Kornimate/medical-research-clean huggingface dataset:
umbilical cord derived mesenchymal stem cells transplantation for active and refractory systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this study will explore safety and efficacy of allogeneic umbilical cord (uc) derived mesenchymal stem cells transplantation (msct) to treat patients with active and refractory systemic lupus erythematosus (sle) who have been resistant to multiple standard treatments. the underlying hypothesis is that the active sle condition is caused by an abnormal immune homeostasis that can be restored by msct.

inclusion criteria: 1. all patients fulfilled the american college of rheumatology (acr) criteria of sle, man or woman aged from 15 to 70 years old, sledai≥8; 2. lupus nephritis with 24h urine protein≥1g; 3. refractory disease as determined by failure of the following regimens: trial of corticosteroids (oral prednisone more than 20 mg/day); trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months; 4. patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital; 5. willing to use contraception throughout the study and for 12 months following treatment

Eligibility criteria:
inclusion criteria: * all patients fulfilled the american college of rheumatology (acr) criteria of sle, man or woman aged from 15 to 60 years old, sledai≥8; * lupus nephritis with 24h urine protein≥1g; * refractory disease as determined by failure of the following regimens: trial of corticosteroids (oral prednisone more than 20 mg/day); trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months; * patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital; * willing to use contraception throughout the study and for 12 months following treatment exclusion criteria: * abnormal liver function (alt higher than 3 times the normal value); * end-stage renal failure; * severe heart and pulmonary failure, or other important organs damage; * uncontrolled infections * pregnant or breast feeding women, male or female who intended to recent pregnancy
evaluation of a breast biblock analgesia for the mastectomy with radical axillary lymphadenectomy surgery

Conditions: Mastectomy, Segmental; Acute Pain; Anesthesia

Summary: this study evaluates the efficacy of the the pecto-intercostal fascial plane block (pif block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a pif block for the breast surgery.

breast surgery is one of the most painful post-operative surgery. this surgery is well known to induce postoperative chronic pain. the paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery. peripheral regional anesthesia for the breast surgery appeared in the past few years. among these techniques are the pec block, serratus block and more recently the pecto-intercostal fascial plane block (pif block). currently in the investigators hospital in every day's practice, an association of the serratus block and the pif block is made, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the pif block). therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for analgesia of the lateral part of the breast. this technique was previously described. the authors evoked the possibility of the association of serratus and pif blocks and described this technique with a patient, but to the investigators knowledge no evaluation of the efficacy of this procedure was made. the objective of the study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy. this is a purely observational study that assesses a current practice in this type of surgery.

Eligibility criteria:
inclusion criteria: * total mastectomy surgery with a complete axillary lymph nodes removal exclusion criteria: * age under 18 * contraindication to the surgery * refusal of the protocol by the patient

Keywords: breast surgery acute pain regional anesthesia
registry 17-009: multi-institutional study examining patients with hcc undergoing liver transplantation

Conditions: Hepatocellular Carcinoma

Summary: this is a registry study examining patients with hcc undergoing liver transplantation including outcomes and predictors of recurrence


Eligibility criteria:
inclusion criteria: * adult patients (age\>18 years) undergoing liver transplant for hepatocellular carcinoma exclusion criteria: * patients under 18 years old * patients who do not have hepatocellular carcinoma * patients who have hepatocellular carcinoma but do not undergo liver transplantation
the relation of high sensitivity c reactive protein and total leucocytic count levels in threatened abortion

Conditions: Abortion Early

Summary: to identify the relation between maternal serum high sensitivity c reactive protein and total and differential leucocytic count values in healthy pregnant women with threatened abortion and the outcome of pregnancy

observational prospective cohort research will be pregnant women attending to obstetrics and gynecology department of university hospital. after enrollment, participants will be divided into two groups: * study group: had 120 healthy women presenting with threatened miscarriage. * control group: had 120 healthy women with an uncomplicated single pregnancy. informed permission will be obtained. all cases subjected to the following: taking complete history, general examination, special investigations including obstetric ultrasonography for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal gestation. laboratory investigations including estimation of the complete blood picture (cbc), highly sensitive crp (hs-crp) single measurement, women over 1st trimester abdominal ultrasonographic examination (6-13weeks) using toshiba with transabdominal transducer probe frequency of 7 mhz to evaluate the following data: measuring of the fetal crown-rump length (crl) done to confirm the fetal gestational age and the viability of the fetus. gestational age will be calculated from the beginning of the last regular menstrual cycle. women who had hormone therapy or progesterone supplements, as well as pregnancies with a discrepancy between lmp and crown rump length of more than three days, were excluded from the research. pregnant women will be under close follow up every 2 weeks by: obstetric u/s, measure blood pressure and inform us if severe bleeding occurs.

Eligibility criteria:
inclusion criteria: * single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group, * an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma, * healthy women who come for routine antenatal care with spontaneous pregnancy. exclusion criteria: * age over 40 * smoking * multiple pregnancies * endocrinological diseases * history of repeated spontaneous abortions.

Keywords: c reactive protein total and differential leucocytic count abortion
probiotics in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus sle patients. ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.

1. patients will be recruited and evaluated for eligibility. 2. patients who met the eligibility criteria will be randomly assigned to either control or interventional group. 3. patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks. 4. collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks. 5. assessment of disease activity using sledai-2k score, quality of life using the validated arabic lupusprov1.8 questionnaire, and pain assessment using the validated arabic version of the short-form mcgill pain questionnaire will be performed at baseline and at the end of the study. 6. safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet. 7. blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years, male or female. 2. patients are willing to sign a written informed consent. 3. patients fulfilling american college of rheumatology classification criteria for sle. 4. patients diagnosed with active systemic lupus erythematosus defined as sledai-2k score more than 4. exclusion criteria: 1. patients ˂ 18 years or ˃65 years of age. 2. patients with a history of drug allergies to probiotics administration. 3. pregnant or breastfeeding females. 4. current probiotics use. 5. patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study. 6. patients suffering from active severe neuropsychiatric manifestations of sle. 7. patients with other auto-immune diseases. 8. patients suffering from any type of cancer. 9. patients participating in other clinical trials.

Keywords: probiotics lactobacillus systemic lupus erythematosus sledai-2k
autologous mitochondrial transplant for cerebral ischemia

Conditions: Cerebral Ischemia

Summary: the investigators propose to infuse healthy autologous mitochondria into cerebral vessels supplying brain tissue experiencing ischemia in patients who undergo standard-of- care endovascular reperfusion therapy.

stroke is one of the leading causes of morbidity and mortality worldwide. more than 80% of strokes are the result of ischemia caused by blockage of one or more cerebral arteries. lack of blood supply starves brain cells of necessary glucose and oxygen, and disturbs cellular homeostasis, eventually resulting in neuronal death. mitochondria are tiny organelles present in nearly all types of human cells and are vital to our survival. much like a battery, they generate most of our adenosine triphosphate (atp), the energy currency of the cell. mitochondria are also involved in other tasks, such as signaling between cells and cell death. all these functions can be impaired during ischemia because of the damage caused to mitochondria. based on many preclinical studies in animals, damage caused by ischemia can be reversed after infusing healthy mitochondria into injured tissues. an ongoing clinical trial in human hearts at boston children's hospital has also demonstrated that transplanting autologous mitochondria via infusion or direct injection is well-tolerated and safe. the investigators at the university of washington are recruiting subjects for a first-in-human-brain trial to confirm the safety of autologous mitochondrial transplant during brain ischemia. the transplantation will be performed within the same procedure as the clinically indicated reperfusion treatment. during standard-of-care endovascular treatment for cerebral ischemia, the investigators will obtain a very small biopsy from the muscle tissue adjacent to our surgical access site. muscle tissue will be processed at bedside to extract the autologous mitochondria as performed in prior human cardiac trial and validated in animal studies. the endovascular treatment proceeds without disruption as clinically indicated, and the mitochondria are infused into the brain artery via micro-catheter during reperfusion.

Eligibility criteria:
inclusion criteria: * eligible for endovascular thrombectomy to treat acute large vessel occlusion * eligible for angioplasty (microcatheter-based balloon/mechanical and chemical angioplasty) to treat acute cerebral vasospasm after aneurysmal subarachnoid hemorrhage * subjects for whom there is likely to be enough time to obtain meaningful consent from patient or legally-authorized representative exclusion criteria: * unable to receive a brain mri scan * known mitochondrial disease * hemodynamically unstable patients in whom standard of care endovascular reperfusion treatment cannot safely be performed or completed

Keywords: autologous mitochondrial transplantation ischemic stroke
4-choice reaction time test for the measurement of psychomotor recovery after general anaesthesia

Conditions: Postoperative Complications

Summary: the recovery of patients after general anaesthesia is usually estimated by using clinical signs and scores. since there is a lack of the agreed objective methods for assessing cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim of this study was to evaluate three psychological tests for this purpose. patients, who were scheduled for ambulatory gynaecological surgery, underwent 3 standard psychological tests before (t1), 15 minutes after the surgery (t2) and on discharge from the recovery room (t3). the tests used were wechsler memory scale (test 1, working memory capacity), d2 - test (test 2, concentration endurance) and computer-based 4-choice-reaction time (4crt, test 3, reaction time) as well as postanesthesia discharge scoring system (padss). the same test battery was used in healthy female volunteers, all test results were compared at the different time points.


Eligibility criteria:
inclusion criteria: * consecutive patients scheduled for ambulatory gynaecologic surgery * age of 18 to 60 years * a physical status i-ii according to american society of anesthesiologists (asa) classification * fluency in german language and the ability to perform all tests exclusion criteria: * chronic consume of analgesics, psychotropic drugs, sedatives or alcohol * if the ambulatory surgery lasted more than 60 minutes * if the schema of standardised general anaesthesia was changed * if the ambulatory setting was changed and the patients unexpectedly remained over night in the hospital.

Keywords: postoperative recovery psychomotor function measurement
comparison of survival benefit of panitumumab with supportive care to best supportive care alone in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type kras (kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic colorectal cancer (crc) * wild-type (without mutation in codons 12 and 13) kras gene in tumor tissue confirmed by a central laboratory * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * at least 1 measurable or non-measurable lesion per response evaluation criteria in solid tumors (recist) version 1.1 guidelines. * treatment failure (defined as failure due to either disease progression \[clinical or radiological\] or toxicity \[treatment intolerance\]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. oxaliplatin and irinotecan may have been administered sequentially or in combination. * disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease * must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of crc * man or woman at least 18 years of age * adequate hematologic, renal, hepatic and metabolic function * negative pregnancy test within 72 hours before randomization (for women of childbearing potential only) * subject or subject's legally acceptable representative has provided informed consent. * other protocol-specified criteria may apply exclusion criteria: * symptomatic brain metastases requiring treatment * history of another primary cancer within 5 years of randomization * prior anti-epidermal growth factor receptor (egfr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule egfr inhibitors (eg, gefitinib, erlotinib, lapatinib) * antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization * radiotherapy within 14 days before randomization. * exclusion criteria for corrected qt (qtc) evaluation subpart of the study: prolongation of qt/qtc interval \> 450 milliseconds at screening * other protocol-specified criteria may apply

Keywords: best supportive care panitumumab chemorefractory wild-type kras overall survival phase 3
high-intensity interval training and vitamin d effects on bone metabolism among women diagnosed with osteoporosis

Conditions: Osteoporosis; Exercise Overtraining; Vitamin D 25-Hydroxylase Deficiency

Summary: the effects of 16-week high-intensity interval training (hiit) and vitamin d supplements on bone mineral density (bmd) in women with osteoporosis. the participants assigned for hitt exercise training with or without vitamin d supplements for 16 weeks, and the levels of serum bone parameters like, osteocalcin (oc), ca, and s-bap were estimated in women with osteoporosis at baseline and after post-training interventions. in addition, the levels of vitamin d were also identified in all women's accordingly.

our study aimed to investigate the effects of 16-week high-intensity interval training (hiit) and vitamin d supplements on bone mineral density (bmd) in women with osteoporosis. thus, serum levels of 25-hydroxy-vitamin d (oh-d), osteocalcin (oc), ca, and s-bap were estimated in women with osteoporosis at baseline and after post-training interventions. one-hundred twenty sedentary women aged (30-50 years) were diagnosed with osteoporosis. patients were classified into four groups, 30 patients in each group; control group (normal daily activities); exercise group (hiit-exercise for 16 weeks); vitamin d group (vitamin d 800iu/ day for 16 weeks), and concurrent group (hiit exercise plus vitamin d for 16 weeks). anthropometric measurements, bmd, serum levels of vitamin 25-(oh) d, osteocalcin, s-bap, and calcium were estimated in all participants' pre- and post-exercise training.

Eligibility criteria:
inclusion criteria: * a healthy non-smoker premenopausal women's * age are 30-50 years old * subjects who diagnosed with osteoporosis based on the clinical features of bone mineral density (bmd) measured from both lumbar spine l2 to l4, and from the right and left sides of the hip region by dual energy x-ray absorptiometry (dexa, unigamma plus ac 230v 50/60hz 400w, usa) scan method. exclusion criteria: * women with; physical disability, * abnormal hormonal levels * severe disease complications such as chronic kidney and liver diseases, * rheumatoid and osteoarthritis diseases * significant overweight (bmi ≥25) and obesity (≥30 kg/m2) per recommended by the world health organization * history of receiving calcium, multivitamin supplements, corticosteroids, anticonvulsants, and heparin which might affects up on the assessment of bone markers and bmd measurements were excluded from this study.

Keywords: exercise training, bmd, osteoporosis, vitamin d deficiency
intra-subject variability following administrations of activated recombinant human factor vii in haemophilia patients in a non-bleeding state

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this trial is conducted in asia and europe. the aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (teg® and rotem®) following two administrations of activated recombinant human factor vii in haemophilia patients in a non bleeding state. the teg® parameters are: r time (reaction time), k time (k time (arbitrary measurement)), a (a angle), ma (maximum amplitude) and ly30 (lysis 30 min after ma) while the rotem® parameters are: ct (clotting time), cft (clot formation time), a (a angle), mcf (maximum clot firmness) and li60 (lysis index 60 min after ct).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of congenital haemophilia a or b with a fviii:c (activated coagulation factor viia clotting activity) or fix:c (coagulation factor ix clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 bethesda units) * non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product exclusion criteria: * known or suspected allergy to trial product or any of its components or to related products * known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia a or b * platelet count below 50,000 platelets/mcl * received any haemostatic treatment (e.g. feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor vii