Kornimate/medical-research-clean huggingface dataset:
unravelling the impact of radiofrecuency in liver surgery: the key to decrease local recurrence?

Conditions: Liver Cancer; Cancer, Treatment-Related

Summary: radiofrequency devices have been increasingly employed in liver surgery in order to achieve proper hemostasis and this use has become more evident with the implementation of minimal invasive surgery. due to its well-known efficacy for tumor ablation (i.e. hepatocarcinoma) it use has been extended in some cases to ablate the liver surface after resection in questionable resection. till date, despite the majority of surgeons apply an additional coagulation in doubtful margins, there is not an evidence that this maneuver really decreases the local recurrence or increases the overall survival. on the contrary, some studies have suggested that non-anatomical resections in order to spare liver parenchyma could lead to major zones of liver ischemia in the remnant liver and thus favoring recurrence. however, major liver ischemia (defined as grade 2 o more) is unlikely to be provoked by 1 cm-depth additional coagulation of the margin. the investigators previously published in a retrospective study the concept of additional margin coagulation within liver resections and narrow margins and demonstrated that the study group had significantly less local recurrence compared to the controls. therefore, in the present study the aim is to continue this evaluation through a multicenter randomized clinical trial.


Eligibility criteria:
inclusion criteria: 1. written informed consent granted prior to the initiation of the surgical procedure, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice 2. 18 year of age or older 3. who performance scale 0-2 (see appendix 1) 4. patients suffering from liver metastases of colorectal origin confirmed either by abdominal ct, abdominal mri or/and by histologic-cytological evaluation. 5. patients suffering from primary liver tumor such as hepatocarcinoma 6. patients suffering from other extra-liver metastases when they are assumed to be curable at any moment are allowed to join the trial (e.g. lung metastases that are amenable to be resected at any moment). 7. patients should not have been previously treated by either local therapy or resection in the liver (naïve for local or resection approach of the liver). 8. any previous chemotherapy regime is permitted. 9. asa (american society of anesthesiology classification) of the patient: 1 to 3 exclusion criteria: 1. previous or concurrent cancer that is distinct from one primary tumor of which the lm come from except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis \& t1). any cancer curatively treated \> 3 years prior to enrollment is permitted. 2. asa 4 3. non-resectable extrahepatic metastases 4. liver metastasis from other origin apart from colorectal 5. any condition that in the opinion of the investigator may interfere evaluation of the study results.
study of cavosonstat (n91115) in patients with cf homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: this will be a double-blind, randomized, placebo-controlled, parallel group study. the purpose of this study is to investigate the efficacy and safety of cavosonstat (n91115) in adult patients with cf who are homozygous for the f508del-cftr mutation and being treated with lumacaftor/ivacaftor (orkambi™).

primary objective: * assess the efficacy of n91115 at 12 weeks when added to preexisting treatment with lumacaftor/ivacaftor in adult patients with cf who are homozygous for the f508del-cftr mutation secondary objectives: * assess the effect of n91115 added to lumacaftor/ivacaftor on safety * assess the effect of lumacaftor/ivacaftor added to n91115 on the pharmacokinetics of n91115, lumacaftor, and ivacaftor

Eligibility criteria:
inclusion criteria: * patients must have been treated with lumacaftor/ivacaftor for at least 8 weeks prior to day 1 (start of dosing) * a history of sweat chloride (sc) ≥ 60 meq/l by quantitative pilocarpine iontophoresis test (qpit) (either before or after starting lumacaftor/ivacaftor treatment) * body weight ≥ 40 kg * ppfev1 40 - 85 % predicted (inclusive) at screening * oxygen saturation ≥ 90% breathing ambient air at screening exclusion criteria: * any acute infection that requires treatment or hospitalization within 2 weeks of study day 1 * colonization with organisms associated with more rapid decline in pulmonary status, such as burkholderia cenocepacia, burkholderia dolosa, and mycobacterium abscessus * any change in the regimen for chronic therapies for cf lung disease (e.g., pulmozyme®, hypertonic saline, azithromycin, tobi®, cayston®) within 4 weeks of study day 1 * are pregnant, planning a pregnancy, or breast-feeding at screening * blood hemoglobin \< 10 g/dl at screening * serum albumin \< 2.5 g/dl at screening * abnormal liver function defined as ≥ 3 x upper limit of normal (uln) * history of abnormal renal function within 3 months of screening * history of ventricular tachycardia or other clinically significant ventricular arrhythmias * history, including the screening assessment, of prolonged qt and/or qtcf (fridericia's correction) interval * history of solid organ or hematological transplantation * history of alcohol abuse or drug abuse * ongoing participation in another therapeutic clinical trial * use of continuous (24 hr/day) or nocturnal supplemental oxygen

Keywords: cystic fibrosis n91115 cavosonstat
study on left atrial function of paroxysmal supraventricular tachycardia after radiofrequency ablation

Conditions: Paroxysmal Supraventricular Tachycardia

Summary: this study to investigate the effects of rf ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (avnrt) and atrioventricular tachycardia (avrt).

a total of 100 patients with persistent，in whom successful rf ablation of slow pathway or accessory pathway was performed. patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. all the patients had echocardiographic study before ablation 、1 day and 1 months after ablation. left atrial systolic function was assessed using atrial ejection force (aef) according to manning's formula (aef = 0.5 x ρ x ma x a(2), r: blood density = 1.06 g/cm(3), ma: mitral orifice area \[cm(2)\], a: a wave velocity). the following left atrial dimensions were assessed: antero-posterior (la-ap), infero-superior (la-is, long axis), medio-lateral (la-ml, short axis). the correlations between aef and electrophysiological parameters were analysed (va - ventriculo-atrial conduction, va/cl - tachycardia cycle length).

Eligibility criteria:
inclusion criteria: patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， age is \>14 years exclusion criteria: atrial fibrillation, atrial tachycardia， structural heart disease, ventricular arrhythmias, patients with impaired left ventricular systolic function or on antiarrhythmics

Keywords: paroxysmal supraventricular tachycardia left atrial function
effects of nmes with and without dynamic bracing on spasticity and movement quality in cp

Conditions: Diplegic Spastic Cerebral Palsy

Summary: the study aims at comparing neuromuscular electrical stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in children with cerebral palsy

cerebral palsy (cp) is a lifelong motor impairment caused by an early brain injury and affects 2-3 per 1,000 live births. it is a complex medical condition that negatively impacts cognition, language, sensations, movement, and gait patterns. it is normally carried out using a comprehensive approach that incorporates numerous approaches targeted at minimizing symptoms and improving functional outcomes. nmes (neuromuscular and muscular electrical stimulation) is an instrument that provides electrical impulses to nerves, causing muscles to contract, while dynamic bracing use muscle power to pre-compress soft tissue to produce the high forces required to control specific pathological diseases. the hip adductors, the knee flexor muscles, and the ankle and foot muscles (gastrocnemius and soleus may experience increased tone, causing the ankles to be held in a plantar-flexed (pointed downward) position) are targeted with nmes in the lower extremity to reduce the spasticity \& improve the quality of movement in cp children. investigating how combining nmes with dynamic bracing benefits lumbar disc bulge patients adds to the growing body of evidence supporting multimodal treatment.

Eligibility criteria:
inclusion criteria: * age between 5 to 12 years. * able to walk with or without an assistive device. classification as level i-ii on the gross motor functional classification system (gmfcs). * able to stand with or without support for 1 minute. * classification as levels i-iii on the manual ability classification system (macs); and the ability to follow and accept verbal instructions. * muscle tone scored ≥2, according to modified ashworth scale. exclusion criteria: * orthopedic surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months * treatment with botulinum toxin in the calf muscles within the previous 6 months * presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task * severe affective or psychiatric impairments; * serious vision or hearing problems * any neurological impairment (epilepsy or any other disease that would interfere with physical activity)

Keywords: nmes dynamic bracing cerebral palsy lower extremity
parenteral nutrition for patients treated for locally advanced inoperable tumors of the head and neck

Conditions: Squamous Cell Carcinoma of the Hypopharynx Stage III; Squamous Cell Carcinoma of the Hypopharynx Stage IV; Laryngeal Squamous Cell Carcinoma Stage III; Laryngeal Squamous Cell Carcinoma Stage IV; Oropharyngeal Squamous Cell Carcinoma Stage III; Oropharyngeal Squamous Cell Carcinoma Stage IV; Squamous Cell Carcinoma of the Oral Cavity Stage III; Squamous Cell Carcinoma of the Oral Cavity Stage IV; Locally Advanced Malignant Neoplasm

Summary: prevention of critical weight loss. in patients with squamous cell carcinoma of the head and neck (scchn) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (pn) support in patients with scchn treated with curative radiotherapy (rtx) in combination with cetuximab (e) or cisplatin (p).

the investigators hypothesize that about 60% of patients receiving rtx without supplemental pn will suffer from critical weight loss of more than 5% during treatment - supplemental overnight pn might result in significant improvement of the nutritional status .

Eligibility criteria:
inclusion criteria: * any patient who is eligible for definitive curative radio-chemotherapy with cisplatin or radio-immunotherapy with cetuximab. * written informed consent obtained prior to any study specific screening activities and patients have to be able to comply with this protocol. * histologically confirmed local advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx or cavum oris treated with definitive radiotherapy in combination with cisplatin or cetuximab. * p16 status available * age ≥ 18 * women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception. exclusion criteria: * distant metastases * prior radiation (head and neck area) * pregnant or lactating women * history of other malignancy; yet patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * concurrent other cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug. * serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent. * participation in another interventional clinical study at time of study inclusion (except follow-up period without treatment for more than 30 days) or denial of the simultaneous participation in a non-interventional study by the pi of the study center.

Keywords: squamous cell carcinoma head and neck scchn parenteral nutrition larynx hypopharynx cavum oris radiotherapy cetuximab cisplatin
national observational study of clinical practices in deceased organ donation

Conditions: Deceased Organ Donation; Critical Illness; Transplantation

Summary: this is a 1-year national prospective cohort study that observes the medical management of consented deceased organ donors at hospitals across canada with a high volume of deceased donation.

this prospective cohort study enrols consecutive adult deceased organ donors with a waiver of research consent and collects various data related to deceased donor care in the icu from the time of consent for donation to the time of organ recovery. clinical data includes donor characteristics, type of donation (after neurological death or cardiocirculatory death), resuscitation methods, cardiopulmonary monitoring techniques, medications, blood work, mechanical ventilation, diagnostic imaging, complications, and methods of death declaration. various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery. the canada-donate study is designed to develop a national platform for future clinical trials in deceased donor care. the main objectives include: 1. establish specialized organ donation research teams at participating icus. 2. observe, record, and describe icu practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future rcts. 3. engage and work with odos from each province to foster data sharing and develop procedures to enhance efficiency in future rcts. 4. investigate the comparative effectiveness of various icu interventions in deceased donor care to improve the conversion of consented donors to actual donors and to improve the number of transplants per donor. 5. produce specific knowledge translation tools that will serve in the future as clinical tools to enhance icu care and research tools to facilitate rcts.

Eligibility criteria:
inclusion criteria: * admitted into a critical care area (icu, ccu, er) * consent has been obtained for organ donation exclusion criteria: * admitted into a paediatric critical care area (nicu, picu)
multiple gestation study

Conditions: Trisomy 13; Trisomy 18; Trisomy 21; Sex Chromosome Abnormalities

Summary: the objectives of the clinical study are to demonstrate the accuracy of our new natus diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. the long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. this will result in fewer unnecessary amniocenteses and cvs procedures, which are associated with a risk of miscarriage.


Eligibility criteria:
inclusion criteria: * age 18 or older at enrollment * clinically confirmed multiple gestation pregnancy * gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate * able to provide informed consent exclusion criteria: * women carrying singleton pregnancy * surrogate or egg donor used

Keywords: trisomy 13 trisomy 18 trisomy 21 sex chromosome abnormalities monosomy x xxx xxy xyy
bortezomib in combination with liposomal doxorubicin and dexamethasone to treat plasma cell leukemia

Conditions: Plasma Cell Leukemia; Multiple Myeloma

Summary: bortezomib/liposomal doxorubicin (v-dd) is preferred to bortezomib single agent in salvage therapy for multiple myeloma (mm). the present study is designed to assessment the efficacy and safety study of bortezomib in combination with liposomal doxorubicin and dexamethasone in treatment of plasma cell leukemia (pcl). primary study endpoint is the overall response rate (scr+cr+vgpr+pr). secondary endpoints is the rate of complete response (scr+cr), partial remission rate (vgpr + pr), duration of response (dor), overall survival (os).

patient with plasma cell leukemia(pcl ) and multiple myeloma (mm); kps ≥ 60scores

Eligibility criteria:
inclusion criteria: * patients confirmed relapsed or refractory pcl who previously untreated or never received treatment with bortezomib * kps ≥ 60 * adequate liver and renal function within 2 weeks of screening: * bilirubin ≤ 1.5 × the upper limit of normal (uln) * alanine aminotransferase (alt) ≤ 2.5 × the upper limit of normal (uln) * aspartate aminotransferase (ast) ≤ 2.5 × the upper limit of normal (uln) * cardiac function \> ⅲ grade and ejection fraction \> 45% * signed informed consent prior to initiation of any study-related procedures that are not considered standard of care exclusion criteria: * has taken bortezomib * kps ≤ 60 scores * mental illness

Keywords: bortezomib pcl
a study of jnj-64281802 against dengue serotype 1 infection in a dengue human challenge model in healthy adult participants

Conditions: Healthy

Summary: the purpose of this study is to assess the antiviral activity of jnj-64281802 versus placebo in terms of reduction of dengue virus 1 (denv-1) ribonucleic acid (rna) viral load (vl).


Eligibility criteria:
inclusion criteria: * healthy on the basis of physical examination, medical history, and vital signs performed at screening. if there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. this determination must be recorded in the participant's source documents and initialed and dated by the investigator * must pass the comprehension test (i.e., obtain a passing score of greater than or equal to (\>=) 75 percent (%), with up to 3 attempts in total) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and answered the potential participant's questions * must have a blood pressure (after the participant is supine for \>=5 minutes) between 90 and 140 millimeters of mercury (mmhg) systolic, extremes included, and less than or equal to (\<=) 90 mmhg diastolic at screening. two repeat measurements are allowed in the absence of any other concerning health screening issues * must have a body mass index (bmi) (weight in kilogram divided by the square of height in meters) between 18.0 and 33.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight of \>=50.0 kg at screening * all women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin) pregnancy test at screening exclusion criteria: * known allergies, hypersensitivity, or intolerance to jnj-64281802 or its excipients, to a previous vaccination, or to specific medications/animals for which antigens may be in the dengue virus (denv)-1 challenge strain preparations, including shellfish, fetal bovine serum, l-glutamine, neomycin, and streptomycin * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 6 months before first dose of study drug, or is currently enrolled in an investigational study, or is planning to be enrolled in an investigational study within 90 days after last dose of study drug * pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after last dose of study drug * plans to father a child during the study or within 90 days after last dose of study drug
anastrozole in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the main purpose of this clinical trial is to study the safety and efficacy of anastrozole in adults diagnosed with pulmonary arterial hypertension (pah). the study will evaluate how well the drug is tolerated. the study will also evaluate if anastrozole effects estradiol (e2) hormone levels, a sex hormone, and improves the function of the lower right chamber of the heart (right ventricle).


Eligibility criteria:
inclusion criteria: * previous documentation of mean pulmonary artery pressure \> 25 mm hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \ 3 wu at any time before study entry. * diagnosis of pah which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or hiv infection. * most recent pulmonary function tests with fev1/fvc \>50% and either a) total lung capacity \> 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest * ability to perform six minute walk testing without limitations in musculoskeletal function or coordination. * if female, post-menopausal state, defined as: * \> 50 years old and * a) have not menstruated during the preceding 12 months or * b) have follicle-stimulating hormone (fsh) levels (\> 40 iu/l) or * \ 40 iu/l) or * having had a bilateral oophorectomy * informed consent exclusion criteria: * treatment with estrogen or anti-hormone therapy (tamoxifen, fulvestrant, etc.) * who class iv functional status * history of breast cancer * clinically significant untreated sleep apnea * left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \< 45% on echocardiography * initiation of pah therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors) within three months of enrollment; the dose must be stable for at least 3 months prior to baseline visit * hormone therapy * hospitalized or acutely ill * renal failure (creatinine \> 2.0) * child-pugh class c cirrhosis * current or recent (\< 6 months) chronic heavy alcohol consumption * current use of another investigational drug (non-fda approved) for pah * enrollment in a clinical trial within one month of screening * age \< 18