Kornimate/medical-research-clean huggingface dataset:
comparison of global, g-tl, & cornell media

Conditions: Infertility

Summary: this is a prospective, randomized clinical trial to compare the global commercial single step media to 1) g-tl (vitrolife), 2) weill cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the vitrolife time-lapse system. the main goal of the study is to identify the best culture medium for optimal embryo development.

culture media are used to culture embryos in order to support their development in the laboratory. new media are being introduced to the market. clinical studies have shown that the use of the single-step global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system. global is a fda approved commercial single-step medium for all embryo culture from day 0 to the blastocyst stage. g-tl (time-lapse) is a fda approved commercial single-step medium from vitrolife. it was developed to be used with time-lapse devices as a continuous embryo culture medium from day 0 to day 5/6. c3 is cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care. c1/c2 is cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. it is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. this medium will be the control.

Eligibility criteria:
inclusion criteria: * 40 years of age or younger (maternal) * 65 years of age or younger (paternal) * 10 or more oocytes * fresh or frozen oocytes (including donor) * fresh or frozen (including donor) sperm can be used * icsi only * frozen embryos from this study can be included in the outcome portion of this study. * pgd and/or pgs patients included exclusion criteria: * patients with less than 10 oocytes * co-culture patients

Keywords: ivf
the role of ninjurin-1 during systemic inflammation

Conditions: Ninj1 Expression; SIRS

Summary: * with the underlying study the investigators address the question if ninjurin-1 (ninj1) expression is altered in patients with systemic inflammatory response syndrome (sirs) in comparison to healthy volunteers. * the adhesion molecule ninj1 is induced following nerve injury where it contributes to nerve generation. besides it is described to facilitate leukocyte migration especially in the nervous system. * the investigators hypothesize that ninj1 expression is increased in sirs patients, which will fortify its impact during inflammation and the transferability from bench to bedside.


Eligibility criteria:
inclusion criteria: * age \> 18 years * cardiac surgery patients exclusion criteria: * included in an interventional study * preoperative infection (e.g. endocarditis)

Keywords: sirs ninj1 sepsis healthy
the efficacy and safety of nab-paclitaxel in pretreated patients with extensive disease of small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: patients with extensive disease(ed) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. currently, there is no standard 3rd line therapy for the patients with ed small cell lung cancer(sclc). as the investigators know, nab-paclitaxel had showing promising efficacy in several cases report in the patients with sclc, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the sclc patients with extensive disease and failed to first line/ second line chemotherapy.

primary end point: objective response rate(orr) secondary end point: progression free survival(pfs), overall survival(os), side effects according to common terminology criteria for adverse events(ctcae) version 4.0 quality of life(qol) etc.

Eligibility criteria:
inclusion criteria: 1. obtain of informed consent. 2. male or female aged 18 years and over. 3. histologically or cytologically confirmed small cell lung carcinoma. 4. extensive disease before receive nab-paclitaxel. 5. failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed. 6. world health organization (who) performance status (ps) of 0 to 2. 7. females of child-bearing potential must have negative serum pregnancy test. sexually active males and females (of childbearing potential) willing to practice contraception during the study. 8. heart index values is in the range, as defined below, within two weeks of randomization: * absolute neutrophils count(anc)≥2.0×109/l * platelets≥100×109/l * serum bilirubin≤2×uln; aspartate transaminase(ast) and alanine transaminase (alt) ≤2.5×uln(≤5×uln if liver metastases) * creatinine clearance≥60ml/min 9. measurable disease according to response evaluation criteria in solid tumors(recist) criteria with at least one measurable lesion not previously irradiated. 10. life expectancy ≥12 weeks. exclusion criteria: 1. as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease). 2. newly diagnosed central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation. 3. known severe hypersensitivity to nab-paclitaxel or any of the excipients of these products.known severe hypersensitivity to pre-medications required for treatment with nab-paclitaxel doublet chemotherapy. 4. prior treatment with paclitaxel. 5. pregnant or lactating woman. 6. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 7. life expectancy of less than 12 weeks.

Keywords: small cell lung cancer chemotherapy nab-paclitaxel
curcumin for type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus; Cardiovascular Abnormalities

Summary: there are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in type 2 diabetic patients. this will trigger oxidative stress system via reactive oxygen species (ros) and lead to a high level of nitric oxide. this can contribute to a significant change in blood vessel and could end up with the complications from cardiovascular disease and increased mortality rate of type 2 diabetic patients. the purpose of the present study was to examine the effectiveness of the curcumin in type 2 diabetic patients on the reduction of atherosclerosis events by examining pulse-wave velocity (pwv) and plasma high-sensitivity c-reactive protein (crp) test and on blood sugar lowering, glycosylated hemoglobin (hba1c), lipid profile, and insulin resistance.


Eligibility criteria:
inclusion criteria: * diabetic patients aged 35 years or older and did not use insulin during the first 5 years of treatment after being diagnosed (with or without symptoms listed in the following inclusion criteria) * patient with hyperlipidemia (cholesterol ≥ 200 mg/dl, tg ≥ 150 mg/dl, ldl ≥ 100 mg/dl and hdl ≥ 35 mg/dl) * patient with hypertension (blood pressure ≥ 130/85 mmhg or take hypertensive drugs) * obesity (bmi ≥ 25) exclusion criteria: * current diagnosis of secondary peripheral arterial disease (pad) (except listed in the inclusion criteria item 1-4) * current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease * current diagnosis of end stage renal function with serum creatinine \> 2.0 mg/dl or on renal dialysis * current diagnosis of cirrhosis with alt ≥ 3 times of normal range

Keywords: type 2 diabetes metabolic syndrome cardiovascular risk
post hematopoietic stem cell transplantation

Conditions: Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major

Summary: this was a prospective, single-arm, multicenter, national, phase ii clinical study. the purpose of this phase ii study was to examine the safety and efficacy of deferasirox to decrease iron overload (iol) in the posttransplant period in patients with beta-thalassemia major.


Eligibility criteria:
inclusion criteria * patients who had hematopoietic stem cell transplantation (hsct) for beta-thalassemia major * hematopoietic stem cell transplantation (hsct) was performed minimum 6 months and maximum 2 years ago * the washout period after the immunosuppressive therapy should be at least 3 months. * signifacant iol should be present including: a. serum ferritin \>1000 μg/l or b. cardiac mri \<20 ms or c. liver iron concentration ≥ 5 mg/g dry weight measured by r2\* mri exclusion criteria * patients who had any contraindication for treatment with deferasirox according to the prescribing information •patients who depended on transfusion * patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias) * patients who were experiencing severe complication of hsct e.g. acute graft-versus host disease (gvhd) * significant proteinuria / increase in serum creatinine

Keywords: hematopoietic stem cell transplantation, beta-thalassemia major, deferasirox, iron overload
increased re-eradication rate of helicobacter pylori by adding n-acetylcystein or metronidazole to the triple therapy

Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Summary: compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and amoxicillin) plus n-acetylcystein versus 10-day concomitant therapy (rabeprazole, clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric helicobacter pylori infection.

background: antimicrobial resistance has decreased the eradication rates of common used triple therapy for helicobacter pylori infection (less than 80%). such treatment for patient previously with treatment failure, the retreatment eradication rate is less then 50%. some studies showed the helicobacter pylori form biofilm to prevent entry of antibiotics, and the n-acetylcystein is helpful to dissolve the biofilm. objective: to determine the eradication rate of the common used triple therapy after adding n-acetylcystein for second line treatment for adults infected with helicobacter pylori in eastern taiwan. design: randomized, open-label, prospective controlled trial. patients: who are previously failed the primary treatment for eradication and still infected by helicobacter pylori. measurements: 13c-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and cyp2c19 genotype of host. intervention: patients with helicobacter pylori eradication treatment failure are recruited and randomly assigned to receive one of the following therapeutic schemes: 1) study group: rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + n-acetylcystein 0.6g bid for 10 days; 2) control group: rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for 10 days. repeat upper endoscopy for histologic evaluation, rapid urease test or 13c-urea breath test after 4 week of treatment to assess the treatment result. the influence on the hybrid therapies of antibiotic resistance of helicobacter pylori and cyp2c19 genotype of host were determined. expected results: the new second line treatment for eradication of helicobacter pylori is effective, and to determine the relation of antibiotic resistance of helicobacter pylori and cyp2c19 genotype of host to the treatment result.

Eligibility criteria:
inclusion criteria: * patient after treatment for helicobacter pylori eradication. * still clinically with evidence of gastric helicobacter pylori infection. exclusion criteria: * woman in breast feeding or pregnancy. * allergy to drugs used in study. * never treated for h. pylori. * intolerance to fructose, lactose. * patients with hematologic, brain or spinal disorders. * patients under 20 years old. * patients with malignancy or with decompensated function of vital organs.

Keywords: helicobacter pylori antibiotic resistance n-acetylcystein biofilm second-line eradication treatment
dose escalation and expansion study of bh3120 alone or with pembrolizuamb in advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: this is a first-in-human, phase 1, dose-escalation and dose-expansion study of bh3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, mtd, rp2d, pk, and efficacy in patients with advanced or metastatic solid tumors. dose-escalation part is planned to establish the mtd or rd for dose-expansion part, while dose-expansion part is designed to assess potential efficacy of bh3120, as a single agent and in combination with pembrolizumab, when administered at the rd to subjects in indication-specific expansion cohorts.


Eligibility criteria:
key inclusion criteria: * have a histologically or cytologically confirmed non-cns solid tumor that is metastatic or unresectable and for whom there is no available standard therapy. * pd-l1 positive expression (tumor proportion score ≥1% or combined positive score ≥1). * have at least one lesion, not previously irradiated that can be accurately measured per recist version 1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * age of 18 years or older (or country's legal age of majority if the legal age was \>18 years) * adequate hematologic and liver function. key exclusion criteria: * has received prior therapy with an anti-4-1bb(cd137) agent. * known active cns metastases and/or carcinomatous meningitis. * known additional malignancy that is progressing or has required active treatment. * history of chronic liver disease or evidence of hepatic cirrhosis. * history of severe toxicities associated with a prior immunotherapy. * has ongoing or suspected autoimmune disease. * known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)-related illness, immunocompromised patients.
pregabalin versus placebo as an add on for complex regional pain syndrome (cprs) of the upper limb managed by stellate ganglion block (the prega study)

Conditions: Complex Regional Pain Syndromes

Summary: the purpose of this study is to assess the efficacy of pregabalin in patients with complex regional pain syndrome type i and to determine whether it provides clinically significant pain relief and whether it improves functioning of the upper limb.


Eligibility criteria:
inclusion criteria: * patients diagnosed with crps type i as per the iasp (international association for the study of pain) criteria which states presence of an initiating noxious event, or cause for immobilization * evidence at some point of swelling, color change, hot/cold/sweaty sensation and no other condition which can account for the pain and dysfunction of the upper limb * men or women between ages 18-65 year old * women should not be pregnant or breast feeding * no change in treatment for 4 weeks prior to recruitment * pain scores of 4/10 on a verbal analogue scale exclusion criteria: * patients with a neurologic disorder unrelated to crps * patients who are already on pregabalin * patients with renal impairment whose creatinine clearance is less than 60 ml/min * patients with congestive heart failure who are also diabetic and taking thiazolidinedione medication like rivoglitazone * unstable psychiatric history * patients with another problem with equal or worse pain * unstable medical condition

Keywords: cprs stellate ganglion block pregabalin pain type i
use of three-dimensional printed models for endovascular planning and follow-up in patients affected by aorto-iliac-femoral-popliteal arterial disease undergoing balloon angioplasty. a single-center, single-blind randomized controlled trial

Conditions: Peripheral Artery Disease (PAD)

Summary: lower extremity peripheral arterial disease is a major health problem. currently, balloon angioplasty represents the most commonly performed treatment for patients affected by vascular claudication or critical limb ischemia. pre-operative planning for aorto-iliac-femoral-popliteal atherosclerotic disease is a complex procedure, since an inappropriate strategy may lead to peri-operative complications. the aim of this study is to propose an innovative planning strategy for balloon angioplasty with the support of complex 3d printed models. the goal is to reduce peri-operative complications and overall costs, while improving technical success and mid-term patency of revascularizations.


Eligibility criteria:
inclusion criteria: * age between 18 and 89 years; * severe claudication or critical limb ischemia (rutherford categories 3-5 \[cronenwett and johnston. rutherford's vascular surgery 7th edition. saunders elsevier 2010\]) and indication already established for endovascular revascularization treatment (according to the current italian sicve guidelines); * atherosclerotic disease involving the aorto-iliac-femoro-popliteal segment; * signed informed consent. exclusion criteria: * age \ 89 years; * preoperative cta not available for any reason (clinical contraindication, logistical impossibility); * patients requiring urgent intervention (lack of time for 3d model printing); * atherosclerotic disease limited to tibial vessels only (absent or non-significant atherosclerosis at aorto-iliac-femoro-popliteal level); * patient refusal to participate in the study.
transdermal vagal stimulation for pots

Conditions: Postural Orthostatic Tachycardia Syndrome

Summary: some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure. these patient are disabled and can't be in upright position for a longer time. the purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.

background postural tachycardia syndrome (pots) is a syndrome characterized by disabling symptoms of inadequate cerebral perfusion on assuming the upright posture, including light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and occasionally syncope. pots is characterized by an excessive increase in heart rate and exaggerated increase in plasma catecholamine levels on standing in the absence of a blood pressure fall. these disabling symptoms persist for more than six months. objective the objective of this study is to study the effect of vagal stimulation on heart rate modulation during supine and upright posture as a treatment modality for patients with pots.

Eligibility criteria:
inclusion criteria: * non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. the criteria are: 1. an increase of heart rate of 30 beats/minute or an upright heart rate of \>= 120 bpm, and 2. chronic problems of symptoms during upright posture for at least 6 month. * subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure. * the age limit is 18-75 years. exclusion criteria: * patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known. * pregnancy.

Keywords: postural orthostatic tachycardia syndrome pots vagal stimulation
lbnp tolerance with skin warming after exercise cold stress

Conditions: Blood Pressure; Blood Loss

Summary: assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold.

individuals who have experienced a hemorrhagic insult are often wrapped in a warm blanket. in individuals who have exercise in a cold environment, it is unknown how this skin warming influence tolerance to simulated blood loss and whether there is an optimal temperature to warm the skin up to in order to lower blood pressure (permissive hypotension). after an initial study visit to examine exercise capacity (visit 1), participants will complete four trials (visits 2 through 5) after exercise in a cold environment, participants will have cold skin temperatures (\~82°f; visit 2). researchers will examine how increasing skin temperature to normal (\~90°f; visit 3), warm (93°f; visit 4) and hot (95°f; visit 5) influences arterial blood pressure and tolerance to simulated blood loss compared to when the skin remains cold. this project will test the hypothesis that skin rewarming to \~95°f lowers arterial blood pressure without impairing tolerance to simulated blood loss (lower body negative pressure; lbnp) relative to when the skin is kept cold (82°f). primary data include core and skin temperatures, arterial blood pressure and lbnp tolerance time. secondary variables include skin blood flow and heart rate. after completing visit 1 first, all participants will complete visits 2 through 5 in a randomized order and participants are blinded. the order will be counterbalanced between participants.

Eligibility criteria:
inclusion criteria: * 18 and 40 years old * free of known disease and illness * speak english * systolic blood pressure \<140mmhg * diastolic blood pressure \<90 mmhg exclusion criteria: * currently pregnant or breast feeding * individuals with diagnosed with cardiac, respiratory, neurological and/or metabolic illness or disease. * currently taking prescribed or over the counter medications known to influence the cardiovascular, pulmonary, renal and/or central nervous system. * current use of tobacco or nicotine products * any physical limitations that impede completion of the tests, such as exercise tests will also be an exclusion criteria. * body mass\< 80 pounds body weight * appendectomy

Keywords: arterial blood pressure permissive hypotension cold stress skin warming blood loss
prevention of depressive relapse by means of physical exercise and lifestyle

Conditions: Depression

Summary: depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes. this study evaluates the potential of these methods as prevention of depressive relapse or recurrence


Eligibility criteria:
inclusion criteria: * a history of at least one episode of major depression. * if medicating - taking a stable (since one month) and therapeutic dosage of antidepressant medication * being able to read and write swedish * having access to the internet exclusion criteria: * fulfilling the criteria for major depression * bipolar disorder * psychosis * substance abuse * suicidality * currently in psychotherapy