Kornimate/medical-research-clean huggingface dataset:
timing of pre-meal insulin versus accurate carbohydrate counting in youth with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the investigators are hoping to figure out how youth with type 1 diabetes can best control their blood glucose levels after meals, by determining whether accurate carbohydrate dosing or the timing of the bolus is more important. there is evidence to suggest that each strategy is important for blood glucose control. unfortunately, for some people, prebolusing is difficult, because they may not know how much they are going to eat. to give an exact dose of insulin 20 minutes before a meal can be difficult. in this study, the investigators would like to show that taking even just part of the insulin bolus 20 minutes before the meal is preferable to waiting until mealtime and taking the entire bolus. to do this, the investigators will have 24 patients in the study, who will each spend 4 mornings at the investigators clinic. the order of the visits will be selected randomly. the visits will include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½ bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. at each visit, the person will eat the same meal, but the timing and amount of the bolus will be different. the investigators will measure the blood glucose levels with a blood glucose meter, and also with a laboratory test called ysi. the investigators will also be measuring the glucose levels under the person's skin with a continuous glucose monitor. the investigators will compare the area under the curve for the different visits, as well as the glucose levels at different points after the meal.


Eligibility criteria:
inclusion criteria: * ages 7-21, inclusive * diagnosis of type 1 diabetes for \>1 year * using carbohydrate counting to dose mealtime insulin * using an insulin pump and continuous glucose monitor to control diabetes * hba1c \<10% exclusion criteria: * celiac disease or other gi abnormality * severe hypoglycemia in the past 6 months * pregnancy * documented hypoglycemia unawareness
differentiation induction in acute myelogenous leukemia

Conditions: Acute Myelogenous Leukemia

Summary: hypothesis: differentiation induction therapy in acute myelogenous leukemia (aml) can be used to achieve disease control and stabilize peripheral blood counts in patients with acute myelogenous leukemia. adult patients (\ 60 years of age) with newly diagnosed aml who cannot achieve standard chemotherapy, patients with relapsed or resistant aml. patients with relapsed or resistant aml who cannot receive intensive chemotherapy. treatment: patients will be treated with all-trans retinoic acid (oral administration), valproic acid (7 days intravenous administration and later oral administration)and theophyllamine (7 days intravenous administration and later oral administration). duration of treatment at least 2 months or until disease progression. maximal duration of treatment 2 years. followup: clinical evaluation, peripheral blood samples, bone marrow samples.

patients to be included: 1. elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (aml) who cannot receive conventional intensive chemotherapy. 2. adult patients of any age (\> 18 years of age)with relapsed or resistant aml who cannot receive conventional intensive chemotherapy or allogeneic stem cell transplantation. we plan to include at least 20 patients, but if possible 30 patients during a 3 years period. the first patient was included november 2004. treatment: all-trans retinoic acid (atra) administered orally 22.5 mg/m2 twice daily for 14 days, repeated every third month. valproic acid started on day 3 of atra therapy, the first week as intravenous administration and later oral administration. theophyllamine started on day 3 of atra therapy, the first week as intravenous administration and later oral administration. duration of treatment at least 2 months unless side effects,until disease progression or an overall duration of treatment of 2 years. supportive therapy according to the hospitals general guidelines. followup: the first week treatment in hospital. later out-patient treatment with regular controls including clinical examination, peripheral blood parameters (including serum valproic acid and theophyllamin levels), bone marrow samples.

Eligibility criteria:
inclusion criteria: * recently diagnosed acute myelogenous leukemia (aml) * patients above 60 years of age * patients who cannot receive conventional chemotherapy * patients with relapsed or refractory aml independent of age exclusion criteria: * chronic myelogenous leukemia in blast phase * intolerance to the study drugs * serious liver disease * no informed consent

Keywords: acute myelogenous leukemia differentiation all trans retinoic acid valproic acid theophyllamin
droxidopa / pyridostigmine in orthostatic hypotension

Conditions: Orthostatic Hypotension

Summary: this study is being done to study the combination of pyridostigmine and low-dose droxidopa for the treatment of orthostatic hypotension.


Eligibility criteria:
inclusion criteria 1. the presence of oh (fall in systolic bp \>=30 mm hg) is required for this study. 2. autonomic testing and clinical evaluation demonstrates oh to be of neurogenic etiology. exclusion criteria: 1. pregnant or lactating females. 2. chronic illnesses or the presence of other conditions that potentially involve the cns or affect autonomic testing. these include congestive heart failure, recent (\<6 months) myocardial infarct, severe anemia, diabetes mellitus, alcoholism, malignant neoplasms, amyloidosis, hypothyroidism, sympathectomy, cerebrovascular accidents, and neurotoxins or neuroactive drug exposure. 3. orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living. 4. any known concurrent infection or severe liver or kidney disease. 5. medications that could affect autonomic function are suspended prior to autonomic testing. therapy with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations. fludrocortisone doses up to 0.2 mg per day will be permitted. stable doses of antidepressants (tricyclics, ssris, snris) will also be permitted. the 48h medication withdrawal is reviewed on a case by case basis - if felt unsafe by the investigators, the withdrawal period may be shortened. this will be documented in the study documents. 6. occasional use of a neuroleptic as an anti-emetic in the past is allowed, but none can have been used within 3 weeks prior to this study. 7. use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a mao-a inhibitor within 3 weeks prior to this study. 8. dementia (dsm-iv criteria - amer. psych. assoc., 1994). the score on the mini-mental state examination must be \>24. 9. history of stroke (diagnosed on clinical grounds as an acute deterioration of neurological function typical of a stroke; confirmatory ct or mri evidence of stroke will be useful but not necessary). 10. history of electroconvulsive therapy. 11. history of brain surgery for parkinson's disease.
a clinical and imaging registry of transcatheter aortic valve implantation using jenavalve system/ j-valve system for patients with pure aortic regurgitation

Conditions: Aortic Valve Disease

Summary: aortic regurgitation (ar) is not uncommon. transcatheter aortic valve implantation (tavi) for treating pure aortic regurgitation is a potential future treatment option for pure ar especially in patients having high risk for open heart surgery. tavi using dedicated device for pure ar has a different anchor mechanism to tavi for aortic stenosis (as). ar patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to as patients. subclinical leaflet thrombosis has been described in as patient receiving tavi, which will affect the durability and antithrombotic regime. follow-up imaging for dedicated tavi device in ar patient is limited.


Eligibility criteria:
inclusion criteria: 1. receiving transcatheter aortic valve implantation (tavi) (using jenavalve/j-valve) in pwh 2. with severe symptomatic ar (nyha iii-iv) despite optimal medical therapy 3. deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) 4. capable of providing informed consent exclusion criteria: 1. evidence of intracardiac mass, thrombus or vegetation 2. anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or ct 3. sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure 4. subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint. 5. chronic kidney disease with egfr \<30 ml/min/1.73m2. 6. cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device 7. contraindicated for ct or mri assessment

Keywords: transcatherter aortic valve intervention
natural killer cells infusion for treating acute myeloid leukemia patients with minimal residual disease

Conditions: Acute Myeloid Leukemia

Summary: this trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(nk) cells infusion for treating acute myeloid leukemia patients with minimal residual disease.

patients of acute myeloid leukemia after chemotherapy with mrd(minimal residual disease) will receive nk cell infusion combined with consolidation chemotherapy. the bone marrow morphology and mrd remission of the patients will be observed 15 days after the same treatment. all patients will be followed up for 1 year. nk cells are prepared in beijing icell biotechnology co.,ltd, which is subsidiary to shanghai icell biotechnology co.,ltd.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with acute myeloid leukemia; 2. mrd after 2 course of standard chemotherapy; 3. no plan for hematopoietic stem cell transplantation; 4. hemoglobin (hb) \>=60g/l, white blood cell count (wbc) \>=2.5x10\^9/l, platelet count \>=30x10\^9/l; 5. patients have self-knowledge ability and can sign informed and voluntary consent forms; 6. patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study. exclusion criteria: 1. intracranial hypertension or unconsciousness; 2. symptomatic heart failure or severe arrhythmia; 3. respiratory failure; 4. with other types of malignant tumor diseases; 5. t lymphocytic acute leukemia; 6. diffuse intravascular; 7. serum creatinine and / or urea nitrogen \>=1.5 times the normal value;coagulation; 8. serum total bilirubin \>=1.5 times the normal value; 9. sepsis or other difficult-to-control infections; 10. uncontrollable diabetes; 11. severe mental disorders; 12. who physical status classification \>=3; 13. people who are allergic to interleukin-2; 14. patients after organ transplant; 15. pregnant and lactating women.
nesbid: neuro-stimulation of the brain in depression

Conditions: Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Transcranial Direct Current Stimulation; Electric Stimulation Therapy

Summary: in canada, approximately 20% of patients with major depressive disorder (mdd) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. although the treatment of choice has historically consisted of electroconvulsive therapy (ect), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients. in this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant mdd will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. ultra treatment-resistant depression will be operationally defined as mdd that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ect, or ketamine. patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. in both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position f3), and the cathode over the right dorsolateral prefrontal cortex (position f4). patients in the sham group will receive electrical stimulation at 2 ma for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment. the study's primary outcome is the change in score on a clinician-graded depression inventory (the montgomery-asberg depression rating scales). secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. information on language ability will also be collected, as will data on side-effects of treatment. scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.


Eligibility criteria:
inclusion criteria: * currently suffering from an mde with a score on the montgomery-åsberg depression rating scale (madrs) greater than 34 (signifying severe depression) * have ultra treatment resistant mdd (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ect, or failure to remit with ketamine) exclusion criteria: * have been diagnosed with psychosis, an addiction disorder (other than nicotine), borderline personality disorder, or antisocial personality disorder, as these conditions could interfere with adherence to the study protocol * are currently using a herbal compound or known nmda-modulating agent, as these substances could interfere with the induction of ltp and thereby limit the effectiveness of tdcs * are pregnant, as tdcs has not been adequately studied in this population * have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tdcs cannot be assured given these comorbidities
respiratory training in low back pain

Conditions: Ultrasonography; Low Back Pain

Summary: objective: to determine the effectiveness of bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in patients with low back pain. methods: a single blinded randomized clinical trial will be carried out. a total sample of 96 patients with low back pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.


Eligibility criteria:
inclusion criteria: * patients with low back pain during 6 weeks exclusion criteria: * neural disorders * systemic disorders * cognitive disorders
galectin-3 blockade in patients with high blood pressure

Conditions: Hypertension

Summary: this study will investigate if modified citrus pectin (mcp) can help people with high blood pressure. mcp is a dietary supplement that is derived from plants, and therefore is not subject to approval by the u.s. food and drug administration (fda). however, mcp has been deemed as 'generally regarded as safe' by the fda. this study will examine whether modified citrus pectin (mcp) can help people with high blood pressure. the study will help understand how mcp may affect the risk for heart disease in patients with high blood pressure.

gal-3 appears to be a potential mediator of cardiac fibrosis, preceding the development of clinical heart failure. in this study, we seek to identify individuals at risk for the development of heart failure based on clinical hypertension and elevated gal-3 concentrations. participants will be randomized to receive a gal-3 inhibitor (mcp) or placebo. the primary outcome will be the effect on collagen metabolism, and secondary outcomes include echocardiographic measures of cardiac structure and function, and non-invasive measures of vascular function.

Eligibility criteria:
inclusion criteria: * age 21-70 years * physician diagnosed hypertension on stable therapy for 3 months * elevated galectin-3 level (above sex-specific median based on framingham heart study measures) * able to understand the protocol and provide informed consent in english exclusion criteria: * uncontrolled hypertension, defined as systolic blood pressure \> 170mmhg, diastolic blood pressure \> 100mmhg * evidence of secondary hypertension * history of heart failure, coronary artery disease, stroke, atrial fibrillation * left ventricular ejection fraction \< 45% on echocardiography * use of aldosterone antagonists * history of liver cirrhosis * history of pulmonary fibrosis * kidney dysfunction, defined as estimated glomerular filtration rate \< 45 ml/min/1.73m2 * anemia, defined as hematocrit \< 37% in men and \< 34% in women * use of chelating agents * history of active cancer or malignancy * known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding * hyperkalemia on screening labs, defined as potassium \>5.2 * anticipated inability to complete or comply with study protocol * history of angioedema

Keywords: hypertension galectin 3 fibrosis vascular stiffness echocardiography
gene therapy for was

Conditions: Wiskott-Aldrich Syndrome

Summary: this is a phase i/ii study to evaluate the safety and efficacy of hematopoietic stem cell genetherapy for the wiskott-aldrich syndrome.

this clinical trial is an ex vivo gene therapy trial. the investigational product corresponds to autologous cd34+ cells transduced with a lentiviral vector harboring the human wasp gene.

Eligibility criteria:
inclusion criteria: * males of all ages * severe was (clinical score 3-5) or absence of was protein in peripheral blood mononuclear cells determined by western blotting and flow cytometry * molecular confirmation by was gene dna sequencing * lack of hla-genotypically identical bone marrow after 3 month search * lack of a 10/10 or 9/10 antigen hla-matched unrelated donor after 3 month search * lack of a hla-matched cord blood after 3 month search * parental, guardian, patient signed informed consent/assent * willing to return for follow-up * only for patients who have received previous allogenic hematopoietic stem cell transplant: * failed allogenic hematopoietic stem cell transplant * contraindication to repeat transplantation exclusion criteria: * patient with hla-genotypically identical bone marrow * patient with 10/10 or 9/10 antigen hla-matched unrelated donor or with hla-matched cord blood * contraindication to leukapheresis * contraindication to bone marrow harvest * contraindication to administration of conditioning medication * hiv positive patient

Keywords: wiskott-aldrich syndrome primary immune deficiency ex vivo gene therapy hematopoietic stem cells
periprosthetic fracture following tibial echinococcosis

Conditions: Cystic Echinococcus

Summary: cystic echinococcus in the bone is rare, comprising 0.5% to 2.5% of all human hydatidosis association of hydatid disease to pathologic fractures involving knee prosthesis have not yet been described a combined surgical and medical approach is of paramount importance to avoid recurrence resulting osseus defects is challenging and require specific prosthesis when treating this entity.

hydatid disease in humans caused by the parasitic tapeworm echinococcus granulosus has an osseous involvement of about 0.5% to 2.5% of all cases in humans. the location of hydatid cysts in the tibia is seldom described in the medical literature, and its diagnosis and treatment is challenging. this paper presents a patient, with a long term, well tolerated, bilateral total knee arthroplasty (tka), treated at our clinic, with a recent history of pain and oedema in her left upper leg. after achieving a, radiologically and histopathologically, well documented, diagnosis of echinococcosis lesion in her left proximal tibia, a surgical intervention was planed, a wide resection of the cyst performed, and a specific anti-helmintic therapy was instituted. four years later the patient returns to the investigators observation complaining of pain and unable to bear weight on her left knee, from which a pathologic fracture, adjacent to the tibial component was diagnosed. after surgical debridement of the newly advanced hydatid cyst growth, the tka was revised, and due to the tibial component failure and the femoral implant loosening, a semi-constrained total knee revision arthroplasty was executed. functional outcome was excellent. although challenges in treatment of musculoskeletal hydatid cysts (hc) lesions have been documented, data regarding the musculoskeletal hc lesions resembling tumor is scarce, and those resulting in a prosthetic failure haven't been published. the authors intend to add data concerning the therapeutic approach to this entity.

Eligibility criteria:
inclusion criteria * patients with echinococcus infection * patients which this infection compromises knee stability. exclusion criteria * bacterial infection * immunocompromised patients

Keywords: echinococcosis, hydatidosis, tkr, fracture
radiomics for prediction of lymph node metastasis in gastric cancer（rplnm）(gipmcs-1701)

Conditions: Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Neoplasms

Summary: this study proposes to establish a ct radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.

this is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in china (nanfang hospital of southern medical university; sun yat-sen university cancer center; first affiliated hospital, sun yat-sen university; the third affiliated hospital, sun yat-sen university) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced ct for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. the study includes the construction of ct radiomics-based prediction model and the validation of the prediction model.

Eligibility criteria:
inclusion criteria: * age \>18 years; * patients providing written informed consent; * pathologically proven gastric cancer scheduled to preoperative enhanced abdomen ct and undergo gastrectomy with type d2 lymphadenectomy; * has undergone \> 64 multi-detector row ct within 14 days prior to surgical resection; .no receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy). exclusion criteria: * preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy); * failed to receive preoperative enhanced abdomen ct or undergo gastrectomy with type d2 lymphadenectomy; * inavailable pathological results for local lymph node status; * inquality of ct images for feature extraction; .patient quit.

Keywords: gastric cancer radiomics computed tomograpy lymph node metastasis prediction