Kornimate/medical-research-clean huggingface dataset:
haploidentical stem cell transplantation and il-15 nk cell infusion for paediatric refractory solid tumours

Conditions: Childhood Solid Tumor

Summary: the investigators propose a new antitumor cell therapy for treating childhood refractory solid tumours. the aim of this study is explore the graft versus tumour effect mediated by allogenic natural killer cells (nks). nk cell alloreactivity can be predicted by donor killer immunoglobulin-like receptors (kirs) and human leukocyte antigen (hla) class i alleles mismatch. cells without an inhibitory hla ligand may trigger natural killer cell activation and elimination of those target cells. reduced risk of relapsed has been described in malignant cancer after haploidentical stem cell transplantation when hla ligands against the inhibitory kirs present in the donor were absent in the recipient (kir-hla receptor-ligand mismatch). nk alloreactivity could also be obtained by natural killer receptor (ncr), toll-like-receptors (tlrs) and nkg2d receptor stimulation mediated by cytokines or tumour cell lines. this will be an open, non randomized, phase i/ii clinical trial, with a double objective: therapeutic exploratory. the investigators aim at studying safety and efficacy of haploidentical stem cell transplantation for the treatment of these malignancies with no cure known. patients will receive an haploidentical stem cell transplantation, followed by il-15 stimulated nk cells infusion one month after transplantation. efficacy of the procedure will be evaluated with up-to-date radiological techniques, molecular studies and functional assays.

the investigators propose a new antitumor cell therapy for treating childhood refractory solid tumours. the aim of this study is explore the graft versus tumour effect mediated by allogenic natural killer cells (nks). nk cell alloreactivity can be predicted by donor killer immunoglobulin-like receptors (kirs) and human leukocyte antigen (hla) class i alleles mismatch. cells without an inhibitory hla ligand may trigger natural killer cell activation and elimination of those target cells. reduced risk of relapsed has been described in malignant cancer after haploidentical stem cell transplantation when hla ligands against the inhibitory kirs present in the donor were absent in the recipient (kir-hla receptor-ligand mismatch). nk alloreactivity could also be obtained by natural killer receptor (ncr), toll-like-receptors (tlrs) and nkg2d receptor stimulation mediated by cytokines or tumour cell lines.

Eligibility criteria:
inclusion criteria: * age 6 months to 22 years. * histological solid tumor confirmation. * measurable solid tumor by image or molecular techniques. * solid tumors that have failed to at least 2 chemotherapy protocols. * suitable haploidentical donor available. * lansky score \> 60%. exclusion criteria: * serum bilirubin \> 3 mg/dl * gfr \< 40 ml/min/1.73 mw * cardiac left ventricular ejection fraction \< 40% * hiv+ * pregnant * unfavorable psycho-social report. * antecedent of abandonment treatment.

Keywords: haploidentical stem cell transplantation nk cell il-15
the vigorous physical activity for glycaemic control in type 1 diabetes (vigor) trial

Conditions: Type 1 Diabetes

Summary: background/justification: regular physical activity (pa) has substantial health benefits in persons with type 1 diabetes (t1d), including reduced risk of complications and cardiovascular mortality. despite these benefits, individuals with t1d remain significantly less active than their peers without diabetes. two major factors likely explain the low rates of pa in young people with t1d: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of pa for achieving optimal glycaemic control. a number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity pa in conventional moderate intensity (i.e. walking) pa sessions may overcome these limitations. no studies have tested the efficacy of high intensity pa for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (rct). study hypotheses: in persons 15-35 years of age living with t1d, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity pa to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity pa to a moderate intensity pa intervention will elicit significant improvements in glycemic excursions, as measured by the mean amplitude of glycaemic excursions (mage), in the 12-hour period following exercise.we are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.


Eligibility criteria:
inclusion criteria: * age: 15-45 years old * have lived with type 1 diabetes for at least 2 years * hba1c \<9.9% * currently physically inactive (\<150 minutes of self-reported structured physical activity per week) * undergone a resting ecg to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise exclusion criteria: * have frequent and unpredictable hypoglycaemia * had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment * are currently participating in structured activity or sport-related activities * are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding * have conditions that would render physical activity contraindicated including: uncontrolled hypertension (bp\>150mmhg systolic or \>95mmhg diastolic in a sitting position); severe peripheral neuropathy; history of cardiovascular disease * have a cognitive deficit resulting in an inability to provide informed consent * currently taking beta blockers * currently taking atypical antipsychotics or corticosteroids

Keywords: type 1 diabetes hypoglycaemia glycaemic variability vigorous intensity physical activity continuous glucose monitoring
efficacy and safety of intravenous and subcutaneous secukinumab in moderate to severe chronic plaque-type psoriasis

Conditions: Plaque-type Psoriasis

Summary: the study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed, * subject must be able to understand and communicate with the investigator and comply with the requirements of the study. * subjects must have participated in the study cain457a2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations. a partial response is defined as having achieved ≥ pasi 50 but \< 75 response. exclusion criteria * pregnant women or lactating women * forms of psoriasis other than chronic plaque -type * ongoing use of prohibited psoriasis treatments * ongoing use of other non-psoriasis prohibited treatments * previous exposure to any biologic drug directly targeting il-17 or the il-17 receptor, except secukinumab in study cain457a2304 * active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy * uv therapy or excessive exposure to sunlight

Keywords: psoriasis plaque inflammatory skin disease scaly patches ain457 secukinumab moderate to severe
testo-trial: use of testosterone in critically ill patients

Conditions: Weaning Failure; Muscle Weakness; Mechanical Ventilation Complication; ICU Acquired Weakness; Mobility Limitation

Summary: the objective of this study is to evaluate whether the use of the anabolic agent testosterone cypionate in critically ill patients, compared to placebo, increases the number of ventilator-free days

it will be a randomized, controlled, double-blind, single-center clinical trial conducted in the intensive care unit (icu) of the state hospital of serrana (he serrana). patients admitted to the icu who meet the eligibility criteria and have given written informed consent will be randomized into control and intervention groups. forty-seven patients will be included in each group, totaling 94 patients. the intervention group will receive 200 mg of testosterone cypionate intramuscularly every 5 days for a total of 3 doses. the control group will receive a placebo on the same schedule. after inclusion in the study, demographic and clinical data, laboratory results, ultrasonographic measurements, and functionality and muscle strength scores will be assessed on days 1, 5, 10, and 15 in the icu and until hospital discharge.

Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation (mv) for seven days or more, or patients on mv with an unsuccessful weaning attempt for at least three days. an unsuccessful weaning attempt is defined as the patient undergoing a spontaneous breathing trial (sbt) on three different days without success, according to the icu protocol; * over 18 years old; * patients with optimized nutritional therapy, defined by caloric and protein goals met for at least three days; * signing the informed consent form (icf). exclusion criteria: * hypersensitivity to the medication, the vehicle of the medication, or the placebo (sesame oil); * venous or arterial thrombosis in the past six months, including acute myocardial infarction, ischemic stroke, acute arterial occlusion, mesenteric ischemia, venous thromboembolism, or pulmonary embolism; * left ventricular ejection fraction (lvef) below 35%; * glutamic-pyruvic transaminase/alanine aminotransferase (gpt/alt) greater than five times the normal level and impaired bilirubin excretion; * patients with liver cirrhosis (child \> b); * pregnant or lactating women; * women of childbearing age; * hematocrit \>52%; * refractory shock, defined as requiring a norepinephrine dose \> 0.5 mcg/kg/min or a vasopressin dose \> 0.04 iu/min; * thrombocytopenia \< 20,000/mm³ without a transfusion plan; * personal history of prostate or breast cancer; * active neoplasm of any site; * primary neuromuscular disease, including amyotrophic lateral sclerosis (als), duchenne muscular dystrophy, myasthenia gravis, or guillain-barré syndrome; * current or previous spinal cord injury above c4 (tetraplegia); * patients with total limitation of therapeutic measures;

Keywords: testosterone mechanical ventilation weaning critical illness
understanding and improving anticoagulation dosing for patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study will survey atrial fibrillation patients to better understand patient perspective of doac treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for af.


Eligibility criteria:
inclusion criteria: retrospective analysis: 1. nvaf documented in at least 2 claims between january 2015 and december 2016 2. cha2ds2-vasc scores of 2 or higher prospective analysis: 1. patient analysis: all patients in researchmatch with diagnosed af. 2. provider analysis: all providers who contributed at least 25 af patients treated with doacs to the symphony claims dataset. all provider specialties (i.e. cardiology, primary care, and other), as well as provider types (i.e. physician, physician extender, and nurse practitioner) will be included. exclusion criteria: retrospective analysis: 1. patients with bioprosthetic or mechanical valves in the mitral position. 2. patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for doac dosing. 3. patients with mitral stenosis. 4. patients without 12-month follow-up data. prospective analysis: 1. provider analysis: all providers who contributed less than 25 af patients treated with doacs to the symphony claims dataset. 2. patient analysis: patients unwilling or unable to consent.
verifying post-delivery anal sphincter integrity using perineal ultrasound: impact on immediate care

Conditions: Delivery, Obstetric

Summary: the main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. this study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.

the secondary objectives of this study are: a. compare the anal incontinence score (measured by the wexner score, qualitative and quantitative assessment) at 3 months between the two groups. b. to assess the safety of perineal ultrasound in the group with "ultrasound" using a visual analog scale for discomfort c. assess the inter and intra operator consistency of perineal ultrasound snapshot readings d. evaluate and compare the rate of infectious complications of perineal sutures between the two groups at 3 months. e. evaluate and compare the quality of life (questionnaires pfiq, pfdi, sf36, euroqol) between the two groups at 3 months.

Eligibility criteria:
inclusion criteria: * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 3 months of follow-up * paturient, vaginal births only * presence of \>= stage 2 perineal lesion * patient accepts a priori the performance of a perineal ultrasound exclusion criteria: * the patient is participating in another study (excepting bbbox (2011-a00327-36), elastomap (2013-a01148-37), elastodéclench, bakri, papillo pma, grosspath, lxrs, dgpostpartum, "scalp lactates", and upsidedown studies) * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * delivery by c-section * intact perineum after delivery (no indication for perineal surgery in light of absence of vaginal lesion) * emergency situation preventing time for perineal ultrasound * history of anal incontinence before giving birth * allergy to ultrasound gel

Keywords: vaginal delivery perineal lesions anal sphincter rupture ultrasound
bicalutamide monotherapy has significant quality of life benefits for men with advanced prostate cancer

Conditions: Prostatic Neoplasms

Summary: the aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer

androgen deprivation therapy is the mainstay of treatment for advanced prostate cancer. there is an increasing tendency towards earlier treatment with hormone manipulation. however, luteinizing hormone-releasing agonists decrease serum testosterone to castrate levels within two weeks of commencement.they are associated with loss of libido, loss of muscle bulk and accelerated bone loss. osteoporotic patients are at high risk of fragility fractures. an alternative is the nonsteroidal antiandrogen bicalutamide which blocks testosterone at the receptor level, allowing androgen deprivation in the prostate without reducing circulating levels of testosterone. this should preserve the desired effects on other androgen-sensitive tissue, resulting in an advantageous side effect profile. the aim of our study is to closely monitor osteoporotic patients commencing bicalutamide for a period of 12 months. patients will be reviewed in a dedicated prostate cancer clinic every 3 months. patients will be questioned regarding adverse events. renal and liver function tests, prostate specific antigen, testosterone, estradiol and bone turnover markers will be measured 3 monthly. measurement of height , weight, body mass index, quadriceps strength using dynamometry, and skeletal mass using arm anthropometry (mid-arm circumference and triceps skinfold thickness), will be carried out 3 monthly. quality of life issues will be assessed 3 monthly using the rand 36-item health survey (sf36) and university of california-los angeles prostate cancer index (uclapci). patients will undergo bone densitometry of the forearm at baseline and 12 months.

Eligibility criteria:
inclusion criteria: * osteoporotic patients (t score ≤ -2.5) with advanced prostate cancer requiring hormone manipulation, due to biochemical relapse following either radical prostatectomy, radiotherapy, brachytherapy, or biochemical progression after initially being observed with prostate cancer. exclusion criteria: * severe hepatic insufficiency, with bilirubin above reference range * previous systemic therapy for prostate cancer * radiotherapy within 6 months * previous other invasive malignancies * any severe concomitant disease.

Keywords: prostatic neoplasms bicalutamide quality of life osteoporosis
effect on rls symptom severity after switching to neupro® in patients who previously experienced augmentation

Conditions: Restless Legs Syndrome

Summary: the objective is to assess the effect of neupro® on the severity of restless leg syndrome (rls) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. in addition, the change in treatment regimen used when switching to neupro® will be evaluated.


Eligibility criteria:
inclusion criteria: * the adult patient has a diagnosis of moderate to severe idiopathic restless leg syndrome (rls) * the patient must be experiencing augmentation due to a prior dopaminergic treatment * the decision to prescribe neupro® has been made by the physician independently of his/her decision to enroll the patient in the study * patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent exclusion criteria: * patients diagnosed with secondary restless leg syndrome (rls) should not be enrolled in this observational study

Keywords: rotigotine neupro® augmentation restless legs syndrome moderate to severe idiopathic adults
effectiveness of a mobile health management program for colorectal cancer survivors with chronic conditions

Conditions: Diabetes Mellitus; Colo-rectal Cancer; Hypertension; Dyslipidemia

Summary: the goal of this clinical trial is to evaluate if a mobile health management program can improve chronic disease management among colorectal cancer survivors with comorbid conditions such as hypertension, diabetes, and dyslipidemia. the main questions it aims to answer are: does the mobile health application improve clinical outcomes such as blood pressure, blood glucose levels, and lipid profiles? does the application enhance participants' health behaviors and self-management capabilities? researchers will compare the mobile health application group to the educational booklet group to see if the digital intervention leads to better health outcomes and adherence to lifestyle changes


Eligibility criteria:
inclusion criteria: * individuals aged 19 years or older colorectal cancer survivors (patients within 5 years of completion of curative treatments such as surgery, radiation therapy, or chemotherapy) who also have chronic conditions (hypertension, dyslipidemia, or diabetes) specific registration criteria: diabetes: fasting blood sugar (fbs) ≥ 126 mg/dl or hba1c ≥ 6.5% dyslipidemia: low-density lipoprotein cholesterol (ldl) ≥ 130 mg/dl hypertension: systolic blood pressure (sbp) ≥ 140 mmhg or diastolic blood pressure (dbp) ≥ 90 mmhg individuals who understand the purpose of this study and provide informed consent to participate individuals who own and use a smartphone (able to use an ict-based health management program) exclusion criteria: * individuals who are unable to speak, listen, or read in korean individuals determined by a physician to be physically or mentally unfit (e.g., shortness of breath, severe depression) to participate in the study individuals who are deemed unable to use the ict-based program
phase ii study of anlotinib in patients with advanced renal cell carcinoma that have failed or are intolerant to tkis therapy

Conditions: Renal Cell Carcinoma

Summary: anlotibib (al3818) is a kind of innovative medicines approved by state food and drug administration（sfda:2011l00661） which was researched by jiangsu chia-tai tianqing pharmaceutical co., ltd. anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for vegfr2、vegfr3、pdgfrβ and c-kit. it has the obvious resistance to new angiogenesis. the trial is to explore the efficacy and safety profile of anlotinib in patients with advanced renal cell carcinoma(rcc) that have failed to tkis therapy.


Eligibility criteria:
inclusion criteria: * 1.patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery * 2.previously failed or are intolerant to tkis therapy(such as sunitinib, sorafenib) * 3.with measurable disease (using recist1.1) * 4.18-75years,ecog ps:0-1,life expectancy of more than 3 months * 5.last tkis therapy≥4 weeks * 6.main organs function is normal * 7.signed and dated informed consent exclusion criteria: * 1.patients has many influence factors toward oral medications * 2.known brain metastases * 3.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade i myocardial infarction, arrhythmias and class i heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (fbg)\>10mmol/l);urine protein≥++,etc. * 4.patients failed to heal wounds or fractures for long-term * 5.patients occurred venous thromboembolic events within 6 months * 6.patients has hiv-positive or organ transplantation

Keywords: renal cell carcinoma（rcc） anlotinib
treatment parameters for the empower neuromodulation system (ens)

Conditions: Alcohol Use Disorder

Summary: the subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know. a clinical-grade nerve conduction assessment system will be used both to provide electrical stimulation at four locations to record peripheral responses. the subject will self-administer two treatment sessions at two active treatment sites.


Eligibility criteria:
inclusion criteria: 1. is 21-75 years old 2. can provide informed consent 3. currently has a stable living situation 4. had one heavy drinking week (\>7 drinks/week for women; \>14 drinks/week for men) over the past 6 months 5. has a breath alcohol concentration of 0.00% at enrollment 6. is willing to follow all study procedures exclusion criteria: 1. has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage 2. has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant) 3. has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps 4. is currently pregnant or breastfeeding 5. has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs 6. has used an investigational drug/device therapy within the past 4 weeks 7. is deemed unsuitable for enrollment in study by the pi

Keywords: aud tens