Kornimate/medical-research-clean huggingface dataset:
autologous transplantation of mesenchymal stem cells for treatment of patients with onset of type 1 diabetes

Conditions: Evidence of Liver Transplantation

Summary: type 1 diabetes mellitus (t1dm)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with t1dm are dependent on exogenous insulin to control their blood glucose continuously. bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for t1dm,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with t1dm.

autologous transplantation of bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously

Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent from patients or child guardian 2. confirmed diagnosis of type 1 diabetes by ada criteria less than 18 weeks • exclusion criteria: 1. body mass index \>30 2. presence of acute stage as active infection,recent myocardial infarction, recent cerebral vascular accident (cva) or acute renal failure. 3. severe organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction). 4. infectious diseases, e.g. hiv infection, or hepatitis b or c infection 5. presence of malignancy

Keywords: mesenchymal stem cells
the benefits and risks of different menopausal hormone replacement therapy regimes in the treatment of menopause syndrome

Conditions: Menopause Syndrome

Summary: a prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(cee) plus natural progesterone or dydrogesterone in menopausal hormone therapy .

this is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(cee) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.participants are randomized into three groups, the cee 0.3 mg/micronized progesterone (mp) 100 mg group; cee 0.625 mg/mp 100 mg group; cee 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.the investigators hypothesize there may be differences of these parameters measured among three groups after intervention.

Eligibility criteria:
inclusion criteria: 1. 40 and 60 years old; 2. natural amenorrhea for more than 6 months but less than 5 years; 3. suffered by menopause symptoms and seeking for treatment; 4. serum follicle-stimulating hormone levels \>40 iu/l and serum estradiol \<30 pg/ml. exclusion criteria: 1. contraindications for menopausal hormone therapy; 2. complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer; 3. cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol; 4. alcohol or drug abuse within the last 3 months; 5. use of hormone therapy in the past 3months; 6. endometrial thickness more than 5mm even after progestin withdrawal; 7. abnormal cervical scraping smear; 8. allergic to any ingredient of the drugs; 9. participation in other clinical trials within the last 6 months.

Keywords: menopause syndrome low dose estrogen progestin
long-term follow-up in patients with acute myocardial infarction cohort

Conditions: Acute Myocardial Infarction; Adverse Event

Summary: ami survivors who participated in the project "construction and key technology research of the whole myocardial protection system for acute myocardial infarction" (project number 2016yfc1301100) and completed the 1-year visit were followed up by telephone at 3 years (within the corresponding follow-up time window) and 5 years after discharge to acquire the patients' medication, health status, and major adverse cardiovascular and cerebrovascular events, including death, heart failure, rehospitalization, re-myocardial infarction, revascularization, stroke, malignant arrhythmia, and bleeding events.


Eligibility criteria:
inclusion criteria: * ami survivors who participated in the project "construction and key technology research of the whole myocardial protection system for acute myocardial infarction" and completed the 1-year visit. * telephone to obtain informed consent from the subjects/family members of the subjects. exclusion criteria: * not available

Keywords: acute myocardial infarction major adverse cardiac and cerebrovascular event optimized treatment
a prospective study of the effect of modified colonoscopy bowel preparation program on intestinal cleaning, examination and disease in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: the purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. risk factors affecting the quality of bowel preparation will also be studied.


Eligibility criteria:
inclusion criteria: * diagnosis: inflammatory bowel disease (ibd) patients, including ulcerative colitis (uc) and crohn's disease (cd), have colonic involvement. * patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing. exclusion criteria: * the diagnosis is not definite. * toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; patients with gastrointestinal bleeding with unstable vital signs. * patients after colon surgery. * serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons. * patients can not cooperate with the use of polyethylene glycol or glycerin enema. * patients or family members cannot understand the conditions and objectives of this study.

Keywords: modified bowel preparation method inflammatory bowel disease risk factors quality of bowel preparation
sport cord test following acl reconstruction

Conditions: Injury of Anterior Cruciate Ligament

Summary: the primary purpose of this study is to determine the interrater reliability and validity of the sportcord test as a measure of physical performance following anterior cruciate ligament (acl) reconstruction. a secondary purpose is to systematically track subjective and objective outcomes on patients following acl reconstruction to help identify differences between those who have subsequent knee problems and those who do not. the study hypotheses are the following: 1) the sportcord test will provide a valid and reliable measure of functional performance following acl reconstruction. 2) patients who have subsequent knee problems in the 12 month study period will exhibit different scores on clinical special tests compared to those who do not.


Eligibility criteria:
inclusion criteria: * undergoing surgical reconstruction for a torn acl. * returning to participation in a sport(s). * will receive physical therapy/rehabilitation after surgical reconstruction for a torn acl. * between ages of 10 and 50. exclusion criteria: * non-weight bearing. * at least 12 weeks removed from surgery. * unable to walk, squat, or jump/land without pain in the surgically repaired knee.

Keywords: physical therapy return to sport
paricalcitol versus calcitriol for efficacy and safety in stage 3/4 chronic kidney disease (ckd) with secondary hyperparathyroidism (shpt)

Conditions: Secondary Hyperparathyroidism; Chronic Kidney Disease

Summary: secondary hyperparathyroidism (shpt) occurs in many patients with kidney disease and leads to bone disease. active forms of vitamin d, calcitriol and paricalcitol, treat shpt, but may have different effects on blood calcium. this study will randomize patients with shpt and stage 3 or 4 ckd to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of shpt treatment.

general design * open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of pth in stage 3 and 4 ckd patients with shpt. * total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up. * patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. a follow up visit will be performed 1 week after stopping study medication.

Eligibility criteria:
inclusion criteria 1. age \>18; able to give informed consent 2. chronic kidney disease, and estimated gfr 15 to 60 ml/min using the abbreviated mdrd equation 3. intact pth (ipth) \>120 pg/ml at baseline 4. albumin corrected calcium \> 8.5 mg/dl to \< 10.0 mg/dl at baseline 5. phosphorus \< 4.6 mg/dl at baseline 6. if on a phosphorus binder; no change in dose within the 4 weeks prior to screening exclusion criteria 1. receiving any active form of vitamin d within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol) 2. receiving \>50,000 iu per month of ergocalciferol or \> 1000 iu of cholecalciferol per day within the previous 30 days. 3. history of primary hpt 4. on prednisone \> 30 days within the previous 6 months 5. receiving bisphosphonates or calcitonin within the previous 12 months 6. non-elective hospitalization within the previous 30 days. 7. expected to initiate dialysis or receive a kidney transplant within the next 6 mo. 8. history of renal or other organ transplant 9. history of parathyroidectomy or previous diagnosis of primary hyperparathyroidism 10. receiving cinacalcet within 4 weeks prior to screening. 11. an active drug/alcohol dependence or abuse history 12. history of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator 13. pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

Keywords: pth active vitamin d hypercalcemia chronic kidney disease
study of exchange of travoprost intraocular implant

Conditions: Open Angle Glaucoma

Summary: the study objective is to evaluate the safety of the operative and surgical exchange procedure of travoprost intraocular implant in subjects with open-angle glaucoma or ocular hypertension.

this prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (oag) or ocular hypertension (oht). all subjects are required to meet eligibility criteria at visit 1 (screening). the purpose of this study is to evaluate the safety of the implantation and exchange of a travoprost intraocular implant in subjects with open-angle glaucoma or ocular hypertension. postoperatively, there are 6 follow-up visits over a 12 month period.

Eligibility criteria:
inclusion criteria: * able and willing to attend scheduled follow-up exams for the duration of the study * able and willing to provide written informed consent on the irb (institutional review board)/iec (institutional ethics committee)-approved informed consent form * best spectacle corrected visual acuity of 20/80 or better in each eye. * previously qualified for gc-009 clinical trial using the travoprost intraocular implant with the travoprost intraocular implant (g2tr) that is present in the study eye. exclusion criteria: * glaucoma status as follows: * traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders * corneal status as follows: * any active inflammation or edema * any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated: * implantation of travoprost intraocular implant * compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) * fellow eye status as follows: * fellow eye actively enrolled in this trial or any other clinical trial * subject status as follows: * pregnant or planning to become pregnant during the course of the study
the safety and efficacy test of nutri-peitc jelly in head and neck cancer patients

Conditions: Head and Neck Neoplasms; Quality of Life; Nutrition Related Cancer

Summary: this triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of nutri-peitc jelly, a functional food, in head and neck cancer patients. the primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. the secondary outcome includes serum p53 and cytochrome c levels and functional status.

previously, nutri-jelly, a novel edible nutritious gel for patients with chewing and swallowing difficulties, was shown to be effective in improving the quality of life of head and neck cancer patients. recently, nutri-peitc jelly is recently developed by addition of phenethyl isothiocyanate (peitc), a phytochemical compound with chemopreventive action in animal bearing oral cancer. it intends to be a functional food for cancer survivor. the dose of peitc in nutri-jelly was based on safe and effective dose determined in animal studies. furthermore, nutri-peitc jelly was proven safe in healthy volunteers who daily consumes for a consecutive month with no serious adverse events. the purpose of this study is to determine safety and efficacy of nutri-jelly with peitc in head and neck cancer patients. independent variable: continuous nutri -jelly with peitc intake dependent variable (outcome): adverse effects, health-related quality of life score, tumor response, progression-free survival, serum p53 and cytochrome c levels and functional status

Eligibility criteria:
inclusion criteria: 1. diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment 2. finished radiotherapy or/and chemotherapy for at least one month 3. has at least one measurable target lesion 4. baseline kps ≥ 40% or ecog 0-3 5. blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l; hb ≥ 9.0 g/dl), renal function (clearance creatinine using the ckd-epi formula (chronic kidney disease epidemiology group) ≥50 ml/min) and hepatic function (sgot , sgpt, serum bilirubin ≤ 1.5 of upper limits of normal 6. able to take the intervention (through mouth or ng tube) without aspiration 7. able to communicate and consent to the study exclusion criteria: 1. cannot come back for the follow-up visits 2. receive or had received n-acetylcysteine during the intervention 3. has systemic diseases that might interfere with the results 4. chronic kidney disease that requires dialysis 5. increased risk of aspiration pneumonia 6. pregnancy or lactation 7. untreated infectious diseases
tarp assisted cooling of hyperthermic individuals

Conditions: Healthy

Summary: this is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness.

this is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness. 12 healthy participants (6 males, 6 females) will participate. visit 1 will be a screening visit, consisting of informed consent followed by completion of questionnaires to determine study eligibility. participants will have their resting vital signs (heart rate, blood pressure), height, weight, and percent body fat measured. visits 2 and 3 will be experimental trials. participants will complete a treadmill protocol consisting of brisk walking wearing a weighted backpack (40 lb) until core temperature reaches 40.0°c. upon completion of exercise, participants will exit the environmental chamber and be cooled in one of two ways in a randomized, counterbalanced manner: 1) tarp-assisted cooling or 2) standard of care. cooling will take place for 20 minutes.

Eligibility criteria:
inclusion criteria: * healthy * aerobic exercise at least twice weekly exclusion criteria: * history of exertional heat illness

Keywords: heat cooling
to evaluate safety and effectiveness of transcatheter aortic valve system in patients with severe aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: to evaluate the safety and effectiveness of transcatheter aortic valve system ( chengdu silara medtech inc. ,chengdu, china)in patients with severe aortic stenosis with or without moderate or lower degree regurgitation

transcatheter aortic valve system (chengdu silara medtech inc. ,chengdu, china) will be used for this study.

Eligibility criteria:
inclusion criteria: 1. age ≥70 years old; 2. symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmhg or peak jet velocity ≥4.0 m/s, or an aortic valve area \<0.8 cm2 or aortic valve area index \<0.5 cm2/m2. 3. nyha functional class ≥ii; 4. life expectancy after aortic valve implantation thought to be \>1 year; 5. native valvular or peripheral vascular anatomy is appropriate for tavr; 6. patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery; 7. patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits. exclusion criteria: 1. anatomy is not appropriate for percutaneous valve implantation. native valve annulus diameter is not in the scope of application(native tav diameter ≤21mm, or ≥30mm); 2. evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: q-wave myocardial infarction, or non-q-wave myocardial infarction, with ck-mb≥2 uln/or elevated tn (who definition); 3. any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization); 4. pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or gorlin syndrome; 5. hematological abnormality, defined as: leukopenia (wbc \<3x10\^9/l), acute anemia (hb \<90g/l), or thrombocytopenia (platelet count\<50×109/l),history of bleeding diathesis or coagulopathy; 6. hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance; 7. severe ventricular insufficiency. left ventricular ejection fraction (lvef) \<20%; 8. echocardiographic evidence of intra-cardiac thrombus or vegetation etc.; 9. active pepticulcer or upper gi bleeding within 3 months prior to the study procedure; 10. cerebral vascular accident (cva) within 3 months prior to the study procedure, including tia; 11. a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated; 12. patients with infective endocarditis or other active stage of infection; 13. currently participating in an investigational drug or another device trial.
a double-blind, randomized, controlled trial of quetiapine versus haloperidol for the treatment of delirium

Conditions: Delirium

Summary: the purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.

a delirious state often founds in general hospitals and remains a significant cause of death. existing methods of treatment includes identification and elimination of factors contributing to the delirium in addition to pharmacological and nonpharmacological treatment interventions (trzepacz et al., 1999). antipsychotics can play an important role in the management of the symptoms of delirium.

Eligibility criteria:
inclusion criteria: * male or female age 18 -75 years * was admitted in maharaj nakhon chiang mai hospital * was diagnosed by the diagnostic criteria for dsm-iv-tr delirium due to a general medical condition or delirium due to multiple etiologies * delirious state (delirium) of the patients was confirmed by using name-assess confusion assessment method (cam) and assessment of severity with delirium rating scale-revised-98 (drs-r-98) * have a written consent from the legal representatives exclusion criteria: * was diagnosed substance withdrawal delirium * having a history drug allergy either from quetiapine or haloperidol * female patients who are pregnant or breastfeeding * no written consent from the legal representatives * received other anti-psychotic drug before attend the study * being ill with renal or hepatic failure

Keywords: delirium rating scale clinical global improvement extrapyramidal side effect
the assessment of progression of paroxysmal af after cabg

Conditions: Paroxysmal Atrial Fibrillation, Coronary Artery Disease

Summary: the aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated cabg and cabg combined with pulmonary vein isolation. hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after cabg in combination with isolation of the pulmonary veins have a better outcomes for the progression of af compared with patients undergoing isolated cabg.

this is a single blinded prospective randomized study involving 72 patients with paroxysmal af and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the cabg + pulmonary veins isolation group over isolated cabg group. patients are divided into two groups, group i - isolated cabg (36 patients), and group ii - cabg and pulmonary veins isolation (36 patients). randomization is conducted by using accidental sampling before operation. the blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about pulmonary vein isolation. subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.

Eligibility criteria:
inclusion criteria: * american college of cardiology (acc)/ american heart association (aha) -indications for cabg * at least 2 ecg-verified (12-channel ecg, holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months * the patient's consent to participate in the study exclusion criteria: * intolerance of antiarrhythmic drugs * heart valve disease requiring invasive treatment * left atria more than 6.5 cm * prior cardiac surgery * active pacemaker treatment * active anti-arrhythmic treatment (aad) class i and iii * contraindication to oral anticoagulant/heparin treatment * ejection fraction less than 30 % (ef \< 30 %) assessed by transthoracic echocardiography

Keywords: paroxysmal atrial fibrillation, cabg, pulmonary vein isolation