Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and efficacy study of mb07803 administered to patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of mb07803 when administered for 28 days in patients with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * fasting plasma glucose between 120 - 270 mg/dl at screening * hba1c measurements between 6.0 - 10% at screening * females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (fsh) greater than or equal to 40 mlu/ml.females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;iud plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug. * body mass index (bmi) in the range of 18.5 - 37 kg/m2 patients with a bmi in the range of 37.5 - 40 kg/m2 who in the investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis * written informed consent exclusion criteria: * type 1 diabetes mellitus * type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone * use of thiazolidinediones (tzds) * currently on more than two oral hypoglycemic agent * history of outpatient insulin use * clinically significant history of cardiac disease within 6 months of informed consent
okko space academy to check children's vision at home

Conditions: Amblyopia

Summary: the purpose of this study is to determine the feasibility of the okko space academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment. there are three objectives to this work: 1. determine the feasibility of the okko space academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement). 2. assess the variability in day-to-day okko health measurements between clinic visits (e.g., do the interim okko home vision measurements predict improvements in visual acuity?) 3. explore agreement between the okko space academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.


Eligibility criteria:
inclusion criteria: * age 3.01 - 8.99 years with amblyopia * currently undergoing or at first visit to start amblyopia patching treatment * vision is fully corrected in glasses * visual acuity between -0.02 and 0.98 logmar * have daily access to an approved smartphone or tablet * parent/child able to read and understand english * patient (child) able to understand spoken english exclusion criteria: * parent not able to read and understand english * patient (child) not able to understand spoken english * parent/child not willing to participate * parent unable to give consent * any other ocular comorbidities * child has cognitive impairment or intellectual disability
early extubation and postoperative complications after liver transplantation

Conditions: Liver Transplantation

Summary: this is a retrospective cohort study. patients who underwent liver transplantation from january 1, 2016 to december 31, 2019 were admitted to the study and divided into two groups. operating room extubation group: early extubation in the operating room immediately following liver transplantation. intensive care unit (icu) extubation group: delay extubation in the icu following liver transplantation. the primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.

patients who underwent liver transplantation from january 1, 2016 to december 31, 2019 were admitted to the study. inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (west haven criteria iii or iv); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. the primary objectives was a composite of 30-day all-cause mortality, in-hospital aki, or in-hospital moderate to severe pulmonary complications. complications were defined and graded as mild, moderate, or severe as described by european perioperative clinical outcome definitions and were included if they occurred in hospital after surgery. the secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, icu and postoperative hospital lengths of stay, and total hospital cost.

Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 years) * undergoing liver transplantation exclusion criteria: * re-transplantation * multi-organ transplants * intra-operative deaths * severe encephalopathy (west haven criteria iii or iv) * patients who had preoperative mechanical ventilation or fulminant hepatic failure * incomplete clinical data
move for your mind - pilot trial

Conditions: Mild Cognitive Impairment; Mild Dementia; Fall Prevention

Summary: move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. the study aims to test the effect of a weekly dalcroze eurhythmics program (arm 1) and a home strength exercise program (arm 2) against control (no exercise) on the rate of falling, quality of life, gait performance and cognitive function. all groups receive vitamin d. in addition the study shall test the feasibility of the recruitment and the interventions in this target population. the study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild dementia. participants are recruited by the memory clinic of city hospital waid. during the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12 month). despite major efforts the target population is very difficult to recruit and adherence to treatment is low. we therefore decided to stop recruitment and to use this trial as a pilot trial for future clinical trials of the same topic.

primary objective to test whether the jaques-dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) will decrease rate of falls in seniors with mci or mild dementia compared with the control group. secondary objectives objective 1: to test whether the jaques-dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases 12-month risk of falling at least once in seniors with mci or mild dementia compared with the control group. objective 2: to test whether the jaques-dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves cognitive func-tion and alertness in seniors with mci or mild dementia compared with the control group. objective 3: to test whether the jaques-dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases gait variability in seniors with mci or mild dementia compared with the control group. objective 4: to test whether the jaques-dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves quality of life in seniors with mci or mild dementia compared with the control group.

Eligibility criteria:
inclusion criteria: * age 65+ years * diagnosed with mci or mild dementia by the memory clinic of city hospital waid exclusion criteria: -

Keywords: dalcroze eurhythmics home exercise vitamin d mild cognitive impairment mci mild dementia
oral combined hydrochlorothiazide/lisinopril versus oral nifedipine for postpartum hypertension

Conditions: Hypertension in Pregnancy; Postpartum Preeclampsia

Summary: the purpose of this study is to see if a combined pill of angiotensin-converting enzyme (ace) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). both medications are part of our usual care for high blood pressure after delivery.

in individuals with preeclampsia, persistent hypertension and edema result in part from the mobilization of up to 8 liters of fluid and sodium from the extravascular to intravascular space. the increased urinary sodium excretion on days 3-5 postpartum likely results from higher atrial natriuretic peptide concentrations in plasma and activation of the renin-angiotensin-aldosterone system. adding diuretics for postpartum hypertension has been associated with better blood pressure control in some of the studies. * cvd is the leading cause for mortality worldwide. * primary prevention is more effective than treating cvd. * pregnancy is often the 1st adult engagement with the healthcare system. * preeclampsia is a risk factor for long term cvd, even after controlling for mutual risk factors. * cvd is the leading cause for pregnancy related mortality. * there is no good data regarding the optimal medications to control blood pressure after delivery. * ace inhibitors play an important role in controlling blood pressure outside of pregnancy and there is extensive evidence to support their cardioprotective effects. * the optimal use of diuretics in the postpartum in patients with preeclampsia, require further study and clarification to augment current management schemes. hypothesis: that in postpartum women with hypertensive disorders, oral combined hydrochlorothiazide/lisinopril will reduce postpartum hypertension at 7 days after delivery compared to usual care with calcium channel blockers.

Eligibility criteria:
inclusion criteria: * postpartum women at ≥ 18 years of age * postpartum diagnosis of persistent hypertension (2 measurements of systolic bp ≥150 and/or diastolic bp ≥ 100 or systolic bp ≥140 and/or diastolic bp ≥ 90 for people with diabetes) requiring an oral medication based on the acog criteria or * hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood pressure medication in the postpartum * chronic hypertension requiring blood pressure medication postpartum exclusion criteria: * urine output \< 30 cc/h prior to screening for eligibility * creatinine \> 1.4 during current admission * end-stage renal disease * hypersensitivity to ace inhibitors or sulfa drugs * idiopathic/hereditary angioedema * hyperkalemia (serum potassium \>5 meq/l) during current admission * pulmonary edema
clinical and microbiological efficacy of chloramine and hyaluronic acid gels in non-surgical periodontitis treatment

Conditions: Periodontitis

Summary: the aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (perisolv) and hyaluronic acid (hyadent bg) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.

objectives: 1. to evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients. 2. to assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone. the treatment will consist of two treatment modalities: (1) control group - full mouth scaling and root planing (srp) (2) test group - full mouth srp + "perisolv"+ hyadent bg gels. the periodontal treatment will be performed in one session without time restrictions. under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and gracey curettes. afterwards, all teeth will be polished using a low-abrasive paste. teeth in the test group (all teeth with pd ≥ 5 mm) will adjunctively be treated with chloramine gel (perisolv), which will be inserted into periodontal pockets before and during srp (2 times). the nozzle will be placed in the pocket mesially, lingually, distally and bucally. teeth will be polished and all treated pockets will be filled with hyaluronic acid gel. teeth in control group will receive srp + polishing

Eligibility criteria:
inclusion criteria: * \> 30 years old; * good general health according to medical history and clinical judgment; * exhibiting at least one pocket in each quadrant with pocket depth (pd) ≥ 5 mm; * radiographic evidence of bone loss ( \> 2 mm from cemento-enamel junction (cej) ); * untreated periodontal disease; * minimum 20 teeth (wisdom teeth excluded); * no removable prosthesis. exclusion criteria: * patients already included in other clinical trials; * periodontal treatment during the last 12 months; * antibiotic treatment 6 months prior to the start of the trial; * antibiotic prophylaxis required for dental treatment; * ongoing medication that may affect the clinical features of periodontitis; * pregnant/lactating.

Keywords: periodontitis scaling and root planing sodium hypochlorite
study of cgc-11047 in patients with metastatic hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research is to determine the effectiveness of cgc-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in psa.


Eligibility criteria:
inclusion criteria: * metastatic hormone refractory prostate cancer. * eastern cooperative oncology group (ecog) performance status of 0-1. * testosterone \<50ng/dl. patients must continue primary androgen deprivation with an lhrh analogue if they have not undergone orchiectomy. * progressive disease after androgen deprivation. exclusion criteria: * patients whose clinical condition would make chemotherapy clearly indicated. * patients who have received systemic chemotherapy for the treatment of metastatic disease. * peripheral neuropathy \> grade 1 * prior anti-angiogenic therapy, including thalidomide. * patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry. * patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. * patients with known brain metastases or history of brain metastases. * history of stroke within 6 months of treatment or other significant neurological limitations. * patients who have received more than 2 prior investigational treatments. * uncontrolled intercurrent illness * patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias

Keywords: prostate cancer hormone refractory metastatic
efficacy 、safety and pk of shr-1314 in patients with moderate-to-severe plaque psoriasis

Conditions: Moderate-to-Severe Plaque Psoriasis

Summary: the purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous shr-1314 in patients with moderate-to-severe plaque psoriasis


Eligibility criteria:
inclusion criteria: 1. men or women at least 18 years of age at time of screening. 2. chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization. 3. moderate to severe psoriasis as defined at baseline/ randomization by: pasi score of 12 or greater, and spga score of 3 or greater (based on a static scale of 0 - 5), and body surface area (bsa) affected by plaque psoriasis of 10% or greater. 4. subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy. 5. body mass index (bmi) is 18 kg/m2 or above at screening exclusion criteria: 1. forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or baseline/randomization. 2. drug-induced psoriasis. 3. had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (week 0). 4. presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the investigator could interfere with assessment of psoriasis. 5. history of inflammatory bowel disease or have other ongoing active autoimmune diseases. 6. at screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. history of congestive heart failure (new york heart association \[nyha\] functional classification ≥iii), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the investigator prevents the subject from participating in the study. 8. active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization. 9. history of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the columbina suicide severity rating scale (c-ssrs) at screening and baseline (posner k et al, 2011), the subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide. 10. all subjects will be tested for tuberculosis status using igra and x-ray test. 11. have evidence of positive test for hepatitis b, hepatitis c antibody, or human immunodeficiency virus (hiv) antibodies. 12. have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.


Eligibility criteria:
major inclusion criteria: * signed informed consent * male or female patients, 18 to 75 years of age * confirmed clinicopathological diagnosis of eoe according to established diagnostic criteria: (a) clinical symptoms of esophageal dysfunction (b) peak eosinophils ≥ 15 in at least 1 high-power field (hpf) - active symptomatic and histological eoe at baseline major exclusion criteria: * clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia * gastroesophageal reflux disease and ppi-responsive esophageal eosinophilia * other clinical evident causes than eoe for esophageal eosinophilia * any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection) * any relevant systemic disease (e.g., aids, active tuberculosis) * abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension * abnormal renal function at screening * history of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma) * history of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit * upper gastrointestinal bleeding within 8 weeks prior to screening visit * concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants * concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate * installation of dietary restrictions within 4 weeks prior to screening visit or during treatment * intake of grapefruit containing food or beverages during the treatment with study medication * known intolerance/hypersensitivity to study drug * existing or intended pregnancy or breast-feeding
systemic lupus erythematosus

Conditions: System; Lupus Erythematosus; Cognition Disorder; Autoimmune

Summary: systemic lupus erythematosus (sle) is a chronic autoimmune and inflammatory disease. the pathogenesis of sle results from interactions between genes, hormones, and the environment; however, the exact etiology is unknown. sle can affect many organs and systems, including the musculoskeletal, hematological, renal, neuropsychiatric, cardiovascular and pulmonary systems, and skin. non-specific general complaints such as malaise, fatigue, arthralgia, anxiety, depression, fever, and weight loss are evident at the onset of the disease and during the activation periods. patients experience hopelessness due to the complexity of the symptoms and the chronic and progressive nature of the disease, and they experience deterioration in their quality of life due to the interaction of anxiety and depression findings with other symptoms. sle is a difficult disease to manage because of the different organ and system involvement processes. in addition, these symptoms of the disease and the nature of chronic pain, including central sensitization, cause it to accompany a process that is affected by the mood of the person. some patients present to a rheumatologist with mild symptoms, while others may present with severe, life-threatening symptoms. the onset of the disease before the age of 18 is defined as childhood onset (juvenile). childhood-onset sle accounts for approximately 1/5 of sle patients. it is known that the main mechanism in the formation of the disease is the production of more than one autoantibody. although childhood sle (jsle) appears to be basically the same disease with similar etiology, pathogenesis, and laboratory findings as in adults, there are differences in the frequency and severity of clinical manifestations. in this respect, the clearest finding is that children with sle have greater disease severity and earlier disease-related organ damage than adults with sle. studies on the disease show that patients with jsle have not only physical but also cognitive effects. the aim of our study is to examine the effects of exercises applied with a dual-task approach on patients' physical and cognitive status in jsle cases.


Eligibility criteria:
inclusion criteria: 1. patients aged 6-16 years diagnosed with jsle by a pediatric rheumatologist 2. those who have had the disease for at least one year 3. those whose medical treatments are in a stable period 4. patients willing to be rehabilitated and able to adapt to the study exclusion criteria: 1. cases older than 16 years old diagnosed with jsle 2. patients with initiation of multi-organ failure 3. those whose medical treatments are in flux 4. wanting to leave the study 5. not participating in assessments 6. not attending treatment programs regularly 7. not being able to adapt to treatment programs at the cognitive level