: 1 -supervised exercise intervention. no intervention: 2 - standard counseling at baseline.

Eligibility criteria:
inclusion criteria: * prediabetes determined by 2 hr ogtt exclusion criteria: * any functional limitation or chronic disease that might have limited the physical exercise and testing * vigorous physical activity/exercise as revealed by questionnaire and physician exam

Keywords: prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
kdr2-2 suspension eyedrop in the treatment of neovascular glaucoma (kdr-nvg) trial

Conditions: Neovascular Glaucoma; Neovascularization

Summary: the clinical trial is aimed to evaluate the anti-neovascular effect of kdr2-2 suspension eyedrop in the treatment of neovascular glaucoma. fourty subjects would receive either 0.96 or 3.84 mg/per day/eye, in a qid fashion, ×7 days (those without complications can continue to 28 days). the anti-neovascular effect of kdr2-2 on iris neovascularization would be evaluated at day 1, day 7, day 14, day 28 after kdr2-2 usage.

neovascular glaucoma (nvg) has a high blinding rate and poor prognosis. anti-glaucoma surgery is the main stake of saving visual function and relieving pain, but the proliferation of iris neovascularization (nvi) makes it difficult to treat nvg. normally, the patients need an intravitreal injection of anti-vascular endothelial growth factor (anti-vegf) agents prior to glaucoma surgery to control the nvi proliferation. kdr2-2, a novel small-molecule tyrosine kinase inhibitor targeting vegf receptor 2 (vegfr2), has demonstrated anti-neovascular effect without obvious side-effects or complications in animal studies and a phase i clinical trial (nct04620109). in this study, 40 patients with nvg will be included to evaluate the effectiveness of kdr2-2 suspension eyedrop on nvi in nvg eyes. the included subjects would receive either 0.96 or 3.84 mg/day/eye, in a qid fashion, ×7 days (those without complications can continue to 28 days). this study aims to and propose a novel, non-invasive and more compliant method for the treatment of nvg.

Eligibility criteria:
inclusion criteria: * age 18-75; * the best-corrected visual acuity (bcva) of the included eyes was \<0.01 (snellen chart); * the bcva of the contralateral eye of the included subjects was \>0.1; * patients with clinically diagnosed neovascular glaucoma; the diagnostic criteria for neovascularization glaucoma were as follows: intraocular pressure \> 21mmhg measured by goldmann applanation tonometer; neovascularization is seen in the iris or anterior chamber angle, with or without corneal edema; * compliance with follow up for more than 28 days and written informed consent obtained; exclusion criteria: * intravitreal injection of anti-vegf drugs within 3 month before enrollment; * participation in other clinical trials within 1 month; * suffering from other ocular diseases that affect ocular examinations (e.g. keratopathy, uveitis, intraocular infection, etc.); * those who plan to receive ocular surgery during the follow-up period; * premenopausal women without birth control; * having other systemic diseases such as severe liver and kidney function damage, cardiovascular disorders, respiratory disorders, etc.) that may affect the anti-neovascular effect of kdr2-2 or more likely to develop adverse events ; * systemic infections under treatment; * any study in which the physician believes that the patient's condition will interfere with the clinical trial (e.g., the patient is prone to stress, mood disorders, depression, etc.);

Keywords: neovascular glaucoma neovascularization anti-vegf vascular endothelial growth factor
impact of anesthesia technique on post-operative delirium after transcatheter aortic valve implantation

Conditions: Delirium; Post-Op Complication; Anesthesia; Aortic Valve Disease

Summary: aortic stenosis is a frequent valvulopathy in europe and north america. it occurs mainly over 65 years (2-7% of the population over 65 years). treatment of symptomatic stenosis is an indication of aortic valve replacement. for patients with high surgical risk (euroscore ii\> 6), tavi (transcatheter aortic valve implantation) is recommended. this type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. the postoperative complications are, on the one hand, well-described surgical complications (cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. there is no consensus on best anesthesia technique for tavi procedure managment. between teams practices are different. it may consist of general anesthesia (ga) or local anesthesia with sedation (lased). elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. it is recommended to screen delirium for patients admitted in intensive care using the cam-icu scale. the aim of the study is to observe the impact of the anesthesia technique (ga versus lased) on delirium in post-operative aortic valve replacement with tavi procedure


Eligibility criteria:
inclusion criteria: * hospital admission for tavi femoral way * age \> 18 years * psychiatric disease exclusion criteria: * opposition of the operator (interventional cardiologist or surgeon) to one of the two anesthesia technique * contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation * opposition of the patient to use his data for research

Keywords: transcatheter aortic valve replacement anesthesia technique delirium
mechanistic study of bleeding risk in coronary patients with cerebrovascular disease

Conditions: Coronary Artery Disease; Cerebral Stroke; TIA (Transient Ischemic Attack)

Summary: background: about 5% of patients with acute coronary syndrome (acs) have had previously ischemic stroke (is) or transitory ischemic attack (tia). this is a high-risk population, with a high incidence of ischemic events, and also of bleeding events. while the high ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk factors, their predisposition to bleeding events is not well understood. hypothesis: the increased bleeding risk in acs patients with history of cerebrovascular event may be justified by a low platelet activity. methods: unicentric, prospective, case-control study, which included approximately 100 post-acs patients with history of is/tia previously to the acute coronary event (case group) and 100 patients without is/tia (control group). the groups were matched for gender, age, and acs type and year of occurrence. all patients were taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. main analysis: platelet aggregation was evaluated by 6 methods: verifynow aspirin®, verifynow p2y12®, pfa 100®, thrombelastography (reorox®), light transmission aggregometry with adp (lta adp) and epinephrine (lta epi) as agonists. additional analysis: genetic, hdl transport and inflammatory evaliation


Eligibility criteria:
inclusion criteria: * post-acs patients with history of is/tia previously to the acute coronary event and taking aspirin * sign the consent form exclusion criteria: * hemorrhagic stroke * another antiplatelet drug than aspirin * use of anti inflammatory drug * severe chronic kidney dysfunction * liver disease * coagulopathy * platelet disfunction * thrombocytopenia or thrombocytosis * refuse to sign the consent form

Keywords: bleeding risk, acute coronary syndrome, platelet agregation,
evaluation of clinical decision support system for large vessel occlusion using brain ct images

Conditions: Ischemic Stroke

Summary: celvo is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain ct images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain ct images by assisting the medical team. the specific aims of this study are to evaluate efficacy of celvo compared to the sensitivity and specificity levels of medical team to diagnosis with and without celvo used.


Eligibility criteria:
inclusion criteria: * adults over 19 years old * brain non-contrast ct, ct perfusion and ct angiography acquired * positive group: a patient diagnosed with large vessel occlusion after a non-contrast ct, ct perfusion and ct angiography * negative group: a normal person or a patient not diagnosed with large vessel occlusion after a non-contrast ct, ct perfusion and ct angiography exclusion criteria: * poor or incomplete brain non-contrast ct, ct perfusion and ct angiography quality
time of effect onset in treating overactive bladder or non obstructive urinary retention by sacral neuromodulation

Conditions: Overactive Bladder; Non Obstructive Urinary Retention

Summary: sacral neuromodulation (snm) is a minimally invasive secondary treatment for overactive bladder syndrome (oab) or for non-obstructive urinary retention (nor), when refractory to conservative treatment. success rates range from 70 to 80%, and good long-term results are reported. the working mechanism of snm is not completely understood, and the only prognostic factor for good response to this treatment is a successful test stimulation period. there is no consensus on the duration of this test stimulation period. the experience in our clinic during test stimulation period is that for responders it takes up to one week to achieve maximal effect, after the system is turned 'on'. on the other hand the investigators notice that after turning the neuromodulation system 'off', it will take a few hours for symptoms to return to the baseline situation. the fact is: no information concerning the so called "time of onset" and "time of offset" (or popular called: wash-in / wash-out) of sacral neuromodulation is available in current literature.


Eligibility criteria:
inclusion criteria: * in order to be eligible to participate in this study, a subject must meet all of the following criteria: patients should have been diagnosed with overactive bladder syndrome and should be put on the waiting list for scheduling treatment with sacral neuromodulation. exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: * patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease * patients who have been treated by means of bladder wall botulin toxin injections in the previous year * patients with evident subsequent complaints of bladder pain syndrome or other pelvic pain

Keywords: overactive bladder non obstructive urinary retention sacral neuromodulation
safety and efficacy of propionyl-l-carnitine in the treatment of peripheral arterial disease (intermittent claudication)

Conditions: Peripheral Vascular Diseases; Intermittent Claudication

Summary: patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. this decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. carnitine allows muscles to function properly. this study will test the safety and efficacy of propionyl-l-carnitine taken in combination with a monitored exercise training program.

to test the hypothesis that propionyl-l-carnitine taken in combination with monitored exercise training may improve exercise performance the study will randomize male or female adults with peripheral artery disease and claudication to receive either proprionyl-l-carnitine or placebo.

Eligibility criteria:
inclusion criteria: * ambulatory outpatient who are able to exercise * intermittent claudication due to peripheral artery disease * willingness to participate in a monitored exercise training program exclusion criteria: * pain at rest, ischemic ulcerations, gangrene of the lower extremity * peripheral artery disease of a non-atherosclerotic nature * any disease process other than pad, that may interfere with performance during the treadmill test or prevent the subject from reaching their claudication-limited pwt * current participation in an exercise training program or previous participtation in a monitored exercise training program within 6 months of the screening visit.

Keywords: perhipheral artery disease claudication exercise intermittent claudication due to peripheral artery disease
restoration quality in molars affected by molar incisor hypo mineralization

Conditions: Molar Incisor Hypomineralization

Summary: restoration quality of molars affected by mih using two different types of restorations direct composite and preformed crowns

mih or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

Eligibility criteria:
inclusion criteria: .children with molar incisor hypo mineralization in one fully erupted molar or more. * age ranging from 7-12 years. * cooperative children * good general health exclusion criteria: * patients participating in other experiments .patients with parents planning to move away within the following year. * patients with only mildly affected mih molars that do not require extensive restorative treatment. * mih-affected molars that have a very poor prognosis and require extraction. * first permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.
a study to evaluate the long-term safety, tolerability and effect of daily oral laquinimod 0.6 mg on disease course in subjects with relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled ms-laq-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.


Eligibility criteria:
inclusion criteria: 1. subjects must have completed the termination visit of ms-laq-302 (completion of all termination visit activities) according to the ms-laq-302 protocol. 2. women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)\] during the study and up to 30 days after the last dose of the study drug.. 3. subjects must be willing and able to comply with the protocol requirements for the duration of the study. 4. subjects must be able to comprehend, sign and date a written informed consent prior to entering the ms-laq-302e study. exclusion criteria: 1. premature discontinuation from the ms-laq-302 study, for any reason. 2. pregnancy \[according to urine dipstick β-hcg test performed at baseline (month 0e) visit\] or breastfeeding. 3. subjects with clinically significant or unstable medical or surgical condition detected or worsened during the ms-laq-302 study, which preclude safe participation and completion of the ms-laq-302e study. acute exacerbation of ms will not exclude participation in the ms-laq-302e study. 4. use of inhibitors of cyp3a4 within 2 weeks prior to baseline visit (v0e, month 0e).

Keywords: relapsing multiple sclerosis