Kornimate/medical-research-clean huggingface dataset:
a phase iv study to evaluate safety, tolerability and effectiveness of rivastigmine patch 15cm2 in patients with severe dementia of the alzheimer's type.

Conditions: Alzheimer's Disease

Summary: this was a multicenter, prospective, phase iv study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm\^2 transdermal patch prescribed in patients with severe dementia of the alzheimer's type as per discretion of treating physician.

this was a multicenter, prospective, single-arm, open-label, phase iv study to evaluate safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm\^2 transdermal patch prescribed in patients with severe dementia of the alzheimer's type as per discretion of treating physician. male and female patients who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent. the prescription decision was independent of the decision for inclusion in the study.

Eligibility criteria:
inclusion criteria: 1. patients willing to participate in the study by providing written informed consent. 2. patients diagnosed with severe dementia secondary to alzheimer's disease (ad) 3 .patient's prescribed with rivastigmine 27mg -15 cm\^2 transdermal patch as per discretion of treating physician exclusion criteria: 1. contraindication as per pi 2. patients simultaneously participating in other studies 3. use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) /until the expected pd effect has returned to baseline (for biologics)\], whichever is longer. 4. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

Keywords: alzheimer, rivastigmine
circulating tumor dna in patients at high risk for lung cancer

Conditions: Cancer of the Lung; Lung Cancer; Lung Neoplasms; Adenocarcinoma of the Lung; Non Small Cell Carcinoma of the Lung; Small Cell Carcinoma of the Lung

Summary: patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor dna (ctdna) to validate the utility of molecular diagnostic assays for the early detection of lung cancer.

specific somatic (i.e. acquired and not inherited) mutations have been found in many cancers. some of these cancers shed this dna into the patient's blood stream and is called circulating tumor dna (ctdna). pathway genomics has developed a new molecular assay that uses blood plasma as the source of dna fragments. the ctdna is isolated, amplified and analyzed for the presence of one or more of 96 known mutations that are found in 9 cancer driver genes. this technique of using a "liquid biopsy" to screen for and monitor cancer has been documented in a number of recent medical publications. however, the majority of published studies are on subjects who have already been diagnosed with cancer. therefore, the investigators wish to look at a population of patients who are scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy without a know history of cancer (other than basal cell carcinomas of the skin). the blood will be drawn at the time of or a few weeks before the procedure. the analysis of the blood sample will take placed in the pathway genomics clinical laboratory which is clinical laboratory improvement amendments of 1988 (clia) certified. following an informed consent process, the patients will fill out a health questionnaire and will have the blood drawn prior to the surgical procedure. up to 30 ml of blood (approximately 2 tablespoons) will be drawn at any one time. the patient will be asked to agree to being contacted by the investigators yearly for up to 5 years to provide follow-up medical information. no patient will be identified in presentations or publications resulting from this work and all data will be reported from analysis of combined information from participants in this study. individuals may participate in this study if they are 18 years of age or older, have not had a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic surgical procedure for a cancer that was diagnosed within the prior month), and are undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed). exclusion criteria: * prior history of cancer.

Keywords: lung cancer lung neoplasms lung nodules screening tests for cancer
long-term open-label extension trial for subjects completing the phase 3 trial of fesoterodine (sp583) for the treatment of overactive bladder syndrome

Conditions: Overactive Bladder Syndrome

Summary: this trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (spm 907) in subjects with overactive bladder syndrome. subjects completing the 12 week treatment period of sp583 had the opportunity to participate if eligibility was confirmed. they received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis. two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy. secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of quality of life questionnaires (khq and iciq-sf). the most important safety variables included the assessment of adverse events, laboratory parameters, changes in ecg, physical exams and measurement of residual urine.


Eligibility criteria:
inclusion criteria: * participated in sp583 exclusion criteria: * failure to complete 12 week treatment with spm 907
combination trial of tipifarnib and alpelisib in adult recurrent/ metastatic head and neck squamous cell carcinoma (r/m hnscc)

Conditions: HNSCC

Summary: this phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a pi3k inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (hnscc) whose tumors overexpress the hras protein and/or are pik3ca-mutated and/or pik3ca-amplified.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. histologically confirmed head and neck cancer of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). 3. documented treatment failure from at least 1 prior systemic therapy in the r/m setting, unless determined not appropriate. 4. measurable disease by response evaluation criteria in solid tumors (recist) v1.1. 5. has a tumor that is dependent upon hras and/or pik3ca. 6. eastern cooperative oncology group (ecog) performance status of 0-1. 7. acceptable liver, renal, endocrine, and hematologic function. 8. must be able to swallow alpelisib whole tablet or oral suspension containing crushed tablets. feeding tube may not be used for alpelisib administration. 9. other protocol defined inclusion criteria may apply. exclusion criteria: 1. histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (eg, mucosal melanoma). 2. ongoing treatment with certain anticancer agents. 3. prior treatment (at least 1 full treatment cycle) with an fti or pi3k, mtor, or akt inhibitor. 4. received treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months. 5. non-tolerable grade 2, or ≥ grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of cycle 1 day 1. 6. major surgery, other than diagnostic surgery, within 2 weeks prior to cycle 1 day 1, without complete recovery. 7. active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. 8. participant with an established diagnosis of diabetes mellitus type 1 or not controlled type 2. 9. participant has impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of the trial drugs based on investigator discretion. 10. participant has currently documented pneumonitis/interstitial lung disease. 11. participant has a history of severe cutaneous reaction, such as stevens-johnson syndrome (sjs), erythema multiforme (em), toxic epidermal necrolysis (ten), or drug reaction with eosinophilia and systemic symptoms (dress). 12. other protocol defined exclusion criteria may apply.

Keywords: hras pik3ca pi3k tipifarnib alpelisib r/m hnscc (recurrent/metastatic head and neck squamous cell carcinoma) head and neck cancer scchn
prognostic significance of preoperative nutritional status on postoperative acute kidney injury

Conditions: Acute Kidney Injury; Pneumonectomy

Summary: the incidence of postoperative acute kidney injury (aki) is high in patients undergoing lung resection surgery, especially in the elderly. early identification of high-risk postoperative aki patients can help develop prevention and treatment management strategies.

the goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (gnri), prognostic nutritional index (pni), and controlling nutritional status (conut) score - on postoperative aki in elderly patients under lung resection surgery.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 65 years 2. lung resection surgery including：pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy. exclusion criteria: 1. patients with an american society of anesthesiologists (asa) physical status v. 2. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 ml/min/1.73 m2 or receiving haemodialysis). 3. those did not have sufficient data required for nutritional evaluation or aki evaluation.

Keywords: acute kidney injury lung resection surgery malnutrition prediction model
role of concentration of biomarkers s100b and nse in serum in mild and moderate head trauma

Conditions: Biomarkers

Summary: in pediatric age groups communication difficulties very sometimes may present further obstacles in obtaining a detailed injury history and early identification of tbi symptoms. most emergency management protocols are focused exclusively on the identification of the relatively small number of patients who may require operative intervention, as early surgery is believed to improve outcome.

however early rehabilitation can also be effective for the much larger number of patients who do not require surgery\[1\] in addition, hall and others recently reported that low doses of ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood. \[2\] accordingly, increased serum concentrations of, for example s100b ( a calcium-binding protein present in high concentrations in glial cells) and neurone-specific enolase ( nse: a cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect the presence and severity of brain tissue damage in acute head injuries. \[3\] in both pediatric age and adults.

Eligibility criteria:
inclusion criteria: * only head trauma without any other body injury exclusion criteria: * blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.

Keywords: s100b, nse moderate brain trauma mild brain trauma
the national amyotrophic lateral sclerosis registry

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this registry is to (a) better describe the incidence and prevalence of amyotrophic lateral sclerosis (als) in the united states;(b) examine appropriate factors, such as environmental and occupational, that may be associated with the disease; (c) better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and (d) better examine the connection between als and other motor neuron disorders that can be confused with als, misdiagnosed as als, and in some cases progress to als.

the national als registry's research notification system allows person with als to participate in clinical trials.

Eligibility criteria:
inclusion criteria: - u.s. citizens 18 years of age or older exclusion criteria: -

Keywords: amyotrophic lateral sclerosis lou gehrig's disease motor neuron disease
the burden of peripheral artery occlusion disease and associated factors in peritoneal dialysis patients

Conditions: Peripheral Vascular Diseases

Summary: the investigators want to evaluate the burden of peripheral artery occlusion disease in taiwan peritoneal dialysis (pd) patients by using ankle-brachial pressure index (abi) and toe-brachial pressure index (tbi). furthermore, the investigators hope to demonstrate the possible casual factors of peripheral artery occlusion disease (paod) in pd patients.


Eligibility criteria:
inclusion criteria: * receive stable peritoneal dialysis patients for more than 3 months exclusion criteria: * active infection, malignancy and recent hospitalization

Keywords: peritoneal dialysis
construction and validation of a tool for automatic identification of care pathways at risk of sub-optimality in the management of severe infections in children (diabact iv)

Conditions: Severe Infection

Summary: community bacterial infection remains to this day a common cause of morbidity and mortality in children, which preventability is a challenge for clinicians. in a previous work, the investigators found that 76% supported children admitted to the icu for severe bacterial infection were appraised as suboptimal and significantly associated with an increased risk of death. in this context, the investigators seek to identify indicators of extractable data pmsi and sniir -am associated with a higher risk of suboptimal early taking care of children with severe bacterial infection in order to combine them and use them as a score or decision tree that the investigators will validate data from a national prospective multicenter study including 512 children admitted to the icu for severe infection. the investigators then propose a score associated with a risk of suboptimality care to evaluate the performance of the healthcare system .


Eligibility criteria:
inclusion criteria for retrospective inclusions: * all children from 1 month to 15 years and 3 months admitted in pediatric resuscitation; * community with severe bacterial infection defined by a bacterial infection documented by the presence of a bacterium from a normally sterile site (pleural cerebrospinal fluid joint fluid, blood, bone biopsy ...), a positive urine culture on a sampling done in aseptic conditions accompanied by a febrile illness (eg pyelonephritis), or purpura fulminans in the absence of documentation. inclusion criteria for prospective inclusions: * the inclusion criteria diabact iii will be expanded to include children 0-1 months. * parents and patient (if applicable) who signed the consent biocollection for participation in the substudy. exclusion criteria: * nosocomial infections as defined by the ministry of health in its january 2007 issue on nosocomial infections namely: nosocomial infections are infections acquired in a healthcare facility. infection is considered nosocomial if it was absent at the time of admission of the patient in the health facility. when the infectious status of the patient at admission is unknown, the infection is generally considered nosocomial if it occurs after a period of at least 48 hours of hospitalization or a period longer than the incubation period of the infection. in case of surgical site infection, the period commonly allowed is 30 days, or if it has been set in place a prosthesis or implant, a year after the intervention. * children with whooping cough, bronchiolitis or viral infections

Keywords: severe infection, pediatrics, sub-optimal care, term care
special drug use investigation for lamictal® (long term)

Conditions: Epilepsy

Summary: the objectives of this post-marketing surveillance (pms) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (aed), and to confirm its efficacy.


Eligibility criteria:
inclusion criteria: * subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of lennox-gastaut syndrome * subjects who are treated with lamotrigine tablets exclusion criteria: * none
canadian outpatient vte management registry

Conditions: Medical Prevention Therapy

Summary: primary objective: - to obtain prospective, clinical practice-based data on how symptomatic vte is managed with low molecular weight heparin (lmwh) enoxaparin in canadian outpatient settings. secondary objective: * to describe the demographic and clinical characteristics of patients with symptomatic vte including characteristics of vte, vte risk factors and bleeding risk factors. * to assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high bmi, impaired creatinine clearance, advanced age, cancer-associated vte. * to assess the degree of adherence in clinical practice to consensus guidelines (accp/american college of chest physician 2008) for the management of acute vte, vis a vis: * appropriate dosing of enoxaparin * recommended duration of initial lmwh therapy * adequate overlap of lmwh with vitamin k antagonists (vka) * recommended duration of longterm vka * frequency of use of lmwh monotherapy to treat cancer-related vte * to access safety outcomes (including bleeding and recurrent vte) * to describe the utilization of resources due to bleeding and recurrent vte during the treatment period.


Eligibility criteria:
inclusion criteria: * objectively confirmed vte * initiation of enoxaparin treatment within day 0-10 after diagnosis of vte: * outpatients who will be treated with enoxaparin + vka in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study * outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study. exclusion criteria: - medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
liothyronine and heart failure. the long term effect of liothyronine on left ventricular ejection fraction (lvef)

Conditions: Heart Failure; Low T3 Syndrome

Summary: purpose: the purpose of the study is to examine if treatment with liothyronine increases left ventricular ejection fraction (lvef) in patients with stable, chronic heart failure.

the patients are examined 3 times. at baseline, after 3 months and after 6 months.after the examination is performed, they begin the study medication while admitted at dept. of cardiology, herlev hospital, for cardiac monitoring.

Eligibility criteria:
inclusion criteria: * patients with stable, chronic systolic heart failure * t3 ≤1.4 nmol/l in two blood samples, tsh is to be normal * lvef ≤ 45 % on prior echocardiography exclusion criteria: * established thyroid illness * atrial fibrillation/flutter * more than 20% ventricular extrasystoles * severe chronic obstructive lung disorder * pregnancy. pregnancy testing will be done for fertile women * age \< 18 years

Keywords: heart failure liothyronine low t3 syndrome
effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial)

Conditions: Rotator Cuff Tendinosis; Rotator Cuff Injuries; Shoulder Tendinitis; Calcific Shoulder Tendinitis; Calcification Tendon; Calcific Tendinitis; Shoulder Pain

Summary: the aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.

rotator cuff calcific tendinopathy (rcct) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. conservative interventions such as extracorporeal shockwave therapy (eswt) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (us-pict) have been commonly recommended as part of the early management for this clinical condition. exercise therapy (et) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with rcct yet. a randomised, single-blinded four parallel group clinical trial will be conducted. participants (n=116) will be randomised in four groups: (1) et; (2) eswt; (3) us-pict or (4) control.

Eligibility criteria:
inclusion criteria: * calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, mri or x-ray); * pain and loss of function in the shoulder; * not currently receiving physiotherapy or eswt. exclusion criteria: * previous treatments on last year (e.g., injections, eswt, us-pict, surgery, etc.); * other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability); * known allergy to any of the pharmacological products used in the study; * taking oral anticoagulants * taking oral steroid within the six months prior to participation in the study; * cancer, systemic disease, pregnancy or infection; * neck pain.

Keywords: exercise therapy lavage rotator cuff calcific tendinopathy shoulder calcification extracorporeal shockwave therapy ultrasound-guided percutaneous irrigation shoulder pain shape up my shoulders sums
biomarker of lung injury in ards patients receiving ecmo support

Conditions: ARDS; Multi-organ Failure

Summary: the goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ards patient survival rate and better post-icu life quality.

the investigators will first identify acute respiratory distress syndrome (ards) patients receiving ecmo support in icu at national taiwan university hospital, and then collect blood, urine and bronchioalveolar lavage fluid (balf) samples at different time points: before setting up ecmo, 2, 6, 12, 24, 72 hours,5 and 14 days after ecmo installment, time to wean ecmo and the day removing ecmo and leaving icu. from the samples, the free radicals, cytokines (il-1, il-6, il-8, il-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. the novel biomarkers to predict the outcome of the patient will be identified.

Eligibility criteria:
inclusion criteria: 1. \>18 years old 2. ards, needing ecmo support exclusion criteria: 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.

Keywords: acute respiratory distress syndrome (ards) extracorporeal membrane oxygenation (ecmo) biomarker