Kornimate/medical-research-clean huggingface dataset:
eagle af (atrial fibrillation) - endoscopically guided laser ablation of persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: the study aims to compare the results of pulmonary vein isolation (pvi) with a single technology approach in patients suffering from paroxysmal atrial fibrillation (paf) with patients who have persistent af of less than 3 months. many studies have shown that electrical reconnection of the pulmonary veins following the index procedure can occur in up to 40% of targeted veins leading to a recurrence of paf. endoscopically guided laser ablation utilising the heartlight system (cardiofocus inc., usa) has been shown to be safe and effective and has also shown promising rates of durable isolation compared to point by point radio frequency techniques. however, the impact of employing this technique for patients with persistent af has not yet been reported. the study hypothesis is that there will be no statistically significant difference between the results of pvi in the two groups of patients.


Eligibility criteria:
inclusion criteria: * failure of at least one specific class i or iii antiarrhythmic drug (aad) * left atrial size \< 50 mm * left ventricular ejection fraction \> 45% * others * specific for paf: diagnosed with self-terminating episodes for no longer than 7 days * specific for persistent af: diagnosed with episodes of \> 7 days and \< 90 days exclusion criteria: * af secondary to a reversible cause of non-cardiac origin * uncontrollable hypertension * left atrial thrombus * others * specific for paf: more than 1 electrical cardioversion in the year prior to enrollment * specific for persistent af more than 4 electrical cardioversions in the year prior to enrollment
a study of ridinilazole (smt19969) compared with fidaxomicin for the treatment of clostridium difficile infection (cdi)

Conditions: Clostridium Difficile Infection

Summary: the purpose of this research study is to evaluate the safety and effectiveness of ridinilazole (smt19969) in treating c. difficile infection (cdi).


Eligibility criteria:
inclusion criteria: * informed consent * clinical diagnosis of cdi plus laboratory diagnostic test * no more than 30 hours antimicrobial treatment for current cdi episode * female subjects of childbearing potential must use adequate contraception exclusion criteria: * life-threatening or fulminant cdi * subjects with 2 or more episodes of cdi in the previous year * females who are pregnant or breastfeeding * history of inflammatory bowel disease * co-administration of potent p-glycoprotein inhibitors * participation in other clinical research studies within one month of screening * subjects that the investigator feels are inappropriate for the study
long-term follow-up in severe traumatic brain injury

Conditions: Traumatic Brain Injury; Neurodegenerative Diseases; Chronic Traumatic Encephalopathy

Summary: the underlying pathophysiology following traumatic brain injury (tbi) in how different neurodegenerative conditions are developed are still unknown. different neuroinflammatory and neurodegenerative pathways have been suggested. the goal of this study is to follow-up patients that have been treated for tbi at the neurosurgical department about 10-15 years after their initial injury, in order to analyze fluid biomarkers of inflammation, injury and degeneration and associate these with structural imaging and long-term functional outcome. the investigators aim to invite about 100 patients back and perform advanced magnetic resonance imaging protocols, sample cerebrospinal fluid and blood for different bio- and inflammatory markers, study genetic modifications and associate it with outcomes being assessed through questionnaires. the investigators' hypothesis is that patients with ongoing inflammatory processes will present with more fluid biomarkers of neurodegeneration, worse clinical presentation and also more structural/atrophic signs on imaging. this will result in an increased understanding of the interplay between neuroinflammation and neurodegeneration in chronic tbi, as well as a panel of tentative biomarkers that could be used to assess level of disability following tbi and chronic traumatic encephalopathy (cte).


Eligibility criteria:
inclusion criteria: * having suffered a traumatic brain injury and being treated at the karolinska university hospital between 2007 and 2015. * age \>18 years of age exclusion criteria: - pregnancy

Keywords: fluid biomarkers neuroinflammatory process auto-immunity structural imaging clinical assessment long-term follow-up
patient understanding of livermultiscan

Conditions: Liver Diseases

Summary: this is a qualitative study to determine which factors affect the patient experience of having a liver mri, what information patients would like to receive after their mri, and how patients would like this information communicated to them.

this is a qualitative study to determine which factors affect the patient experience of having a liver mri, what information patients would like to receive after their mri, and how patients would like this information communicated to them. each individual will receive at least an mri scan (livermultiscan), with many also receiving a fibroscan (transient elastography). patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. the interviews will be thematically analysed and trends identified by significance.

Eligibility criteria:
inclusion criteria: * individuals with experience of liver disease. * individuals over the age of 16. * individuals willing to give informed consent for participation in the study. exclusion criteria: * individuals with any contraindication to magnetic resonance imaging.
differences in malaria infection levels in hiv-infected infants and children receiving pi- and nnrti-based haart

Conditions: HIV Infections; Malaria

Summary: more than 1.5 million deaths of african children under 5 years of age have been due to plasmodium falciparum malaria. when hiv and malaria are present as coinfections, they enhance each other's progression. the primary purpose of this study is to compare the malarial infection levels in hiv-infected infants and children receiving protease inhibitor (pi)- or non-nucleotide reverse transcriptase inhibitor (nnrti)-based highly active antiretroviral therapy (haart).

the world health organization (who) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. the malaria burden is compounded by the hiv epidemic, which is most prevalent in areas endemic for malaria, notably sub-saharan africa where nine in ten children younger than 15 years of age are infected with hiv. the purpose of this study is to compare parasitemia levels in hiv-infected infants and children receiving pi- or nnrti-based haart regimens. this study will enroll a total of 140 participants, 35 from each of the 4 groups in impaact p1060. this substudy will last until 24 weeks after the last p1060 enrollment or until p1060 study discontinuation. participants must meet enrollment criteria for p1060 as well as additional criteria for this study. study visits will occur as a part of p1060 study visits, all of which include a physical exam, blood collection, and assessments of hiv-related symptoms. participants are also encouraged to return to the primary clinic site for intercurrent illness visits for assessment, thick and thin blood smear, and filter paper blood collection, however these visits are not mandatory for study participation.

Eligibility criteria:
inclusion criteria: * enrolling in study impaact p1060 * parent/legal guardian agrees to seek medical care for intercurrent illness at the study site, whenever possible, and agree to not use at-home remedies for febrile illness in the child exclusion criteria: none.

Keywords: coinfection
pregnancy cohort in multiple sclerosis (ms)

Conditions: Multiple Sclerosis (MS); Clinically Isolated Syndrome (CIS)

Summary: multiple sclerosis (ms) is a common inflammatory demyelinating disorder of the central nervous system frequently affecting females in their reproductive phase of life. in this prospective observational study, we obtain data on the outcome of pregnancies in ms patients and the influence of pregnancy on clinical, laboratory and mri parameters in ms.


Eligibility criteria:
inclusion criteria: * age \> 18 years * signed informed consent * diagnosis of multiple sclerosis or clinically isolated syndrome exclusion criteria: * clinically relevant comorbidities * contraindications for mri, e.g. pacemaker, metal implants, allergy against gadolinium * alcohol or drug abuse

Keywords: pregnancy
samurai-nvaf study: anticoagulant therapy for japanese stroke patients with nonvalvular atrial fibrillation (nvaf)

Conditions: Stroke, Acute; Atrial Fibrillation

Summary: the purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/tia and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.


Eligibility criteria:
inclusion criteria: * consecutive acute ischemic stroke/tia patients with nvaf exclusion criteria: 1. rheumatic mitral valve disease 2. a history of prosthetic valve replacement or mitral valve surgical repair 3. active infective endocarditis 4. patient, family member or legally responsible person does not have given informed consent 5. inappropriate patient's conditions for study enrollment in the opinion of the investigator

Keywords: anticoagulation recurrent stroke bleeding
the relation between diabetic neuropathy and muscle mass in type 2 diabetes mellitus patients

Conditions: Diabetic Neuropathy; Sarcopenia

Summary: the goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass

the goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients, aged above 45 years old, and muscle mass; where it uses ultrasound to measure anterior thigh muscle thickness and adjusts it to body mass index to calculate muscle mass and the participants perform clinical tests i.e hand grip strength test and chair stand test in order to assess muscle power. depending on both muscle mass and muscle power/function, sarcopenia could be assessed in this group of patients, and its relation to diabetic neuropathy, tested by nerve conduction studies, would be researched.

Eligibility criteria:
inclusion criteria: * the study group consisted of patients diagnosed with type 2 diabetes mellitus aged ≥45 years old exclusion criteria: * type 1 dm, gestational diabetes mellitus * severe cardiopulmonary disease, significant/previous neurological disorder (e.g., ischemic stroke, parkinson disease) causing difficulty during daily activities (e.g., walking), visual deficit, and psychiatric problem * other neuropathy-associated factors such as: alcohol, nutrition, poisoning and drug addiction * patients with renal diseases, malignancy and autoimmune diseases * patients on long term use of steroids

Keywords: diabetic neuropathy muscle mass sarcopenia nerve conduction studies
a study to evaluate inca033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms

Conditions: Myeloproliferative Neoplasms

Summary: this study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (dlt) and determine the maximum tolerated dose (mtd) and/or recommended dose(s) for expansion (rde) of inca033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.


Eligibility criteria:
inclusion criteria: * life expectancy \> 6 months. * willingness to undergo a pretreatment and regular on-study bm biopsies and aspirates (as appropriate to disease). * existing documentation from a qualified local laboratory of calr exon-9 mutation. * participants with mf or et as defined in the protocol. exclusion criteria: * presence of any hematological malignancy other than et, pmf, or post-et mf. * prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. * participants with laboratory values exceeding the protocol defined thresholds. * has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. * active invasive malignancy over the previous 2 years. * history of clinically significant or uncontrolled cardiac disease. * active hbv/hcv or known history of hiv. * any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for tgbs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * participants undergoing treatment with g-csf, gm-csf, or tpo-r agonists at any time within 4 weeks before the first dose of study treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myeloproliferative neoplasms myelofibrosis essential thrombocythemia calr mutation
big data and models for personalized head and neck cancer decision support (bd2decide)

Conditions: Cancer of Head and Neck

Summary: the purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (hnc) patients disease outcome, in particular for advanced stage (stage iii, iv) human papillomavirus (hpv) negative patients and to validate prognostic models for overall survival.

the clinical study is devoted to the validation of a decision support system for hnc patients management in the frame of a h2020 project.

Eligibility criteria:
inclusion criteria: * signed informed consent * histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma * clinical stage iii and iv * patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy * adequate archival pre-treatment tumor specimen available (ffpe macrodissected sections) * availability of baseline diffusion-weighted imaging (dwi) - magnetic resonance imaging (mri) acquisition (non-trace ) with more than 3 b-values (ranging from 0 (included) to 1000 s/mm2), and a field map acquisition. * mri images, t1 and t2 weighted, (slice thickness lower than 3 mm), head and neck in a single volume, and/or ct scan of the head and neck performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast * male or female ≥ 18 years old exclusion criteria: * any previous haed and neck cancer. * patients with previous malignancies in the last 5 years before treatment for head and neck cancer, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage t1a or t1b prostate cancer, and basal/squamous cell carcinoma of the skin. * any previous malignancy that was treated with surgery and or radiation of the head and neck region. * histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).

Keywords: prognostic modelling radiomics clinical decision support system big data analysis multiscale prognostic signatures patient-clinician co-decision tools
airway management with supraglottic devices in unruptured intracranial aneurysms

Conditions: Airway Management

Summary: endovascular techniques for the treatment of intracranial aneurysms are growing.

retrospective analysis of the investigators experience in the last 8 years with the airway management in endovascular therapy for unruptured aneurysms. a total of 206 participants will be included from 2010 to 2018. airway management (anticipated difficult airway, need for lm repositioning, orotracheal intubation because of failed laryngeal mask insertion, airway complication), intraoperative monitoring, aneurism size and location, intraoperative and perioperative complications will be registered. statistics will be compared between groups with t test or x test, as appropriate.

Eligibility criteria:
inclusion criteria: * patients that underwent endovascular treatment for unruptured aneurysm exclusion criteria: * ruptured aneurysm

Keywords: supraglottic devices
comparison of standard rapi̇d sequential intubation protocol with rocuronium in emergency department

Conditions: Rapid Sequence Induction and Intubation; Rocuronium

Summary: airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. rapid sequential intubation is one of the most frequently used techniques in advanced airway management. however, anesthetic agents and paralytic agents have some concerns with some side effects. in our study, this study aimed to compare the effect of standard rapid sequential intubation protocol and application of rocuronium priming technique on the procedure time and hemodynamic profile.

this study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in ankara city hospital emergency medicine clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. patients who applied to the emergency department and needed rapid sequential intubation were included in our study. randomization was done according to the order of arrival of the cases. the demographic characteristics of the patients included in the study and the presence of diabetes mellitus were recorded. routine rapid sequential intubation was performed in the standard group. in the priming group, 10% of the rocuronium dose was administered approximately 3 minutes before the induction agent. intubation time, amount of drug used, vital signs before and after intubation, and end tidal carbon dioxide level to confirm intubation were recorded.

Eligibility criteria:
inclusion criteria: * be over the age of 18 * need for advanced airway * to give consent or consent to participate in the study consent of relatives of those who are unable to give exclusion criteria: * have an indication of a crush (rescue) airway * have one of the difficult airway predictor look, evaluate, obstruction, neck mobility criteria * maxillofacial anomaly or trauma * detected during laryngoscopy with a cormack-lehane score of 3 and 4 patients * those who have inconveniences in applying ketamine to the clinic of the patient * with a rocuronium or ketamine allergy

Keywords: rapid sequence induction and intubation rocuronium
nevirapine + 3tc based maintenance therapy for hiv infection

Conditions: HIV Infections

Summary: type of study: investigator initiated clinical study study design: one arm, open label, pilot study (n=10) research question is treatment with nevirapine + 3tc sufficient for hiv maintenance risk category b (no investigational drugs, non standard tx) therapies with 2 drugs are often done in hiv-maintenance. this is a systematical evaluation of such a two drug trial. rescue therapy is well defined within the protocol. centers (n) st. gallen only participants 10 hiv patients already on nevirapine + 2 non-nuke rt-inhibitors study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. clinical follow up will then continue sponsor/investigator pietro vernazza, kantonsspital st. gallen principal investigator pietro vernazza, md. kantonsspital st. gallen co-investigators patrick schmid, md, matthias hoffmann, md financial source none (pilot study) if study demonstrates good results, an snf grant proposal will be submitted

this is a pilot study to evaluate the efficacy of a two drug combination for long term hiv maintenance therapy. the study is conducted in order to confirm the feasibility of the combination of nevirapine and lamivudine (3tc) in patients with long term fully suppressive therapy. patients (n=10) with a stable (\>6 months) nevirapine based triple therapy and a full viral load suppression for at least 2 years will continue their therapy for 6 months with nevirapine+3tc. the primary endpoint is treatment failure defined as an hiv-rna value \>100 cp/ml, confirmed by a second measurement. preliminary stopping rules are defined if results indicate futility. futility is defined as a situation, where the investigators would stop their plan to conduct a multicenter comparative trial. futility is reached, when the study documents more than 1 failure in the first 5 patients over 24 weeks of observation or more than 2 failures in all 10 patients. only 10 patients will be followed in this single center pilot study. after an amendement (april 2017) the total number of 20 patients was increased to 20. futility was defined as more than 2 failures in 20 patients.

Eligibility criteria:
inclusion criteria: * hiv-pos, 18 years * stable art, nevirapine based (plus 2 nukleotide-analogues), at least 6 months * viral load suppression at least 24 months prior to inclusion (\<50cp/ml) exclusion criteria: * chronic hepatitis b necessitating tenofovir therapy
humidity strategy to decrease morbidity and mortality in extremely low birth weight infants

Conditions: Extremely Low Birth Weight

Summary: the purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.


Eligibility criteria:
inclusion criteria: * inborn premature infants with weight ≤ 1000 g at birth exclusion criteria: * outborn infants. * failure to obtain parental consent for the study. * congenital malformations likely to affect life expectancy or neurosensory development. * unlikely to be available for follow up.

Keywords: elbw humidity bpd
navtemadlin (krt-232) with or without anti-pd-1/anti-pd-l1 for the treatment of patients with merkel cell carcinoma

Conditions: Merkel Cell Carcinoma

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, for the treatment of patients with merkel cell carcinoma (mcc) who have failed treatment with at least one anti-pd-1 or anti-pd-l1 immunotherapy or in combination with avelumab in mcc patients who are anti-pd-1 or anti-pd-l1 treatment naïve. inhibition of mdm2 is a novel mechanism of action in mcc.


Eligibility criteria:
inclusion criteria: * for cohort 1, 3 and 4 patients must have failed treatment with at least one pd-1 inhibitor or pd-l1 inhibitor for metastatic mcc * for cohort 2, patients must not have received any anti-pd-1 or anti-pd-l1 therapy * for cohort 3, patients must not have received any prior chemotherapy * for cohort 4, patients must have received at least one prior line of chemotherapy * ecog performance status of 0 to 1 * histologically confirmed mcc. disease must be measurable, with at least 1 measurable lesion by recist 1.1 * mcc expressing p53wt based on any clia or test approved by local health authority or a validated test (cohort 1 and 2) * mcc expressing p53wt based central lab test (cohort 3 and 4) * adequate hematological, hepatic, and renal functions exclusion criteria: * for cohort 2, subjects must not have autoimmune disease, medical conditions requiring systemic immunosuppression, prior stem cell transplant, or active infection with hbv or hcv. * patients previously treated with mdm2 antagonist therapies or p53-directed therapies * history of major organ transplant * patients with known central nervous system (cns) metastases that are previously untreated * grade 2 or higher qtc prolongation (\>480 milli-seconds per nci-ctcae criteria, version 5.0)

Keywords: navtemadlin (krt-232)