Kornimate/medical-research-clean huggingface dataset:
effects of dexmedetomidine vs midazolam on microcirculation in septic shock patients

Conditions: Septic Shock

Summary: to investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following dexmedetomidine administration in patients with septic shock.

prospective randomized double blinded study. investigators planned to enroll 60 cases diagnosed with septic shock all patients will be sedated with midazolam and remifentanyl in accordance with a local unit protocol. after a period of six hours of hemodynamic stability, patients were randomized to receive either continuous infusion of dexmedetomidine at 0.4 μg/kg per hour and remifentanyl (dex group) or a continuous infusion of a midazolam and remifentanyl (mdz group).

Eligibility criteria:
inclusion criteria: * patients aged over 18 years * septic shock requiring norepinephrine (ne) to maintain a mean arterial pressure (map) of at least 65mm hg despite appropriate volume resuscitation (fluid challenge of 20 ml/kg-40 ml/kg) * septic shock criteria were defined according to the new sepsis-3 definition exclusion criteria: * pregnancy * uncontrolled hemorrhage * terminal heart failure * significant valvular heart disease * documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve * refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment) * 2nd and 3rd degree of av-block ,the onset of septic shock more than 24 h before enrollment , * apache ii \> 30 at enrollment * severe liver cirrhosis (child b or c) * new onset of myocardial infarction within 30 days or heart failure (nyha 4) * attending other trial in icu within one month * allergic history to dexmedetomidine
rapid processing and immunohistochemistry method for optimising diagnosis time in solid organ donors, suspected malignancy

Conditions: Donors; Organ Donor; Organ Transplants

Summary: comparison of the diagnostic yield of intra-operative histological analysis of donor tissue with suspected neoplasia performed with the standard method versus the experimental method, which involves optimisation of sample freezing and analysis with the ihc fast track procedure

optimisation of frozen material can be achieved with specific tools that improve the quality of freezing and the cutting of histological sections, allowing a lower incidence of artefacts, with better histological definition. these instruments would also allow the execution of automated ihc protocols, with increased diagnostic sensitivity and specificity and better risk stratification for donors with malignancy. all this should lead to an increase in the donor pool with better oncological risk stratification and, consequently, increase the number of organs to be allocated, making it possible to respond more promptly to the great demand for organs needed for transplantation. moreover, not only would the certain exclusion of a neoplasm allow the use of donors who would otherwise have been considered to be at unacceptable risk and therefore excluded from the donor process, but a more precise diagnosis of the neoplasm (where present) would allow the second opinion to stratify the risk more accurately, with a more rational use of organs. all organ donors who request extemporaneous intraoperative examinations to define the oncological risk of donation during the study period will be recruited.

Eligibility criteria:
inclusion criteria: * organ donors (legally dead by brain or cardiac death) with suspected neoplasia. * sending organs/tissues of all types and locations for extemporaneous examination request exclusion criteria: * none

Keywords: transplants
risks and benefits of scrotal drainage in penile prosthesis implant

Conditions: Erectile Dysfunction

Summary: the goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.

after being informed about the study, all patients give writted informed consent. after that they will be randomized in two groups (a with drainage, b without drainage) using a random sequence generator. then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. in the group a it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 ch in aspiration) for 24 hours. the drainage will be removed on the first post-operative day. the degree of the hematoma will be determined using a 5-point likert scales already approved in previous cases. subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. after that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. during the clinical check-ups, it will also be defined the time of use of the penile prosthesis.

Eligibility criteria:
inclusion criteria: * written informed consent signed voluntarily according to the rules of good clinical practice (declaration of helsinki) and national regulations (appendix b). * genetically male patient. * age ≥ 18 years. * patient suffering from ed of variable and/or multifactorial etiology. * patient suffering from ed not responsive to ipde-5. * patient suffering from unresponsive or non-tolerant ed exclusion criteria: * absence of signed written informed consent (appendix b). * age \<18 years. * genetically female patients. * patient with active peno-scrotal infection. * patient with active systemic infection. * immunosuppressed patient. * patient with haematological pathologies that may cause an increased risk of bleeding. * patients suffering from peyronie's disease who must undergo simultaneous plaque surgery. * any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the study. * the patient declares that it will be impossible for him to participate in follow-up consultations.
a proof-of-concept study to assess the efficacy, safety and tolerability of itepekimab (anti-il-33 mab) in participants with non-cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: act18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, phase 2 study with 3 treatment groups. the purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with ncfb aged 18 years of age up to 85 years of age (inclusive). study details include: * the study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * the treatment duration will be up to 24-52 weeks. * the follow-up duration will be 20 weeks. * site/phone visits are at a monthly interval.


Eligibility criteria:
inclusion criteria: * participant must be 18 to 85 years of age inclusive. * clinical history consistent with ncfb (cough, chronic sputum production and/or recurrent respiratory infections). * participants with a fev1 % predicted ≥30%. * participants with at least 2 moderate or 1 severe pulmonary exacerbations (pes) in the past 12 months. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * have bronchiectasis due to cf, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (ntm) lung infection, or pulmonary fibrosis. * known or suspected immunodeficiency disorder. * pulmonary exacerbation which has not resolved clinically during screening period. * have significant haemoptysis. * have any clinically significant abnormal laboratory values at screening or diseases or disorders. * history of lung transplantation. * history of malignancy within 5 years before screening, or during the screening period * currently being treated with antimicrobial therapy for tuberculosis (tb). * currently on active treatment for allergic bronchopulmonary aspergillosis (abpa). * participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease * known allergy to itepekimab or to excipients * live-attenuated vaccine(s) within 4 weeks prior to screening or plans to receive such vaccines during the study * unstable ischemic heart disease * cardiomyopathy or other relevant cardiovascular disorder * clinically significant new abnormal electrocardiogram (ecg) within 6 months prior to, or at screening * history of human immunodeficiency virus (hiv) infection or positive hiv 1/2 serology at screening. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
safety and effect of mirapex(pramipexole) tablet among korean rls

Conditions: Restless Legs Syndrome

Summary: safety and effect of mirapex(pramipexole) tablet among korean restless legs syndrome patients: an open-label, postmarketing surveillance study

study design:

Eligibility criteria:
inclusion criteria: 1. moderate to severe primary restless legs syndrome 2. male or female patients aged at least 18 years exclusion criteria: 1. any contraindications according to basic product information (company core data sheet) or local labelling; hypersensitivity to pramipexole or to any of the excipients. 2. ongoing treatment with mirapex 3. pregnant and breastfeeding women 4. concomitant pharmacologic treatment with other dopaminergic drugs(including l-dopa) 5. secondary rls
the effect of sildenafil on sleep-disordered breathing in obese patients with sexual dysfunction

Conditions: Sildenafil; Sleep Apnea; Sexual Dysfunction; Obesity

Summary: sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. the aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. in addition we wish to assess the effect of sildenafil on sleep-disordered breathing.


Eligibility criteria:
inclusion criteria: * age - 40-65 years * bmi equal to or over 30 exclusion criteria: * a known cardiorespiratory, liver or kidney disease * treatment with nitrates or alfa blockers * performed polysomnography in the past
multicenter study using glaukos® trabecular micro-bypass stent model gts400 using the g2-m-is injector system in conjunction with cataract surgery

Conditions: Primary Open-angle Glaucoma

Summary: evaluate the safety and efficacy of the glaukos trabecular micro-bypass stent model gts400 using the g2-m-is injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

the purpose of this study is to evaluate the safety and efficacy of the glaukos trabecular micro-bypass stent model gts400 using the g2-m-is injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility criteria:
inclusion criteria: * mild to moderate open-angle glaucoma * characteristics consistent with mild/moderate glaucoma * use of one (1) to three (3) medications at time of screening exam exclusion criteria: * pigmentary or pseudoexfoliative glaucoma * prior incisional glaucoma surgery

Keywords: primary open-angle glaucoma poag trabecular meshwork istent inject
transforaminal epidural injection in acute sciatica

Conditions: Sciatica; Sciatica Due to Intervertebral Disc Disorder; Sciatic Radiculopathy

Summary: patients suffering from sciatica are treated conservatively for the first 8 weeks due to the favourable prognosis. this period is preferably extended up to 14-16 weeks after which patients may opt for surgery. however, patients may experience severe discomfort due to pain in the leg which can lead to decreased physical activity and socio-economic problems. an adequate therapy to alleviate symptoms during this period of 'wait-and-see' is lacking. in this study, patients will be randomized to treatment with transforaminal epidural injections or standard oral pain medication.

sciatica is a condition of radicular pain in the leg and is usually caused by herniation of a lumbar intervertebral disc. the herniated disc compresses a lumbar nerve root that continues its route into the sciatic nerve. about 13% to 40% of all people will suffer from sciatica at least once during their lifetime. sciatica can have severe socio-economic effects; patients are immobilised by the pain they experience and therefore cannot go to work or participate in social events. most cases resolve spontaneously with conservative therapy using only standard analgesics and/or physiotherapy. in a large rct it was demonstrated that outcome of conservative and surgical therapy was comparable after 26 weeks. with this knowledge the guidelines for surgical treatment of sciatica were adjusted and it is nowadays usual care to offer surgery only after at least 8 weeks of conservative care and preferably after 14-16 weeks of conservative care. this decision is made together with the patient in a process of shared decision making. although this treatment regimen has been demonstrated to be efficacious and cost effective, the burden for a patient during these weeks of conservative care is usually high. the investigators seek to find a type of conservative care to reduce the discomfort due to the pain and to enable the patient to remain physically active. not only will this add to the quality of life of the patient, but it will also prevent the patient from taking a sick-leave. in this study, patients will be randomized to either treatment with transforaminal epidural injections or to standard care consisting of oral pain medication.

Eligibility criteria:
inclusion criteria: * diagnosed with sciatica by gp * nrs leg pain of 6 or more on a 10-point nrs scale * minimum duration of symptoms of 3 weeks and maximum duration of 8 weeks exclusion criteria: * age under 18 years * condition preventing to receive transforaminal epidural injection * severe scoliosis * transforaminal epidural injection received in 6 months before randomization date * surgery for sciatica at the same level * surgery for sciatica at another level within one year before inclusion * pregnancy

Keywords: sciatica acute sciatica transforaminal epidural injection leg pain lumbar spine back pain lumbar surgery herniated intervertebral lumbar disk cost-effectiveness
a phase 2, multi-center study to compare the efficacy and safety of a chemokine ccr2/5 receptor antagonist with ranibizumab in adults with diabetic macular edema

Conditions: Macular Edema, Diabetic

Summary: the study hypothesis under test is that administration of the ccr2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. the current treatment option for these subjects is an injection directly into the eye, while this ccr2/5 antagonist would be an oral drug which has the potential to be just as effective. this ccr2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat diabetic macular edema.

study recruitment was stopped on april 9, 2015. this decision was taken for business reasons due to changes in the prioritization of the drug development portfolio. this decision was not as a result of any evolving safety, efficacy issue or changes in the risk:benefit assessment of this product or regulatory interactions.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus (type 1 or type 2) showing diabetic macular edema in the eye * reduced visual acuity resulting from retinal thickening * female subjects of non-childbearing potential ≥18 years and male subjects greater than or equal to 18 years. a subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. * female subjects who are not of childbearing potential must meet at least one of the following criteria: * have undergone a documented hysterectomy and/or bilateral oophorectomy; * have medically confirmed ovarian failure; or * achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (fsh) level within the laboratory's reference range for postmenopausal females. exclusion criteria: * severe impaired renal function * any intraocular condition or previous surgery in either eye that would likely require medical or surgical intervention during the study duration or if allowed to progress untreated for the 16 weeks of study duration, would likely contribute to a reduction in visual acuity.

Keywords: chemokine antagonist diabetic macular edema diabetes diabetes mellitus macular edema diabetic retinopathy anti-vegf
assessing the effects of increased mitochondrial function exercise training on muscle performance

Conditions: Impaired Mitochondrial Function, Muscle Performance

Summary: as people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. to understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. there is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail. this is possible by measuring how the muscles work and respond to exercise before and after taking the supplement alongside an aerobic (i.e. cycling) and resistance (i.e. weight lifting) exercise programme. this will give us the basic information investigators would need to see if this is a useful idea.


Eligibility criteria:
inclusion criteria: * male * age between 65-75 years * body mass index between 19-29 * no active cardiovascular or metabolic disease * no active respiratory disease * no current musculoskeletal injuries * a sedentary lifestyle (i.e. does not engage in strenuous, planned physical activity) * the ability to give informed consent exclusion criteria: * currently taking a statin drug or nsaids * have a current peptic ulcer * have any renal impairment * have a known hypersensitivity to acipimox * suffer from vertigo * smoker
predicting acute postoperative pain by the preoperative lower back pain

Conditions: Benign Gynecological Disease

Summary: to investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy


Eligibility criteria:
inclusion criteria: * women scheduled for elective gynecological laparoscopy exclusion criteria: * psychiatric disease eg. anxiety, depression, etc. * diagnosed as cancer * the use of vasoactive drug * chronic pain except lower back pain
doxorubicin, cisplatin, 5-fluorouracil in patients with advanced adenocarcinoma of the stomach or esophagus

Conditions: Adenocarcinoma of Stomach; Adenocarcinoma of GE Junction; Adenocarcinoma of Esophagus

Summary: the purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. we will also be collecting information about the side effects and safety of this combination.

* patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. in addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil intravenously as a continuous infusion for the duration of the study. in order to do this, patients will receive an infusion pump that can be carried with them. treatment cycles will be repeated every 21 days for a maximum of 8 cycles. * prior to enrollment in this study and while the patient is receiving the therapy, routine blood tests and x-ryas (including chest x-rays and ct scans) will be performed to check the body's response to the treatment. blood tests will be checked once a week and chest x-rays and ct scans will be checked every 6 weeks. * patients with progressive disease or intolerable side effects will be removed from the study. patients with stable disease or tumor response will continue therapy for a maximum of 8 cycles.

Eligibility criteria:
inclusion criteria: * measurable, locally unresectable or metastatic adenocarcinoma of the stomach, ge junction or esophagus * no more than one prior chemotherapy regimen * ecog performance status of \< or equal to 2 * life expectancy \> 12 weeks * anc \> 1,500/mm3 * hemoglobin \> 9.0 gm/dl * platelets \> 100,000/mm3 * sgot \< 3 x uln * total bilirubin \< 2.0 mg/dl * creatinine \< 1.5 mg/dl exclusion criteria: * prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of study entry * clinically apparent central nervous system metastases or carcinomatous meningitis * myocardial infarction in the past 6 months * major surgery in the past 2 weeks * uncontrolled serious medical or psychiatric illness * pregnant or lactating women * concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * history or clinical evidence of congestive heart failure

Keywords: doxorubicin cisplatin 5-fluorouracil stomach cancer esophagus cancer
a comprehensive assessment of trunk, scapula and upper limb in neurological patients. reliability, validity and interrelatedness

Conditions: Multiple Sclerosis; Stroke

Summary: the study aimed to provide insights in the coordination between trunk, shoulder and upper limb while reaching. two main phases are present in this study: in phase a: the psychometric properties of two tests: clinical scapular protocol (clinscap) in pwms (persons with multiple sclerosis) and healthy controls. 1. to investigate the test-retest reliability of the clinical scapular protocol (clinscap) and the reaching performance scale (rps) in pwms 2. to investigate the discriminative of the clinscap between pwms and healthy controls 3. to investigate the discriminative of the rps between pwms and healthy controls 4. to investigate the concurrent validity of clinscap and rps in pwms, compared with upper limb dysfunction measurements. in phase b: 5. to investigate the prevalence of trunk, scapula and upper limb impairments in pwms and stroke patients. 6. to investigate the interaction between trunk, scapula and upper limb impairments in pwms and stroke patients.


Eligibility criteria:
inclusion criteria for all participants: healthy controls, pwms (persons with multiple sclerosis) and stroke patients * age \> 18 years * able to understand and execute the test instructions * able to sit on a chair with low back support for 10 minutes inclusion criteria specific for pwms: * diagnosed with ms (multiple sclerosis) using mcdonald criteria * able to move at least 1 out of 3 joints (wrist, elbow or shoulder): medical research council score 3. inclusion criteria for stroke patients: * first- ever single, unilateral (ischemic or hemorrhagic) stroke * no apraxia or hemi spatial neglect * able to move at least 1 out of 3 joints of the affected upper limb (wrist, elbow or shoulder): medical research council score 3. exclusion criteria: * other medical conditions interfering with the upper limb function or trunk (orthopedic or rheumatoid impairment) * perceived pain in one of the upper limbs of more than 4/10 (visual analog scale) * severe cognitive or visual deficits interfering with testing * for the pwms: a relapse or relapse-related treatment in the last month prior to the study