Kornimate/medical-research-clean huggingface dataset:
visbiome effect on colorectal anastomosis and local recurrence

Conditions: Colorectal Cancer

Summary: determine whether the administration of visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence

randomized study of visbiome after colorectal surgery. subjects will be randomized 1:1 to either vsl3 or no vsl3.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of biopsy proven rectal cancer (ct/mri) * willing and able to comply with protocol requirements * able to tolerate surgery * able to comprehend and have signed the informed consent * absence of metastatic disease * clinical performance status of ecog 0 or 1 * life expectancy of greater than 3 months * planned ileostomy as part of their routine care exclusion criteria: * severe or refractory ulcerative colitis defined as mayo score of greater than or equal to 10, endoscopic disease activity score 3 * untreated enteric infection (positive stool test for any of the following: clostridium difficile, salmonella, shigella, yersinia, campylobacter, enteropathogenic e. coli or other enteric infection at the discretion of the investigator * severe immunodeficiency, inherited or required (e.g. hiv, chemotherapy or radiation therapy) * patients with the following laboratory abnormalities: absolute neutrophil count \<1000/ul, platelets \<50 x 10\^9/l, hemoglobin \<6.5g/dl * history of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish) * active intestinal obstruction * non-steroidal anti inflammatory medications (nsaids) as long-term treatment, defined as for at least 4 days per week each month * cholestyramine use * any condition in which the investigator thinks vsl3 administration may pose a health risk (e.g. severely immunocompromised) * simultaneous participation in another interventional clinical trial * patients who are pregnant, breast feeding or planning pregnancy during study trial period * patients with any other signification medical condition that could confound or interfere with evaluation of safety, tolerability or prevention compliance with the study protocol at the discretion of the investigator
navigation brain stimulation for evaluation of the neuroprotective drug efficiency in patients after ischemic stroke.

Conditions: Stroke

Summary: ischemic stroke (is) causes high mortality and severe disability. to improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs. there is a large number of the so-called neuroprotective drugs, which were effective in laboratory, but didn't show positive results in clinical studies with using traditional clinical scales scores as a primary outcome measures. specialists suggest, that the investigators could receive better results if the investigators change design of the studies, particularly if the investigators select more precise and sensitive method of assessment. aim of this study: to determine the role of navigated brain stimulation (nbs) for evaluation of the changes in the motor centers and motor tracts after administration of different cerebroprotective drugs. (the substances won't be compared to each other).


Eligibility criteria:
inclusion criteria: * patients from 3 to 6 months after ischemic stroke * hemispheric infarction * paresis from 2 to 4 scores by medical research council weakness scale (mrc) exclusion criteria: * history of seizures * pregnancy, lactation * cognitive deficiency (poor compliance) * acute renal failure * acute hepatic failure * oncological history * cardiac pacemakers and other metal implants * regular intake of any nootropic drugs * modified ashford scale scores 3 and more * regular intake of anticonvulsants, neuromuscular relaxants

Keywords: navigation brain stimulation (nexstim) cerebroprotective drug effectiveness acute ischemic stroke
percutaneous neuromodulation therapy (pnt) with chronic low back pain patients

Conditions: Low Back Pain

Summary: the purpose of this study is to assess the benefits of percutaneous neuromodulation therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.


Eligibility criteria:
inclusion criteria: * low back pain for at least 6 months * if lower extremity pain present, must be present for at least 3 months * visual analog scale (vas) score for low back pain at least 50 out of 100 * lumbar or lumbosacral surgical intervention without pain relief * central sensitization symptoms * agrees to follow randomized treatment plan * 18 years of age or older * signed informed consent form exclusion criteria: * significant change to low back or lower extremity pain within 4 weeks prior to enrollment * nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities * three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine * three or more lumbar vertebral segments fused * lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months * any additional surgical intervention required 3 months post-enrollment * symptoms consistent with sympathetically-maintained pain * evidence of serious neurological deficits or impairments * significant changes in pain medications within 4 weeks prior to enrollment * psychosocial issues that conflict with valid reporting by patient * prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation * current use of another electrical stimulation device for low back or lower extremity pain * current enrollment in another clinical trial within the last 30 days * current or prior malignancy or cancer * serious or uncontrolled systemic illness * body mass index (bmi) greater than 40 * pregnant or intends to become pregnant during the study * implanted medical device * relationship with study staff * unable to attend study office visits or complete study measures

Keywords: chronic low back pain lower extremity pain central sensitization percutaneous neuromodulation therapy
impact of liraglutide on sensory perception, sensory specific satiety, liking and wanting in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus; Overweight

Summary: besides their potential action in the treatment of type 2 diabetes mellitus (t2dm), glp-1 analogues decrease satiety and food intake leading to a significant weight loss in patients. however, little is known about their effects on food hedonic sensations and taste perception. the aim of this study is to investigate the impact of liraglutide on the liking and wanting components of the food reward system, taste sensitivity and sensory specific satiety in type 2 diabetes mellitus (t2dm) patients. according to the review of literature in animal models, it is expected that liraglutide will modify food preference and gustative perception in humans. thirty t2dm patients will be studied before and after 3 months of treatment with liraglutide (1.2 mg/day). same tests will be carried out on two consecutive days before and after the treatment administration. olfactory liking, recalled liking and wanting for several food items will be assessed. sensory specific satiety will be measured as well as detection thresholds for salty, sweet and bitter tastes. subjects will also answer questionnaires on hunger, pleasure in eating, and food intake.


Eligibility criteria:
inclusion criteria: type 2 diabetic patients 1. with glycemic unbalance despite anti-diabetic treatments and 2. overweight (bmi \> 25 kg/m²) exclusion criteria: * impaired renal function (creatinine clearance \< 50 ml/min), * pregnancy, * congestive heart failure, * acute and chronic infection, * evolutive cancer, * cirrhosis, * ongoing antibiotic treatment, * smoking (more than 5 cig/day), * alcohol consumption (more than 20 g/day), * aversion for the foods eaten or smelt during the study, * impaired comprehension for cognitive tasks, * treatments known to interfere with olfactory and gustative performances

Keywords: liraglutide glp-1 analogue food preference gustative perception liking wanting t2dm body mass composition leptin ghrelin
dietary supplement on symptom awareness and heart rhythm in patients with cardiac arrhythmia

Conditions: Cardiac Arrhythmia

Summary: the main aim of this study, which was carried out in two parallel groups, is testing the efficacy of a specific micronutrients combination in adults with heart rhythm disturbances and accompanying symptoms. it is therefore the investigators hypothesis that daily oral administration of the specific micronutrients combination will lead to a decrease of symptoms awareness and to a reduction of heart rhythm disturbances in adults with or without structural heart disease. the principal endpoints will be a decrease in the total score of symptoms awareness.


Eligibility criteria:
inclusion criteria: * pvb in the long-term ecg recording (registration at least 18 hours): at least 500 pvb/24 h or supraventricular tachycardia (≥10 episodes/24h, outside sporting activity) or svpb with vegetative symptoms (increased sweating, inner unrest, shaky hands, red dermographism) and no cardial pretreatment exclusion criteria: * left ventricular ejection fraction \[ef\] ≤ 40 % * therapy with spironolactone \> 50 mg/d * therapy with torasemide \> 20 mg/d * supplementation or therapy with dietary supplements or drugs which contain vitamins and minerals (above all potassium and magnesium) * creatinine in the serum \[i. s.\]:≥ 1,4 mg/dl (men), ≥ 1,2 mg/dl (women) * potassium i. s. ≤ 3,4 mmol/l and \> 5,4 mmol/l * magnesium i. s. ≤ 0,7 mmol/l and \> 1,0 mmol/l * acute and chronic diarrhea * hyperthyroidism anamnestic or due to the current tsh (thyroid stimulating hormone)-value * pacemaker

Keywords: heart rhythm disturbances and symptoms dietary supplement
versartis trial in pre-pubertal japanese children with growth hormone deficiency (ghd) to assess long-acting growth hormone (somavaratan, vrs-317)

Conditions: Pediatric Growth Hormone Deficiency; Growth Disorders

Summary: the trial will consist of three stages: 1) a 30 day phase 2 pk and pd evaluation of somavaratan, 2) an optional phase 2 extension and 3) a 12 month phase 3 safety and efficacy stage. upon completion of the pk/pd stage, the pk/pd profiles for the ghd children in this study will be compared to the pk/pd profiles for the ghd children treated in the western study phase 1b/2a study (protocol 12vr2) and identify the somavaratan dose to be used in the phase 3 stage in japan. the phase 3 stage will continue dosing for 12 months to obtain safety and efficacy data on 48 subjects.

the trial will consist of three stages: 1) a 30 day phase 2 pk and pd evaluation of somavaratan, 2) an optional phase 2 extension and 3) a 12 month phase 3 safety and efficacy stage. the study is a randomized, multi-center, open label study. the primary endpoint is height velocity at 12 months.

Eligibility criteria:
inclusion criteria: * chronological age ≥ 3.0 years and ≤ 9.0 years (girls) or ≤ 10.0 years (boys) * pre-pubertal status * diagnosis of ghd as documented by two or more gh stimulation test results * height sd score ≤ -2.0 at screening * weight for stature ≥ 10th percentile * igf-i sd score ≤ -1.0 at screening * delayed bone age exclusion criteria: * prior treatment with any growth promoting agent * history of, or current, significant disease * chromosomal aneuploidy, significant gene mutations (other than those that cause ghd) or confirmed diagnosis of a named syndrome * birth weight and/or birth length less than 5th percentile for gestational age * a diagnosis of attention deficit hyperactivity disorder * daily use of anti-inflammatory doses of glucocorticoid * prior history of leukemia, lymphoma, sarcoma or cancer * ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening * significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants * significant abnormality in screening laboratory studies

Keywords: ghd
study of xl228 administered intravenously to subjects with advanced malignancies

Conditions: Cancer; Lymphoma

Summary: the purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor xl228 (active against igf1r, src, fgfr, and bcr-abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.


Eligibility criteria:
inclusion criteria: * the subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. subjects treated at the mtd (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (nsclc), or small cell lung cancer (sclc). certain other eligibility requirements must also be met. * the subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means. * the subject is ≥18 years old. * the subject has an eastern cooperative oncology group (ecog) performance status ≤2. * the subject has adequate organ and marrow function. * the subject is capable of understanding the informed consent document and has signed the informed consent document. * sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study. * female subjects of childbearing potential must have a negative serum pregnancy test at screening. exclusion criteria: * the subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug. * the subject has received radiation to \>25% of his or her bone marrow within 30 days of treatment with xl228. * the subject has not recovered to national cancer institute (nci) common terminology criteria for adverse events (ctcae) v3.0 grade ≤1 from adverse events (aes) due to investigational or other agents administered more than 14 days prior to study enrollment. * the subject has a primary brain tumor. subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks. * the subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * the subject has a psychiatric illness or social situation that would limit compliance with study requirements. * the subject is pregnant or breastfeeding. * the subject is known to be positive for the human immunodeficiency virus (hiv). * the subject has a known allergy or hypersensitivity to components of the xl228 formulation. * the subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

Keywords: solid tumor multiple myeloma
the pk/pd study of multiple dose of shr3824 in healthy volunteers

Conditions: Type 2 Diabetes

Summary: shr3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. in this multiple-dose study the investigators evaluated the safety, tolerability and pk/pd profiles of shr3824 in healthy subjects.


Eligibility criteria:
inclusion criteria: * chinese male and female subjects aged 18 to 45 years. * bmi:18 -25 kg/m2. * healthy according to medical history, physical examination findings, 12-lead ecg findings, and clinical laboratory evaluations. exclusion criteria: * history of or current clinically significant medical illness as determined by the investigator. * history of clinically significant allergies, especially known hypersensitivity or intolerance to lactose. * pregnancy or breastfeeding . significant acute or chronic medical illness, including renal impairment, or recent surgery. * donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.

Keywords: shr3824 type 2 diabetes mellitus sglt2
gcpgc in chemotherapy-induced neutropenia

Conditions: Chemotherapy Induced Neutropenia

Summary: this study is adaptive design and it consists of stage i and stage ii. stage i is multi-center, parallel-group, single-blind, phase ii study to determine the adequate dose of gcpgc in chemotherapy-induced neutropenia. 2 different doses of gcpgc will be investigated in a total of 60 breast cancer patients who are receiving chemotherapy. stage ii is multi-center, parallel-group, double-blind,phase iii study to evaluate the efficacy and safety of once per cycle gcpgc in chemotherapy-induced neutropenia compared to neulasta (pegfilgrastim). a total of 120 patients receiving chemotherapy will participate into this phase.

gcpgc ia a solution for containing pegfilgrastim. pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (g-csf) with a polyethylene glycol (peg) which has long half life compared to filgrastim, resulting in dosing advantage.

Eligibility criteria:
inclusion criteria: * women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia * body weight of 45kg and more * ecog performance status 2 and less * anc ≥1,500mm3 and platelet ≥100,000/mm3 * life expectancy of 3 months and more * given written informed consent exclusion criteria: * had previous exposure to pegfilgrastim or filgrastim * had received systemic antibiotics within 72hrs of chemotherapy * prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m

Keywords: pegfilgrastim neutropenia
covid 19 pandemic. emerging legal and ehical disputes over patient confidentiality

Conditions: Covid 19 Pandemic From Ethical View

Summary: many critical ethical questions arise in pandemic covid 19planning, preparedness and response. these include: who will get priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources? in the face of a pandemic, what obligations do health-care workers have to work not withstanding risks to their own health and the health of their families? how can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? what obligations do countries have to one another with respect to pandemic covid 19 planning and response efforts?


Eligibility criteria:
inclusion criteria: * adult aged 18 years to 60 years * medical personel graduated from egyptian faculty of medicine. * non medical personel live in egypt exclusion criteria: * personel less than 18 years old . * medical personel not graduated from egyptian faculty of medicine. * non medical personel live outside egypt
pep-buddy in copd: effect on dyspnea severity and mechanism of action

Conditions: COPD

Summary: chronic dyspnea is the most characteristic symptom of patients with chronic obstructive pulmonary disease (copd), with intermittent increases during exercise and other events.despite optimal standard therapy, episodic dyspnea is a common occurrence in copd. recently, the pep buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (pep). although currently the available evidence is limited, it indicates that utilizing the pep-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. more research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. therefore, the aim of our study is to explore the potential of this device for patients with copd and episodic breathlessness.


Eligibility criteria:
inclusion criteria: 1. age ≥40 years 2. read, understood and signed informed consent 3. copd gold class ii-iv/ b or e (fev1\<60% of predicted, cat ≥10 points) 5. optimized standard therapy according to the study physician 6. episodic breathlessness requiring intervention (i.e. taking rest during physical activities, as needed inhalation medication, breathing techniques, as needed opioids) at least three days per week exclusion criteria: 1. other severe disease causing episodic breathlessness 2. life expectancy ≤ 3 months 3. exacerbation of copd 4 weeks prior to inclusion 4. change in copd management targeted at breathlessness 8 weeks prior to inclusion 5. inability to use the pep buddy device 6. currently participating in another interventional clinical study 7. any other conditions, which, in the opinion of the investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.
pharmacokinetics study of valtoco® in pediatric subjects with epilepsy

Conditions: Epilepsy

Summary: this is a phase 1/2a, open-label, single-dose, pk study of valtoco with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.


Eligibility criteria:
inclusion criteria: * subject has a clinical diagnosis of epilepsy and, in the opinion of the investigator, may need benzodiazepine intervention for seizure control. * subjects having either partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness, for which rescue medications have been used at least once in the last 3 months or in the opinion of the investigator, may need a benzodiazepine intervention for seizure control 1-2 times every 3 months on average. exclusion criteria: * subjects whose body weight are \ 33 kg. * subject is undergoing intracranial electroencephalogram (eeg) monitoring. * in the opinion of the investigator, a history of clinically significant medical history that would jeopardize the safety of the subject or impact the validity of the study results (such as significant gastrointestinal, renal, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration. * subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening. * participation in a clinical trial within 30 days prior to the first dose of study drug. * inadequate or difficult venous access that may jeopardize the quality or timing of the pk samples.
randomized trial comparing laparoscopic-assisted rectosigmoid resection versus laparoscopic rectosigmoid resection with transrectal specimen retrieval

Conditions: Symptomatic Recurrent Diverticular Disease; Benign Adenomatous Sigmoidal Polyp, Requiring Surgery; Early Non-transmural Sigmoidtumor

Summary: laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. most patients can be included within a standardized perioperative care program called enhanced recovery after surgery (eras). a new evolution as a primary step towards a complete natural orifice translumenal endoscopic surgery (notes)-procedure is a hybrid approach (transrectal and laparoscopic). the dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. the anastomosis is created intracorporeally using a triple stapled technique. there are no trials available in the literature concerning these 2 techniques. therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.


Eligibility criteria:
inclusion criteria: * age 18-90 * symptomatic recurrent diverticular disease * benign adenomatous polyp, requiring surgery * early non-transmural sigmoidtumor * signed written informed consent, approved by ethical committee exclusion criteria: * patients unsuitable for laparoscopy * pregnancy * asa \>iii * coagulation disorders * anti-coagulants