Kornimate/medical-research-clean huggingface dataset:
maximum tolerable concentration of abnobaviscum fraxini intravesically in patients with superficial bladder cancer

Conditions: Superficial Bladder Cancer

Summary: the aim of this phase ib/iia study is to investigate the maximum tolerable concentration of abnobaviscum® fraxini for intravesical instillation in patients with superficial bladder cancer. secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.

a dose-escalation-study according ich/gcp (international conference on harmonisation/good clinical practice) with different concentrations of abnobaviscum® fraxini is conducted in two hospitals in germany and egypt. patients with superficial bladder cancer tag1/g2 or t1g1/g2 are enclosed after tur-b (transurethral resection bladder). the tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. a direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete tur of all other lesions according a study design established by the eortc-genito-urinary group (european organisation for research and treatment of cancer). a re-tur is conducted after 12 weeks. tumor response is measured by biopsy of the marker lesion and by cytology. safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. after treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.

Eligibility criteria:
inclusion criteria: * patients with clinically proved superficial bladder cancer (ta g1/g2 or t1g1/g2) 2 - 7 weeks before transurethral resection * written informed consent for study participation and for documentation of disease data including further distribution of these data exclusion criteria: * muscle invasive bladder carcinoma and/or carcinoma in situ (cis) * intravesical instillation therapy within 6 months prior to study enrolment * radiotherapy of the bladder prior to study enrolment * contracted bladder (capacity less than 100 ml) * non treated acute or chronic urinary tract infection * allergy against mistletoe extract preparations * subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml) * severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse) * pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception * participation in another clinical study within 30 days prior to this study * administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment * chronic progressive infections (e. g. tuberculosis) * pre-treatment with mistletoe extracts/mistletoe lectins

Keywords: superficial bladder cancer mistletoe extract maximum tolerated dose marker tumor remission recurrence rate
does duloxetine reduce chronic pain after total knee arthroplasty?

Conditions: Neuropathic Pain

Summary: range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(tka). duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). investigators will compare the neuropathic pain following tka in duloxetine group (n=84) with those in non-duloxetine group (n=84). investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the s-lanss pain scale (preoperatively and postoperatively 3 and 6 months). all participants will receive postoperative pain control after tka using the same pain control regimen except duloxetine.

both groups of participants will receive pain control regimens as follows: preemptive analgesia : celebrex celecoxib, patient controlled analgesia (postoperation 28 hours), during admission : celebrex bp or vimovo bp +ultracet er bp, targin hs, discharge medication: celebrex bp or vimovo bp, ultracet er bp(prn) drug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet er), oxycodone/naloxone (targin)

Eligibility criteria:
inclusion criteria: * osteoarthritis of knee requiring tka exclusion criteria: * rheumatoid arthritis * other inflammatory arthritis * neuropsychiatric patients * hepatic insufficiency * renal insufficiency * patients older than 75 * allergy or intolerance to study medications * patients with an asa of iv (angina, congestive heart failure, dementia, cerebrovascular accident) * chronic gabapentin or pregabalin use (regular use for longer than 3 months) * chronic opioid use (taking opioids for longer than 3 months)
dexamethasone for covid-19 related ards: a multicenter, randomized clinical trial

Conditions: Respiratory Distress Syndrome, Adult; Covid-19

Summary: there is compelling data indicating that there is an excessive inflammatory response in some patients with covid-19 leading them to develop ards that can be severe with a very poor prognosis. many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. the current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in argentina, in patients with ards with confirmed respiratory infection due to sars-cov-2 (covid-19). after recovery trial prepublication, low dose (6 mg qd for 10 days) dexamethasone was recommended as the usual care treatment for severe covid-19. at this time only 3 patients had been included in the trial. thus, we updated our recommendations for centers and decided to compare two different doses of this glucocorticoid for the treatment of adrs due to covid-19.


Eligibility criteria:
inclusion criteria: * ards according to berlin's definition * pcr confirmed covid-19 * length of mechanical ventilation less or equal to 72 hours exclusion criteria: * pregnancy or breast-feeding women * terminal illness with very poor prognosis according to the investigator judgement * therapeutic limitation * known immunocompromised condition * chronic use of systemic corticosteroids * participation in another randomized crinical trial * more than 5 days of treatment of low dose dexamethasone for covid-19 * abscence of informed consent * active participation in other randomized clinical trial
a study to assess mitomic prostate test for prostate cancer screening

Conditions: Prostate Cancer

Summary: to evaluate the diagnostic accuracy of the mitomic prostate test (mpt) comparing to prostate biopsy within the intended use population.

to determine the clinical performance of a blood-based test for clinically significant (cs) prostate cancer (pca) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (psa \< 10 ng/ml). the test quantifies a previously described 3.4 kb mitochondrial dna (mtdna) deletion.

Eligibility criteria:
inclusion criteria: * men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total psa \< 10ng/ml within the previous 3 months. * extended sextant biopsy pattern that must include a minimum of 12 cores. mri targeted biopsy preferred where available. * age, total psa, biopsy pathology, prostate medication history, and ethnicity data must be available; * the index biopsy must occur following and within 16 weeks of blood draw. exclusion criteria: * subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample; * previous diagnosis of prostate cancer; * prostate biopsy within the previous 3 months; * men with a total psa\>10ng/ml within the previous 3 months; * provides less than the required amount of blood; * considered incompetent to provide informed consent; * does not understand and read language of informed consent; * age, total psa, biopsy pathology information, medication history or ethnicity data unavailable; * males who are not of screening age (\<45); * subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as atypical suspicious acinar proliferation (asap); * blood collected after index biopsy. * subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.
pharmacokinetics of iv formulation

Conditions: Invasive Aspergillosis

Summary: open label evaluation of a single intravenous dose of f901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.

open label single intravenous dose, single group study. eight subjects (ideally 4 male and 4 female, minimum of two females) will be studied. the drug product will be a f901318 solution for infusion (6mg/ml). the dose will be 4 mg/kg delivered in the fasted state (8 hours minimum) by intravenous infusion over 2 hours. each subject will be on study for approximately 6 weeks. each subject will reside at the clinical research unit (cru) from day -1 (the day before dosing) to day 4 (72 hours post-dose). blood samples for pharmacokinetic evaluation will be obtained up to and including 120 hours post dose. safety and tolerability will also be assessed. subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood sampling. all subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Eligibility criteria:
inclusion criteria: 1. subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg. 2. females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening and day -1 3. subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ecg) and clinical laboratory evaluations (hepatic transaminases must be within normal limits, congenital non haemolytic hyperbilirubinaemia is acceptable) 4. subjects will have given their written informed consent to participate in the study and to abide by the study restrictions exclusion criteria: 1. female and male subjects who are not, or whose partners are not willing to use appropriate contraception with two reliable forms of contraception or who are not otherwise unable to conceive children (hysterectomy, oophorectomy, tubal ligation or post menopausal). 2. subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety 3. subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety
cyrotherapy vs. apc in gave

Conditions: Watermelon Stomach

Summary: to see if either method of treatment for watermelon stomach shows better results

watermelon stomach (ws) is endoscopically recognized by characteristic stripes of angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the majority of patients. current endoscopic treatment options, including argon plasma coagulation (apc) endoscopic cryotherapy is a novel technique that has the potential to safely and more effectively treat ws by virtue of its mechanism of injury and mode of application.

Eligibility criteria:
inclusion criteria: 1. confirmed ws at endoscopy that is associated with significant anemia (hb \< 10 g/dl) and/or overt bleeding (melena, hematochezia or hematemesis) and/or blood transfusions within the past 6 months 2. able to give informed consent 3. age \> 18 years exclusion criteria: 1. endoscopic or histological findings inconsistent with ws 2. known coagulopathy (inr \> 2), severe thrombocytopenia (platelet count \< 50,000), or bleeding diathesis 3. endoscopic treatment of ws within the past month 4. unable or unwilling to give informed consent.

Keywords: watermelon stomach cryotherapy argon plasma coagulation
efficacy of trimetazidine in diabetic patients

Conditions: Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies

Summary: subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure. therefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.


Eligibility criteria:
inclusion criteria: 1. age from 40-75 years 2. patients with echocardiographic evidence of grade i or ii diastolic dysfunction with lvef ≥50% exclusion criteria: 1. patients with valvular, congenital or ischemic heart disease. 2. patients with inadequately controlled hypertension (blood pressure\>140/90 mm hg) 3. patients with hba1c% \<10 % 4. patients with history of intolerance or allergic response to tmz 5. patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance \< 30 ml/min) 6. patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases. 7. patients with parkinson's disease or motor disorders 8. pregnancy and breast feeding

Keywords: trimetazidine diastolic dysfunction diabetes mellitus
monitoring your exercise-related metrics over time via wearable electronic devices

Conditions: Cancer; Diabetes

Summary: to test the use of a continuous activity and heart rate tracker (fitbit) and continuous glucose monitor (cgm) in monitoring daily exercise-related activities.

primary objective: to evaluate the feasibility of a cgm-based physical activity intervention that includes the use of cgm and fitbit®. secondary objectives: to examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention. exploratory objective: examine cancer-related biomarkers and their associations with daily glucose pattern.

Eligibility criteria:
inclusion criteria: * men and women at least 18 years old * body mass index (bmi) 25 kg/m2 * engage in less than 150 minutes of moderate-intensity pa per week in the past month * capable of participating in moderate-vigorous unsupervised exercise (as determined by the physical activity readiness questionnaire (parq) or a medical release from their physician) * self-reported ability to walk one block without pain or discomfort * have a smart phone with daily internet access that is compatible with the librelink app * ability to speak, read, and write in english * for the cancer survivor cohort (participant accession number #21 and beyond), individuals must have been diagnosed with stage i-iii breast or colorectal cancer and completed adjuvant therapy (i.e., chemo and/or radiation therapy). exclusion criteria: * self-reported current diagnosis or history of type 1 diabetes or type 2 diabetes * self-reported use of oral antidiabetic agents (oads) * previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator) * current use of a continuous glucose monitor * fasting glucose \> 125 mg/dl * pregnancy * self-reported health issues that limit physical activity * on dialysis * work overnight shifts * unwilling to use cgm * current participation in other wellness or weight loss-related program or intervention * currently on a low-carb diet * unable to receive redcap survey through their mobile phones
ultrasound-assisted versus conventional landmark-guided spinal anesthesia in patients with abnormal spinal anatomy

Conditions: Anesthesia, Spinal; Ultrasonography; Scoliosis

Summary: spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. this study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.


Eligibility criteria:
inclusion criteria: * adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, * with asa physical status classification i, ii, iii, * and with (1) or (2) 1. documented scoliosis in preoperative l-s-spine x-ray (cobb abgle \> 10 degree) 2. previous history of lumbar spinal surgery exclusion criteria: * patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic) * patients with morbid cardiac diseases * pregnancy
feasibility and safety of the 360-degree turn test delivered via telehealth

Conditions: Multiple Sclerosis

Summary: walking, balance problems and falls are common in patients with multiple sclerosis. the 360-degree turn test is a test used to evaluate balance. telerehabilitation is a rehabilitation system that has been increasingly used in recent years. still, there is a need for studies on whether there is any difference between face-to-face evaluations with patients and telehealth methods. this study aims to investigate the feasibility and safety of the 360-degree turn test delivered via telehealth.

the 360-degree turn test will be performed in the participant's home environment using a standardized protocol from previously published literature. exercise professionals will administer the test during a single videoconferencing exercise appointment. prior to the study commencement, clinicians will be given a 30-minute education session and written protocol to facilitate the standardized and safe performance of the test. the test will be performed in the participant's home environment using videoconferencing. the clinician will explain the 360-degree turn test. clinicians will record the device used by the participant. where possible, participants will be instructed to adjust their device or camera to improve clinician visibility. the test will be stopped immediately if the participant reports increased pain, a moderate-significant increase in breathlessness, or is unsteady.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple sclerosis * edss score ≤ 5.5 exclusion criteria: * not giving consent * history of dislocation or surgery in the lower limbs * history of fall within six months * any other disease, medication or intervention that can cause balance disturbance * patients who cannot use devices that is required for teleconference * patients that cannot understand english/ turkish

Keywords: telehealth multiple sclerosis 360-degree turn test
evaluation of a combination of a plant extract and a probiotic on glucidic metabolism in women with pcos and high insulin levels

Conditions: Polycystic Ovarian Syndrome; Insulin Resistance

Summary: the aim of the present study is to evaluate the effect of the combination of a plant extract (bsl_ep044) and lactobacillus bsl_ps6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.

polycystic ovary syndrome (pcos) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. it is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance. the beneficial effect of the extract plant bsl-ep044 on glycemic metabolism in women with pcos is widely studied and demonstrated and lactobacillus bsl_ps6 appears to exert a synergistic effect by supplementing the effect of bsl-ep044. the hypothesis of our study is that the addition of the probiotic strain lactobacillus bsl_ps6 to extract plant bsl-ep044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to pcos. the main objective of the present study is to evaluate the effect of the combination of a plant extract (bsl_ep044) and lactobacillus bsl_ps6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.

Eligibility criteria:
inclusion criteria: * being diagnosed with polycystic ovarian syndrome according to the rotterdam criteria. * homa values between 2.5 and 3. * body mass index of less than 35 kg/m2. * accept freely to participate in the study and sign the informed consent document. exclusion criteria: * women in treatment with oral antidiabetics. * being pregnant or intending to get pregnant. * be in fertility treatment. * to suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.

Keywords: polycystic ovarian syndrome extract plant probiotics insulin resistance