Kornimate/medical-research-clean huggingface dataset:
safety study of larazotide acetate to treat celiac disease.

Conditions: Celiac Disease

Summary: to demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

clin1001-002 was a phase 1b, randomized, double-blind, placebo controlled study to determine the safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of larazotide acetate in subjects with celiac disease subjects. study subjects were randomized (2:1) to receive single oral doses of larazotide acetate 12 mg or matching placebo once daily for 3 days. subjects received a single-blinded gluten challenge (5 mg amygluten) on day 2. intestinal permeability was measured each day following dosing. intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by a 6-hour urine collection. serial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose; for zonulin determinations at baseline (prior to first dose) and 3 hours post dose; and for cytokine determination at baseline and 3 hours post dose (days 2 and 3 only) and on day 7. sucrose, lactulose, mannitol, zonulin and larazotide acetate concentrations were determined by validated analytical methods.

Eligibility criteria:
inclusion criteria: * subject must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report). * subject must be on a gluten-free diet for at least the past 6 months. exclusion criteria: * subject has anti-tissue transglutaminase (ttg) \> 10 eu as measured by serology * subject intermittently consumes clinically significant quantities of non-steroidal anti-inflammatory agents ("nsaids") and proton-pump inhibitors, within the last 3 days prior to the treatment visit.

Keywords: larazotide acetate
lung cancer next generation sequencing using the oncomine comprehensive assay

Conditions: Lung Cancer Stage IV

Summary: currently, publicly funded standard of care testing in ontario for stage iv lung cancer patients uses individual gene tests to look for mutations in the egfr and alk genes. this testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. this study will evaluate the utility and added value of using a next generation sequencing (ngs) panel, the oncomine comprehensive assay v3, to profile stage iv lung cancer patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted) * stage iv disease * sufficient ffpe tumour tissue for occp testing * performance status 0-2 * candidates for targeted therapy (tkis) and/or clinical trials as determined by the patient's medical oncologist * prognosis \> 6 months * known translocations of ret, met exon14 skipping variants, or met amplification are allowed exclusion criteria: ● patients with known egfr, kras, braf and erbb2 mutations or alk or ros1 fusions at study entry unless acquired resistance to molecularly targeted therapy
central line placement-evaluation of line depth as a factor in need for line replacement secondary to malposition

Conditions: Vascular Access Complication

Summary: this is a single center, randomized, controlled trial in which tunneled central line catheters will be placed in two distinct, select positions. the catheter tip position will then be followed up prospectively after placement to determine whether there is any malpositioning of the tip and if one placement is better than the other.

optimal central line placement is vital to catheter longevity. if malpositioned, the catheter may need to get replaced, potentially causing additional morbidity to the patient and additional cost to the healthcare system. in our department, a retrospective study looking at catheter tip position at inital placement and incidence of malposition. in this study, 404 catheter placements were reviewed, and a total of 162 (40.1%) were replaced. out of the 162 replaced, 36 (22.2%) were replaced secondary to malposition. from this study, we were also able to conclude that catheter tips placed in a deeper position, approximately one and a half vertebral bodies below the carina, were less likely to be malpositioned in the future upon radiographic review. current standard of care does not dictate positioning of the line in a specific loacation. in the presence of these findings, we are proposing to conduct a single center randomized control trial in which tunneled central line catheters will be placed in two distinct, select positions. after informed consent is obtained from the patient and family, they will be randomized to one of two treatment groups. the shallow group will have the tip of the catheter located approximately one vertebral body above the carina. the deep group will have the catheter tip placed 1.5 to 2.5 vertebral bodies below the carina. central line placement will be performed under fluoroscopy in the operating room to optimize catheter placement. chest x ray in the post operative area will be used to confirm catheter tip position. the catheter tip position will then be followed up prospectively using chest x ray films at or within three months after placement to determine whether there is any malpositioning of the tip.

Eligibility criteria:
inclusion criteria: * children from 0-18 years of age needing a tunneled central line (port or broviac) for treatment of their disease. exclusion criteria: * wire exchanged lines * non ultrasound placed lines, femoral lines, saphenous vein lines, and cut downs * short gut syndrome children \< 1 year of age

Keywords: catheter placement
outcomes and discharge of long-stay psychiatric patients

Conditions: Mental Disorders

Summary: an increasing number of severely ill patients require long-term care in non-hospital residential facilities (rfs). despite the magnitude of this development, only a few detailed longitudinal studies on fairly larger samples of residents have provided important information about this population. the perdove study is the first study carried out in italy aimed at obtaining comprehensive data about the course and outcome of patients living in rfs, and test whether discharge to independent accommodations is a real option for many patients. the major aims are three: (1) to describe the sociodemographic, clinical, and treatment-related characteristics of patients treated in rfs during an index period in 2010; (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up; and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each individual patient. the primary endpoint was discharge within one year as a measure of good outcome. the perdove study is an observational cohort study, involving 23 rfs all belonging to the st john of god order, located in northern italy. the first step involves the evaluation of all rfs with a structure schedule, which assesses the following areas: logistics structure, general organization: internal rules, meals, clothing and personal hygiene; staff and users' characteristics and meetings, documentation system and evaluation activities; rehabilitative activities provided inside the rf itself. in the second step a research assistant completed a standardised assessment of each resident with the manager and staff; clinical diagnoses were made by treating clinicians. a number of standardised instruments were administered. at one year follow-up, changes in clinical and life conditions of the patients were evaluated and selected rating scales were administered again. for patients discharged to the community or to other rfs, a research assistant contacted the patient's psychiatrist and asked him/her to fill out the follow-up documentation. with regard to residents' discharge, investigators hypothesised that the likelihood of community discharge would be associated both with the level of social support outside the facilities, and with the degree of patients' psychological and social impairment.


Eligibility criteria:
inclusion criteria: * psychiatric diagnosis * age \< 65 * staying in september 2010 in any of 23 rfs located in northern italy exclusion criteria: * elderly patients (over 65 yrs) * primary diagnosis of organic mental disorder * refusal of signing an informed consent

Keywords: severe mental disorders discharge outcome evaluation
autopulse assisted prehospital international resuscitation trial (aspire)

Conditions: Cardiac Arrest

Summary: the autopulse assisted prehospital international resuscitation (aspire) trial compares the efficacy of circulatory assist by manual chest compression versus an automated chest compression device (autopulse™) during the resuscitative attempt following out-of-hospital cardiac arrest.

extensive early experience yielded no reliably validated instances of out-of-hospital arrest associated with tachyarrhythmia being resuscitated without successful defibrillatory shock. this together with the increasing availability of automated external defibrillators (aeds), at increasingly attractive prices, led, in the past decade, to a strong emphasis on early defibrillation. this emphasis may have inadvertently resulted in a decreased emphasis on cardiopulmonary resuscitative techniques, particularly in light of publications decrying the uniformly poor quality of cpr performed by laymen, medical professionals, and even ems personnel. however, recent research strongly suggests that assisted reperfusion prior to defibrillation may actually significantly improve survival rates. these reports, based on clinical studies, have received substantial confirmation from carefully controlled laboratory studies, particularly in pigs. if assisted reperfusion prior to defibrillation (and subsequent to failed shock) is important, it is reasonable to suppose that the benefit is related to quality of chest compressions. observations of resuscitative efforts in the field indicate that maintaining compressions is one of the more difficult tasks, for a variety of reasons. observations in the laboratory with trained paramedics show that the depth of compression and the compression rate diminish rapidly with time from the onset of cpr, without the participant being aware that his/her effort is actually diminished. the desire to provide consistent and quality compressions has led to the development of a mechanical compression assist device called the autopulse. it is a self-contained, portable chest compression device that is rapidly field deployable.

Eligibility criteria:
inclusion criteria: * all persons with out-of-hospital cardiac arrest who are attended by a vehicle involved in the randomization process and who are treated by the emergency medical service (ems). exclusion criteria: * persons under the age of 18 * victims with traumatic arrest * less than the legal age of consent * resuscitation attempt discontinued because of do not resuscitate (dnr) orders or on request of authorized decision-maker * wards of the state, including prisoners * chest or abdominal surgery within 6 weeks * site specific exclusions

Keywords: cardiac arrest ooh-cardiac arrest cpr chest compressions chest compression device
effect of indacaterol on inspiratory capacity (ic)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (ic), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (copd). in particular, spirometric timepoints are included to elucidate the peak-ic in a period of approximately 4 hour post inhalation


Eligibility criteria:
inclusion criteria: * co-operative outpatients with a diagnosis of copd (moderate as classified by the gold guidelines, 2008) and including: * smoking history of at least 10 pack years * post-bronchodilator fev1 \<80% and ≥50% of the predicted normal value (visit 2). * post-bronchodilator fev1/forced vital capacity (fvc) \<70% (visit 2). exclusion criteria: * patients who received any corticosteroid (including inhaled) for 3 months prior to screening other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd indacaterol qab149 inspiratory capacity
a study of ly2951742 in healthy japanese and caucasian participants

Conditions: Migraine Disorders

Summary: the main purpose of this study is to evaluate the safety of the study drug known as ly2951742 in healthy japanese and caucasians. the study will also investigate how the body processes the drug and how the drug affects the body. the study is expected to last about 5 to 7 months, depending on the arm.


Eligibility criteria:
inclusion criteria: * participants are either caucasian or first generation japanese. * participants' body mass index (bmi) is between 18.0 and 35.0 kilogram per meter square (kg/ m\^2). exclusion criteria: * participants are heavy caffeine drinkers defined by regular intake of more than 5 cups of coffee (or equivalent in xanthine containing beverages) per day, and/or are unable or unwilling to abide by caffeine restrictions as specified in the protocol. * participants are smoking within the previous 6 months. * participants have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing or have received a vaccination within 1 month. * participants have known allergies to ly2951742, related compounds or any components of the formulation, or history of significant atopy. * participants are allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.
effects of a psychotherapy intervention in depressed patients with coronary artery disease

Conditions: Depression; Coronary Artery Disease

Summary: in patients with coronary artery disease (cad), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. the aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with cad. therefore, depressed patients diagnosed with cad will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. the manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. the psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the type d personality, which may explain why recent cognitive behavioural psychotherapy (cbt) trials produced only small effects in depressed cad patients. the investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. it will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.


Eligibility criteria:
inclusion criteria: * patients with coronary artery disease * german speaking men and women * recent coronary angiogram (\<= 3 months old) * depression score (hads-d) \>= 8 * written informed consent exclusion criteria: * severe heart failure * other acutely life- threatening conditions * severe chronic inflammatory disease * current suicidal tendency * severe depressive episode * other severe mental illness.

Keywords: coronary artery disease depression psychotherapy randomized controlled trial
bemiparin versus enoxaparin in the prevention of venous thromboembolism among icu patients

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention among intensive care unit patients.

a prospective randomized trial to compare thromboprophylaxis using bemiparin and enoxaparin in critically ill patients in icu. the study included one hundred bedridden patients in intensive care unit who are at high risk for developing venous thromboembolism and require long term anticoagulation patients were divided into two groups each one consists of 50 patients. one group received bemiparin 3500 iu subcutaneous once daily and the other group received enoxaparin 40 mg subcutaneous once daily as a prophylaxis against thromboembolism. patients were followed up for 60 days for the development of deep venous thrombosis, pulmonary embolism and complications related to the injected anticoagulant.

Eligibility criteria:
inclusion criteria: * sepsis , stroke , major burn , respiratory failure , traumatic brain injury , malignancy and post arrest who are intubated and mechanically ventilated on continuous iv sedation exclusion criteria: * hypersensitivity to low molecular weight heparins , hypercoagulability , congenital or acquired bleeding disorder, prolongation of activated partial thromboplastin time or prothrombin time by 20% compared to normal values; thrombocytopenia (platelet count \ 200 mmhg; diastolic blood pressure \>100 mmhg\]; impaired kidney function: serum creatinine \> 2.0 mg/ dl and bleeding gastrointestinal ulcer.
the promus element rewards study

Conditions: Coronary Stenosis

Summary: this study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. the information gathered from the group that receives the promus element stent will be compared to other groups that receive other contemporary drug eluting stents.


Eligibility criteria:
inclusion criteria: * patients, male or female, 18 years or older; * patients with de-novo coronary lesions and slated to receive a promus element stent; * patients who are slated to undergo ivus after stent deployment during implantation procedure exclusion criteria: * patients receiving more than one drug-eluting stent within the same lesion during implantation procedure; * patients with in-stent restenosis; * patients who had ivus imaging attained with manual pullback.
safety and efficacy of degradable magnesium metal clips in surgical margins of radical surgery for malignant bone and soft tissue tumors

Conditions: Sarcoma, Soft Tissue; Sarcoma, Spindle Cell

Summary: to verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.

the purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. the study will be divided into two groups: experimental group: the tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. the lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. control group: the tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. electrocautery and suture ligation are used to handle the tumor bleeding sites. the lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Eligibility criteria:
inclusion criteria: 1. participants must be of either gender, aged between 18 and 65 years; 2. diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas; 3. must have undergone standard chemotherapy and require en bloc resection; 4. participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments. exclusion criteria: 1. severe dysfunction of the heart, liver, kidney, lung, or brain. 2. pregnant women or women who are breastfeeding. 3. history of autoimmune disease, hiv infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs. 4. history of syphilis (treponema pallidum), active infection with hepatitis b or c, and positive for verified antigens. 5. participation in any other clinical study currently or within 3 months prior to the screening visit. 6. patients have any other conditions that the researcher deems unsuitable for the study. age is between 18 to 75 years old.

Keywords: soft tissue sarcoma biodegradable magnesium metal
use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with crohns disease failing infliximab therapy

Conditions: Crohn's Disease

Summary: to compare treatment outcome in patients with crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (ab) status.


Eligibility criteria:
inclusion criteria: 1. patient must be able to understand the information given to him/her and give written informed consent. 2. definitive diagnosis of crohn's disease (confirmed by recent radiological, endoscopic and/or histological evidence according to international criteria) . 3. age minimum 18 years. 4. previous good response to at least 3 doses (5mg/kg) of infliximab (as judged by the treating physician). 5. loss of response to standard doses of infliximab (as judged by the treating physician). 6. last infliximab infusion given at least 4 weeks before inclusion. 7. for patients with luminal disease, the cdai should be above 220 points at inclusion. 8. for patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, mr, ultrasound or physical examination) should be present. exclusion criteria: 1. any contraindication to continued infliximab treatment 2. short bowel syndrome 3. bowel resection within 12 weeks of inclusion. 4. current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease. 5. pregnancy 6. history of alcohol or drug abuse within the prior year 7. patients who do not meet concomitant medication criteria. 8. any other condition, which in the investigator's judgment would make the patient unsuitable for inclusion in the study.