Kornimate/medical-research-clean huggingface dataset:
chemoradiotherapy in elderly patients with oesophagus cancer

Conditions: Oesophagus Cancer; Elderly Patients

Summary: management of elderly patient with cancer is a therapeutic challenge and a public health problem. the mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. surgery is a standard treatment reserved to about 30 % of patients. the other 70 % are considered unfit for surgery for various reasons, including ageing. chemoradiotherapy (crt) is standard treatment for patients with esophageal cancer unfit for surgery. the validated treatment scheme is external beam radiotherapy (ebrt) 50 gy over 5 weeks combined with cisplatin and 5fu infusion. however it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. crt has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.

choice of the combined chemotherapy carboplatin and taxanes delivered concurrently to radiotherapy is attractive. a dutch randomized study (cross trial) compared preoperative crt to surgery in 368 patients with t1-t3 and n0n1. in the preoperative crt group, patients received 41.4 gy by ebrt over 5 weeks combined with carboplatin (auc 2) and paclitaxel (50 mg/m2). a 30 % tumor sterilization rate and a reduction of metastasis considered a distant effect of chemotherapy were observed. the 5-year survival was statistically better with crt group. the preoperative crt was well tolerated and few acute toxicities were observed. intriguingly, in a french randomized study, conducted in less locally advanced disease, the combination of 45 gy and 5 fu infusion and cisplatin did not induce more tumor sterilization rate, suggesting carboplatine/paclitaxel is more effective than 5fu/cisplatin in crt. study design since the optimal doses of each component radiotherapy- carboplatin - paclitaxel are unknown, we plan to conduct a phase i/ii study * phase i: the objective is to determine the maximum tolerated dose (mtd) and recommended doses for phase ii (rp2d) of each component considering the treatment scheme of dutch study as reference: * for chemotherapy 3 levels: 50%, 75% and 100% of the standard dutch dose (carboplatin auc 2 and paclitaxel 50 mg/m2) * for radiotherapy 3 levels: 41.4 gy/1.8 gy/f; 45 gy/1.8 gy/f; 50.4 gy/1.8 gy/f basel level being : 41.4 gy and 50% of standard ct doses the phase i is conducted with increasing doses of each component with 9 levels. * phase ii: after the determination of rp2d of each component, the study is continued as a phase ii in order to assess tumor response secondary objectives: quality of life, progression free and overall survivals

Eligibility criteria:
inclusion criteria: * esophageal cancer, squamous and adenocarcinoma types, t1-3, n0-1, m1a (tnm 6th), * age \> 75 years, * who status \< 2, balducci 1, adequate bone marrow reserve, normal renal and hepatic function. exclusion criteria: * age \< 75 years

Keywords: oesophagus cancer
biomarkers in patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: dna analysis of tumor tissue may help doctors predict how well patients will respond to treatment. purpose: this research study is studying biomarkers in patients with head and neck cancer.

objectives: * to determine the mutation rates of hras and pik3ca in patients with head and neck squamous cell carcinoma (hnscc) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ecog-e5397. * to determine the association between hras or pik3ca mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ecog-e5397. outline: dna is isolated from one unstained slide per patient. the mutations in hras and pik3ca are determined using beaming technology.

Eligibility criteria:
disease characteristics: * treated on protocol ecog-e5397 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage iii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the lip and oral cavity stage iii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the paranasal sinus and nasal cavity stage iv squamous cell carcinoma of the hypopharynx stage iva squamous cell carcinoma of the larynx stage iva squamous cell carcinoma of the lip and oral cavity stage iva squamous cell carcinoma of the oropharynx stage iva squamous cell carcinoma of the paranasal sinus and nasal cavity stage ivb squamous cell carcinoma of the larynx stage ivb squamous cell carcinoma of the lip and oral cavity stage ivb squamous cell carcinoma of the oropharynx stage ivb squamous cell carcinoma of the paranasal sinus and nasal cavity stage ivc squamous cell carcinoma of the larynx stage ivc squamous cell carcinoma of the lip and oral cavity stage ivc squamous cell carcinoma of the oropharynx stage ivc squamous cell carcinoma of the paranasal sinus and nasal cavity untreated metastatic squamous neck cancer with occult primary
diagnostic value of exome/ genome sequencing, conventional methods in rare diseases and familial tumor syndromes

Conditions: Rare Diseases; Genetic Predisposition

Summary: for the retrospective data analysis, patients with genetic diseases of any age and, if available, other family members, for whom genetic analyzes were carried out between 10/2016 and 12/2020, should be included. this equates to approximately 13,000 records, minus combined analyzes in the same patient, an estimated 12,000 individuals.

the methodological developments of the last few years allow the broad use of next-generation-sequencing (ngs) -based methods in the routine molecular genetic diagnosis of genetic diseases.the aim of the retrospective data analysis is to create a solid data basis for further discussion regarding the development and mapping of diagnostic algorithms and subsequent supply routes. for the genome data, this evaluation is to be expanded to include the evaluation of the polygenic risk scores (prss) in the sense of an additional finding.

Eligibility criteria:
inclusion criteria: * patient with genetic disease or * family members * genetic analysis between 10/2016 and 12/2020 at the institute for medical genetics and applied genomics at the university hospital tübingen exclusion criteria: - none

Keywords: rare diseases genetic predisposition next generation sequencing (ngs) polygenic risk scores (prss) repeat-expansion genetic variation
99tc-mdp in postmenopausal women with differentiated thyroid cancer and osteoporosis

Conditions: Differentiated Thyroid Cancer; Osteoporosis

Summary: postmenopausal women with differentiated thyroid cancer (dtc) taking suppressive doses of levothyroxine (l-t4) are thought to have accelerated bone loss and increased risk of osteoporosis. therefore, the investigators try to investigate the effects of 99tc-mdp,alendronate sodium in postmenopausal women with dtc under tsh suppression and osteoporosis.

differentiated thyroid cancer (dtc) has become one of the most common endocrine malignancies. according to american thyroid association (ata) and chinese thyroid association (cta), most of dtc patients undergo total or near total thyroidectomy, radioiodine ablation and tsh (thyroid stimulating hormone) suppression. osteoporosis (os) and fractures are important comorbidities in patients with dtc, with potential negative impact on quality of life (qol) and survival. the main determinant of skeletal fragility in dtc is the tsh suppression. postmenopausal women with dtc under tsh suppression therapy are more vulnerable to os. technetium-99 methylene diphosphonate (99tc-mdp) is a decay product of 99mtc-mdp (used for bone scintigraphy) and a novel bisphosphonates, which has been used in china for diseases like rheumatoid arthritis (ra), ankylosing spondylitis (as) and osteochondral lesions of the talus, etc. however, as a member of bisphosphates, little attention has been paid to its anti-os effect for dtc under tsh suppression.

Eligibility criteria:
inclusion criteria: (1) they were pathologically diagnosed with dtc including papillary or follicular carcinoma. (2) they received a near total thyroidectomy and radioiodine treatment. (3) tsh suppression should be at least one year before the study. (4) bone mineral density (bmd) in lumbar spine and/or hip was tested by dual-energy x-ray absorptiometry (dxa) at baseline, 6 month (m) and/or 12m follow up. 5) the diagnosis of osteoporosis was t-score ≤-2.5 sd at the lumbar spine, or hip. exclusion criteria: 1. patients having medications for osteoporosis before tsh suppression treatment; 2. secondary osteoporosis ; 3. severe liver or kidney disease; 4. myelosuppression; 5. digestive disease; 6. long term use of immunosuppressive agent, estrogen or estrogen receptor modulators. this study was approved by the institutional review board of hospital research ethics. all the patients were fully acquainted with their treatment and consented to participate in the clinical trial.

Keywords: differentiated thyroid cancer bone mineral density thyroid stimulating hormone suppression
surgical surveillance trial to evaluate a shortened infusion time of intravenous ibuprofen

Conditions: Pain

Summary: the primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.


Eligibility criteria:
inclusion criteria: * patients scheduled for surgery with anticipated need for postoperative analgesia exclusion criteria: 1. patients with inadequate iv access 2. patients \<18 years of age 3. history or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (nsaids) 4. active hemorrhage or clinically significant bleeding 5. pregnant or nursing 6. patients in the peri-operative period in the setting of coronary artery bypass graft (cabg) surgery 7. inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an institutional review board \[irb\]), and agree to abide by the study restrictions 8. refusal to provide written authorization for use and disclosure of protected health information
ultra sounded guided posterior transverse abdominis plane & lateral femoral cutaneous nerve blocks analgesia post hip hemiarthroplasty

Conditions: Postoperative Pain

Summary: combined ultrasound guided posterior trans versus abdominal plane \& lateral femoral cutaneous nerve blocks for postoperative analgesia after hip hemiarthroplastic surgery

to evaluate the effectiveness of postoperative analgesia for hip hemiarthroplastic surgeries by using ultrasound guided posterior trans versus abdominal plane \& lateral femoral cutaneous nerve blocks

Eligibility criteria:
inclusion criteria: * hemiarthroplaty surgery * asa 1 - asa 4 exclusion criteria: * allergic to local anesthetics * patient refusal
study evaluating changes in bone mineral density (bmd), and safety of rhbmp-2/cpm in subjects with decreased bmd

Conditions: Osteoporosis

Summary: the main purpose of this study is to assess whether a locally-administered rhbmp-2/cpm injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. all subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin d (all taken by mouth). subjects that are randomly selected to receive treatment with rhbmp-2 will receive an injection directly into the hip. the injection is given in a surgery room using a light anesthesia.


Eligibility criteria:
inclusion criteria: * community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years. * bmd t-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. subjects with bmd t-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present: * age greater than 75 years * family (maternal) history of fragility fracture * previous fragility fracture (self) after age 45 * subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy. exclusion criteria: * metabolic bone disorder or disease affecting bone and mineral metabolism (eg, paget's disease, vitamin d deficiency \[ less than 20 ng/ml\], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia). * coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months. * inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (sle), spondyloarthropathy, reiters syndrome, or crohns disease.

Keywords: bone mineral density bone morphogenetic protein osteoporosis
prevalence of strokes secondary to a reversible cerebral vasoconstriction attributable to cannabis consumption in young subjects (≤ 45 years) hospitalized for an ischaemic stroke

Conditions: Stroke; Cannabis Use

Summary: incidence of strokes has increased these last 20 years in young population. this rise could be linked to alcohol, tobacco or drug use like cannabis. cannabis has previously been descripted as a potential factor of reversible vasoconstriction. the main objective is to show that an exhaustive assessment of a stroke facing a young person frequently lead to a diagnostic of reversible vasoconstriction due to cannabis use. evaluation will focus on prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in young subjects. there's a real public healthcare interest in terms of primary and secondary prevention to evaluate the role of cannabis as a risk factor of stroke in young population.


Eligibility criteria:
inclusion criteria: * subject between 18 and 45 years old * stroke confirmed by medical imaging * written informed consent (subject, nearby or emergency procedure) * subject affiliate to a local healthcare insurance office * for female of childbearing potential, an adequate contraceptive measur exclusion criteria: * subject with psychiatric disorder, unable to understand the study or cooperate * subject under guardianship or forfeiture of liberty * pregnant or breastfeeding woman * subject in period of exclusion due to another study or still in follow-up of an interventional study
nasal photodisinfection in all patients presenting for surgery for a wide range of surgical procedures

Conditions: Surgical Site Infections; Nosocomial Infection; Healthcare Associated Infections

Summary: this is a phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (apdt) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.

the purpose of the proposed study is to gather data regarding the safety and efficacy of nasal photodisinfection treatment in eliminating colonization of the anterior nares with s. aureus. the anterior nares are often considered the primary reservoir of s. aureus and other pathogens on the body, therefore, this product could play an important role in helping to eliminate this pathogen reservoir in patients. since photodisinfection is a non-antibiotic approach that does not generate antibiotic resistance, this could be a beneficial approach to achieving nasal disinfection. additionally, photodisinfection has an extremely broad spectrum of activity and is effective against bacterial, viral, and fungal pathogens including emerging pathogens such as c. auris. this is a phase 2 study. nasal cultures will be performed on all patients admitted for surgery at memorial health university medical center over a 1-month period. this will determine the prevalence rate of s. aureus and other pathogens in community patients who are being admitted for surgery. the results of this culture will not be known to the research staff until several days later. clinical trial subjects will universally receive a nasal disinfection treatment followed by a post-treatment culture. this will demonstrate the efficacy of nasal disinfection against staphylococcus aureus and methicillin-resistant staphylococcus aureus.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form within 30 days of surgery. 2. stated willingness to comply with all study procedures and availability for the duration of the study. 3. male or female ≥ 18 years of age. 4. patient being admitted for a surgical procedure. 5. ability to tolerate a 4-minute non-painful nasal light illumination. exclusion criteria: 1. male or female \<18 years of age. 2. inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants. 3. known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate. 4. nasal obstructions precluding placement of light illuminator.

Keywords: staphylococcus aureus photodynamic therapy photodisinfection methylene blue nasal decolonization surgical infections
neurotropism and neuroinflammation in covid-19 patients with delirium.

Conditions: Covid19; Delirium; Post-traumatic Stress Disorder

Summary: emerging evidence indicates that sars-cov-2, the etiologic agent of covid-19, can cause neurological, neuropsychological and psychiatric complications. given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of covid-19. therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that covid-19 may have on the central nervous system. these putative effects include the possibility that the cns serves as a reservoir for the virus, and that covid-19 triggers cns deleterious inflammatory cascades and neurodegenerative process. the public implications of these effects are very important in the long term.

the brainstorm project aims at creating a proof-of-concept dataset from severe covid-19 patients with delirium. for the first time, this longitudinal study will rely on repeated and concomitant: i) sars-cov-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - csf), ii) systemic and central immune response characterization, associated to the assessment of cns damage biomarkers (peripheral blood and csf), iii) in vivo brain pet-tspo acquisitions (positon emission tomography using a radioligand that targets the translocator protein, which is upregulated in activated microglia), iv) structural/functional brain mri assessment (pwi/dwi mismatch imaging, quantification of gray and white matter microstructural integrity, dti, functional connectivity), v) multi-domains neurocognitive assessment. this dataset will be made fair to allow open data use and to prepare future studies.

Eligibility criteria:
inclusion criteria: * adult patients (male or female \> or = 18 years) * covid-19 (positive respiratory track pcr test \< 30 days) * delirium (cam-icu criteria) * informed and written consent to participate in the study by patient's surrogate. exclusion criteria: * medical decision of withdrawal of life sustaining treatments previous to patients recruitment * former neurological or psychiatric disability * mri or pet scan contraindication * pregnancy * hemodynamic or respiratory failure precluding patient's transport / mri or pet scanning

Keywords: covid-19 delirium microglial activation sars-cov-2 neurotropism
pharmacokinetic study of alpelisib in subjects with hepatic impairment.

Conditions: Hepatic Impairment

Summary: to characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.


Eligibility criteria:
inclusion criteria: -other then hepatic impairment, subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram (except for additional inclusion criteria for hepatic impaired subjects). -subjects must weigh at least 50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2. additional criteria for hepatic impaired subjects: -subjects must have a score clinically determined and calculated as per the child-pugh classification and consistent with the degree of hepatic impairment in which study is currently enrolling. -stable child-pugh status within 28 days prior to dosing. exclusion criteria: all subjects: * subject has received a liver transplant at any time in the past and is on immunosuppressant therapy. * smokers not willing to limit the use of tobacco to 10 cigarettes per day. -surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject's safety in case of participation in the study. -use of any herbal medications/supplements. history of acute pancreatitis within 1 year of study entry. additional criteria for subjects with normal liver function: -use of any prescription or non-prescription medication. -positive hepatitis b surface antigen (hbsag) or hepatitis c test result. additional criteria for hepatic impaired subjects: -use of any prescription or non-prescription medication, that has the potential to interact with alpelisb. concomitant medications without potential to interact with alpelisib must be stable in dose. -encephalopathy grade 3 or worse. -total bilirubin \> 6 mg/dl. screening or baseline ecg: qtcf\>480msec for both genders other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hepatic impairment healthy volunteers clinical pharmacology study byl719 alpelisib