Kornimate/medical-research-clean huggingface dataset:
dual-energy computed tomography (dect) in acute neck infections: comparison with magnetic resonance imaging (mri)

Conditions: Neck Abscess

Summary: the purpose of this prospective study is to compare mri and dect in imaging acute neck infection. 50 patients suspected for neck infection will undergo both modalities, which will then be compared in terms of depiction of edema, conspicuity of inflammation, and characterization and number of abscesses. we hypothesize that dect will have diagnostic performance comparable to that of mri, and superior to that of traditional single-energy ct. this study will yield important new information about the performance of dect, a novel and rapid method for emergency imaging.

deep neck infections present challenges even in modern medicine, due to complex anatomy and potentially lethal complications. true extent of the infection is difficult to assess clinically. therefore, medical imaging is useful in determining the exact location and extent of disease. in suspected neck infection, computed tomography (ct) has traditionally been the first-line imaging method. however, magnetic resonance imaging (mri) provides excellent soft-tissue characterization surpassing that of ct in the initial evaluation of neck infections. previous studies have shown than mri is superior to ct in terms of lesion conspicuity and number of affected spaces in neck infections. as an alternative to mri, dual-energy ct (dect) could offer improved soft tissue sensitivity compared with traditional single-energy ct. dect refers to ct imaging carried out with two kinds of spectra of x-ray. in this prospective comparative study, we will recruit emergency patients with suspected neck infection. neck mri will be completed as part of standard clinical care, and dect as part of this research study. after study completion, dect and mri will be compared by neuroradiologists, both modalities at separate occasions, blinded to the clinical information and diagnosis as well to the result of the other modality. clinical care will be based on mri as is usual practise. surgical findings will be considered gold standard.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * suspicion of acute neck infection as deemed by the referring physician exclusion criteria: * history of a serious adverse reaction to intravenous iodine- or gadolinium-based contrast agent * severe kidney dysfunction (egfr \< 30 ml/min/1.73m2) * foreign metallic objects incompatible with mri in the body * inability to give informed consent, as deemed by study physician * inability to follow study instructions

Keywords: computed tomography magnetic resonance imaging
ph1b/2 study of the safety and efficacy of shr-a1811 combinations in advanced her2 expression gastric cancer

Conditions: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Summary: this is an open,multicentre phase ib/ii study. the purpose of phase ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of shr-a1811 in combination with chemotherapy and/or immunotherapy in her2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients. the phase ii study was designed to evaluate the efficacy and safety of shr-a1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic her2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.


Eligibility criteria:
inclusion criteria: 1. age from 18 to 75, male and female participants 2. local advanced unresectable or metastatic disease pathologically documented adenocarcinoma of gastric or gastroesophageal junction; 3. her2 expression ; 4. phase ib: failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; phase ii: previously untreated patients; 5. ecog 0-1; 6. the expected survival ≥3 months; 7. sufficient bone marrow and organ functions; exclusion criteria: 1. there were ascites, pleural effusion and pericardial effusion that needed to be treated; 2. major surgery was performed within 4 weeks; 3. have active autoimmune disease or history of autoimmune disease; 4. patients with interstitial pneumonia; 5. there was severe infection within 4 weeks before starting the study treatment; 6. patients with active pulmonary tuberculosis infection history within 1 year before enrollment; 7. serious cardiovascular and cerebrovascular diseases; 8. gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
efficacy and safety of olmesartan associated with chlorthalidone in essential arterial hypertension control

Conditions: Essential Arterial Hypertension

Summary: the purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility criteria:
inclusion criteria: * signed consent of the patient; * participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the brazilian society of cardiology (2010), who have never been treated and have indication for drug combination treatment. obs: the diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmhg, with two months difference between measurements exclusion criteria: * patients with any clinically significant disease that in the investigator is opinion can not participate in the study; * secondary hypertension diagnosis or blood pressure above 190x100 mmhg in the screening/randomization visit; * morbid obesity or immunocompromised patients; * participants with greater than 10 mmhg difference in the measurements of systolic or diastolic blood pressure between the two arms; * participants who do not have the two upper limbs; * participants with important electrocardiographic changes; * creatinine clearance - less than 60 ml /min; * history of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months; * microalbuminuria in urine sample greater than 30 mg/g; * patients with history of hypersensitivity to any of the formula compounds; * pregnancy or risk of pregnancy and lactating patients; * participation in clinical trial in the year prior to this study.
intravitreal bevacizumab for low vision in neovascular age-related macular degeneration (amd)

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (ivbi) with respect to simple observation in patients with subfoveal choroidal neovascularisation (cnv) secondary to age-related macular degeneration (amd) presenting at baseline with best corrected visual acuity (bcva) less than 20/200.

there is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (cnv) secondary to age-related macular degeneration (amd) presenting at baseline with best corrected visual acuity (bcva) less than 20/200. treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements. aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (ivbi) with respect to simple observation in

Eligibility criteria:
inclusion criteria: * age-related macular degeneration * naïve subfoveal choroidal neovascularization * best-corrected visual acuity less then 20/200 exclusion criteria: * previous treatments * any other condition able to limit the visual improvement

Keywords: age-related macular degeneration bevacizumab
efficacy of facilitated tucking during pain procedure in preterm infants

Conditions: Facilitated Tucking; Non Nutritive Sucking; Preterm; Pain Relief

Summary: preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. the support for the pain of the preterm is a priority for nurses and neonatologists. previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks ga). unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. so, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. facilitated tucking alone has been validated for preterm less than 37 ga during heel stick procedure with the pipp score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.

after randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. the sequence will be filmed. evaluation of pipp and dan will be done after viewing by 3 independent experts. each child will receive only one procedure.

Eligibility criteria:
inclusion criteria: * newborn from 28 weeks to 31 weeks +6 days ga. * age from 0 to 48 hours of life. * admission in intensive care unit or neonatal unit. * need for more than 4 heel stick procedures per 24 hours. * one parents's consent exclusion criteria: * hemodynamic instability with initropic drug need. * therapeutic hypothermia in context of neonatal asphyxia. * curarized child. * neurologic anomaly of contact/tonus. * lidocaine application during the 4 hours before the procedure

Keywords: facilitated tucking non nutritive sucking preterm pain relief
anatomo-clinico-biological profiles in severe nasal polyps

Conditions: NASAL POLYPS

Summary: nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population. therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. local corticosteroid therapy, using nasal sprays, is the background treatment. surgical management is offered to patients in case of failure of medical treatment. although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. there is currently no possibility of determining the probability of response to treatments in patients. it is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. this correlation will serve as a predictor of treatment response.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 year-old * patient with nasal sinus polyposis resistant to medical treatment and requiring surgical treatment with ethmoidectomy type is considered for the first time * having signed the consent form * having an health insurance exclusion criteria: * current or past biotherapy treatment * taking general corticosteroid therapy within 4 weeks of surgery * protected person * pregnant women or lactating women
nd:yttrium aluminum garnet laser treatment for lichen sclerosus

Conditions: Lichen Sclerosus; Lichen Sclerosus Et Atrophicus

Summary: this study evaluates the efficacy of nd:yttrium aluminum garnet laser (nd:yag) treatment of lichen sclerosus in comparison with topical corticosteroid treatment. half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

lichen sclerosus (ls) is a chronic skin disease of unknown cause and very unpleasant symptoms which significantly influences the quality of life of the affected patients. large majority of ls lesions is located in anogenital region where initial white flat papules usually develop into large, white patches of thin, itchy skin causing fusion of labia minora, narrowing of the introitus and burying of the clitoris. most common symptoms are itching, pain, soreness, burning, dyspareunia and dysuria all strongly interfering with sexual function and patient's self image. existing treatment options with systemic and topical medications (oral retinoids, topical steroids) have some drawbacks and recently the use of laser was proposed for treatment of ls. this study evaluates the safety and efficacy of nd:yttrium aluminum garnet laser (nd:yag) treatment of lichen sclerosus in comparison with topical corticosteroid treatment. half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed lichen sclerosus * voluntary signed informed consent exclusion criteria: * pregnancy * use of photosensitizing medication * pathology other than lichen * damage of tissues in the treatment area * other inflammation * refusal to sign informed consent

Keywords: lichen sclerosus laser nd:yag randomized controlled trial
safety and feasibility of mr-guided laser thermal ablation of brain lesions

Conditions: Glioblastoma

Summary: this will be an open-label, pilot, exploratory, single centre clinical investigation. this is an early feasibility single arm study. no formal hypothesis is proposed. a total of up to 15 evaluable subjects receiving a non-radical ablation is planned. the safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment. a minimal invasive neurosurgical approach with a magnetic resonance imaging (mri)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the laser applicator prior to ablation.


Eligibility criteria:
inclusion criteria: 1. lesions eligible for laser interstitial thermotherapy (litt), target tumor ≤10cc in volume 2. age ≥ 18 and \< 80 years 3. ability to undergo contrast-enhanced computed tomography (ct), positron emission tomography (pet)-ct and contrast-enhanced mri. 4. women of childbearing potential must have a negative pregnancy test. 5. eastern cooperative oncology group (ecog) performance status of ≤2 6. primary glioblastoma/astrocytoma who grade iv confirmed by 1)magnetic resonance imaging according to rano citera and 2)frozen section biosy diagnosis, and considered not suitable for open surgery or other primary treatment, or recurrent glioblastoma/astrocytoma who grade iv confirmed by magnetic resonance imaging according to rano criteria. 7. ≥3 months since last radiotherapy of the brain 8. supratentorial tumor localization with or without prior surgery for recurrence. 9. life expectancy of ≥3 months 10. the subject reports having understood and has signed the informed consent form (icf) and is willing to comply with all investigation visits and assessments. 11. anticipated compliance with treatment and follow-up exclusion criteria: 1. subject contraindicated for mri, including subjects who may have contraindications due to implanted medical devices 2. subject evaluated not to be fit for surgery due to liver/kidney/other organ dysfunction verified by laboratory tests 3. identified intratumoral cystic or haemorrhagic transformation in target tumor 4. known bleeding disorder 5. ecog performance status of \>2 6. previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s 7. pregnancy or breastfeeding 8. the subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation 9. the subject is considered by the investigator to be unsuitable to participate in the investigation for any other reason. 10. any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation

Keywords: laser thermotherapy magnetic resonance guidance interventional thermal ablation clearpoint neuro navigation magnetic resonance thermometry minimal invasive mrg litt tranberg thermoguide stereotactic laser ablation
thulium fiber laser vs. holmium:yag laser for the ureteroscopic treatment of patients with urinary stone disease

Conditions: Kidney Stone; Ureteral Stone

Summary: this is a randomized controlled trial which aims to compare the efficacy and safety of thulium fiber laser (tfl) and holmium:yttrium-aluminum-garnet (ho:yag) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of tfl.


Eligibility criteria:
inclusion criteria: * renal/ureteral stones \> 4 mm exclusion criteria: * anatomical abnormalities
clinical study of patellar resurfacing and non-resurfacing in total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: the literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. this study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.

sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. patients were randomized to receive resurfacing or retention of the patella. all patients received the scorpio nrg knee prosthesis. evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. knee society score and feller score outcomes were measured. anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.

Eligibility criteria:
inclusion criteria: * degenerative oa * 50-75 years * all patients with oa were bilateral knee oa exclusion criteria: * previous patellectomy * inflammatory arthritis * patellar fracture * patellar instability * previous extensor mechanism procedures * high tibial osteotomy, * severe valgus or varus deformity (\> 20°), severe flexion contracture (\> 30°) * previous unicondylar knee replacement * a history of septic arthritis or osteomyelitis.

Keywords: osteoarthritis patellar resurfacing anterior knee pain
study on patients with rasmussen encephalitis treated with adalimumab: efficacy and tolerance in the short and long term

Conditions: Rasmussen Encephalitis

Summary: since the initial study of cases reported between 2009 and 2015, adalimumab has become in france the immunomodulatory reference treatment used after failure of corticosteroids and immunoglobulins before a possible recourse to the hemispherotomy. this observational study is intended to document the long-term efficacy and safety of adalimumab therapy in patients with rasmussen encephalitis.

rasmussen encephalitis (er) is a particularly severe chronic inflammatory brain disorder resulting in the progressive destruction of a hemisphere. it is a rare disease although at present no precise prevalence is available. it begins preferentially in children. this inflammatory process is accompanied by a progressive loss of function of the affected hemisphere, associated with a pharmaco-resistant partial epilepsy. the diagnosis is based on a bundle of clinical, radiological and electroencephalographic arguments. csf analysis directs diagnosis in 50% of cases. no anti-epileptic treatment can stop seizures. only hemispherotomy (surgical disconnection of a cerebral hemisphere) allows it but it is associated with definitive motor and cognitive deficits. over the last 20 years, new therapeutic trials have focused on immuno-modulatory treatments targeted at the t-lymphocyte pathway, including tacrolimus. although they seem to be more effective than immunoglobulins or corticosteroids, it remains transient. in addition, the number of published cases is low. in this context, starting in 2009, it has been proposed to use adalimumab (ab anti tnf) based on: * 1 / study of a case index * 2 / knowledge of the pathophysiology of rasmussen encephalitis. to date, very few data provide precise information on the efficacy or tolerance of the use of this product in the longer term. this information is essential to confirm the place of adalimumab in the therapeutic arsenal against rasmussen encephalitis. thus, in the continuation of the work carried out previously (french study on the cases between 2009 and 2015), the aim of this research projet is to complete the follow-up of the patients who previously took part in in the first study and to establish the follow-up of the patients treated by adalimumab since then.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of rasmussen encephalitis * patient aged more than 2 years * compliant treatment with adalimumab exclusion criteria: * patient with a differential diagnosis * patient suffering from rassmussen encephalitis but not treated with adalimumab * patient who has not signed the informed consent
co-administration of propofol and remifentanil for lumbar puncture in children

Conditions: Spinal Puncture

Summary: the objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

lumbar punctures (lp) are performed in approximately one thousand oncology patients per year at the hospital for sick children. in a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during lp in children. the present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a hemato-oncological disorder * scheduled to undergo a lumbar puncture * aged 3-12 years * unpremedicated exclusion criteria: * children who are known or suspected to be difficult to ventilate by face mask * children who are deemed medically unfit to receive either of the two study medications * children who are obese (weight for height \> 95th percentile) * children who do not have an indwelling intravenous line

Keywords: lumbar puncture pediatrics propofol remifentanil sedation oncology