Kornimate/medical-research-clean huggingface dataset:
heterogeneity and evolution of hepatocellular carcinoma in post-transplant hcc recurrence

Conditions: Hepatocellular Carcinoma Recurrent; Liver Transplant; Complications

Summary: objective of study: this study will evaluate the heterogeneity and evolution pathway between primary hcc and tumor relapse after liver transplant. according to the "seed-soil" theory, the primary hypothesis of this study is that hcc patients with different molecular-subtype experience altered different pattern of post-transplant recurrence, thus may have altered postoperative recurrence-free survival (rfs). because the donors' liver construct different microenvironment for ctc(circulating tumor cells) colonization. the investigators design this translational study to ①explore potential high recurrent risk hcc molecular-subtypes which might benefit from neoadjuvant systematic therapy or early adjuvant systematic therapy;②identify the molecular subtype heterogeneity of primary and recurrent hcc to guide the precision medicine.

40 specimens will be obtained from the primary tumor during liver transplant surgery and biopsy/specimens from intrahepatic tumor or lung metastasis when the patients experience postoperative relapse. the molecular-subtype of hcc will be determined via whole exom sequence(wes), immunohistochemistry(ihc) and rna-seq.

Eligibility criteria:
inclusion criteria: * patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed * patients have post-transplant hcc recurrence(cohort 1), indication for being an candidate in the waiting list for liver transplant according to multidisciplinary board evaluation(cohort 2) * the time frame between liver transplant and diagnosis of post-transplant hcc recurrence\> 6 months * no prior hepatectomy or systemic therapy or local therapy (tace etc.) exclusion criteria: * history of oncological systemic treatment * early recurrence(\<6 months) * multiple organ transplantation
a pilot dose escalation trial of a densified chemotherapy association of docetaxel and epirubicin driven by mathematical modeling in metastatic breast cancer patients: the model1 study

Conditions: Metastatic Breast Cancer

Summary: to determine the maximum tolerated dose of a densified regimen of the association of docetaxel (dtx) and epirubicin (epi), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a formal procedure based on mathematical models in order to manage the severity of induced neutropenia. the models used in this project allow: * an optimal administration schedule of the planned total dose per cycle (number of infusions and calculating their rates and durations) * an individualization of the administration schedule from the second cycle (based on observations from the first cycle), and * an assessment of the risk of a dose-limiting toxicity event combining several severe non-hematological toxicities (conditioning the decision for dose escalation). using formal mathematical models the investigators expect controlling the hematological and non-hematological toxicities in order to realize the full series of six cycles of densified dtx+epi chemotherapy (2 weeks per cycle) for each patient. for each patient, chemotherapy is considered feasible if it is possible, in the absence of tumor progression, to consider 6 cycles of treatment without observing any serious adverse events and without: * patient death that may be related to the treatments; * decision of the patient to interrupt treatment for physical or psychological tolerance reasons; * decision of the investigator to discontinue treatment, in the absence of disease progression.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, * ecog performance status ≤ 2 * diagnosed with metastatic her2-negative hormone-resistant chemotherapy-naive breast cancers, previous adjuvant chemotherapy treatment are allowed. * histologically or cytologically proven breast cancer metastases or associated with ca 15-3 levels 50% above the normal value * hormone resistance defined by the presence of negative hormone receptors or disease progression within 6 months of the initiation of hormone therapy. * adequate renal and liver function (asat and alat \< twice the upper limit normal value (uln) if no liver metastases, or \< 4×uln if liver metastases; total bilirubin \< 2×uln), * adequate cardiac function (left ventricular ejection fraction (lvef) \> 50%), * neutrophils ≥ 1200/mm3 * platelets ≥ 105/mm3 exclusion criteria: * cerebral metastases and meningeal involvement, * other malignant diseases, * significant comorbidities, * previous chemotherapy for metastatic disease, or previous chemotherapy with a total cumulative dose greater than 600 mg/m² for epi or greater than 450 mg/m² for dtx

Keywords: drug combination accelerated chemotherapy mathematical model hematotoxicity individualized dosage
height, ulnar length and forearm function in multiple hereditary exostoses

Conditions: Exostoses, Multiple Hereditary

Summary: the purpose of the present registry is to describe the epidemiology of forearm deformities in patients with hereditary multiple exostoses and to identify, independent predictors of severity of the disease and potential association with genotypic patterns

hereditary multiple exostoses (hme) is a rare pediatric autosomal dominant disorder caused by loss-of-function mutations in the genes encoding the heparan sulfate (hs)-synthesizing enzymes ext1 or ext2. hme affects 1 in 50,000 people and has 100% penetrance but great variability in phenotypic expression. hme is characterized by formation of cartilaginous outgrowths, called osteochondromas or exostoses, next to the growth plates of many axial and appendicular skeletal elements, causing multiple, painful disfiguring and disabling skeletal deformities, and potential malignant transformation into peripherral chondrosarcoma. the involvement of upper-limb bones by hme is associated with greater loss of function than elsewhere in the body, but even here the loss of function may be limited. moreover, the constant relationship between height and ulnar length has long been recognized in forensic medicine and has been recently analyzed also in hme, in order to predict the clinical and functional outcomes of the upper limb. the present registry aims to collect demographic, clinical, functional and radiographic information from patients with hme in order to establish phenotypic predictors of severity of the disease and potential association with genotypic patterns

Eligibility criteria:
inclusion criteria: - patients with hme (\> 2 exostoses) exclusion criteria: * patients with solitary exostoses * patients, adults or minors, who are unable to give their timely informed consent.

Keywords: multiple hereditary exostoses, forearm, height, ulnar length
clinical evaluation of single versus multi-shade direct composite resin veneers

Conditions: Tooth Discoloration

Summary: the aim of this study was to clinically evaluate single and multi-shade direct veneers.

the use of direct, light-activated resin composites in esthetic restorative dentistry has grown dramatically in response to growing needs. recent developments have resulted in the creation of restorative materials and methods that, particularly in the anterior area, attempt to restore the natural appearance of the teeth. numerous clinical conditions, including tooth discolorations, severe fractures, misaligned teeth, and dental caries lesions, can significantly affect smile harmony and esthetic appearance, which can lower quality of life. modern cosmetic dentistry began with the introduction of laminate veneers in the 1970s, which combined the ideas of tooth conservation and aesthetics. because laminate veneers (lvs) offer the potential to satisfy the need for extremely beautiful, minimally invasive, long-lasting restorations with superior clinical performance, they have gained popularity as a treatment option. direct composite veneering preserves natural tooth structure, may be completed chairside, doesn't require repeated appointments, doesn't require luting agents, is minimally invasive, readily repaired, and is less expensive because there are no laboratory fees. furthermore, their abrasion rates are comparable to those of real tooth structures.

Eligibility criteria:
inclusion criteria: * good hygiene. * vital discolored anterior teeth exclusion criteria: * severe discoloration * para functional activities * non-vital teeth. * pregnancy

Keywords: omnichroma veneers usphs criteria
transient osteoporosis of pregnancy: a possible peptide mediator

Conditions: Transient Osteperosis

Summary: transient osteoporosis of pregnancy (toop) is uncommonly encountered in orthopedic and obstetric practice, with most reports consisting of single cases. this rare condition consists of significant osteoporosis affecting the hips and spine, causing significant morbidity, and putting young female patients at risk for vertebral and femoral neck fractures. the pathogenesis of transient osteoporosis of pregnancy is unknown, with various theories as to its etiology. recently, a number of reports have described elevated levels of pthrp in patients with transient osteoporosis in pregnancy and of the postpartum period our goal in this study is to assess the role of pthrp in transient osteoporosis of pregnancy


Eligibility criteria:
inclusion criteria: * signed informed consent
optisure lead post approval study

Conditions: Heart Failure; Tachycardia, Ventricular

Summary: the purpose of this post approval study is to characterize the chronic performance of the sjm optisure family of hv leads in patients.


Eligibility criteria:
inclusion criteria: eligible patients will meet all of the following: 1. have an approved indication, as per acc/aha/hrs/esc guidelines, for implantation of an icd or crt-d system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). 2. have been implanted with a st. jude medical optisure lead in the last 30 days or are scheduled for an optisure lead implant. 3. have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 4. are 18 years or above, or of legal age to give informed consent specific to state and national law. exclusion criteria: patients will be excluded if they meet any of the following: 1. enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by sjm, during the course of this clinical study. 2. have a life expectancy of less than 5 years due to any condition.

Keywords: hv lead icd crt-d system treatment of heart failure treamtent of life-threatening ventricular tachyarrhythmia optisure
french observatory for patients with type 3 glycogenosis

Conditions: Glycogen Storage Disease Type III

Summary: glycogen storage disease type iii (gsd-iii) or cori/forbes disease, is caused by autosomal recessive mutations in the agl gene, which codes for the glycogen debranching enzyme (gde) involved in the release of glucose-1p from glycogen branches. abnormal glycogen accumulation is responsible for frequent hypoglycaemia and symptoms in the liver and striated muscles (gsd-iiia), although some patients present with liver involvement only (gsd-iiib). in childhood, the phenotype is mainly characterised by hepatomegaly, short stature and hypoglycaemia, with minimal skeletal muscle involvement. while liver symptoms improve spontaneously around puberty, skeletal muscle weakness develops progressively in adulthood and becomes a major feature of gsd-iiia. currently, there is no treatment other than dietary management tailored to the individual to limit glycogen storage and avoid hypoglycaemia. the french gsd-iii registry is a multicentre online registry dedicated to patients with type iii glycogen storage disease followed in france. it has been approved by ethical and regulatory authorities. its main inclusion criteria is the presence of a proven pathogenic agl gene mutation and/or reduced glycogen debranching enzyme activity. the aims of the registry are to provide a tool for recording detailed diagnostic, metabolic, neurological, cardiac and biological data on french patients with gsd-iii, so as to enable i) a precise natural history of the disease, ii) identification of the outcome measures most sensitive to disease progression, iii) assessment of the frequency of the various complications of the disease and iv) identification of prognostic factors.


Eligibility criteria:
inclusion criteria: * patients with molecularly characterised glycogen storage disease type iii exclusion criteria: * patients diagnosed with gsd type 3 refusing to take part in the study
evaluation of pain location, pain quality and pain patterns in subjects with chronic pain

Conditions: PAIN; CHRONIC DISEASE

Summary: in earlier work, the sponsor developed a computer image processing system for analysis of pain diagrams from patients with chronic pain. this system was then tested in a study in over 500 chronic pain patients seen by both primary care practitioners and pain specialists. the hypothesis was that pain location would correlate with the pain type and the underlying cause of the pain. in the study, the computer analysis demonstrated clear correlations between pain diagram data and diagnosis/pain type. the present study extends these observations in a web-based setting, with a focus on the value of computer analysis of pain diagrams as diagnostic predictors.

earlier work performed by the sponsor (tmt) included development of a matlab/imagej computer image processing system for generation of composite images from pain diagrams drawn by patients with pain, and for calculation of related quantitative variables. the system was tested in a pharmaceutical company-sponsored us study in over 500 chronic pain patients seen by primary care practitioners, and then seen by pain specialists. the hypothesis was that pain location would correlate with the pain type and the underlying cause of the pain. tmt's analysis established correlations between the pain diagram information and the underlying diagnosis and pain type (e.g., nociceptive or neuropathic) reported by the pain specialists. the present study extends these observations in a web-based setting, with particular emphasis on automated computer-generated visual pain patterns as diagnostic predictors.

Eligibility criteria:
inclusion criteria: * male and female subjects at least 18 years of age and of legal age of consent for the state in which they live. * able to respond to a questionnaire written in english. * report chronic pain (constant or recurring pain lasting more than 30 days and causing significant discomfort or limitation of activity). * provide informed consent to participate in the study. exclusion criteria: * currently participating in another clinical trial. * institutionalized person such as a prisoner or nursing home resident. * questionnaire response suggests a medical or psychological condition that, in the opinion of the investigator, would compromise participation in the study, or suggests any other condition which, in the investigator's judgment, might increase the risk to the subject or decrease the chance of obtaining valid data. * pain has resulted in a workman's compensation case. * pain has resulted in litigation.

Keywords: chronic pain pain computer analysis pain diagrams
pharmacokinetics, pharmacodynamics, and impact of inorganic nitrate on exercise in hfpef

Conditions: Heart Failure; Diastolic Heart Failure

Summary: this study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in hfpef. there are two primary goals for this study: 1. determine the population-specific pharmacokinetics and dose of kno3 that can be safely given to subjects with hfpef. 2. determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak vo2), and physiologic adaptations to exercise.

this study randomized subjects to either placebo (n=3) or kno3 (n=9) given a sequential dosing regimen: 6 mmol twice daily for 1 week followed by dose escalation to 6 mmol thrice daily for 1 week). although a primary goal of the study was to assess the safety of kno3 and within-group changes in various end points in kno3-treated subjects, a small number of placebo-treated (pb, n=3) subjects were included only to assess for any potential training effect on repeated exercise and kansas city cardiomyopathy questionnaire (kccq) measurements. potassium chloride, given in equivalent doses, was used as the pb to account for differences in blood pressure or flow that could be attributed to potassium. the study was initially designed to be single-blinded to allow the principal investigator to be aware of arm allocation because of potential concerns for methemoglobinemia with drug administration. one investigator, who was the primary investigator responsible for supervising all visits and measurements during the study, remained blinded to treatment allocation throughout the entirety of the study. all physiological and imaging data were analyzed in a double-blind manner.

Eligibility criteria:
inclusion criteria: 1. nyha class ii-iii symptoms. 2. lv ef \> 50%. 3. stable medical therapy for at least 1 month. 4. evidence of significant diastolic dysfunction, meeting the european society of echocardiography criteria for hfpef. exclusion criteria 1. any rhythm other than sinus with native conduction. 2. inability to exercise. 3. moderate or greater valvular disease. 4. hypertrophic, infiltrative, or inflammatory cardiomyopathy. 5. pericardial disease. 6. current angina. 7. acute coronary syndrome or coronary intervention within the past 2 months. 8. primary pulmonary arteriopathy. 9. clinically significant lung disease. 10. ischemia on stress testing without subsequent revascularization. 11. treatment with phosphodiesterase inhibitors that cannot be withheld. 12. treatment with organic nitrates or allopurinol. 13. significant liver disease impacting synthetic function or volume control. 14. poor echocardiographic windows. 15. egfr \ 2.5. 16. current smoking. 17. alcohol dependency. 18. history of barret's esophagus. 19. g6pd deficiency 20. methemoglobinemia - baseline methemoglobin level \>3% prior to any study medication.
use of fish oils to reduce the frequency and duration of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation.

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes. atrial fibrillation is a heart condition which effects a large percentage of the population . atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted . certain pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation. fish oil supplements may be of benefit to patients with heart problems.recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances. by interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker. exclusion criteria: * patients with chronic atrial fibrillation
deep brain stimulation (dbs) of the nucleus basalis meynert (nbm) to treat cognitive deficits in light to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: in the study at hand, six patients with light to moderate alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis meynert.

in the study at hand, six patients with light to moderate alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis meynert. the stereotactic implantation of the electrodes will be guided by computerized tomography (ct) and magnetic resonance tomography (mrt). basically, even though deep brain stimulation is an invasive method, there are only few side effects. surgical risks correspond with the risk of dbs in morbus parkinson or other movement disorders (0,4-6%). after the baseline examination, the patients will be implanted with the electrodes; accordingly all follow-ups are accomplished postoperative. from the second week after the operation, the conventional stimulation takes place as a doubleblind, randomized change between on and off periods. modifications of the stimulation parameter to obtain the best possible result are possible. throughout the one-year observation-period, the patients will be followed closely to monitor the effects of dbs on their cognitive abilities, psychopathological well being, the quality of life, praxie and nutritional condition using standardized neurological and psychiatric rating scales.

Eligibility criteria:
inclusion criteria: * german speaking male/female subjects * age:60-80 * ad assessed by dsm-iv, icd-10 and nincds-adrda-scale * no lewy-body-dementia or other form of dementia * mmst \>18 and \<26 * stable psychopharmacological medication * no psychotic symptoms, no suicidal tendency * education for at least 8 years * written informed consent of the patient * consent of at least two family members * no contraindication regarding pet-examination * no contraindication regarding anesthesia or stereotactic operation exclusion criteria: * legal accommodation * clinical co-morbidity * contraindication of mrt examination * psychotic symptoms last six months * aggressive behavior or suicidal tendency * verbal iq \<85 * stereotactic operation in previous history * neoplastic neurological diseases * serious organic disease

Keywords: (light to moderate)
pilot study to clinical evaluate lacrima medical device in insomnia patients

Conditions: Chronic Insomnia

Summary: the study will assess the safety, tolerability and feasibility of lacrima investigational medical device vs. sham device in adult patients with chronic insomnia


Eligibility criteria:
main inclusion criteria: 1. adult subjects, 18 years of age and older at screening 2. diagnosis of primary insomnia based on international classification of sleep disorders, revision no 2 3. total score of pittsburgh sleep quality questionnaire is \> 5 4. latency to persistent sleep is \> 30 minutes based on pittsburgh questionnaire 5. able to understand and provide written informed consent main exclusion criteria: 1. patients using any pharmacological treatments for insomnia for 14 days 2. patients currently using stimulants drugs 7 days 3. patients currently using antidepressants causing sleepiness 4. patients who are unable to commit to avoid consumption alcohol during the study 5. patients who are unable to commit to avoid consumption caffeine after 12 pm 6. patients who have a clinical significant or unstable medical or surgical condition

Keywords: insomnia, medical device, sleep latency