Kornimate/medical-research-clean huggingface dataset:
radiotherapy of the prostate and the pelvic lymph nodes after neoadjuvant antihormonal treatment

Conditions: Prostate Cancer

Summary: for patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. however, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. the platin trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. a higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.

the platin trial is designed as a prospective, non-randomized, five-arm trial. arm 1: definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate. arm 2: as arm 1, with additional boost to macroscopic lymph node metastases. arm 3: postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed. arm 4: as arm 3, additional boost to macroscopic lymph node metastases. arm 5: patients with previous radiotherapy to the prostate bed. radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer with gleason score * risk of lymph node involvement \>20% (according to roach formula), pelvic lymph node metastases in ct/mri or histologically confirmed lymph node involvement * karnofsky index \>/= 70% * age 18-75 years * neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy * written informed consent exclusion criteria: * stage iv (distant metastases) * lymph node metastases outside the pelvis * rising prostate-specific antigen (psa) under antihormonal treatment * severe wound complications after laparatomy * severe lymph edema of the legs, elephantiasis, postthrombotic syndrome * decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy * history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin) * previous irradiation of the pelvic lymph nodes * concurrent participation in a clinical trial that might influence the results of either trial
why in hospital after vats lobectomy

Conditions: Carcinoma, Non-Small-Cell Lung; Pain, Postoperative; Postoperative Nausea and Vomiting; Infection; Air Leakage; Atrial Fibrillation

Summary: the study aims to identify specific or potential reasons that prolong the length of hospital stay after video-assisted thoracoscopic surgery lobectomy. the hypothesis is that patients who are still in hospital after video-assisted thoracoscopic surgery lobectomy are associated with prolonged air leak, infection, pneumonia, atrial fibrillation or other complications or social factors.


Eligibility criteria:
inclusion criteria: * patients referred to elective vats lobectomy * speaks and understands danish * informed consent obtained exclusion criteria: •age \< 18 years

Keywords: in hospital lobectomy video-assisted thoracoscopic surgery
a trial to learn if receiving aln-pnp sirna is safe and well tolerated, and how it works in adult participants with nonalcoholic fatty liver disease (nafld) and a genetic risk factor

Conditions: Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH); Genetic Risk Factor

Summary: this study is researching an experimental drug called aln-pnp. this study is focused on participants who are known to have nonalcoholic fatty liver disease (nafld), and a specific variant of the patatin-like phospholipase domain containing 3 (pnpla3) gene. the aim of this study is to see how safe, tolerable, and effective the study drug is. this study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how the study drug works to change liver fat content in nafld * how much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in your blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) * better understanding of the study drug and nafld


Eligibility criteria:
key inclusion criteria: 1. participants from 18 (or country's legal age of adulthood) to 65 years of age, inclusive, at screening visit 1 2. body mass index (bmi) from 23.0 kg/m\^2 to 40.0 kg/m\^2, inclusive, for east asians (including but not limited to south koreans, chinese, taiwanese, and japanese) and bmi from 27.0 kg/m\^2 to 40.0 kg/m\^2, inclusive, for any other ethnicity at screening visit 1 3. meets genotype criteria for the rs738409:g pnpla3 risk allele: homozygotes (for part a and part b) or heterozygotes (optional part c); p.i148m variant (pnpla3 rs738409:g \[p.i148m\]) at screening visit 1 4. liver fat content ≥8.5% as measured by mri-pdff at screening visit 3 5. generally stable diet (based on participant's recall) for at least 3 months prior to the screening visit key exclusion criteria: 1. evidence of other forms of known chronic liver disease, as defined in the protocol 2. has a contraindication to mri examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve), severe claustrophobia, or other contraindications for mri 3. is taking a medication to treat a co-morbid condition that is not permitted during the study 4. has any laboratory parameter assessments at screening, as defined in the protocol 5. history of type 1 diabetes 6. bariatric surgery within approximately 5 years prior or planned during the study period 7. has lost or gained more than 4.0% body weight over the 3 months prior to or during the screening period 8. has known human immunodeficiency virus (hiv) infection, evidence of current or chronic hepatitis b virus (hbv) infection, or current or chronic hepatitis c virus (hcv) infection, as defined in the protocol 9. was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit note: other protocol defined inclusion/exclusion criteria apply

Keywords: homozygous heterozygous
accelerated itbs for depression and suicidality

Conditions: Major Depressive Disorder; Suicide

Summary: the overall objective of this current study is to evaluate the feasibility, safety, and tolerability of "high dose" aitbs in psychiatric inpatient and outpatients with treatment-refractory unipolar, non-psychotic major depressive disorder, using patients receiving ect as an active comparator. developing a better understanding of the feasibility and tolerability of adapting this treatment to an acutely ill patient population could lead to huge breakthroughs for clinician decision-making and for the further optimization of brain stimulation depression protocols. the results of this study can help guide future confirmatory efficacy trials of high-dose aitbs by providing a better understanding of how feasibility, safety and tolerability compare to ect, as well as unforeseen challenges of its use.


Eligibility criteria:
inclusion criteria: * • ability to provide informed consent * availability for the duration of the study and willingness to comply with all study procedures * age 18 to 90 * diagnosis of major depressive disorder by dsm-5 criteria * depressive symptoms are thought to be caused primarily by a major depressive episode and not by some other neurologic or psychiatric illness * failure of or intolerance to at least 2 antidepressant treatments of different therapeutic classes (can include psychotherapy trial or neurostimulation trial) * meets criteria for clinical eligibility for ect treatment, including optimization of any medical conditions and completion of any medical testing or clearance as clinically indicated * able to consent voluntarily to treatment * score of at least 2 on the madrs item 10 * ability to sit or lie down for an extended period of time and willingness to adhere to the theta burst stimulation protocol exclusion criteria: * • presence of implanted ferromagnetic devices or materials, including cardiac pacemaker, cochlear implant, deep brain stimulation device, vagus nerve stimulation device, shrapnel, facial or scalp piercings that cannot be removed, or metallic face or head tattoos * pregnancy or lactation * previous bad reaction or intolerance to transcranial magnetic stimulation * febrile illness within 1 week * treatment with another investigational drug or other intervention within 30 days * recent substance abuse or use disorder within the past 6 months, excluding tobacco or infrequent cannabis use * history of epilepsy or seizure disorder * history of penetrating traumatic brain injury, multiple sclerosis, or history of brain surgery or intracranial hemorrhage * primary psychiatric or medical/neurologic illness other than mdd that is more likely to account for depressive symptoms, including severe personality disorder or psychotic illness * severe or moderate intellectual disability * major neurocognitive disorder * involuntary commitment or petition filed for involuntary ect treatment

Keywords: transcranial magnetic stimulation, theta burst, accelerated tms, ect, electroconvulsive therapy, depression, suicidality
total infectome characterization of eye infections

Conditions: Eye Infections; Diagnosis

Summary: multiple pathogens can cause eye infection. in recent years, emerging and resurging viral infections represent an important public health problem. many emerging viruses cause infectious diseases involving ophthalmic manifestations, including mpox virus, zika, ebola, and sars-cov-2. broad and unbiased pathogen surveillance is essential, so we design this unbiased metagenomic sequencing based study to investigate the total infectome of eye infections. the study is historical and prospective in design.

this is an investigator-initiated observational study to describe the total infectome of eye infections using metagenomic sequencing. the eye infections, including acute conjunctivitis, keratitis, uveitis, and endophthalmitis, are diagnosed by experienced ophthalmologists according to routine clinical exams. for the collection of additional biological samples apart from the diagnosis and treatment process, written informed consent is required from the eligible subjects or their legal guardians at the recruitment time is required. the application for exemption of informed consent has been made for using clinical surplus samples. after completing informed consent, subjects will be sampled, and their clinical information will be collected. biospecimens, including conjunctival sac swabs (1 swab for each involving eye), or intraocular fluid (more than 100μl), will be collected for metagenomic sequencing using the illumina novaseq x plus platform. the clinical information of participants will be collated from electronic medical record information system, including (1) demographic characteristics: age, sex, comorbidities; (2) laboratory examination: blood routine test, immune inflammatory factors, clinical microbiology examination (pcr, serological examination, culture, etc.); (3) imaging examination: anterior segment photograph, corneal endothelial cell examination, corneal confocal microscopy, fundus photograph. meta-transcriptomic analysis of the ocular samples will be conducted to identify viruses, bacteria, fungi and parasites. the abundance of pathogens is indicated as the rpkm (i.e. reads per million divided by the length of the reference genome, measured in kilobases). eligible participants will be recruited consecutively between august, 2024 and december, 2026 in department of ophthalmology, shanghai general hospital. the total study duration is expected to be two years from the first subject enrolled to the final analysis.

Eligibility criteria:
inclusion criteria: 1. patients with a clinical diagnosis of one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis). 2. biological samples has been collected for clinical microbiological examination, or consented to participate in this study. exclusion criteria: 1. patients who have no historically clinical surplus specimens.

Keywords: infectome metagenomic sequencing
evaluation of pet-ct using somatostatin agonists labeled with gallium68 in neuroendocrine tumors

Conditions: Gastro-Entero-Pancreatic Tumors (GEPs)

Summary: gastro-entero-pancreatic tumors (geps) are a subset of neuroendocrine tumors (nets) derived from the primitive gut and include digestive and bronchial nets. historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (srs) labeled with indium-111 (octreoscan®). this reference imaging is complementary to tomography (ct) and liver mri. however srs sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy. the use of somatostatin agonists (dotatoc, dotatate, dotanoc), radiolabeled with gallium-68 (68ga) enables targeting of somatostatin receptors (sstrs) with a pet resolution. this has improved diagnosis of tne with a gain in sensitivity of over 20% compared to srs. furthermore, patient irradiation and imaging protocol are significantly reduced.


Eligibility criteria:
inclusion criteria: * • age ≥ 18, * patient with one of the following situations : suspicion of gep, initial staging of non-metastatic gep, gep with unknown primary tumor, restaging of gep justifying focused therapeutic approach * reference imaging within the last 3 months: multiphasic thoracoabdominal ct scan, liver mri and srs (spect/ct). exclusion criteria: * pregnant or breast-feeding woman * other cancer disease * gep with grade 3 tumours * non gep tne (paragangliome, medullar thyroid cancer)
long term use of xalacom in patients glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: the objective of this investigation is to evaluate the safety and efficacy of long-term treatment with xalacom in medical practice. also, occurrence of unknown and known adverse drug reactions (adrs) in subjects treated with xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

all the patients whom an investigator prescribes the first xalacom® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * patients need to be administered xalacom® in order to be enrolled in the surveillance. exclusion criteria: * patients not administered xalacom®.

Keywords: xalacom regulatory post marketing commitment plan safety
sodium status in septic patients and its relation to prognosis an hospital stay

Conditions: Sodium Disorder

Summary: the aim of the present study is to identify the prevalence and prognostic impact of sodium imbalance on sepsis and septic shock patients

sepsis and septic shock are among the most prevalent causes of intensive care unit (icu) admissions. they account for around 10-50% of the mortality rate, which remains high despite extensive research of the surviving sepsis campaign, and national core measures sepsis is defined as "organ dysfunction that threatens the patient's life caused by the impaired host response to infection" septic shock is defined as hypotension and serum lactate level greater than two mmol/l, as well as not responding to adequate fluid resuscitation requiring the use of vasopressors to maintain the mean blood pressure of 65 mm hg or higher . sepsis and septic shock are considered medical emergencies . acute hypernatremia is considered one of the features of homeostasis disturbances, which is common in septic patients with an incidence reaching up to 47% finding biomarkers which predict the outcome of sepsis is challenging . since electrolyte imbalance, specifically hypernatremia, is one of the commonest problems associated with sepsis and septic shock patients \[20, 21\]. it is, therefore, of current interest to study the evolution of sepsis in patients who have been shown to have hypernatremia. recent evidence shows that serum sodium levels may not be completely explained by fluid balance or sodium intake . some studies suggest that sodium is intimately tied to the immune system, thus raising the question of whether inflammatory states such as sepsis can play a role in the development of hypernatremia

Eligibility criteria:
inclusion criteria: the diagnosis of sepsis and septic shock was made prior to the icu admission. sepsis and septic shock were defined according to the 3 definition using the quick sofa score of 2 or more sepsis : 2 or more of the sirs criteria : * temperature \>38 or \<36 c * heart rate \>90 beats/minute * respiratory rate \>20 cycle /minute * wbc \>20,000 or \< 4,000 plus the presumed existence of infection * blood pressure can be normal septic shock : the same as sepsis plus refractory hypotension * after bolus of 20- 40 ml/kg patient has one of the following : * sbp \>90 mm hg * map \<65 mm hg * decrease of 40 mm hg of base line hypernatremia \[na+\]\> 145 mmol/l eunatremia \[135-145\]mmol/l hyponatremia \<135 mmol/l exclusion criteria: patients under the age of 18 years patients with a previous diagnosis of hyperaldosteronism patints diagnosed with cushing syndrome, patients diagnosed with diabetes insipidus.
impact of a personal digital assistant (pda) - based dietary adherence intervention on interdialytic weight gain and blood pressure in hemodialysis patients

Conditions: End-Stage Renal Disease

Summary: with this study the investigators will test, in a randomised clinical trial (rct), the efficacy of a behavioral dietary adherence enhancement intervention paired with pda-based dietary self-monitoring for controlling sodium intake. seventy hemodialysis patients will be recruited from units in pittsburgh, pennsylvania. participants will be randomized to a 4-month pda-based dietary counseling intervention or to a 4-month attention control. potential participants will be stratified by whether or not they have diabetes. data on primary and secondary outcomes will be obtained at baseline and four months. primary dependent variables are: 1. adherence to dietary sodium targets as assessed from 3-day food recalls, 2. average monthly interdialytic weight gain, and 3. average pulse pressure. secondary dependent variables are: 4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the nutrient data system.


Eligibility criteria:
inclusion criteria: * those individuals who are 21 years of age or older * literate * community-dwelling adults * receiving maintenance hd for at least 3 months exclusion criteria: * individuals who cannot read or write * those who do not speak english * those who plan to move out of the area or change dialysis centers within the next 6 months * those with a terminal illness and life expectancy of less than 12 months * those who are scheduled for a living donor transplant * individuals who cannot see the pda screen or use the stylus to make selections from the pda screen. * those individuals with a score ≤ 26 on the mini mental status exam. * also excluded will be individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake.

Keywords: hemodialysis dietary adherence sodium
effect of a medical food supplement in hospitalized patients recovering from surgery

Conditions: Hip Fracture

Summary: the objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.


Eligibility criteria:
inclusion criteria: * subject is \> 45 years of age. * subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. * subject plans to undergo hip fracture surgery. * subject has anticipated length of hospital stay of at least 4 weeks. subject is able to consume foods and beverages orally. * subject has admission total protein ≤ 70 g/l. * subject has screening serum albumin ≤ 38 g/l. exclusion criteria: * subject is known to be allergic or intolerant to any ingredient found in the study product. * subject has pre-planned surgery other than hip fracture surgery during the study period. * subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances. * subject has active malignancy * subject has chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv. * subject has diagnosis of iddm. * subject has uncontrolled niddm determined by hba1c \> 8%.