Kornimate/medical-research-clean huggingface dataset:
safety study of subclavian and internal jugular venous catheterization

Conditions: Time to Insertion; Rates of Complications

Summary: there is no randomized controlled trial to compare the rates of complications associated with internal jugular and subclavian venous catheterization. the aim of this study is to compare mechanical, infectious, and thrombotic complications of internal jugular and subclavian venous catheterization. an improved understanding of cvc-related risks might help clinicians to choose one approach over the other in specific clinical settings.

central venous catheterization is often necessary to treat critically ill patients hospitalized in intensive care units (icus). however, this procedure may lead to serious and sometimes life-threatening complications, including mechanical, infectious, or thrombotic complications. the choice of insertion site can influence the incidence and type of such complications. the most frequently used sites for cvc insertion are the internal jugular and the subclavian vein. however, in an individual patient, criteria for choosing one approach over the other remain unclear.

Eligibility criteria:
inclusion criteria: * admission to icu * requiring central venous catheterization * without contraindications to attempt both jugular and internal jugular access exclusion criteria: * the presence of a central venous catheter at admission * central venous catheterization within 2 weeks prior to admission * emergency catheterization for a life-threatening situation * major blood coagulation disorders * anatomic defect precluding catheterization at either site * skin lesions or recent surgery at either site

Keywords: central venous catheter complications internal jugular vein randomized trial subclavian vein
a study of atg-010 in combination with atg-008 in patients with relapsed/refractory diffuse large b-cell lymphoma

Conditions: Relapsed/Refractory Diffuse Large B-cell Lymphoma

Summary: this is an open label, phase ⅰb study of atg-010 in combination with atg-008 in patients with relapsed/refractory diffuse large b-cell lymphoma (rr dlbcl)

this is a multi-center, open label, phase 1 study conducted in rr dlbcl patients. the mtd and/or rp2d of study treatment, atg-010 in combination with atg-008, will be selected using boin design for the dose escalation phase. additional patients will be enrolled as an expansion cohort after mtd and/or rp2d is determined.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. ecog performance score of ≤2. 3. estimated life expectancy of \>3 months. 4. previously treated, pathologically confirmed dlbcl 5. patients must have received at least 2 but no more than 5 previous systemic regimens (for non-dh/th, non-de dlbcl and dlbcl not transformed from fl or cll), or at least 1 but no more than 5 previous systemic regimens (for dh/th, de dlbcl, and dlbcl transformed from fl or cll) for the treatment of their dlbcl. 1. prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy. 2. salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy. 3. any maintenance therapy will not be counted as a separate line of systemic therapy. 4. radiation with curative intent for localized dlbcl will not be counted as 1 line of therapy 6. documented radiographic evidence of progressive dlbcl of the last line (or refractory dlbcl) prior to the first dosing. exclusion criteria: 1. female patients who are pregnant or lactating 2. dlbcl with mucosa-associated lymphoid tissue \[malt\] lymphoma, or primary mediastinal (thymic) large b-cell lymphoma (pmbl) 3. known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable cns disease could be considered). 4. patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the investigator must provide detailed documentation for ineligibility) 5. use of any standard or experimental anti-dlbcl therapy (including radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \<21 days prior to cycle 1 day 1. 6. autologous stem cell transplant (sct) \<6 months or prior allogeneic sct, or car-t cell infusion \<6 months prior to cycle 1. 7. major surgery within 4 weeks of the first dose of study treatment.

Keywords: lymphoma, hodgkin's lymphoma , non-hodgkin's lymphoma
japan long-term safety for tiotropium plus olodaterol

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol fdc and olodaterol (delivered by the respimat inhaler) in japanese patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic obstructive pulmonary disease. 2. relatively stable airway obstruction with post fev1\< 80% predicted normal and post fev1/fvc \<70%. 3. male or female japanese patients, 40 years of age or older. 4. smoking history of more than 10 pack years. exclusion criteria: 1. significant disease other than copd 2. clinically relevant abnormal lab values. 3. history of asthma. 4. diagnosis of thyrotoxicosis 5. diagnosis of paroxysmal tachycardia 6. history of myocardial infarction within 1 year of screening visit 7. unstable or life-threatening cardiac arrhythmia. 8. hospitalization for heart failure within the past year. 9. known active tuberculosis. 10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. history of life-threatening pulmonary obstruction. 12. history of cystic fibrosis. 13. clinically evident bronchiectasis. 14. history of significant alcohol or drug abuse. 15. thoracotomy with pulmonary resection 16. oral ß-adrenergics. 17. oral corticosteroid medication at unstable doses 18. regular use of daytime oxygen therapy for more than one hour per day 19. pulmonary rehabilitation program in the six weeks prior to the screening visit 20. investigational drug within one month or six half lives (whichever is greater) prior to screening visit 21. known hypersensitivity to ß-adrenergic drugs, anticholinergics, bac, edta 22. pregnant or nursing women. 23. women of childbearing potential not using a highly effective method of birth control 24. patients who are unable to comply with pulmonary medication restrictions 25. patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.
long term outcomes of hybrid percutaneous approach

Conditions: Coronary Artery Disease

Summary: bioresorbable vascular scaffolds (bvs) are considered as a new revolution in coronary intervention due to their potential advantages for long term follow up. however, current generation bvs have also some drawbacks that restrict the use for complex lesions. using bvs and drug eluting stents (des) together -implanting des for bvs inappropriate segments -may be a feasible option to avoid the disadvantages of permanent foreign body and to reduce very late adverse events. in this context, we investigated the clinical outcomes following treatment with hybrid strategy with concomitant use of bvs and des for complex lesions. a single center retrospective cohort was performed enrolling 40 patients with complex lesions treated with hybrid approach from february 2015 up to april 2017. lesion segments with a large plaque burden and/or severe calcification, aorto-ostial and bifurcation lesions that may be unfavorable for bvs, treated with des. bvs and des were implanted with minimal overlap of des and bvs struts. the primary end-point was target lesion failure (tlf) which was a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization (tlr). during follow-up, coronary angiography was performed when patients had ischemic symptoms.


Eligibility criteria:
inclusion criteria: * treated with bvs in combination with des exclusion criteria: * treated with only des or bvs

Keywords: bioresorbable vascular scaffold
assess safety and efficacy of vad044 in hht patients

Conditions: Hereditary Hemorrhagic Telangiectasia (HHT)

Summary: part i: the purpose of this phase 1b proof of concept study, randomised, placebo controlled, double blind, multicentre study is to asssess safety and efficacy of 2 doses of vad044 in adult hht patients. part ii: the purpose of this open-label extension following the completion of the randomised double blind treatment and follow-up period (part i of the study) is to assess the long-term safetty, tolerability and efficacy of vad044 in adult hht patients.

part i: after being informed about the study and the potential risks, all patients giving written informed consent will undergo a two months screening and observation period to determine eligibility for study entry. at day 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio to 30mg vad044 (once daily), 40 mg (once daily) or placebo (once daily). part ii: patients who have completed the study part i can participate in the open-label extension study (part ii).the patients can roll over immediately after last visit of the part i or at any time at their convenience and according to their availability, but within a timeframe no longer than 8 months after the last visit (visit 12) of the part i. all patients in part ii will receive 30 mg of vad044 once daily for the first 4 weeks afterwards the daily dose can be increased to 40 mg daily for up to 12 months.

Eligibility criteria:
for part i of the study: inclusion criteria: * diagnosis of hht by the curaçao criteria * several epistaxis/week * anaemia * covid-19 vaccination or positive covid-19 antibody test * patient has given written informed consent to participate in part i exclusion criteria: * type 1 diabetes or uncontrolled type ii diabetes (insulin or non-insulin dependent) * active covid-19 infection * active uncontrolled infection or known to be serologically positive for hiv, hep b, hep c infection * recent procedures on nasal telangiectases (\<6 weeks) * requiring therapeutic anticoagulation * use of drugs with anti-angiogenic properties in the past 8 weeks * laboratory abnormalities fort part ii of the study: inclusion criteria: * completion of part i of the study * all adverse events or serious adverse events occuring during part i of the study have resolved * patient has given written informed consent to participate in part ii exclusion criteria: - same as in part i.

Keywords: osler-weber-rendu disease arteriovenous malformations
oral care to prevent ventilator-associated pneumonia

Conditions: Oral Hygiene, Oral Health; Ventilators, Mechanical

Summary: this study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

the universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in atatürk university training and research hospital anesthesia and reanimation intensive care unit between september 2019 and february 2020. a total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. in the data collection phase, 'patient identifier information form', 'patient monitoring form', 'oral assessment scale' and 'tracheal aspirate culture result form' were used. in the evaluation of the data, number and percentage distributions, kruskal wallis, mann withney-u, wilcoxon analysis, chi-square test were used.

Eligibility criteria:
inclusion criteria:• patients on mechanical ventilator who have been in intensive care for at least 48 hours * male and female patients over the age of 18 * patients without thrombocytopenia, leukopenia and oral stomatitis, aphthae, candiasis, gingivitis * patients whose respiratory support is provided by a mechanical ventilator * patients who are considered to be able to provide mechanical ventilator support for 7 days * patients without any respiratory-related infectious pathogens * obtaining informed consent from the patient if he/she can give consent or from his/her guardian if he/she is unable to give consent. * it was determined as patients who did not undergo any intraoral surgical intervention. exclusion criteria: patients with pneumonia patients younger than 18 years -

Keywords: mechanical ventilation nursing oral care pneumonia
magnetic resonance imaging autopsy study

Conditions: Stillbirths; Sudden Infant Death

Summary: the aim of this project is to establish whether magnetic resonance (mr) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and determination of the cause of death. this will be achieved by acquiring a database of whole-body, post-mortem mr images in approximately 400 fetuses, infants and children, over a 3 years period. images will be acquired on a dedicated 1.5t research mr scanner. mr images will be reported by an expert group of paediatric radiologists, and compared, in a blinded fashion, with reports from conventional autopsy performed by expert perinatal and paediatric pathologists. importantly, the post-mortem information will be assessed with reference to the needs of the parents, referring clinicians and hm coroners. the detection of central nervous system abnormalities will be assessed separately. the study will be performed across two sites: a dedicated children's hospital (great ormond street hospital) and a teaching hospital, with large obstetric, fetal and neonatal departments (university college london hospital), which are linked academically by university college london. co-ordination of the project will be managed by a steering committee, which will ensure accurate collation and comparison of the data.


Eligibility criteria:
inclusion criteria: * fetuses, newborns and infants undergoing conventional autopsy exclusion criteria: * lack of parental consent

Keywords: autopsy mri stillbirths neonatal death sudden infant death
exome analysis position in the strategy of genetic predisposition factors identification in early-onset cancer

Conditions: Cancer; Genetic Predisposition

Summary: 5 to 10% of cancers are due to the presence of a constitutional genetic alteration. it can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). in both cases, this genetic alteration is constitutional and transmissible to descendants. it is hereditary. when an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". however, this analysis does not always identify the genetic predisposing factors for cancer. new techniques called "high-throughput exome sequencing (shd-e)", allow more than the analysis of the the gene panel. these analysis allow to identify alterations in other genes that could contribute to the development of cancer. the objective of the ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.

the main objective of this study is to evaluate the interest of the shd-e approaches after a negative result of the analysis called " gene panel " tested in routine in order to identify a genetic factor of predisposition to the cancer.

Eligibility criteria:
inclusion criteria: index case: 1. major or minor patient 2. histological or cytological evidence of malignant tumor diagnosis 3. patient with cancer before age 40 (or before age 30 for breast cancer). 4. absence of anomaly found on the oncogenetic panel tested in the predisposition concerned 5. patient affiliated to a social security scheme 6. signature of informed consent extrican 7. availability of a tumor sample if needed secondary functional studies 8. availability of both parents when the trio approach will be necessary in the population 1 (or validation of the indication in cpr in case of non-availability of both parents) 9. availability of affected relatives in population 2 (or validation of the indication in spc in case of non-availability of the related person) related: 1. major or minor patient 2. histological or cytological evidence of the diagnosis of malignant tumor if 3. patient affiliated to a social security scheme 4. signing informed consent extrican exclusion criteria: index and related case: 1. refusal of the patient participation 2. psychiatric illness and / or condition of the patient compromising the understanding of the information or the realization of the study 3. patient under guardianship, curatorship or safeguard of justice 4. pregnant woman

Keywords: genetic mutations early sporadic or familial cancer gene panel exome analysis high-throughput exome sequencing
viagra in the treatment of primary dysmenorrhea

Conditions: Dysmenorrhea

Summary: the primary hypothesis is that a 100mg single dose of sildenafil citrate (viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.

it is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. a large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (nsaids) being the most effective with the overall success rate of more than 75%. sildenafil citrate (viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of cyclic guanosine monophosphate (cgmp) in the uterine muscle. sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. to date it has not been used in the treatment of primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: * primary dysmenorrhea at current visit, with a visual analogue scale (vas) score of \>35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe. exclusion criteria: * secondary dysmenorrhea * any current medication * serious medical condition

Keywords: sildenafil
a high-resolution magnetic resonance imaging study to evaluate the effect of rosuvastatin on carotid atherosclerotic plaques

Conditions: Arteriosclerosis; Diabetes Mellitus; Lipid Disorder

Summary: the aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by high-resolution contrast enhanced magnetic resonance imaging (ce-mri). enrolled patients have a baseline ce-mri examination for screening carotid atherosclerotic plaques and are randomized to either low dose of rosuvastatin (5mg) group or high dose of rosuvastatin (20mg) group. after 26 weeks, all patients received ce-mri examination again and each pair of baseline and follow-up ce-mri assessments was analyzed in a blinded fashion. moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.


Eligibility criteria:
inclusion criteria: -patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction exclusion criteria: * planning coronary stenting * heart failure * uncontrolled hypertension（≥200/110mmhg) * uncontrolled diabetes mellitus (hba1c≥9.5%) * hepatic insufficiency * renal dysfunction * cancer

Keywords: coronary arteriosclerosis carotid atherosclerotic plaque rosuvastatin
analgesia in lingual frenulotomy in the newborn

Conditions: Frenulum Breve

Summary: ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of the newborns. this condition can be associated with difficulty in breastfeeding which can be painful for the mother, dysfunctional swallowing and future speech difficulties. the prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is estimated to be between 36 and 80%. since an early intervention can prevent the difficulties that may occur during the child's growth and can also improve the mothers and patients' quality of life, it is important to evaluate the lingual frenulum in the first days of life. the treatment of ankyloglossia consists in the frenulotomy which allows the release of the lingual frenulum and is a relatively simple procedure with few side effects and minimal post-operative. different methods performed with or without local anaesthesia by means of scissors, blade, laser (etc.) are described in literature for the procedure the newborn. the hypothesis of the study is that the addition of a water and sugar solution to the standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and determine the activation of different brain areas. the primary aim of the study is to evaluate whether the administration of a water and sugar solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic protocol, may lead to an additional benefit in terms of pain reduction evaluated according to the neonatal infant pain scale (nips). the secondary aim of the study is to evaluate through a hitachi multichannel near-infrared spectroscopy (nirs) the effects of the addition of a water and sugar solution to the standard analgesic protocol with topical lidocaine on the cortical activation.


Eligibility criteria:
inclusion criteria 1. term newborns (37 - 41 weeks of gestational age) within the first 10 days of life; 2. birth weight ≥ 2500 grams; 3. presence of ankyloglossia; 4. indication to the frenulotomy according to the hazelbaker assessment tool for lingual frenulum function (hatlff): anatomical-functional evaluation with a score lower than 8. exclusion criteria: 1. syndromic diagnosis (genetic/hereditary); 2. pathology of main organ (heart disease, brain disease etc.); 3. drugs intake that may interfere with the collected data (sedatives).

Keywords: ankyloglossia frenulotomy water and sugar solution
comparison of surgical procedures to reduce urinary stress incontinence

Conditions: Urinary Incontinence

Summary: the primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. the secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. follow-up will be a minimum of two years and up to four years.


Eligibility criteria:
* predominant stress urinary incontinence by self-report,examination and test; * urethral hypermobility; * eligible for both surgical procedures; * ambulatory; * not pregnant; * \>12 months post-partum; * no systemic disease known to affect bladder function; * no current chemotherapy or radiation therapy; * no urethral diverticulum, augmentation cytoplasty, or artificial sphincter; * no recent pelvic surgery; * available for follow-up and able to complete study assessments; * signed informed consent.

Keywords: stress urinary incontinence surgery