Kornimate/medical-research-clean huggingface dataset:
circulating tumor cells (ctcs) in advanced gastric cancer

Conditions: Gastric Cancer

Summary: to assess the predictive value of circulating tumor cells (ctcs) for recurrence of advanced gastric cancer after radical resection. to identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection.


Eligibility criteria:
inclusion criteria: * having signed informed consent * age≥ 18 years old * histologically confirmed gastric adenocarcinoma * preoperative clinical examination and imaging indicating operable disease * complete resection (r0 resection) * d2 or d2+ resection exclusion criteria: * other tumor type than adenocarcinoma * patients who have been given preoperative chemotherapy/chemoradiation. * staging investigations or intraoperative exploration indicating inoperable disease * r1 or r2 resection * d0 or d1 resection * patients unreliable for follow up * past history of malignancy

Keywords: ctcs before and after gastrectomy
pd-l1 expression in lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this study will measure pd-l1 expression in metastatic nsclc (primary tumour and metastatic lesions) using \[99mtc\]-nm-01 spect/ct and compare to pd-l1 percentage expression determined by immunohistochemistry (ihc).

a non-blinded, single centre, single interventional arm phase ii diagnostic imaging study.

Eligibility criteria:
inclusion criteria: * aged 18 or above * patients with histopathology confirmed untreated metastatic nsclc scheduled for systemic anti-cancer therapy * ecog status ≤ 1 * willingness and ability to comply with scheduled study visits and tests exclusion criteria: * pregnant or breast-feeding women * concomitant uncontrolled medical conditions as per investigator assessment * \> 3 months between ihc pd-l1 and study recruitment * significant abnormality of haematology (one or more of: hb ≤ 90g/l, absolute neutrophil count (anc) ≤1.5 x109/l, platelet count ≤75 x109/l) * significant abnormality of renal function (defined as cockcroft-gault calculated creatinine clearance ≤30 ml/min) * significant abnormality of liver function (one or more of: ast or alt ≥2.5x uln or ≥ 5x uln if patient has liver metastases; total bilirubin ≥1.5xuln. in the case of patients with gilbert's syndrome then direct bilirubin must be confirmed as ≤ uln) * significant cardiovascular disease, including new york heart association (nyha) heart failure ≥class iii, myocardial infarction within 3 months of enrolment, unstable arrhythmia or unstable angina * history of uncontrolled allergic reactions and/or have hypersensitivity to anti-pd-l1 monoclonal antibodies, kanamycin a or aminoglycoside therapies, or other excipients that may induce hypersensitivity

Keywords: pd-l1 expression immunohistochemistry spect/ct imaging molecular imaging heterogeneity
subcutaneous amifostine (ethyol®) in the prevention of radiochemotherapy-induced esophagitis and pneumonitis in patients with unresectable non-small cell lung cancer

Conditions: Esophagitis; Pneumonitis; Non-Small Cell Lung Carcinoma

Summary: the primary objective of this study is to assess the activity of subcutaneous (sc) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable stage iiia or iiib non-small cell lung cancer (nsclc) receiving combined modality therapy.


Eligibility criteria:
you may be eligible for this study if you are 18 years of age or older and: * have unresectable stage iiia or iiib non small cell lung cancer * have never had prior chemotherapy with paclitaxel or carboplatin * have never had prior thoracic radiation therapy (xrt)

Keywords: - non-small cell lung cancer
back in the game: a smartphone application to support athletes returning to sport after serious injury

Conditions: Anterior Cruciate Ligament Injury

Summary: returning to sport is one of the primary concerns of athletes following injury. yet, after serious injury, up to 50% of athletes do not return to competitive sport. psychological factors play an important role in the athlete's return to sport after anterior cruciate ligament (acl) reconstruction, and physical and psychological readiness to return to sport often do not coincide. there are currently no easily accessible programs for non-professional athletes to help address the psychological factors that impact on their return to sport after injury. the aim of this trial is to test whether a smartphone application (app) delivering cognitive-behavioural therapy to address psychological factors including fear, confidence and recovery expectations, is effective for improving the number of people who return sport following acl reconstruction. we hypothesise that patients who use the app in addition to receiving usual rehabilitation care after acl reconstruction will return to sport in greater numbers than patients who receive usual rehabilitation care only.


Eligibility criteria:
inclusion criteria: * unilateral primary anterior cruciate ligament rupture * time between injury and anterior cruciate ligament reconstruction not greater than 12 months * playing contact pivoting or non-contact pivoting sport at least twice per week prior to anterior cruciate ligament injury * intend to return to sport following anterior cruciate ligament reconstruction * age 15 to 30 years at anterior cruciate ligament injury * normal/healthy contralateral knee exclusion criteria: * collateral ligament injury requiring surgery * posterior cruciate ligament injury * meniscus injury/treatment that requires alteration to usual rehabilitation programme * articular cartilage injury/treatment that requires alteration to usual rehabilitation programme * previous anterior cruciate ligament injury to either knee * injury to either leg that required medical care during the previous 12 months * other injury or illness that could affect knee rehabilitation * taking medication for mental health problems

Keywords: knee injuries anterior cruciate ligament injuries telemedicine
impact of auricular vagus nerve neuromodulation on covid-19 positive inpatients outcome

Conditions: Covid19; SARS-CoV Infection

Summary: the covid-19 pandemic has already overwhelmed the sanitary capacity. additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. a decrease of heart rate variability (hrv) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. in contrast, auricular vagus nerve stimulation was proven not only to increase hrv values in healthy humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of sars-cov2 is likely to be partially responsible for covid-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of covid-19 inpatients within 15 days.


Eligibility criteria:
inclusion criteria: * covid-19 positive inpatient (pcr or other certified test mandatory) * inpatient showing at least one of the following criterion: abnormal respiratory auscultation and spo2 \< 94% without oxygen therapy, or acute respiratory failure requiring either oxygen therapy or high-flow oxygen therapy or non-invasive respirator and/or invasive respirator. exclusion criteria: * inpatient requiring legal protection * pregnant or breastfeeding woman * intensive care inpatient or patient undergoing surgery secondary non inclusion criteria : - unintentional blinding removal.

Keywords: non-invasive neuromodulation vagus nerve
safety of exposure to natalizumab during pregnancy

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) preferentially affects young adults with a female predominance. ms is not associated with an increased risk of complications or abnormal pregnancy outcomes. nevertheless, disease-modifying therapies can have a teratogenic effect. discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus. natalizumab (ntz) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting ms (rrms). when it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. at present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: pregnancy and postpartum under ntz (group1), pregnancy partially under ntz (with or without immunomodulator (im) supplementation, group 2), or ntz stopped before pregnancy (with or without im supplementation, group3). the first part of the babyzumab study, a retrospective study of natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of ntz treatment the investigators analyzed the annual relapse rate (arr) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the ofsep database. the investigators showed that the risk of relapses was four times higher in group 2 versus group 1 (p=0,014) and six times higher in group 3 versus group 1 (p=0,001). in the literature, there are few studies of newborns from ntz-exposed pregnancies. no specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to ntz-exposed mothers in the third trimester of pregnancy.


Eligibility criteria:
inclusion criteria: * age greater than 18 years at the index date (date of pregnancy onset) of data collection, * rrms according to mcdonald's 2017 criteria (thompson et al., 2018) * affiliated person or beneficiary of a social security scheme. * followed up at one of the participating centers (ofsep centers) * ntz exposure during pregnancy according to 3 pre-defined sub-groups: continuation of ntz throughout pregnancy and postpartum (group 1), exposure during the first trimester (group 2) exposure during the first and the second trimester (group 3). * participants capable of expressing non objection * french-speaking, without comprehension disorders exclusion criteria: * patient concerned by articles l 1121-5 to l 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Keywords: natalizumab safety pregnancy
education interventions model for rational drug use (rdu)

Conditions: Asthma

Summary: the purpose of this study is to develop, implement and evaluate an economically viable and efficient interventions education model for rational drug use, adaptable to different pathological situations and should be implemented into brazil heath care system.

currently, the educational interventions regarding the use of medicines need to be expanded and more effective, and thus set themselves up in strategies for reorganization of dispensing drugs in health services and provide support to the population to obtain greater control over their health. the pharmacist, in turn, inserted in the multidisciplinary team has an important role in health education with the aim of improving knowledge about the disease and the various treatment options, reflecting positively on treatment adherence and clinical outcomes as a result and quality of life related to patient health. thus, health education, to share knowledge, represents an important task and involves attentive listening to the community to identify their needs and then solve them. from this perspective, therefore, the educational means to educate health and an integral formation of individuals as social actors critics who understand and question the social relations, transforming subjects into citizens participating in the process of health education, helping to raise awareness , knowledge and understanding of living conditions and relationships with health, promoting quality of life.

Eligibility criteria:
inclusion criteria: * subject with asthma diagnosed according to criteria of the global strategy for asthma management and prevention; * subject is a male or female with 18 to 73 years-old; * subject who has access to medications supplied by the the brazil heath care system; * subject unable to perform the procedures or conditions such as pregnancy that may affect the results of the study; * literate subject without cognitive disorders, alzheimer's, dementia, that can limit the ability to participate in this study; * subject who have availability to attend the monthly meetings; * subject provides written informed consent and attend the first evaluation. exclusion criteria: * subject who cannot be classified in the inclusion criteria.

Keywords: pharmaceutical education rational drug use asthma
evaluate the effects of patupilone on the pharmacokinetics of midazolam and omeprazole in patients with advanced malignancies

Conditions: Solid Tumors

Summary: the purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.


Eligibility criteria:
inclusion criteria: * male or female patients 18 years or older * histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist * life expectancy of 3 months or more * patients with adequate hematologic parameters exclusion criteria: * hypersensitivity to midazolam or omeprazole or related compounds * female patients who are pregnant or breast-feeding. * patients with a severe and/or uncontrolled medical disease * patients with a known diagnosis of human immunodeficiency virus (hiv) infection * patients having received an investigational agent within 30 days prior to study entry other protocol defined inclusion/exclusion criteria may apply.

Keywords: cancer epo906 patupilone
evaluation of architectural changes in mandibular bone pattern after functional treatment by fractal dimension analysis

Conditions: Orthopedic Disorder

Summary: in this study it was aimed to examine the changes in mandibular bone after functional treatment by using fractal dimension (fd) and cortical thickness (ct) analysis.

in this study it was aimed to examine the changes in mandibular bone after functional treatment by using fractal dimension (fd) and cortical thickness (ct) analysis. the study will perform on 42 mandibular retrognathia cases. the treatment group (t), comprised of 30 cases treated with functional appliance for one year in puberty. the control group (c) consists of 12 patients who had insufficient oral hygiene; didn't take any orthodontic treatment for one year. fd and ct analysis will evaluate for both sides. fd measurements will perform on processus condylar, antigonial notch, and ramus regions in the panoramic radiographs. paired t-test will apply to analyze all between groups (before (t1) and after treatment (t2), before (c1) and after (c2) control). also, independent t-test wişll use to determine whether there was any difference between the treatment group (∆t=t2-t1) and the control group (∆c=c2-c1).

Eligibility criteria:
inclusion criteria: 1. males and females were matched. 2. treatment period of the treatment group was 1 year. 3. observation period of the control group was also 1 year. 4. all groups had class ii malocclusion (anb ≥ 5) with the retrognathic mandible in the period of puberty and had no systemic problem and impacted teeth. 5. monoblock and twin-block appliances were applied to the treatment group. 6. patients in the control group had insufficient oral hygiene and after oral-care was provided, they were taken into treatment. exclusion criteriteria: 1. radiographic images that do not have sufficient diagnostic quality

Keywords: functional orthodontic appliances fractal dimension panoramic radiographs orthodontics
irisin expression and gene polymorphism with peripartum cardiomyopathy.

Conditions: Peripartum Cardiomyopathy

Summary: this is an observertional study aimed at study the association between the level of irisin expression and (fibronectin type iii domain containing 5 (fdnc5) gene polymorphism in female patients with peripartum cardiomyopathy.


Eligibility criteria:
inclusion criteria: * this study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy exclusion criteria: * age less than 18 or more than 45 year old * females with dilated cardiomyopathy due to other etiology or outside the time frame of occurrence of peripartum cardiomyopathy

Keywords: peripartum cardiomyopathy, irisin
analgesia and pancreatic cancer surgery

Conditions: Pancreatic Neoplasms

Summary: long-term survival for patients with pancreatic carcinoma is low, even following resection, the 5-year survival rate of patients ranges from 10 to 25%1. most treatment failure is due to local recurrence, distant metastasis or both within one to two years after surgery2-4. surgery has been suggested to accelerate the development of preexisting micro metastases and to promote the establishment of new metastases5. release of catecholamine and proinflammatory products secondary to surgical stress is believed to promote cancer progression6. maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. however, general anesthesia including numerous induction agents, volatile anesthetics and opioids, is associated with immunosuppression especially on the cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7. therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer progression. currently, most studies available in humans are retrospective and observational to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related outcomes8-12. only one randomized study investigating major abdominal cancer surgery is available13. however, it is not specific to an individual cancer type and perioperative cell-mediated immunity is not evaluated. in this study, we aimed to identify whether epidural block beneficial to early surgical and late cancer-related outcomes in patients receiving pancreatic cancer surgery. perioperative cell-mediated immunity functions including natural killer cells, helper and cytotoxic t-lymphocytes were also investigated.


Eligibility criteria:
inclusion criteria: * pancreatic cancer expected to receive curative whipple operation exclusion criteria: * palliative operation * preoperative chemotherapy or radiotherapy * patients with metastasis * contraindications for epidural catheter placement * prior spine surgery
assessing clinical outcomes in alzheimer's disease agitation

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation,Psychomotor

Summary: this is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of axs-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with alzheimer's disease.

enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with axs-05 and monitored for a treatment response. patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with axs-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease (ad) based on the 2011 national institute on aging-alzheimer association (nia-aa) criteria. * diagnosis of clinically signification agitation resulting from probable ad according to the international psychogeriatric association (ipa) provisional definition of agitation. exclusion criteria: * patient has dementia predominantly of non-alzheimer's type. * patient has symptoms of agitation that are not secondary to ad (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced). * unable to comply with study procedures. * medically inappropriate for study participation in the opinion of the investigator.

Keywords: ad agitation axs-05 nmda receptor antagonist dextromethorphan bupropion axsome accord
sanitation demand creation in peri-urban slums of lusaka, zambia

Conditions: Diarrhea

Summary: this intervention will experimentally test the hypothesis that sanitation can be improved in a peri-urban setting using state-of-the-art behaviour change communications. formative research indicated that landlords are the effective decision-makers about investments in sanitation on their plots (which can include a number of tenant households as well). landlords will therefore be the primary targets of the intervention. the study will take the form of a randomized controlled trial of the intervention evaluated at the plot level. the intervention will invite enrolled landlords to a series of meetings in which various mechanisms will be used, each designed to increase their likelihood of improving the toilet(s) on their plot. these meetings will be the main vehicle for a status-building campaign associated with increasing wealth by improving plot sanitation, understanding tenants' implicit demand, understanding the processes by which toilets can be improved, and a competition rewarding landlords that make the greatest improvements to the improvement of their toilet(s). the desired improvements will be measured via multiple primary outcomes that measure aspects of changes to hardware and software components, including indicators of hygienic quality, psychological desirability, accessibility, and ecological sustainability. this is because the investigators argue that, to have a significant impact on population-level diarrheal disease indicators, any sanitation solution must be: * effective at reducing exposure to pathogens (i.e., hygienic), * desirable (i.e., seen as valuable or humane), and * accessible (i.e., no one excluded), so that it can be used by all * for a reasonably long time (i.e., sustainable)


Eligibility criteria:
plots will be selected for inclusion in the study based on meeting the inclusion criteria. the intervention will be delivered to the landlord on each plot assigned to the intervention arm. intervention inclusion criteria: * plot located in bauleni compound * adult landlord (age 18 or higher) resides on plot intervention exclusion criteria: \* none data will be collected from the landlord and one randomly selected tenant from all eligible adult tenants on each plot. data collection inclusion criteria: \* adult landlord or tenant (age 18 or higher) resides on selected plot most of the time data collection exclusion criteria: \* none

Keywords: sanitation demand peri-urban behavior change lusaka zambia