Kornimate/medical-research-clean huggingface dataset:
adalimumab in the treatment of chronic pouchitis

Conditions: Ulcerative Colitis; Pouchitis

Summary: this study wants to investigate the efficiency of biological treatment for chronic pouchitis. chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. it is examined in patients with ulcerative colitis. the primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis. secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. it is a double-blinded randomized placebo controlled study.


Eligibility criteria:
inclusion criteria: * operated with proctocolectomy and construction of an ipaa * prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria. * diagnosed with chronic pouchitis as defined above * pdai ≥ 7, with the clinically part of pdai \>2 and the endoscopic part of pdai \>3 * age \>18 years * negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites * serology negative for chronic hepatitis b * negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test) * signed informed consent exclusion criteria: * treatment with glucocorticoids within the last 4 weeks * diagnosed with crohn's disease * need of an interpreter or if patients do not understand oral or written information. * surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch * abuse of medicine, alcohol or drugs * ongoing treatment with nsaid (non steroid anti inflammatory drug) * pregnancy or nursing * a diverting stoma * malignancy or other severe chronic disease or expected longevity less than one year * patients diagnosed with immune deficiency * ongoing infectious disease * contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks

Keywords: ipaa pouchitis ulcerative colitis pouch adalimumab humira
an evaluation of the effectiveness and safety of anidulafungin compared to caspofungin for the treatment of deep tissue infection due to candida

Conditions: Candidiasis; Fungemia

Summary: the purpose of this study is to gather information on the use of anidulafungin for the treatment of serious candida infection. it is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.


Eligibility criteria:
inclusion criteria: * diagnosis of deep tissue candida infection, defined as growth of candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection. * male or female ≥ 16 years of age. * expected hospitalization for at least fourteen (14) days. exclusion criteria: * pregnancy or breast feeding or planning to become pregnant during the study. * recent treatment with one of the study drugs over the last 30 days. * allergy to either study drug or to this class of drugs. * significant liver dysfunction. * suspected candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Keywords: candidiasis; invasive candidiasis; deep tissue candidiasis; candida; candidemia; fungal infection
siblings with ischemic stroke study

Conditions: Stroke

Summary: the purpose of this study is to find the genes that increase the risk of developing an ischemic stroke using dna samples collected from concordant (stroke-affected) sibling pairs.

stroke is the third leading cause of death in the united states and a leading cause of acquired disability in adults. each year, about 700,000 people experience stroke in the country. ischemic stroke, which constitutes about 80 percent of all strokes, is a complex genetic disorder--the result of interactions between multiple genes and multiple environmental exposures. genes affecting cholesterol, blood pressure, clotting, and other factors may increase the risk of ischemic stroke. in this clinical study, investigators are studying groups of siblings in which at least two of the siblings have had an ischemic stroke. the goal of this multi-center study is to find the genes that increase the risk of developing an ischemic stroke. to accomplish the aims of the study, researchers are using dna samples collected from concordant (stroke-affected) sibling pairs to determine if there are regions in the human genome associated with ischemic stroke or that may harbor stroke susceptibility genes. two teaspoons of blood will be collected from each participant and submitted for genetic analysis. understanding the genetic predisposition to stroke could have major benefits for public health.

Eligibility criteria:
inclusion criteria: * subject diagnosed by a study neurologist as having had a symptomatic ischemic stroke in the past. * head computed tomography (ct) or magnetic resonance imaging (mri) done within 7 days of symptom onset confirms absence of etiology other than ischemic stroke. * subject reports having at least one living sibling with a stroke. * subject is 18 years of age or older. exclusion criteria: * the index ischemic stroke occurred within 48 hours after a cardiovascular or cerebrovascular procedure. * the index ischemic stroke occurred within 60 days after a non-traumatic subarachnoid hemorrhage. * the subject has brain biopsy-proven central nervous system vasculitis. * the subject is known to have any one of the following genetic disorders: cadasil (cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy), fabry's disease, homocystinuria, melas (mitochondrial myopathy, encephalopathy, lactic acidosis, stroke), or sickle cell anemia. * the subject has a mechanical aortic valve or mechanical mitral valve. * the subject had untreated or actively treated bacterial endocarditis at the time of the index ischemic stroke.

Keywords: stroke ischemic stroke siblings
functional magnetic resonance imaging of pancreatic cancer: a feasibility and reproducibility study

Conditions: Pancreatic Cancer

Summary: novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. several mr techniques can serve for this purpose. however, optimalisation of these techniques is needed and their reproducibility should be assessed.

background of the study: novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. several mr techniques can serve for this purpose. however, optimalisation of these techniques is needed and their reproducibility should be assessed. objective of the study: to optimize dce-mri, t2\* mri and dwi in pancreatic cancer at 3t and investigate its reproducibility. study design: in the first part of the study, patients with pancreatic cancer will undergo an mr measurement protocol once at 3t, to optimize mr techniques (dce-mri, t2\* mri and dwi). in the second part of the study, to assess reproducibility patients will undergo the mr measurement protocol twice within one week before start of any treatment.

Eligibility criteria:
inclusion criteria: * patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on ct imaging. * any tumor with a size ≥ 1cm * who-performance score 0-2 * written informed consent exclusion criteria: * any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol. * contra-indications for mr scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-mr compatible metallic implants in their eye, spine, thorax or abdomen; or an aneurysm clip in their brain; patients with severe claustrophobia. * renal failure (gfr \< 30 ml/min) hampering safe administration of gadolinium containing mr contrast agent. * for the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for mri scanning.

Keywords: pancreatic cancer mri reproducibility optimalization
safety and efficacy study of aa4500 (xiaflex™, proposed name) in the treatment of advanced dupuytren's disease

Conditions: Advanced Dupuytren's Disease

Summary: this was a phase 3, 9-month, open-label study conducted in the united states. subjects with a diagnosis of advanced dupuytren's disease in a metacarpophalangeal (mp) or proximal interphalangeal (pip) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled. this study was designed to be part of the larger clinical program, for adult patients with dupuytren's contracture with a palpable cord, where the data from 2 pivotal placebo-controlled studies (aux-cc-857 (nct00528606) and aux-cc-859 (nct00533273)) and 7 non-pivotal studies were evaluated.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of advanced dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for mp (80° for pip) joints, caused by a palpable cord. * had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. * were naïve to aa4500 treatment or had received one or two injections of aa4500 for the treatment of advanced dupuytren's disease in auxilium studies aux-cc-851, aux-cc-853, or aux-cc-855. * were judged to be in good health. exclusion criteria: * had a chronic muscular, neurological, or neuromuscular disorder that affected the hands. * had received treatment for advanced dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of aa4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon. * had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
sarcopenia and physical activity intervention: a randomized-controlled trial

Conditions: Sarcopenia

Summary: sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strength and performance and increased risk of falls and fractures, physical disability and premature death. with the present project the investigator aim to assess the effect of a feasible exercise program to improve muscle strength (primary outcome), and muscle volume and performance and other measures potentially associated with sarcopenia (secondary outcomes) in elderly and people living with hiv (plwh) with sarcopenia. the investigators plan to enroll 98 elderly and 98 plwh in a multicentric, 48-week, randomized, parallel-group, open label, superiority trial comparing the effect of a home-based and app-monitored strength exercise intervention versus no intervention. the investigators expect that participants who exercise will improve strength and other parameters and that improvement at week 12 and week 48 will be higher than in no-exercise controls.


Eligibility criteria:
inclusion criteria: * sedentary * \>60 year-old in the elderly group or \>50 year-old for the plwh group; * with sarcopenia, as defined by both relative loss of muscle mass by bioimpedentiometry (bia) and low muscle strength by handgrip exclusion criteria: * any disease requiring hospitalization in the 6 weeks before enrollment; * medical conditions contraindicating the proposed exercise as established by a sport medicine specialist; * current substance or alcohol abuse or use of drugs that may influence balance and coordination; * not being able to walk without assistance and to perform the prescribed exercises as by protocol.
development of an mhealth behavioral sleep medicine intervention for use during medication assisted treatment for moud

Conditions: Opioid Use Disorder; Poor Quality Sleep

Summary: this study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. an initial program will be built utilizing input from persons beginning medications for opioid use disorders.

this pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mhealth app to individuals initiating treatment with medications for opioid use disorder. additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. participants (n=40, 20 per group) will be randomized to download the mhealth app to their smartphones and complete the intervention within 6 weeks. the control group will receive a simplified version of the app with sleep hygiene instructions. both groups will complete daily electronic sleep diaries for the following 6 weeks. each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. at the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.

Eligibility criteria:
inclusion criteria: * no experience of withdrawal symptoms in past 2 weeks * being stabilized on buprenorphine 1. initiated buprenorphine in past 3 months 2. modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol) * currently experiencing clinically significant sleep disturbance (psqi \> 5) * able to read and understand english * owns an android or ios smartphone * at least 18 years of age exclusion criteria: * current psychotic symptoms * current active suicidal ideation * severe visual impairment * current use of benzodiazepines * current severe sud other than oud (i.e., \> 5 criteria met for any other sud type per dsm-5) * peripartum women
untire: cancer-related fatigue with digital treatment

Conditions: Colorectal Cancer; Fatigue

Summary: this research is being done to find out if using a smartphone app as digital treatment to reduce cancer related fatigue is feasible and easy to use. this research study is evaluating a smartphone application named the "untire" app. the untire app was designed as a digital treatment plan for people experiencing cancer related fatigue (crf).

this is a single arm, pilot study evaluating the feasibility, acceptability, and effectiveness of a self-managed digital therapeutic application, the untire app, for the treatment of cancer-related fatigue in the colorectal (crc) cancer patient community. the untire app was developed by psychology oncologists and combines proven treatments for cancer related fatigue like cognitive behavioral therapy, mindfulness exercises, physical activities, education, and positive tips. the untire app helps a patient recognize and learn about daily behaviors, fatigue levels, and energy levels. the untire app has been tested on all different cancer types globally and has been proven to decrease fatigue and improve overall quality of life but this is the first-time investigators are examining the strengths and weaknesses of using the untire app as a digital treatment plan for cancer related fatigue. the research study procedures include screening for eligibility and study interventions including smartphone app use and evaluations with questionnaires and follow up visits. participants will be in this research study for up to 12 months. it is expected that about 60 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * \>/= 18 years of age * owns a smart phone or ipad * diagnosis of metastatic colorectal cancer, adenocarcinoma * actively undergoing treatment for metastatic disease * speak and read english at a 6th grade level or higher * a score of 1 or greater on the pro ctace dfci fatigue (questions 53a or 53b) exclusion criteria: * patients in surveillance * patients receiving end of life care * patients taking dexamethasone other than for the control of nausea * patients taking methylphenidate (ritalin) for the treatment of crf

Keywords: colorectal cancer fatigue
the role of salivary alpha amylase in sepsis

Conditions: Sepsis

Summary: critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. the associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome. salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli. salivary alpha-amylase (saa) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (sns) activity.

critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. the associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome. although sepsis is one of the oldest syndromes in medicine, it is a challenging healthcare problem even nowadays. in spite of the era of modern an¬tibiotics and intensive therapy sepsis is still one of the leading causes of morbidity and mortality. based on the novel results and advances of pathobiology, management and epidemiology of sepsis, the definitions of the syndrome have been changed recently. sepsis-3 consensus de¬fines sepsis as a life-threatening organ dysfunc¬tion caused by a dysregulated host response to infection. the diagnosis of sepsis is most often not easy especially in newborns or in patients whose im¬mune response is not adequate. therefore, it is of most importance to introduce diagnostic biomarkers which can predict or verify systemic inflammation as early as possible. these tests should also be applicable for monitoring of the disease progression and efficacy of therapy as well. salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli. salivary alpha-amylase (saa) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (sns) activity. saa is a digestive enzyme that breaks down starch into glucose and maltose, and enzymatic activity (in units/ml) is used as a proxy for saa concentration. the use of salivary alpha amylase as a marker of sympathetic activity seems justified. salivary alpha amylase release from the salivary glands is under strong control of local sympathetic nerves. its salivary concentration rapidly increases during acute stress, and its use as a marker of sympathetic activation is also validated by pharmacological studies.

Eligibility criteria:
inclusion criteria: * the newly diagnosed patients with sepsis according to sepsis-3 consensus definition using sofa score * the newly diagnosed patients with septic shock according to sepsis-3 consensus definition using sofa score * aged more than 18 years old. exclusion criteria: * evidence of an immunocompromised as malignancy, * received corticosteroids, * recieved chemotherapy, * recieved radiotherapy * recieved cytotoxic drugs * advanced hepatic disease * renal disease * pregnancy.
recurrence rate of minimally invasive endoscopic treatment of internal hemorrhoids

Conditions: Internal Hemorrhoid

Summary: 2.1 main objective: to observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade i-iii internal hemorrhoids 2.2 secondary objective: to observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids


Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old, both sexes 2, grade i-iii internal hemorrhoids with symptoms related to internal hemorrhoids 3. the purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed exclusion criteria: * 1. patients with contraindications to endoscopic minimally invasive treatment (1) grade iv internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) i-iii degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs. 2. patients with a history of allergy to narcotic drugs 3. patients who were deemed by the investigator to be ineligible for participation in the trial
stem cell applications in biliary atresia patients

Conditions: Biliary Atresia; Fibrosis, Liver; Stem Cell

Summary: recently, mesenchymal stem cell (msc) transplantation has emerged as a promising treatment for liver cirrhosis in adults. additionally, bone marrow-derived stem cell transplantation has shown success in treating children with biliary atresia (ba). this study aims to evaluate the efficacy of umbilical cord-derived mesenchymal stem cell (uc-msc) therapy in ba through a multicentric randomized controlled trial.

biliary atresia (ba) is the most common cause of chronic cholestasis in neonates and accounts for at least 50% of pediatric liver transplants. the incidence of ba is estimated to range from 1:5000 to 1:19000 live births. if the operation is not performed, all patients will die due to complications of liver cirrhosis. recently, mesenchymal stem cell (msc) transplantation has been found to be a promising treatment for liver cirrhosis in adults. stem cell transplantation derived from bone marrow has also been successfully applied to children with ba. the aim of this study is to demonstrate the efficacy of umbilical cord-derived mesenchymal stem cell (uc-msc) therapy in ba by planning a multicentric randomized controlled trial.

Eligibility criteria:
inclusion criteria: * infants were diagnosed with liver cirrhosis due to biliary atresia following kasai's operation. * the patients two months old or older and exhibited signs of cirrhosis after the procedure, including hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices (confirmed by endoscopy), and cirrhosis (confirmed by liver biopsy). exclusion criteria: * epilepsy * neurological disorders * coagulation disorders * diabetes * syndromic type biliary atresia * allergies to anesthetic agents * severe health conditions such as cancer or failure of the heart, lungs, liver, or kidneys, active infections, and severe psychiatric disorders.

Keywords: biliary atresia liver fibrosis stem cell