Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of sitaxsentan in the treatment of pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: this is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with nyha functional class ii, iii or iv). the purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. patients who complete this trial may be eligible to take part in an extension trial (protocol fph01-x). eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.


Eligibility criteria:
inclusion criteria: 1. nyha class ii, iii or iv 2. 16 to 75 years of age 3. specific peak vo2 range 4. pph, pah due to connective tissue disease or select congenital heart disease 5. qualifying cardiac catheterization 6. history of cxr and qualifying pulmonary function test 7. history of qualifying ventilation-perfusion lung scan 8. history of qualifying echocardiogram 9. women of childbearing potential must use contraceptives 10. stable dose of corticosteroids if prescribed exclusion criteria: 1. significant lung disease 2. chronic liver disease 3. uncontrolled sleep apnea 4. history of specific types of left heart disease 5. any disorder that compromises ability to give informed consent 6. uncontrolled sleep apnea 7. inability to perform bicycle exercise test 8. on-going treatment with an experimental drug or device within the last 30 days 9. hiv infection 10. specific liver dysfunction 11. chronic renal disease 12. pregnancy/nursing 13. chronic active hepatitis b or c 14. chronic flolan or tracleer use within the last 30 days
21dif039: prone to supine breast mri ii, p2s2 breast mri trial

Conditions: Breast Cancer Female

Summary: the purpose of this study is to determine whether a supine breast mri obtained with a second intravenous injection of gadolinium contrast immediately after a standard clinical prone breast mri will provide sufficient tumor visualization to allow a radiologist to define and outline the tumor edges ("segment" the tumor). accurate segmentation will allow a 3-d image of the tumor to be generated to create a breast cancer locator (bcl) surgical device to in aid removal of breast cancers.

the clinical pre-operative breast mri exam will be obtained in the prone position with intravenous (iv) gadolinium (gd) contrast injection per standard of care clinical protocol. after completion of the standard clinical prone breast mri, the participant will be re-positioned and the investigative supine breast mri protocol with a second dose of iv gd will be obtained. a second dose of contrast equal to the first dose will be given, and additional images will be obtained in the supine position. subtraction images will be generated for both the prone and the supine sequences. it is hypothesized that the second contrast injection will generate tumor-to-fibroglandular contrast differences such that supine subtraction images will allow visualization and segmentation of the tumor equal to prone segmentation images. it is expected that the addition of a second injection of contrast will improve the ability to visualize and accurately segment the supine post-gd images. while the total dose of gadolinium delivered in two injections is twice the amount normally given during a clinical prone breast mri, this total dose is equal to that administered for other clinical mri studies such as cardiac mri. no additional imaging or testing will be required for this research study following the standard clinical mri.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. female gender. 3. histologic diagnosis of invasive breast cancer or ductal carcinoma in situ. 4. tumor size at least 1 cm in diameter as visualized on mammogram or us. 5. a staging, pre-operative breast mri is considered to be clinically indicated. 6. ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted. exclusion criteria: 1. absolute contraindication to mri, including presence of implanted electrical device. (pacemaker or neurostimulator incompatible with mri), aneurysm clip, or metallic foreign body in or near eyes. 2. severe claustrophobia. 3. contraindication to the use of gadolinium-based intravenous contrast, including anaphylaxis. any known history of nephrogenic systemic fibrosis (nsf). 4. history of median sternotomy. 5. pregnancy. all women of child-bearing age will be questioned about possible pregnancy status. in women who are unsure of pregnancy status, a urine pregnancy test will be performed. 6. patients who have received neoadjuvant chemotherapy for their current diagnosis. 7. known compromised renal function including chronic, severe kidney disease (gfr \< 30 ml/min/1.73m2), or acute kidney injury.
digital literacy intervention to address support, literacy and communication in older adults

Conditions: Quality of Life; Aging; Technology; Literacy

Summary: the investigators propose a person-directed, values-based digital literacy intervention to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home. this intervention will be a way to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home.

this is a one-arm pilot trial to test the feasibility and acceptability of the intervention digital literacy pilot intervention to address support, literacy and communication in older adults. each participant will receive 4-6 home visits with 3-4 interim phone calls based on the participant's individual digital literacy needs and goals. each participant will receive internet connectivity (if not already available), a tablet (if not already available) and tailored action plans co-developed by the participant and the interventionist. in each participant will also have pre and post-intervention visits with the research team. in earlier phases, research team members conducted preliminary activities to design the intervention using human-centered design techniques.

Eligibility criteria:
inclusion criteria: * aged 65 years old or older * english proficient * willingness to improve digital literacy exclusion criteria: * severe cognitive impairment as defined by a 6-item callahan cognitive screener * hospitalization overnight more than 3 times in the last 12 months by self-report.

Keywords: literacy digital intervention older adults technology
genetic predisposition for chronic non-specific low back pain

Conditions: Low Back Pain

Summary: patients with inflammatory back pain were shown to differ from healthy controls in genotype of the angiotensin-converting enzyme (ace), which regulates vasoconstriction/-dilatation. the aim of this study is to investigate whether genetic reduction of muscle perfusion might be a pathophysiological pathway of how genes influence chronic non-specific low back pain (lbp).

the following genes will be investigated: * insertions-/deletions-polymorphism of the angiotensin-converting enzyme (ace-i/d gene polymorphism; 3 genotypes: ace-ii, ace-id, ace-dd). * anti-adhesive extracellular matrix protein tenascin-c: gene polymorphism rs2104772 the goals of this study are to investigate whether these genotypes correlate with 1) endurance of back muscles, 2) comorbidities such as asthma and diabetes and 3) the risk for lbp as assessed by a lbp-classification tool.

Eligibility criteria:
inclusion criteria: * 18-65 exclusion criteria: * spinal surgery * spinal fracture * inflammation * tumour * severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)
does preoperative sleep quality affect the postoperative emergence delirium in children undergoing strabismus surgery

Conditions: Postoperative Delirium; Strabismus; Sleep Disorder

Summary: sleep is important in maintaining the physiological function of the human body. recently several studies have reported that preoperative sleep quality is associated with postoperative emergence delirium (ed) the ed is a common in pediatric patients undergoing general anesthesia with sevoflurane, but studies on the association of sleep quality have been rare. the investigators, therefore, aimed to investigate the relationship between postoperative delirium and pre and postoperative sleep quality in pediatric patients receiving strabismus surgery through this study

this study aimed on pediatric patients aged 4-12 years, undergoing elective strabismus surgery. informed consent was obtained from both parents and children on the day of pre-anesthetic evaluation visit. the child and his or her parents were questioned on preoperative patient's sleep quality based on pittsburg sleep quality index (psqi). surgery was performed under the same anesthesia as usual. after the operation, extubation was performed and patient was moved to post anesthesia recovery room (pacu). during the stay in pacu, one investigator measured degree of ed by watcha and paed (post anesthesia emergence delirium ) scale to minimize bias. one day after the surgery, the investigator mede a phone call to the parents of the patient to obtain information for postoperative psqi.

Eligibility criteria:
inclusion criteria: * healthy children without any underlying diseases * 4\~12 years old * undergoing strabismus surgery exclusion criteria: * any underlying diseases * disagree

Keywords: postoperative delirium sleep quality pediatric anesthesia strabismus surgery
comparative effects of methylprednisolone and prednisolone on the risk of acute decompensated heart failure - an emulated target trial

Conditions: Heart Failure; With Decompensation

Summary: the investigators aim to emulate a target trial to compare the risk of acute decompensated heart failure in users of methylprednisolone compared to prednisolone. the exposure is prescriptions of methylprednisolone or prednisolone tablets and the primary outcome is heart failure hospitalizations within the following 6 months, i.e. acute contacts with secondary or tertiary health care resulting in a primary diagnosis of heart failure. secondary outcomes include broader heart failure diagnoses and the initiation of loop diuretics. data preparation includes an initial observation period of 2 years, inclusion criteria such as age, corticosteroid formulation types / dosages and prescription codes, as well as removal of duplicate prescriptions and measures to reduce potential carry-over effects.


Eligibility criteria:
1. individuals aged \< 18 years in january 2008 will be excluded 2. analyses will be restricted to tablets, as prednisolone is only available in this form. 3. to allow for equipotent dose comparisons, we will focus only on 4 mg and 16 mg methylprednisolone and their counterparts in prednisolone at 5 mg and 20 mg, respectively. patients with other doses will be excluded. 4. to facilitate comparisons of treatments prescribed for similar conditions, we will only include prescriptions with an international classification of diseases, 10th edition (icd10) or international classification of primary care, 2nd edition (icpc2) refund code. 5. patients with prescriptions for diagnosis codes including palliative care, cancer symptoms, medical complications, and organ transplants will be excluded. this exclusion aims to reduce the inherent heterogeneity within these groups, allowing for a more comparable baseline risk. 6. an initial 2-year observational period, spanning from january 2008 to december 2009, will be used to establish comorbidities. accordingly, only prescriptions of methylprednisolone or prednisolone dispensed from january 2010, onward, will be eligible for analyses. 7. to minimize the risk of carry-over effects, we will exclude all prescriptions prescribed \ 6 months since the last prescription was dispensed (see section 7 for justification for why a 6-month interval was chosen). 8. duplicate prescriptions (same date, drug and dosage) will be kept in the analyses as a single treatment course. cases of duplicate prescriptions on the same date, but where the drug or dosage is different will be excluded. 9. baseline of the treatment course will be defined as the date when the prescription of either methylprednisolone or prednisolone was dispensed.

Keywords: methylprednisolone prednisolone emulated target trial
a safety, efficacy and pharmacokinetic study of btct4465a (mosunetuzumab) as a single agent and combined with atezolizumab in non-hodgkin's lymphoma (nhl) and chronic lymphocytic leukemia (cll)

Conditions: Lymphocytic Leukemia, Chronic; Lymphoma, Non Hodgkin

Summary: this is a phase 1/2 dose-escalation study of btct4465a (mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory b-cell nhl and cll. the study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility criteria:
key inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * b-cell hematologic malignancies expected to express the cluster of differentiation 20 (cd20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival * adequate hepatic, hematologic, and renal function key exclusion criteria: * pregnant or lactating women * monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug * treatment with radiotherapy within 2 weeks prior to the first btct4465a (mosunetuzumab) administration * systemic immunosuppressive medication within 2 weeks prior to study drug * autologous stem cell transplantation (sct) within 100 days prior to study drug, or any prior allogeneic sct or solid organ transplantation * autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia * history of central nervous system (cns) lymphoma or other cns disease * significant cardiovascular or pulmonary disease * hepatitis b or c or human immunodeficiency virus (hiv) * receipt of a live attenuated vaccine within 4 weeks prior to study drug * prior treatment with chimeric antigen receptor t-cell (car-t) therapy within 30 days before first btct4465a (mosunetuzumab) administration
impact of clinical care pathway on prognosis and therapeutic medical care of infective endocarditis

Conditions: Infective Endocarditis (IE)

Summary: infective endocarditis (ie) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. however, the mortality increase despite recent diagnosis and therapeutic advances. only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. in fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. in addition, epidemiologic studies concern only a part of ie, not including most of the time the patients hospitalized in non-referent center. the aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. secondary objectives was (i) to evaluate the application of european recommendations concerning trans-oesophageal echocardiogram (toe), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center. for this, 300 patients addressed in the 22 french participating centers for a possible or certain ie according to duke criteria were prospectively included during 3 years. patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.


Eligibility criteria:
inclusion criteria: - adult with infective endocarditis episode according to duke criteria exclusion criteria: * patients with a new episode of infective endocarditis that led to its prior inclusion in the study
safety and tolerability of tozadenant as adjunctive therapy in levodopa-treated patients with parkinson's disease.

Conditions: Idiopathic Parkinson Disease

Summary: phase 3, international, multicenter, open-label 12 month safety study.

each patient will participate for up to 52 weeks, which includes a screening period, followed by a baseline visit and open-label treatment for 1 year with a safety follow-up 4 weeks after the last treatment. * screening period: up to 6 weeks. * open-label treatment period: 52 weeks (1 year) * post-treatment safety follow up: 4 weeks.

Eligibility criteria:
inclusion criteria: * patient understands study requirements and has given his/her written informed consent on an institutional review board (irb) or independent ethics committee (iec) approved consent form. * parkinson's disease diagnosis consistent with uk parkinson's disease society brain bank diagnostic criteria * minimum of 3 years since diagnosis. * meet hoehn and yahr pd stage * good response to levodopa * stable regimen of anti-pd medications * patients must have been taking a levodopa-containing anti-pd medication continuously for at least the previous 12 months * patient has documented a minimum amount of off time. * if of childbearing potential (male and female) must use an acceptable method of contraception exclusion criteria: * previous tozadenant study participation * current or recent participation in another study. * secondary or atypical parkinsonism * neurosurgical intervention for pd (except dbs if electrode placement has been performed over 12 months prior to screening) * patient is taking apomorphine, budipine, istradefylline, tolcapone, or duopa™/duodopa® * treatment with excluded medications * untreated or uncontrolled hyperthyroidism or hypothyroidism * clinically significant out-of-range laboratory * mmse out of range * current episode of major depression (stable treatment for depression is permitted). * recent suicide attempt or suicidal ideation type 4 or type 5 of the columbia-suicide severity rating scale (c-ssrs) * women lactating or pregnant * hypersensitivity to any components of tozadenant or excipients * abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study * history of hepatitis or cholangitis

Keywords: motor fluctuations off time on time dyskinesia
human bone graft for hallux valgus correction according to the austin procedure

Conditions: Hallux Valgus

Summary: this observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.

for the treatment of bone fractures metal screws have been used for decades. removal of material is the major disadvantage of conventional osteosynthesis and requires a second intervention, with all the complications and risks for each patient. moreover, the metal screw disturbs as foreign material in the bone and irritates the surrounding soft tissue. in order to overcome the drawbacks of metal screws human bone screw grafts can be used instead representing a biodegradable osteosynthesis material with ideal material properties. the bone graft helps to create a solid, bony connection. this connection leads to an extension, a bone remodeling, bone installation and optimal reparation process in the affected area. this observational study is being conducted in order to overcome the lack of systematic research to objectively confirm the benefits of the product. in total 50 patients will be enrolled in this study in several centers in austria this observational study will use shark screw® grafts manufactured by two tissue banks, the austrian tissue bank surgebright and the german institute for cell and tissue replacement (dzig). the shark screw® grafts were approved by the competent austrian authority (ages) in 2016. all patients participating in this observational study, due to a medical indication, undergo hallux valgus correction according to the austin procedure using the bone screws mentioned above. a 12 month postoperative observation period is set. five routine follow-up examinations including clinical examination and x-ray analysis will be performed. in case the an additional routine follow-up examination is necessary for clinical reason within 24 month post-operative, the patient remains in the study.

Eligibility criteria:
inclusion criteria: * indication for the use of a human bone graft in the surgical treatment of hallux valgus treatment using austin procedure * legal capability of adults * written consent to participation in the study after previous written and oral education * age ≥ 18 years exclusion criteria: * insufficient knowledge of the german language * alcohol and drug abuse * pregnant or breastfeeding woman * foreseeable compliance issues * neoplastic diseases, malignant bone tumors, rheumatoid arthritis * active osteomyelitis * ulcerations in the area of the skin of the surgical area * revision surgery after primary hallux valgus surgery

Keywords: human bone graft screw foot and ankle surgery hallux valgus deformity
weekly docetaxel plus cisplatin or oxaliplatin for agc

Conditions: Stomach Neoplasm; Stage IV; Recurrent

Summary: to evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. the primary endpoint will be the response rate.

gastric cancer is the most frequently occurring malignancy in korea, and is one of the main causes of cancer death. while treatment options for agc have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. this altered toxicity profile suggests a potential for better tolerance and increased dose intensity.

Eligibility criteria:
inclusion criteria: * histologically proven gastric cancer * aged 75 years or less * performance status 0 to 2 * no prior chemotherapy * inoperable, recurrent, or metastatic * normal marrow, hepatic and renal functions exclusion criteria: * active infections * severe co-morbidities * pregnant or lactating women * active brain metastasis * neuropathy of grade 2 or higher