Kornimate/medical-research-clean huggingface dataset:
a trial of pulmozyme withdrawal on exercise tolerance in cystic fibrosis subjects with severe lung disease (topic)

Conditions: Cystic Fibrosis

Summary: this was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (cf) whose routine treatment included pulmozyme. patients were randomized to either continue pulmozyme or have therapy withdrawn for 2 weeks (placebo group). patients must have had stable cf symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.


Eligibility criteria:
inclusion criteria: * signed informed consent form and, if applicable, assent form * age ≥ 14 years old at screening * proven diagnosis of cf * ability to perform acceptable and reproducible spirometry maneuvers at screening * fvc ≤ 45% predicted for race, height, age, and sex at screening * chronic use of pulmozyme for at least 3 months in the last year and daily or twice daily use during the 14 days prior to screening * stable regimen of chest physiotherapy (cpt) for at least 14 days prior to screening * ability to complete the 6-minute walk test at screening * ability to complete the 6-minute walk test and spirometry at visit 2 * if on routine tobramycin solution for inhalation (i.e., tobi®) or other cycled antibiotic therapy, intention to either start or stop therapy at the time of visit 2 (based on routine therapy cycle; no other planned change in this antibiotic regimen for 28 days before or 28 days after visit 2) * clinically stable with no change in medications during the 14 days prior to screening exclusion criteria: * use of an investigational drug or device within 28 days prior to screening * previous episode of acute respiratory failure requiring assisted ventilation within 2 years prior to screening * previous lung transplant * any cardiac disease that would contraindicate performing the 6-minute walk test * pregnancy or nursing * known hypersensitivity or other contraindication to the use of pulmozyme * previous completion or premature discontinuation of study drug or withdrawal from this study * more than one prior screening failure for this study at any time or any prior screening failure for this study within the last 28 days

Keywords: lung disease cf pulmozyme
continued access to rxdx-105

Conditions: Non Small Cell Lung Cancer; Ovarian Cancer; RET Gene Mutation; BRAF Gene Mutation

Summary: this study is being done to see if people with non-small cell lung cancer (nsclc) or ovarian cancer benefit from continued treatment with the study drug, rxdx-105.


Eligibility criteria:
inclusion criteria: * this individual patient protocol includes treatment for 3 patients previously enrolled on irb #15-270 (phase1/1b clinical trial rxdx-105-01): exclusion criteria: * any patients other than those described above are excluded.

Keywords: rxdx-105 memorial sloan kettering cancer center 18-487
an observational study of epilepsy: biology and outcomes using real-world data

Conditions: Epilepsy

Summary: the goal of this observational study is to learn more about phenotypic, genetic, biochemical, neurophysiological and radiological patterns in epilepsy. participants will be asked to consent to use of clinical and paraclinical data (obtained during standard care) for research, and will be asked to donate blood samples at their routine clinic visits.

this is an observational study of people with epilepsy seen in south wales, which will employ quantitative methods of analysis to meet the study aims. the study will build upon data already collected during routine clinical appointments from people with epilepsy who have come into contact with the national health service (nhs) epilepsy service at cardiff \& vale university health board. the epilepsy service has clinical data on over 5000 people with epilepsy, and biological samples on approximately 400 people through the welsh neuroscience research tissue bank. the investigators propose to approach individuals being seen in the epilepsy clinics to gain consent for access to their routinely collected clinical and paraclinical data, and prospective donation of biological samples (predominantly blood samples, though consent will be sought for surplus brain tissue and cerebrospinal fluid (csf) if brain surgery or lumbar puncture are being performed as part of clinical care, as well as hair, nail, and urine in some circumstances). this will enable a comprehensive disease register of a population-based sample of people with epilepsy to be established. interrogating the clinical and paraclinical data will allow investigation into clinical phenotypes, short- and long-term outcomes in epilepsy, and the relationship of clinical, demographic and biological variables. biological samples will allow biochemical and genetic analysis of potential markers of disease, clinical phenotype, and prediction of outcomes including treatment responses, and allow contribution to the epi25 international collaborative (http://epi-25.org/). inclusion in the study will involve no change to the normal clinical care or treatment of participants (except where participants choose to provide biological samples), and additional clinic visits will not be required outside of standard nhs care.

Eligibility criteria:
inclusion criteria: * individual is being investigated for epilepsy and under the clinical care of the epilepsy unit at cardiff \& vale university health board or regional clinics in cwm taf. * individual is at least 16 years old. * informed consent sought and given by individual. exclusion criteria: * none
pd-1 inhibitor plus anti-egfr therapy and radiotherapy in locally advanced npc resistant to induction chemotherapy

Conditions: Nasopharyngeal Carcinoma

Summary: because nasopharyngeal carcinoma （npc）is very sensitive to radiation and the specificity of the anatomical structure, radiotherapy has become the core treatment for npc. although induction chemotherapy combined with cisplatin-based concurrent chemoradiotherapy can effectively improve the overall survival and progression-free survival of npc, such a sequential pattern can further exacerbate the toxic side effects of treatment, such as mucosal reactions and gastrointestinal toxicity. therefore, it is particularly important to explore another treatment mode with high efficiency and low toxicity. secondly, patients with poor response after induction chemotherapy indicate chemotherapy resistance. whether patients can still benefit from concurrent platinum-based chemotherapy in the followed radiotherapy is doubtful. pd-1 inhibitor and anti-egfr monoclonal antibody have proved to improve outcomes of head and neck cancers including ebv-related npc, which have also showed relatively low toxicity. in this study, radiotherapy combined with pd-1 inhibitor and anti-egfr monoclonal antibody were applied to treat patients with locally advanced npc who were resistant to induction chemotherapy.


Eligibility criteria:
inclusion criteria: histologically confirmed locally advanced npc; ihc egfr positive; eastern cooperative oncology group (ecog) performance status of 0 or 1; imaging assessment of mr after induction chemotherapy revealed the responses to induction chemotherapy are less than 50% partial response(pr) or ebvdna copy number decreased by less than 50%; no prior anti-tumor treatment; normal complete blood count; normal hepatic function; normal renal function (creatinine ≤ 1.5 times the upper limit of normal). - exclusion criteria: previous radiotherapy; a history of any other type of malignancy; pregnancy or lactation; allergy to anti-egfr monoclonal antibody; ihc egfr negative; allergy to pd-1 inhibitor; obvious disfunction of liver, renal, cardiac or lung function; un controlled infection; systemic metastasis or distant metastasis; patients with severe gastrointestinal diseases; patients with mental disorders affecting patient participation in trial judgement; cannot take contrast-mri imaging. -

Keywords: nasopharyngeal carcinoma pd-1 inhibitor anti-egfr monoclonal antibody induced chemotherapy resistance
sidestream dark-field (sdf) imaging of the intestinal microcirculation

Conditions: Sepsis

Summary: sepsis is the most frequent cause of death in critically ill patients in non-coronary care intensive care units in the developed world. microcirculatory disturbances are central to the development of the disorder, leading to organ dysfunction, multi-organ failure and fatal outcome. in particular the intestinal microcirculation is impaired early in the course of the disease. this may result in a breakdown of the gut barrier function with translocation of bacteria and their toxins into the systemic circulation, thus sustaining a "gut derived" septic state. therefore, the impaired intestinal microcirculation has been suggested to act as the "motor of multiple organ failure" in sepsis. the aim of the project is to evaluate a new diagnostic tool and the impact of activated protein c administration on the intestinal microcirculation in patients with severe sepsis and compare the findings with septic patients who are not candidates for apc therapy and healthy patients post bowel surgery using an innovative diagnostic tool (side stream dark-field imaging, sdf).


Eligibility criteria:
inclusion criteria: * ileostomy, no infection at the site of stoma, informed consent. * diagnosed sepsis according to american college of chest physicians/society of critical care medicine criteria13. * indication for treatment according to hospital guidelines exclusion criteria: * infection at the site of stoma, * moribund patients
effects of a clinical dietary intervention during inpatient treatment

Conditions: Metabolic Syndrome; Osteoarthritis, Hip; Osteoarthritis, Knee; Rheumatoid Arthritis; Fibromyalgia

Summary: the purpose of the study is a scientific and prospective documentation of the clinical effects of an inpatient treatment at the immanuel hospital of berlin, in the department for complementary and integrative medicine, with the use of a modified fasting regime. a pre- and post- as well as group comparisons are planned. patients that are admitted to the inpatient department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis and fibromyalgia will be enrolled in the study.

at the beginning, during and at the end of the treatment at the inpatient department routine blood parameters, anthropometric parameters and certain scores and parameters specific to the different conditions will be measured. questionnaires will be filled out by patients before and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.

Eligibility criteria:
inclusion criteria: * the patient is consents to participating in the trial during the first 24h of his or her stay in the inpatient naturopathic department of the immanuel hospital. * written informed consent is given * the referral diagnosis is one of the following: diabetes mellitus type 2/metabolic syndrome, osteoarthritis of the hip, osteoarthritis of the knee, rheumatoid arthritis, fibromyalgia. exclusion criteria: * language barries to understanding the instructions of the study personnel * dementia or other strong cognitive impairment * pregnant or lactating women * taking part in another study at the same time

Keywords: fasting natural therapies prolonged fasting
efficacy of prophylactic internal iliac artery balloon catheterization in the management of placenta previa and accreta

Conditions: Placenta Previa; Placenta Accreta

Summary: placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. this study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.

placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. this study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. between june 2015 and august 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. both groups benefitted similar management protocol with the exception of interventional radiology operation. intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.

Eligibility criteria:
inclusion criteria: * pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or magnetic resonance imaging. exclusion criteria: * any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.
effect of carnitine on uremic cardiomyopathy

Conditions: Disorder of Fatty Acid Metabolism

Summary: patients on chronic hemodialysis without obstructive coronary artery disease identified by coronary angiography were randomly divided into the two groups: carnitine group and control group. spect using ffa analogue, bmipp, was performed before and one year after intravenous administration of l-carnitine (1000 mg on every dialysis session). control group received the examination of bmipp spect at the same time of the carnitine group. the effects of chronic intravenous administration of l-carnitine on myocardial fatty acid metabolism were investigated among this population.

patients on chronic hemodialysis in toujinkai hospital who had no obstructive coronary artery disease identified by coronary angiography and left ventricular dysfunction were randomly divided into the two groups: carnitine group and control group. to evaluate the possible effect of carnitine administration on myocardial fatty acid metabolism, spect using ffa analogue, bmipp, was performed before and one year after intravenous administration of l-carnitine (1000 mg on every dialysis session). control group received the examination of bmipp spect at the same time of the carnitine group. circulating concentrations of total, free, and acyl l-carnitine were measured every three months in the carnitine group. clinical data including blood chemistry, blood pressure, or cardiac functions by echocardiography were obtained every 6 months in both groups. the effects of chronic intravenous administration of l-carnitine on myocardial fatty acid metabolism and cardiac functions were investigated among this population.

Eligibility criteria:
inclusion criteria: * patients on chronic hemodialysis without significant obstructive coronary artery disease identified by angiography within one years of the study, and who had left ventricular dysfunction: * reduced left ventricular systolic function (left ventricular ejection fraction \<55%) and/or * left ventricular hypertrophy evaluated by echocardiography) exclusion criteria: 1. moderate or worse valvular heart disease, 2. past histories of acute or old myocardial infarction and/or coronary revascularization by percutaneous coronary intervention or coronary artery bypass grafting within one year of the study.

Keywords: carnitine hemodialysis fatty acid imaging heart
plasma biomarkers p-dac, v1

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: this is an exploratory, translational, non-interventional and multi-centre clinical study. the aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in pdac.

this study will involve two cohort groups, all patients involved will have pdac. cohort a: target is 80 resectable pdac patients who will receive standard treatment of chemotherapy +/- radiotherapy cohort b: * cohort b1 = target is 80 unresectable locally advanced pdac patients who will receive standard treatment of chemotherapy +/- radiotherapy. * cohort b2 = target is metastatic pdac patients who will receive standard treatment of chemotherapy +/- radiotherapy. control patients: target is 50, with acute pancreatitis admitted to hospital for observation/treatment. blood samples will be taken at the following time points: * prior to resection, whenever feasible for cohort a * prior to ct, for both cohort a and b * during ct, for both cohort a and b * follow-up, approximately every 3 to 6 months for two years for cohort a

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * ability to give written informed consent * histologically or cytologically-confirmed pdac * patients who will receive standard treatment of ct +/- radiotherapy and present with: cohort a: resectable cancer or cohort b.1: unresectable locally advanced cancer or cohort b.2: metastatic cancer * eastern cooperative oncology group (ecog) performance status 0 - 2 exclusion criteria: * presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study
safety and efficacy of human bone marrow stem cells for treatment of hbv-related liver cirrhosis

Conditions: Liver Cirrhosis; End Stage Liver Disease

Summary: hbv related liver disease is a common medical problem in china. an estimated 7.18% of the chinese (about 93 million) is infected with hepatitis b, and most of the hbv- related hepatitis can developed into liver cirrhosis. liver transplantation is the only available life saving treatment for patients with end stage liver disease. however, lack of donors, surgical complications, rejection, and high cost are serious problems. stem cells(scs) possess plasticity and have the potential to differentiate into hepatocyte; thus, scs hold great hope for therapeutic applications. adult bone marrow is the most common source of scs for clinical applications.previous study showed that bone marrow derived stem cells (bmscs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. in this study, the patients with hbv-related liver cirrhosis will undergo administration of human autologous bmscs via hepatic artery to evaluate the safty and efficacy of human autologous bmscs treatment for these patients.


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years 2. hbv-related liver cirrhosis 3. child-pugh score 9-15 4. written consent exclusion criteria: 1. hepatocellular carcinoma or other malignancies 2. severe problems in other vital organs(e.g.theheart,renal or lungs) 3. pregnant or lactating women 4. severe bacteria infection 5. anticipated with difficulty of follow-up observation 6. other candidates who are judged to be not applicable to this study by doctors

Keywords: liver cirrhosis end stage liver disease hbv autologous stem cell bone morrow
expanded indications in the med-el pediatric cochlear implant population

Conditions: Hearing Loss, Sensorineural

Summary: the purpose of this investigation is to demonstrate the safety and effectiveness of med-el cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current fda-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.


Eligibility criteria:
inclusion criteria: * children 7 months to 5 years 11 months of age at the time of implantation * bilateral, severe to profound sensorineural hearing loss (snhl) in the high frequencies and * for subjects implanted under 12 months of age: bilateral, severe to profound snhl in the low frequencies * for subjects implanted at 12 months to 5 years 11 months of age: bilateral, mild to profound sensorineural hearing loss in the low frequencies * insufficient functional access to sound with appropriately fit amplification and aural habilitation * objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age * radiologic evidence of potential for full insertion with one of the included electrode arrays * ability to undergo general anesthesia * at least one parent/guardian who is fluent in one of the available languages of the leaq * parental commitment to study parameters exclusion criteria: * magnetic resonance imaging (mri) evidence of cochlear nerve deficiency * active middle ear infection * permanent conductive hearing loss * treatable mixed hearing loss * current or history of meningitis * common cavity * skin or scalp condition precluding use of external audio processor * suspected cognitive impairment, organic brain dysfunction, or syndromic etiology that may affect performance * asa (american society of anesthesiologists) class 3 or higher in subjects under 12 months of age * history of prior use of a hearing implant * unrealistic parental/patient expectations * child is not able to complete speech perception testing in english
forearm immobilization in t2d

Conditions: Healthy; Type 2 Diabetes

Summary: the aim of the present study is to assess the impact of short-term forearm immobilization on forearm muscle glucose uptake and amino acid net balance and kinetics in individuals with t2d compared with a control group with normoglycaemia.

participants with and without t2d will undergo 2 days of forearm immobilization as a model of local physical inactivity. before, throughout, and after immobilization arteriovenous forearm balance measurements will be combined with a stable isotope tracer infusion to measure muscle glucose uptake and amino acid balance, uptake, and efflux.

Eligibility criteria:
inclusion criteria: * males and females with or without diagnosed type 2 diabetes (diagnosed at least one year prior) * apply lifestyle changes and/or use metformin as oral glucose-lowering medication as treatment for t2d * aged 18-65 years at the time of signing informed consent * 18.5 \< bmi \< 30 kg·m2 exclusion criteria: type 1 or a genetic form of diabetes * any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmhg systolic and/or ≥90 mmhg diastolic) * chronic use of any prescribed or over-the-counter pharmaceuticals (excluding oral contraceptives and contraceptive devices) * do not consume three regular meals a day (breakfast, lunch, and dinner) and or follows a low carbohydrate diet * smoking or chewing tobacco * known anaemia * regular use of dietary protein and/or amino acid supplements (\>3 times per week) * currently involved in a structured progressive resistance training program (\>3 times per week) * a personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia * any previous motor disorders or disorders in muscle and/or lipid metabolism * history of kidney disease * history of liver disease * pregnant or breastfeeding * history of any drug or alcohol abuse in the past two years * any musculoskeletal injury of the arms in the 12 months before starting the study * claustrophobia * unable to give consent