Kornimate/medical-research-clean huggingface dataset:
sorafenib or lenvatinib plus haic of 130 mg/m² oxaliplatin, and 5-fu vs sorafenib or lenvatinib plus haic of 85mg/m² oxaliplatin, and 5-fu for unresectable advanced hcc: a randomised phase 3 trial

Conditions: Hepatocellular Carcinoma

Summary: a randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. however, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. it is unknown which oxaliplatin dose is better.


Eligibility criteria:
inclusion criteria: * kps≥70; * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl). * patients must have at least one tumor lesion that can be accurately measured; * with vascular invasion or extrahepatic metastasis * diagnosed as unresectable with consensus by the panel of liver surgery experts; * no past history of tace, haic, chemotherapy or molecule-targeted treatment; * no cirrhosis or cirrhotic status of child-pugh class a only * meet the following laboratory parameters:(a) platelet count ≥ 75,000/μl; (b)hemoglobin ≥ 8.5 g/dl;(c) total bilirubin ≤ 30mmol/l;(d) serum albumin ≥ 32 g/l;(e) asl and ast ≤ 6 x upper limit of normal;(f) serum creatinine ≤ 1.5 x upper limit of normal;(g) inr \> 2.3 or pt/aptt within normal limits; (h) absolute neutrophil count (anc) \>1,500/mm3; * ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * evidence of bleeding diathesis. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug
odense androgen study: study of androgens, body composition, and muscle function in danish men

Conditions: Bone Diseases

Summary: objective: * to define a reference-population of healthy young men (20-29 years old). * to establish reference-intervals for: 1. total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone). 2. total and free igf-1. * to study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens. * to identify the androgens (or estrogens) that primarily reflect the following parameters: 1. muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit. 2. bone mineral density and bone metabolism. 3. total and visceral fat mass. 4. lipid- and glucose metabolism and glucocorticoid metabolism. 5. sexual function and quality of life. * to study the modifying effect of birth weight, the ar gene cag-repeat polymorphism, and the level of igf-1 on associations between serum androgens and the measures above: ethics, design and schedule: the local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 caucasian men, 20 to 29 year old, living in the county of funen. the only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. a basic questionnaire was mailed to 3000 men, randomly drawn from the danish central personal registry. adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. informed consent was obtained from 783 men. the examinations started in march 2002 and terminated in may 2003. within subject variation was determined for all study parameters in 20 men. the men included matched the men answering the questionnaire on all questionnaire items and demographics. all analyses have been performed, except for the additional serum sex hormone assays, igf-1 assays and ar gene analyses. a sequential rule-out from the reference population was performed on the following criteria: 1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina \< 10 ml (each), history of spermatic cord torsion. 2. severe chronic disease. 3. regular medication or abuse of anabolic steroids. 4. body mass index \< 19 kg/m2. 5. safety serum parameters: luteinizing hormone (lh) \ 8.4 u/l, alanine-amino-transferase (alat) \>70 u/l and thyrotropin (tsh) \>6.0 mu/l.


Eligibility criteria:
inclusion criteria: * age: 20-29 years * residence: county of funen, denmark exclusion criteria: * opioid drug addiction * cancer * severe chronic disease

Keywords: androgens bone muscle estrogens fat lipid and glucose metabolism
use of pressure muscle index to avoid over-assistance during pressure support ventilation

Conditions: Mechanical Ventilation

Summary: pressure support ventilation (psv) is the most commonly used mode in mechanical ventilated patients. studies have shown that over-assistance was prevalent in patients undergoing psv. up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. pressure muscle index (pmi) was introduced recently to evaluate the degree of spontaneous breathing effort. we hypothesize that pmi might be used as an indicator for over-assistance during psv. in this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero pmi. inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.


Eligibility criteria:
inclusion criteria: * mechanical ventilated patients within 48 hours after the transition from a controlled mode to psv exclusion criteria: * history of neuromuscular disease * history of diaphragm dysfunction and surgery * history of esophageal, gastric or lung surgery * decreased level of consciousness * central respiratory drive dysfunction * considered withholding of life support

Keywords: mechanical ventilation pressure support inspiratory effort work of breathing lung injury
rationales for wound care management in old world cutaneous leishmaniasis patients

Conditions: Wound Healing

Summary: the rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (owcl) are the following: 1. the effectiveness of the current mainstay treatment with intralesional antimonials for cl is subject to discussion, especially in l. major lesions which are predominant in northern afghanistan 2. the importance of wound care management in patients with owcl has been emphasized by gonzalez et al. (2008) and its efficacy is confirmed in the kabul trial with l. tropica patients. parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.


Eligibility criteria:
inclusion criteria: 1. present a suspected old world cutaneous leishmaniasis lesion confirmed by giemsa stained wound smears with no other skin diseases or infections and who 2. have never been previously treated with antimonial injections or any other form of anti-leishmanial medication. exclusion criteria: 1. patients with more than one lesion are excluded. 2. patients with a lesion age of \> 3 months are also excluded. the experience of the kabul trial shows that patients presenting themselves for the first time with a lesion, which is older than three months, have either been pre-treated somewhere else and/or show a poor compliance during the trial. 3. patients below 12 years of age have to be excluded from the trial, because they cannot fill in the eq-5d and skindex questionnaire part of the health economic evaluation. 4. intralesional antimony injections are too painful for lesions located on the nose, lips or eyes. therefore, patients presenting these lesions are excluded from the trial. 5. for compliance reasons addicted patients and patients not available for follow-up are exclude from the trial. 6. patients with major uncontrolled diseases as tuberculosis, diabetes or hiv are excluded from the trial, since their management requires additional co-medications, which may affect wound healing.
a study to evaluate the efficacy and safety of bismuth-containing quadruple therapy with oral vonoprazan (tak-438) 20 mg compared to esomeprazole 20 mg twice daily in paticipants with helicobacter pylori infection

Conditions: Helicobacter Pylori

Summary: the purpose of this study is to evaluate the efficacy of helicobacter pylori (hp) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all hp-positive participants.

the drug being tested in this study is called vonoprazan (tak-438). vonoprazan is being tested to treat people who have helicobacter pylori infection. the study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results. participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): vonoprazan 20 mg esomeprazole 20 mg all participants will be asked to take one tablet in combination with bismuth containing quadruple therapy (amoxicillin, clarithromycin and bismuth potassium citrate) twice at the same time each day throughout the study. this multi-center trial will be conducted in china. the overall time to participate in this study is 10 weeks. participants will make multiple visits to the clinic, and 28 days after last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. helicobacter pylori (hp)-positive participants as determined by \^13c-urea breath test (\^13c-ubt) at the start of the study (visit 1 \[screening\]) and who require hp eradication in physician judgment. exclusion criteria: 1. participant had any of the following conditions at the start of the study (visit 1, screening): acute upper gastrointestinal bleeding, active gastric ulcer (gu) or duodenal ulcer (du) characterized by defective mucos with white coating (with or without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion (agml), or acute duodenal mucosal lesion (adml). however, participants with gastritis, gastric or duodenal erosion are permitted to participate. 2. participants with zollinger-ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion. 3. participant has a history of malignancy or was treated for malignancy within 5 years before the start of the screening visit (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ). 4. participant has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis b surface antigen \[hbsag\] or hepatitis c virus \[hcv\]- antibody-positive).

Keywords: drug therapy
status epilepticus population study (steps)

Conditions: Epileptic Seizures

Summary: the aim of this observational multicenter cohort study is to gain a deeper understanding regarding the effects of treatment adaption based on information from outcome prediction models, risk stratification, as well as treatment monitoring, detection, prevention, and management of complications on course and outcome of adult patients with status epilepticus (se).


Eligibility criteria:
inclusion criteria: * adult patients (i.e., patients ≥18 years of age) with diagnosed se between 2005 and 2023 who have been treated at the university hospital of basel or the cantonal hospital aarau. exclusion criteria: * patients younger than 18 years. * patients with repetitive epileptic seizures not qualifying for se. * patients with documented refusal of the general consent.

Keywords: status epilepticus electroencephalogram
fundoplication in laparoscopic peh repair based on flip

Conditions: Paraesophageal Hernia

Summary: prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.

prospective randomized controlled trial in which patients who meet criteria will be randomized to receive a concurrent fundoplication or no fundoplication at the time of paraesophageal hernia repair. patients with known objective gastroesophageal reflux disease prior to surgery, those found to have a short esophagus in the operating room or defective gastroesophageal reflux barrier by intra-operative impedance planimetry measurements and/or endoscopic valve grade will be excluded.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic paraesophageal hernia repair exclusion criteria: * history of a prior hiatal hernia/paraesophageal hernia repair * patients with objective gerd preoperatively * intra-operative short esophagus * defective gastroesophageal reflux barrier as determined by impedance planimetry (flip) * defective gastroesophageal reflux barrier as determined by intra-operative endoscopy

Keywords: paraesophageal hernia repair laparoscopic paraesophageal hernia repair peh repair lap peh repair flip functional luminal imaging probe gerd gastroesophageal reflux disease
participant(s) with autism and high pain tolerance treated with high dose naltrexone

Conditions: Autism Spectrum Disorder

Summary: high dose naltrexone with response gauged by pain tolerance as measured by the cold pressor test may help treat autism.

clinical trial: cause and treatment of high opioid tone autism key words: autism, neurobiological systems engineering, opioid tone, cold pressor time, clinical trial abstract introduction: neurobiological systems engineering models are useful for treating patients. we show a model of "high opioid tone" autism and present a hypothesis about how autism is caused by administration of opioids during childbirth. main symptoms: clinical diagnosis of autism in a 25 year old man was confirmed by a social responsiveness scale (srs) self - rating of 79, severe, and a social communications questionnaire (scq - 2) by the patient's father scoring 27. cold pressor time is a measure of pain tolerance obtained by having the subject submerge their normal forearm in a painful ice water bath. cold pressor time (cpt) was 190 seconds - unusually long, consonant with the high pain tolerance of autism. therapeutic intervention and outcome measure: primary outcome measure is the cold pressor time (cpt). at naltrexone 50 mg/day cpt fell to 28, repeat 39 seconds. secondary outcome measures are social responsiveness scale (srs) and social communications questionnaire (scq-2). srs fell to 54 and scq - 2 to 9; both non - significant for autism. change in relatedness was experienced ambivalently, understood as feelings never before experienced - causing pain. non - compliance with naltrexone was followed by cutting open his palm and drinking alcoholically. transference focused psychotherapy has helped him remain naltrexone - compliant while he works on issues of identity and relatedness. conclusion: the model suggests studies that could be conducted to both prevent and treat this form of autism.

Eligibility criteria:
inclusion criteria: diagnosis of autism - exclusion criteria: lack of ability to give informed consent -
allogeneic hsct in mds patients based on risk according to r-ipss

Conditions: MDS and Allogeneic Stem Cell Transplantation

Summary: an "intention-to-treat" study to evaluate the impact of allogeneic hsct with total marrow and lymphoid irradiation (tmli), followed by treg/tcon adoptive immunotherapy, on overall survival in patients affected by myelodysplastic syndrome (mds), according to ipss-r.

mds patients with intermediate, high, or very-high r-ipss risk will be enrolled. allogeneic stem cell transplantation with regulatory and conventional t cell adoptive immunotherapy will be proposed to eligible high and very-high risk mds patients. intermediate risk mds patients will be assessed for risk modification every six months and moved to transplant in case of increased risk. intermediate risk mds patients will be also evaluated for the presence of molecular alterations (tp53, asxl1, runx1). overall survival of the entire cohort will be assessed as primary endpoint. incidence of treatment related mortality, acute graft versus host disease, chronic graft versus host disease, relapse will be also assessed.

Eligibility criteria:
inclusion criteria: * patients affected by myelodysplastic syndrome with ipss-r int, high or very high; * age \<71 years; * signature of the informed consent. exclusion criteria: * patients affected by myelodysplastic syndrome with ipss-r very low or low; * patients affected by myelodysplastic syndrome/myeloproliferative neoplasm; * age \>70 years; * no signature of the informed consent
the evaluation of tablo in-clinic and in-home

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to evaluate the tablo hemodialysis system when used in-center by trained individuals and in-home by trained subjects.


Eligibility criteria:
inclusion criteria: * subject has end stage renal disease (esrd) adequately treated by maintenance dialysis achieving a kt/v ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist. * subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min. exclusion criteria: * life expectancy less than 12 months from first study procedure. * subject has had a recent major cardiovascular adverse event within the last 3 months. * subject has new york class iii or iv congestive heart failure, or ejection fraction less than 30%. * subject with fluid overload due to intractable ascites secondary to liver cirrhosis. * subject has uncontrolled blood pressure. * subject is intolerant to heparin. * subject is seroreactive for hepatitis b surface antigen. * subject has an active, life-threatening, rheumatologic disease. * subject has a history of adverse reactions to dialyzer membrane material. * subject is expected to receive an organ transplant during the course of the study. * subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
gen2 isthmus-dependent atrial flutter ablation study

Conditions: Atrial Flutter

Summary: irrigated catheter for ablation of isthmus-dependent atrial flutter

this study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter

Eligibility criteria:
inclusion criteria: * scheduled for ablation of isthmus-dependent atrial flutter exclusion criteria: * prior ablation of isthmus-dependent atrial flutter * atypical or scar flutter * significant heart disease * intracardiac thrombus * prior cardiac surgery (within 1 month) * contraindication to heparin
peanut protein supplementation to augment muscle growth and improve markers of muscle quality and health in young adults

Conditions: Sarcopenia

Summary: this study will evaluate the adaptations in skeletal muscle that occur in response to 10 weeks of weight training with or without peanut protein supplementation in untrained men and women ages 18-30

this is a two-phase study using both novel and conventional methods to assess how pp supplementation affects muscle tissue in young adults who engage in resistance training. these two phases will be conducted as part of a 10-week randomized controlled trial in which men and women aged 18-30 years (n=40), will be stratified by gender and randomized to a resistance training intervention (whole body, two days per week) with pp powder (72g daily; n=10 males, n=10 females) provided during the intervention (immediate group, ig) or after the intervention (wait-list control, wlc, n=10 males, n=10 females). the aims of this study are to determine the acute (deuterium oxide tracer) and chronic (peripheral quantitative computed tomography) effects of pp during resistance training on skeletal muscle myofibrillar protein synthesis rates, changes in skeletal muscle size and quality, changes in whole and appendicular body composition (dual energy x-ray absorptiometry), changes in inflammatory markers and the fecal microbiome.

Eligibility criteria:
inclusion criteria: * body mass index (body mass/height squared) less than 35 kg/m2 * resting blood pressure averaging less than 140/90 mmhg (with or without medication) exclusion criteria: * known peanut allergy * actively participating in resistance training for more than 2 days/week * any known overt cardiovascular or metabolic disease * metal implants that will interfere with x-ray procedures * medically necessary radiation exposure in the last six months (except dental x-ray) * any medical condition that would contradict participating in an exercise program, giving blood or donating a skeletal muscle biopsy (i.e. blood clotting disorder or taking blood thinners) * pregnant or trying to become pregnant

Keywords: resistance training muscle hypertrophy muscle quality
acute heart failure study in patients admitted to emergency department for dyspnea

Conditions: Heart Failure

Summary: no studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (ahf) in patients admitted to emergency department. that's why the expert group of the ahf of south west of france mobilizes to conduct this study to evaluate the diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of ahf to emergencies.

there is no recommendation of the french society of emergency medicine (sfmu) on the management of the acute heart failure in the emergency department. the present study hypothesizes that identifying anamnestic and clinical criteria of ahf in patients admitted to emergency department for acute dyspnea would optimize the management of these patients upon arrival to the emergency department and to implement rapidly the appropriate therapeutic strategies. all patients admitted for dyspnea will be enrolled by the emergency physicians (after verification of inclusion and exclusion criteria) in the 3 participating centers. then, all files will be analyzed retrospectively from information collected by a committee of experts cardiologists and emergency physicians of each center. the primary objective is the evaluation of diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of ahf in emergency department for the construction of a clinical prediction score of acute heart failure. the secondary objective is the description of the diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * admitted to emergency department for acute dyspnea exclusion criteria: * traumatic dyspnea * shock / systolic blood pressure \<90 mmhg

Keywords: acute heart failure dyspnea predictive value