Kornimate/medical-research-clean huggingface dataset:
hypofractionated chemoradiotherapy and thymosin α1 in unresectable or recurrent thymic epithelial tumor

Conditions: Thymoma and Thymic Carcinoma

Summary: this phase ii study was to assess the efficacy and toxicity of hypofractionated radiotherapy (hrt) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (tets).

hrt using the imrt technique was administered. for patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (sbrt) could be used. all patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Eligibility criteria:
inclusion criteria: * pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors. * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria. * eastern cooperative oncology group (ecog) performance status 0-1. * unresectable disease or recurrent intrathoracic disease which could be encompassed within radiation fields. * white blood cell count ≥4×109 /l, neutrophile granulocyte count≥1.5×109 /l, platelet count≥100×109 /l, hemoglobin ≥100 g /l, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (uln),aminotransferase two times less than the uln. * fev1 \>0.8 l * cb6 within normal limits * patients and their family signed the informed consents exclusion criteria: * previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. * any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia). * malignant pleural effusion or pericardial effusion. * weight loss \>10% within the past 3 months. * recruited in other clinical trials within 30 days * drug addiction, long-term alcohol abuse and aids patients. * uncontrollable epileptic attack or psychotic patients without self-control ability. * severe allergy or idiosyncrasy. * not suitable for this study judged by researchers.

Keywords: unresectable or recurrent thymoma and thymic carcinoma hypofractionated chemoradiotherapy thymosin a1
pamneu - memory in neurology

Conditions: Cognitive Impairment

Summary: memory in neurology project (pamneu) aims to map the distribution and severity of cognitive impairment in patients of outpatient neurologic offices across the geographical area of the czech republic. 1000 patients in 50 neurologic offices will undergo cognitive tests (alba and picnir) and psychometric scales (faq-cz and gds-cz) to asses their functional state and depressive symptoms. the trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in neurologic care according to the icd-10. additionally, the feasibility of alba and picnir methods to uncover previously undiagnosed cognitive impairments will be evaluated.


Eligibility criteria:
inclusion criteria: * dispensarization of at least six months in an outpatient neurologic office with an icd-10 diagnosis * age\>=50 * permanent residency in the geographical area of the czech republic exclusion criteria: * diagnosis of mental retardation (f70-f79) according to icd-10 * refusal to sign the informed consent and consent with gdpr * uncorrected visual impairment * uncorrected auditory impairment * impairment of hand movement preventing the patient from filling in the questionnaires. * inability to participate in the project

Keywords: cognitive impairment outpatient neurologic service population distribution
a study to evaluate administration of sbt101 gene therapy in adult patients with adrenomyeloneuropathy (amn)

Conditions: AMN; AMN Gene Mutation; X-ALD

Summary: this is a phase 1/2 randomized, blinded, dose-escalation study to evaluate the safety and efficacy of intrathecal (it) administration of sbt101, a recombinant adeno-associated virus serotype 9 (aav9) containing a functional copy of the human adenosine triphosphate (atp)-binding cassette transporter subfamily d member 1 (abcd1; habcd1) gene, in adult patients with adrenomyeloneuropathy (amn) aged 18-65 years. patients will receive a single dose of sbt101 via it route (or an imitation procedure) and will be followed for safety and efficacy for 2 years. patients receiving sbt101 will be followed for an additional 3 years (5 total) for safety. patients receiving an imitation procedure will be offered the opportunity to receive sbt101 after 2 years, as data indicate.

the study consists of two parts after infusion of sbt101: part 1: a blinded 24-month core study period to evaluate the safety and potential impact of sbt101 on disease progression. part 1 will consist of 2 phases: phase 1: dose-escalation phase: two (2) doses of sbt101 (dose level 1 cohort and dose level 2 cohort) will be evaluated to establish the maximum tolerated dose (mtd). phase 2: dose-expansion phase: additional patients will be enrolled to receive sbt101 at the mtd part 2: an unblinded 3-year long-term safety follow-up period with annual follow-up visits to evaluate the safety of sbt101 and disease progression.

Eligibility criteria:
inclusion criteria: 1. diagnosed with x-linked adrenoleukodystrophy (ald), including proven mutation in the abcd1 gene through confirmatory genetic testing, and supported by elevated circulating vlcfa levels. 2. clinical evidence of spinal cord involvement but still able to ambulate independently exclusion criteria: 1. evidence of or past diagnosis of inflammatory cerebral disease. 2. 15 years or more have elapsed since the initial onset of myeloneuropathy manifestations such as walking or running difficulties, bladder dysfunction, increased muscular tone, spasticity, weakness, balance problems, etc. 3. contraindications for mri procedure and/or contrast materials. 4. contraindication to steroids, sirolimus, tacrolimus, and/or anesthetic medications. 5. unstable adrenal function (e.g., untreated or inappropriately treated adrenal insufficiency). 6. history of diabetes or abnormal fasting plasma glucose (≥126 mg/dl) or hemoglobin a1c ≥6.5%. 7. patients who have received a gene therapy.

Keywords: amn x-ald adrenoleukodystrophy x-linked adrenoleukodystrophy adrenomyeloneuropathy myeloneuropathy spastic paraplegia hereditary spastic paraplegia hsp ald abcd1 aldp cald ccald brain diseases, metabolic, inborn brain diseases, metabolic hereditary central nervous system demyelinating diseases leukoencephalopathies demyelinating diseases heredodegenerative disorders, nervous system metabolism, inborn errors peroxisomal disorders metabolic diseases adrenal insufficiency gene therapy aav9 adeno-associated vector
expanded access using allogeneic bone-marrow derived human mesenchymal stem cells (allo-hmsc) for a individual parkinson's disease subject

Conditions: Parkinson Disease

Summary: this is a expanded access use of allogeneic bone marrow-derived mesenchymal stem cells for a single subject with moderate parkinson's disease that has progressed.


Eligibility criteria:
persistence of the immune response to hepatitis b in 7-9 years old children previously vaccinated with dtpa-hbv-ipv/hib

Conditions: Hepatitis B

Summary: persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of hbv vaccine


Eligibility criteria:
inclusion criteria: * a male or female aged 7 to 9 years at the time of study entry . * subjects who have received a total of 4 doses of dtpa-hbv-ipv/hib vaccine or a total of 4 doses of hbv vaccine in previous vaccination studies. * evidence of previous hepatitis b booster vaccination or disease since administration of the fourth dose of dtpa-hbv-ipv/hib or hbv vaccine.

Keywords: prophylaxis for hepatitis b disease
predictors of infective endocarditis among patients managed for staphylococcus aureus bacteremia, particularly staphylococcus aureus bacteriuria, and time to blood culture positivity

Conditions: Bacteremia; Endocarditis, Bacterial

Summary: staphylococcus aureus is a frequent cause of primary or secondary bacteremia. it is also responsible for many cases of infective endocarditis, for which the therapeutic management is specific. the frequency of infective endocarditis among staphylococcus aureus bacteremias varies between 2.7% and 23.4%. many factors associated with the risk of developing endocarditis in patients with s. aureus bacteremia have been described. two parameters of potential interest remain excluded from this work: blood culture growth time, a marker of bacterial inoculum, and the presence of bacteriuria, which is common during bacteremia. the objective of this study is to evaluate the interest of these two parameters in the prediction of the presence of endocarditis during s. aureus bacteremia. investigators will conduct a retrospective study including all patients managed for staphylococcus aureus bacteremia and in whom a urine culture was performed. the primary objective is to describe the factors associated with the occurrence of endocarditis in patients managed for s. aureus bacteremia and who received a urine cytobacteriological examination (uce). the secondary objectives are: to evaluate the factors associated with the occurrence of s. aureus bacteriuria in patients with s. aureus bacteremia and to evaluate the risk factors for mortality in patients managed for s. aureus bacteremia.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age for whom: * blood cultures returned positive for s. aureus * a cytobacteriological examination of the urine was performed concomitantly with the positive blood culture for s. aureus * has been tested for infective endocarditis by echocardiography. * french-speaking patient exclusion criteria: * patient with s. aureus bacteremia who has not had an ecbu or echocardiography performed * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his or her data for this research
a trial investigating the mechanism of action of nnc0109-0012 (anti-il-20 mab) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to methotrexate

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of the trial is to investigate the mechanism of action of nnc0109-0012 (anti-il-20 mab) through synovial biopsies in subjects with rheumatoid arthritis (ra) and an inadequate response to methotrexate.


Eligibility criteria:
inclusion criteria: * male or female age at least 18 and below or equal to 75 years at the time of signing informed consent * a diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010 * subjects with acr global functional status of 1 to 3 * active ra, characterised by: das28 (disease activity score 28) (crp (c-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count * active synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency power doppler ultrasound scan at screening and randomisation exclusion criteria: * subjects with arthritis due to other autoimmune diseases than ra * body weight above 90.0 kg * history of or current inflammatory joint disease other than ra (e.g. gout, psoriatic or reactive arthritis, lyme disease, juvenile idiopathic arthritis, excluding secondary sjogren syndrome and hypothyroidism) * any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) * subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit * female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication * male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
open-label extension study of efficacy, safety and tolerability of secukinumab in patients with active lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in study cain457q12301 (nct04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (ln).

investigators used their clinical judgement to decide if it might be beneficial, in terms of overall improvement and response to therapy, for subjects to enter the extension study. the planned total combined duration for the core study and this extension study was five years. at week 104 of the core study cain457q12301, eligible subjects who completed the assessments associated with the core study visit subsequently continued in the extension study on the dose of secukinumab 300 mg administered every four weeks. a total of 31 subjects were enrolled and received secukinumab 300 mg every four weeks until study termination. recruitment in this study was stopped on 26-may-2023. this study along with the core study (cain457q12301) were terminated early by novartis due to futile results of interim analysis 1 of the core study. there were no safety related reasons for early termination of either of the studies.

Eligibility criteria:
key inclusion criteria: * subject must have both participated in core study and completed the entire treatment period up to and including week 104 of the core study cain457q12301. * subject must be deemed by the investigator to benefit from secukinumab therapy. * signed informed consent must be obtained prior to participation in the study. key exclusion criteria: * any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test. * women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in european union (eu) 20 weeks). highly effective methods of contraception are recommended due to the known teratogenic effect of soc (mpa).

Keywords: lupus nephritis secukinumab (ain457) estimated glomerular filtration rate urine protein-to-creatinine ratio standard of care background therapy
testing a training program to enhance emotional management skills and professional resiliency in healthcare providers

Conditions: Burnout, Professional; Adaptation, Psychological

Summary: the behaviour change institute (bci) was created in 2008 within capital health to provide healthcare providers with evidence-based skills in helping patients change. in addition, the bci has also become a resource within the organization to assist with other needed changes, such as helping healthcare providers use new or different procedures to provide better patient care. through our work at the bci we have identified the need to help healthcare providers to better cope with change. the purpose of this project is to implement and to evaluate an evidence-based professional resiliency training program for staff to help them better cope with change. this professional resiliency training program is based on an empirically supported form of therapy called acceptance and commitment therapy. the training takes the form of a hands-on, applied workshop designed to increase resiliency and flexibility in a workplace setting.

the behaviour change institute (bci) was created in 2008 within capital health to provide healthcare providers with behaviour change counselling skills. these skills are backed by evidence-based theory and competency training methods and are designed to be used by healthcare providers to help their patients change their behaviours. acquiring these skills involves change for the healthcare provider. through our work at the bci we have come to identify the need to help healthcare providers effectively manage their emotions in such situations in order to learn behavior change counselling skills and to continue to use them effectively over time. the ability to effectively manage emotions, including discomfort and distress, may differentiate between individuals who are able to successfully adopt and maintain new behaviours over time from those who do not (brown, lejuez, kahler, strong, \& zvolensky, 2005). that is, we have identified that there is a significant need to support healthcare providers to more effectively manage emotions in order to help them change. the acceptance and commitment therapy for the workplace program (act-w) is an evidence-based program designed to help individuals manage emotions and stress by learning skills to accept negative feelings, thoughts, and sensations and to move toward valued behaviours (flaxman, bond, livheim, hayes, 2013). the act-w program has been shown to increase the ability to manage emotions and stress (flaxman \& bond, 2010) and to increase the ability to learn new behaviours (bond \& flaxman, 2006; luoma et al., 2007; varra, hayes et al., 2008). the purpose of this project is to evaluate the implementation of the act-w training program for healthcare providers through the bci.

Eligibility criteria:
inclusion criteria: * employees (full time or part time; administrative or clinical) within service areas with managerial approval to attend the training program. exclusion criteria: * none
comparison of the effects of deep and moderate neuromuscular blockade on optic nerve sheath diameter

Conditions: Intracranial Hypertension

Summary: increased intracranial pressure (iicp) is a common problem in traumatic brain injuries and many medical diseases. early recognition of iicp can save lives. several invasive and non-invasive methods have been described for iicp diagnosis. in recent years, ultrasonographic measurement of optic nerve sheath diameter (onsd) has become a popular method due to its high sensitivity and specificity for iicp estimation. studies have shown that onsd's ultrasonographic measurement correlates with the iicp and can detect intracranial hypertension. the onsd measurement has advantages such as being easily applied by the clinician at the bedside, being non-invasive, providing immediate results, reproducibility and low cost. it is known that artificial carbon dioxide pneumoperitoneum created in laparoscopic surgeries increases intracranial pressure.however, it is not easy to estimate the degree of changes in icp during laparoscopic surgery under general anesthesia. in the literature, there are many studies on the sonographic measurement of optic nerve sheath diameter to evaluate the effects of trendelenburg position on intracranial pressure with the use of different anesthetic drugs in laparoscopic surgeries. in addition, there are studies reporting that deep neuromuscular blockade in laparoscopic surgeries increases surgical vision and decreases analgesic requirement in postoperative period. the relationship between neuromuscular block level and intracranial pressure is not clear. from this point of view, the investigators would like to evaluate the effect of moderate and deep neuromuscular block level on intracranial pressure by sonographic measurement of optic nerve sheath diameter in laparoscopic cholecystectomy operations performed with standard pressure artificial carbon dioxide pneumoperitoneum.


Eligibility criteria:
inclusion criteria: * between 18-65 years * asa i-ii * patients undergoing elective laparoscopic cholecystectomy exclusion criteria: * intracranial hypertension * glaucoma * chronic obstructive pulmonary disease * pseudotumor cerebri * cerebral venous sinus thrombosis * i̇ntraoperative hemodynamic instability * mean arterial blood pressure\<65 mmhg * body mass index\> 35 * asthma * kidney or liver problems * lupus * crohn's disease or ulcerative colitis * previously had any gastrointestinal bleeding * hypertension * peripheral arterial disease * angina, heart attacks, or mild or moderate heart failure * stroke

Keywords: optic nerve sheath diameter deep neuromuscular block moderate neuromuscular block intracranial hypertension
exemestane in combination with fulvestrant in postmenopausal women with hormone sensitive advanced breast cancer

Conditions: Breast Cancer

Summary: the purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.


Eligibility criteria:
inclusion criteria: * proven breast cancer * metastatic or locally advanced breast cancer * hormonally responsive disease defined as estrogen (er) and/ or progesterone receptor (pr) positive (\>10% staining by immunohistochemistry) * postmenopausal status * no more than 1 prior chemotherapy for stage iv metastatic breast cancer allowed * ecog (eastern cooperative oncology group) performance status 0-2 * adequate organ function * exclusion criteria: * no prior exemestane or fulvestrant * uncontrolled intercurrent illness including but not limited to: * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * myocardial infarction within the last 3 months * psychiatric illness/social situations that would limit compliance with study * lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease. * presence of bleeding diathesis or coagulopathy, patients requiring coumadin

Keywords: postmenopausal women