Kornimate/medical-research-clean huggingface dataset:
study of ngr-htnf as single agent in patients affected by advanced or metastatic malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: the main objective of the trial is to document the progression free survival (pfs) in advanced or metastatic malignant pleural mesothelioma patients treated with ngr-htnf as single agent. safety will be established by clinical and laboratory assessment according to nci-ctc criteria.

this is a phase ii, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using simon's two-stage design method.

Eligibility criteria:
inclusion criteria: * patients \>18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen * histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed * prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy * ecog performance status 0 - 2 * adequate baseline bone marrow, hepatic and renal function, defined as follows: * neutrophils \> 1.5 x 10\^9/l and platelets \> 100 x 10\^9/l * bilirubin \< 1.5 x uln * ast and/or alt \< 2.5 x uln in absence of liver metastasis * ast and/or alt \< 5 x uln in presence of liver metastasis * serum creatinine \< 1.5 x uln * absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "technical data sheet human albumin" specifically used in pharmacy department for ngr-htnf dilution) * patients may have had prior therapy providing the following conditions are met: * chemotherapy and radiotherapy: wash-out period of 28 days * surgery: wash-out period of 14 days * normal cardiac function and absence of uncontrolled hypertension * patients must give written informed consent to participate in the study exclusion criteria: * concurrent anticancer therapy * patients may not receive any other investigational agents while on study * clinical signs of cns involvement * patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Keywords: ngr-htnf malignant pleural mesothelioma
ttns versus sham therapy for children with ioab (tapas part i)

Conditions: Overactive Bladder Syndrome

Summary: part i of the tapas trial forms part of a twofold clinical rct: part 1) a prospective rct comparing the efficacy of transcutaneous tibial nerve stimulation (ttns) with ttns sham therapy for children with idiopathic overactive bladder on clinical and patient reported outcomes (proms). part 2) a prospective rct comparing ttns versus percutaneous tibial nerve stimulation (ptns) on clinical outcomes and proms.

non invasive neuromodulation therapy for children with the overactive bladder syndrome is a highly under investigated topic in medical literature. only 2 studies ( patidar et al. and boudaouid et al.) investigated the use of tibial nerve stimulation with adhesive electrodes. 1) in the first trial the superiority of ttns vs.sham therapy for the therapeutic management of children with oab naive to any pharmacological treatment will be examined. clinical outcomes will be assessed by the use of daytime and nighttime bladder diaries. assessment of outcomes at baseline, after 6 weeks and 12 weeks of treatment, and investigation of mean time to partial or complete relapse following 6 weeks observation. after a wash-out period of 6 weeks, patients from the part i sham group will be able to be included for tapas part ii.

Eligibility criteria:
inclusion criteria: * children between 5 and 12 years old, clinically diagnosed with the idiopathic overactive bladder syndrome with urinary incontinence (daytime and/or nighttime) * untreated, except from urotherapy. exclusion criteria: * enuresis nocturna due to nocturnal polyuria * dysfunctional voiding * neurogenic bladder * psychiatric disorders, behavioural disturbances or mental disabilities * treated before with pharmacotherapy or invasive therapies for oab * children with parents unable to record reliably micturition diaries.
study of diroximel fumarate in the real-world setting

Conditions: Relapsing Forms of MS

Summary: the primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (rms) treated with diroximel fumarate (drf) in routine clinical practice. the secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of drf on relapses; to assess the impact of drf on cognition; to assess the impact of drf on participant reported outcomes (pros) and to explore the real-world safety profile of drf (ie, gastrointestinal \[gi\] tolerability, lymphocyte dynamics, adverse events \[aes\] leading to discontinuation, and serious adverse events \[saes\]).


Eligibility criteria:
key inclusion criteria: * have a diagnosis of ms and satisfy the approved therapeutic indication for drf per the uspi. * drf prescribed and planned to be initiated within 60 days after enrollment. key exclusion criteria: * history of gastric bypass or required use of feeding tubes. * have received prior treatment with drf. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: clinically isolated syndrome multiple sclerosis relapsing forms of multiple sclerosis active secondary progressive disease
study evaluating refacto® in hemophilia a undergoing major surgery

Conditions: Hemophilia A

Summary: the primary objective of this clinical research study is to evaluate the safety and efficacy of refacto in subjects with hemophilia a undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.


Eligibility criteria:
inclusion criteria: * age ≥ 6 years * male previously treated patients (≥150 exposure days) with moderate or severe hemophilia a (i.e. ≤ 5% fviii:c) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor viii (fviii) infusions (surgical and post-surgical prophylaxis) * ability to adhere to the protocol requirements exclusion criteria: * hypersensitivity to refacto, murine allergen, or hamster allergen 2 history of fviii inhibitor or current inhibitor, defined as \> 0.6 bu * prior participation in this study * any concomitant bleeding disorder other than hemophilia a

Keywords: hemophilia a
hand therapy intervention versus traditional occupational therapy to prevent chemotherapy induced peripheral neuropathy

Conditions: Adenocarcinoma of Pancreas

Summary: a pilot randomized feasibility trial with a blinded evaluator.

chemotherapy-induced peripheral neuropathy (cipn) has a dose limiting effect which can greatly affect quality of life and often limits the amount of treatment patients can receive in treating their cancer. in the discipline of hand therapy, there is a science-based body of knowledge with effective protocols to treat neuropathies associated with injury and disease. these interventions have not been explored on patients with cipn.

Eligibility criteria:
inclusion criteria: 1. patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination 2. patients who have no prior evidence of peripheral neuropathy of the hands 3. age 18 years or older 4. able to sit for minimum of 30 minutes for hand therapy sessions exclusion criteria: 1. patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months 2. patients taking duloxetine or gabapentin 3. history of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes 4. inability to sit for minimum of 30 minutes 5. documented cognitive problems limiting ability to participate in hand therapy
relationship between prenatal maternal distress and the quality of general movements at 3 months

Conditions: Cerebral Palsy; Infant Development; Maternal Distress

Summary: depression and anxiety symptoms are common during pregnancy which may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. there is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. the neurological footprints of these structural changes on the young brain may be caught early in life by a video assessment of general movements (gms) quality.

depression and anxiety symptoms are common during pregnancy and are estimated to affect 7% - 20% of pregnant women, constituting significant risks for mothers and babies. depression and anxiety may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. increasing evidence shows that prenatal exposure to maternal depression and anxiety is associated with several lifelong adverse outcomes in children, including physical health problems, emotional and behavioral difficulties, and low verbal iq. such maladaptive outcomes are thought to have a neurobiological basis and there is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. however, what is more important is that the neurological footprints of these structural changes on the young brain can be caught early in life. the neurological status of infants can be determined early in life by video assessment of general movements (gms) quality. in this study at the age of 3 months, a video assessment of the quality of gms will be performed to evaluate neurologic conditions.

Eligibility criteria:
mothers inclusion criteria: * mothers aged 18 to 40 years, * singleton pregnancy * no smoking during prengnancy * no illicit drug or alcohol use during pregnancy, * no major health conditions requiring invasive treatments (e.g., dialysis, blood transfusions, chemotherapy), * no diagnosis of psychotic illnesses (eg, schizophrenia,bipolar or borderline personality disorder), and * no major autoimmune diseases * no pregnancy-related complications: (including prenatal infection, pregnancy-included hypertension, gestational diabetes, oligohydramnios, polyhydramnios, preterm labor, vaginal bleeding, placenta previa, or anemia). infant inclusionary criteria: * infants were born at 36-42 wk of gestation * uncomplicated singleton birth, * no pre-existing neurologic conditions or major head trauma, neonatal intensive care unit stay limited to observation only (ie, no interventions), and * infant discharged from the hospital with the mother. mothers exclusion criteria: * post partum depression and/or anxiety * delivery complication infant exclusion criteri: * infant birth before 36 weeks gestation * infant weight lower 2500gr at birth * apgar score 0f \<7 at 5 minutes * major neonatal complications * identified neurologic, genetic or congenital syndrome
study about preventive treatment of folliculitis induced by epidermal growth factor receptor inhibitors

Conditions: Metastatic Colorectal Cancer; Non-Small-Cell Lung Carcinoma

Summary: patients will receive local prophylactic treatment (diprosone cream) during 8 weeks from the beginning of the egf-r inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.


Eligibility criteria:
inclusion criteria: * indication of cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with irinotecan or * indication of erlotinib, in patients with metastatic non-small-cell lung carcinoma, after failure of at least one chemotherapy treatment * no pre-existing cutaneous toxicity exclusion criteria: * contraindication to local corticotherapy * previous history of severe hypersensibility reactions (grade iii or iv) due to cetuximab, irinotecan or erlotinib * betamethasone or one of excipient product allergy

Keywords: egf-r inhibitors
use of red cell distribution width for prediction of new-onset atrial fibrillation in critically ill sepsis patients

Conditions: Atrial Fibrillation New Onset

Summary: red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population..

this study was done retrospectively on sepsis patients admitted to intensive care units. data will be retrieved from patient medical records. the primay end point will be occurrence of new-onset af during icu stay. the secondary outcomes will be 28-day mortality. the presence of anisocytosis or rdw variations has been classicaly used as a test for iron deficiency anemia. increasing evidence points to its potential as a predictor for various conditions such as heart failure , malignancy, ischemic heart disease and sepsis. study investigators will examine the relationship between rdw levels and incidence of atrial fibrillation in critically ill sepsis patients as well as 28-day mortality.

Eligibility criteria:
inclusion criteria: * for all patients according to third international consensus definitions for sepsis and septic shock (sepsis-3) , adult patients with suspected infection are identified, having quicksofa (qsofa) score meeting ≥2 of the following criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mmhg or less * sepsis patients with newly developed atrial fibrillation during icu stay. exclusion criteria: all patients with concomitant valvular disease, cardiomyopathy, cardiac dysrhythmias, previous cardiac surgery, secondary hypertension, hyperthyroidism, severe head injury, stroke, coma, acute coronary artery disease or underlying cardiac dysfunction\[cardiac index (ci) \<2.2 l/min/m 2 \], severe liver disease (child-pugh grade c), chronic renal failure were excluded from the study. in addition, pregnant patients were excluded.
repetitive tms and occupational therapy in children and young adults with chronic hemiparesis

Conditions: Pediatric Stroke; Cerebral Palsy; Chronic Hemiparesis

Summary: the purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rtms) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (\< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.

rtms is a noninvasive technology that can induce changes in brain function that may lead to functional improvement in people with hemiparesis. this is a randomized, double-blinded, sham-controlled rtms study in conjunction with intensive daily occupational therapy (ot) for 2 weeks to improve motor function in hemiparetic patients. participants will be followed for at least 12 weeks after rtms to detect any clinical change. the sham group participants will be offered an open-label active rtms treatment plus ot after the 12 week assessment.

Eligibility criteria:
inclusion criteria: * age ≥ 10 years; \< 21 years * hemiparesis * manual ability classification system (macs) level i through iv * provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy * written assent form signed by participants younger than 18 years of age exclusion criteria: * underlying degenerative or metabolic disorder or supervening medical illness * severe depression or other psychiatric disorder * any participant who is pregnant * any contraindication to tms (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps) * any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable) * any botulinum toxin (botox, myobloc) or phenol injection within the last 3 months prior to the study or during the course of the study (if applicable) * any upper extremity surgery within the last 6 months prior to the study or scheduled during the course of the study (if applicable)
basiliximab combined with ruxolitinib as second-line treatment of grade 3-4 steroid-resistant agvhd

Conditions: Safety and Efficacy

Summary: acute graft-versus-host disease (agvhd) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. the recognized first-line treatment for grade 3-4 agvhd is systemic glucocorticoid. however, there is no recognized second-line treatment for grade 3-4 steroid-resistant agvhd (sr-agvhd). the investigators try to observe the efficacy and safety of early application of anti-cd25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe sr-agvhd.

adults ages 18-65 with grade 3-4 sr-agvhd design participants with grade 3-4 steroid-refractory acute gvhd (progression after 3 days or lack of improvement after 5 days of 1.5-2 mg/kg/d systemic steroids) receive combined therapy of basiliximab and ruxolitinib. basiliximab is given 20mg twice a week for week 1, and then once a week until gvhd of the participants reaches grade 1(3 episodes for minimum). ruxolitinib is given 5mg twice a day for one day and then escalates to 10mg twice a day if the participant is not administered with triazole antifungal agent. the drug dose will be adjusted according to participants' clinical manifestations, blood cell count, infection status and so on. for participants with lower gastrointestinal gvhd, intravenous cyclosporine or tacrolimus is given and plasma concentration is monitored in a safe and effective range. best supportive treatment is given, including broad-spectrum anti-infection, nutrition support, and blood transfusion. the investigators access the efficacy and safety of second-line therapy once a week from day 14 until complete remission is received. then the investigators access the hematological disease status, agvhd, cgvhd, infection state once a month.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary grade 3-4(according to magic criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids). * age 18-65. * ecog score≤3. * must be able to understand and willing to participate in the study and sign the informed consent. exclusion criteria: * refractory/secondary graft-versus-host disease. * severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc. * clinically uncontrolled active infections. * other malignant tumors with progression. * ecg: qt interval \> 450 ms. * allergic to arsenic agent. * pregnant or lactating women. * expected survival \<60 days. * undergoing other drug clinical trials.
application of a protocol of personalized medicine in patients with type 2 diabetes mellitus and multiple doses of insulin in routine clinical care

Conditions: Type 2 Diabetes Mellitus; Multiple Dose Insulin Therapy

Summary: the goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (t2dm) treated with multiple dose insulin injections (mdi). the main question\[s\] it aims to answer are: • are c-peptide titers and b-cell autoimmunity useful to help the decision of suspending prandial insulin in patients with t2dm treated with mdi? participants will: * wear a continuous glucose monitor for 10-14 days * will be asked for a c-peptide and gad antibody test (gada) * will stop prandial insulin and switch to other diabetes treatments if needed if c-peptide is \> 0.7 mmol/l and/or c-peptide is \> 0.3 mmol/l and gada are negative * will be followed-up by their gp in routine clinical practice * will be assessed after 6 months (cgm, hba1c, quality of life (qol)

an algorithm will be applied in which, depending on the presence/absence of pancreatic autoimmunity and the estimation of pancreatic reserve, the same treatment will be maintained and cgm (continuous glucose monitoring) will be initiated or the prandial insulin and the treatment will be adjusted following the main clinical guidelines.

Eligibility criteria:
inclusion criteria: * type 2 diabetes treated with multiple dose insulin therapy exclusion criteria: * gestation or planning gestation in the following 12 months * glucocorticoid use for an acute condition * transient insulinisationt (less than 6 months) * any condition that prevents the patient or their caregiver from following up for 6 months * severe mental illness * drug or alcohol abuse

Keywords: type 2 diabetes meliitus multiple dose insulin therapy personalized medicine
transcranial direct current stimulation (tdcs) as an adjunct to cognitive behaviour therapy (cbt)

Conditions: Depression

Summary: this study will investigate whether transcranial direct current stimulation (tdcs) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.


Eligibility criteria:
inclusion criteria: 1. participants will be ≥ 18 years old. 2. have a dsm-iv diagnosis of major depressive episode of minimum 4 weeks duration. 3. madrs score ≥ 20 at study entry. exclusion criteria: 1. participant is unable to give informed consent. 2. dsm-iv diagnosis of psychotic disorder (lifetime). 3. bipolar disorder diagnosis and not on a mood stabiliser. 4. eating disorder (current or within past year). 5. obsessive compulsive disorder (lifetime). 6. post-traumatic stress disorder (current or within past year). 7. mental retardation. 8. drug or alcohol abuse or dependence (preceding 3 months). 9. inadequate response to ect (current episode of depression). 10. rapid clinical response required, e.g., high suicide risk, inanition or psychosis. 11. clinically defined neurological disorder or insult. 12. metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. 13. pregnancy. 14. concurrent long acting benzodiazepines, ritalin or dexamphetamine medication. 15. change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial. 16. participant becomes hypomanic or manic, as defined by dsm-iv.