Kornimate/medical-research-clean huggingface dataset:
exploratory non comparative study to evaluate the efficacy of highly bioavailable curcumin (flexofytol) in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the efficacy of bio-optimized curcumin(flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.


Eligibility criteria:
inclusion criteria: * 45 to 80 years of age * internal femorotibial gonarthrosis responding to the clinical and radiological criteria of acr * symptomatic knee for more than 6 months * mean knee pain on the last 24 hours of at least 40 mm on vas * kellgren \& laurence grade ii to iii * patients able to avoid nsaids and analgesics during the study * patients having signed informed consent * patients able to follow the study instructions exclusion criteria: * related to the osteoarthritis pathology: * osteoarthritis linked to a metabolic arthropathy * predominant associated symptomatic femoropatellar osteoarthritis * chondromatosis or villonodular synovitis of the knee * recent trauma (\< 1 month) of the knee responsible for the pain * inflammatory flare * pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis... * paget disease * homolateral coxarthrosis * articular prosthesis * knee joint effusion * related to previous and associated treatments: * corticosteroids injection in the previous month, whatever the joint concerned, * hyaluronan injection in the evaluated knee during the previous 6 months, * nsaid or analgesics in the 72 hours prior to inclusion * no modification of slow-acting drugs for oa and/or dietary supplements taken within less than 6 months prior to the study(ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for oa, homeopathy for oa...), * anticoagulant (coumarinic) treatment and heparin * general corticotherapy, * contraindication to paracetamol. * related to associated pathologies: * patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...) * related to patients: * pregnant or breastfeeding women * pre-menopausal women with no contraception * patients unable to write * patients enrolled in a clinical trial in the previous 3 months * patients under juristic protection or under guardianship.

Keywords: osteoarthritis curcumin biomarker pain
preoperative twice daily chemoradiation in addition to chemotherapy prior to surgery in stage iii non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: patients are randomized to (arm a) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfrt)with concurrent carboplatin and vindesine then surgery and, if no or r1/2-resection, additional hfrt versus (arm b) 3 cycles of cisplatin/etoposide, followed by surgery and then rt. the primary endpoint was progression free survival (pfs). with 500 patients evaluable an improvement of median pfs from 10 to 14 months could be detected.

patients are randomized to (arm a) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfrt; 45 gy, 2x1.5 gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or r1/2-resection, additional hfrt (24 gy; 2x1.5 gy/d) versus (arm b) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then rt (1.8 gy/d) with 54 gy or, if no or r1/2-resection, 68.4 gy. the primary endpoint was progression free survival (pfs). with 500 patients evaluable an improvement of median pfs from 10 to 14 months could be detected. (university of münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to university of heidelberg this account is announced above)

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer proven by histology * stage iiia / stage iiib * mediastinoscopy * performance score ecog 0,1 * predicted postoperative fev 1 \> 1.0 l exclusion criteria: * small cell lung cancer * cardiac disability (nyha iii/iv) * prior radio- or chemotherapy * pregnancy * other malignancy

Keywords: multimodality treatment
botswana smoking and abstinence reinforcement trial

Conditions: Smoking Cessation; Hiv

Summary: many people living with hiv in southern africa, specifically botswana use tobacco products. using tobacco makes some of the effects of hiv worse and even causes excess deaths. the investigators plan to use an intervention called screening, brief intervention and referral to treatment (sbirt) to help people to quit smoking and also a drug called varenicline. apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. finally, the investigators will estimate the cost of the intervention.

the investigators will utilize a stepped wedge cluster randomized trial to implement bsmart. bsmart will be sequentially rolled out to 15 participating hiv treatment and care facilities assigned in three steps. each step will provide data for a 12- month control/pre-implementation, a 12-month implementation, and a 12-month maintenance period. the investigators will stratify botswana's hiv treatment and care facilities into three levels of facilities. the investigative team will randomly assign each of the three levels of facilities to one of three study steps. each step will comprise (i.e. have representation) from 3 levels of facilities, giving each level of facilities the same probability of beginning the intervention at any step).

Eligibility criteria:
inclusion criteria: * hiv infected * self reported current daily smoker * age 18 and older * engaged in hiv care as defined by being on art for at least 6 months * willing/able to provide informed consent in english or setswana exclusion criteria: * less than 18 years of age * pregnant * unable or cognitively impaired to provide consent
model-based iterative reconstruction (mb-ir veotm) in ultra low-dose abdominal ct versus adaptative statistical iterative reconstruction (asir): a prospective study for acute renal colic

Conditions: Model-based Iterative Reconstruction (MB-IR VEOTM)

Summary: the purpose of this study is to determine if model-based iterative reconstruction (mb-ir veotm) in ultra low-dose abdominal ct as the same accuracy for the diagnosis of acute renal colic versus standard ct with adaptative statistical iterative reconstruction (asir).

renal colic is a common recurrent pathology in young patients, multi explored by imaging such as ct and abdominal radiography. abdominal mdct(multidetector computed tomography) without injection is the gold standard in diagnosis of acute flank pain suspect of renal colic due to high sensitivity (96%) and excellent specificity (100%). the increased use of medical imaging examinations using ionizing radiation (+57 % between 2002 and 2007) makes it essential to optimize protocols, including ct-scans which represents 10.1 % of procedures and 58 % of the collective effective dose. model-based iterative reconstruction (mb-ir veotm) (ge healthcare, milwaukee, wi) can use a low dose acquisition, reducing the effective dose delivered to the patient almost 80% comparing a standard ct with the last algorithm: adaptative statistical iterative reconstruction (asir). mb-ir veotm shows great potential for substantially reducing radiation doses at routine abdominal ct. asir is limited in this regard owing to reduced image quality and diagnostic capability. further investigation is needed to determine the optimal dose level for mbir(model base iterative reconstruction) that maintains adequate diagnostic performance. in general, objective and subjective image quality measurements do not necessarily correlate with diagnostic performance at ultralow-dose ct. objective: prospective clinical study, equivalence between two ct protocols for the diagnosis of acute renal colic. show that a low dose acquisition with model based iterative reconstruction (mb-ir veotm) is as good as a standard ct with adaptative statistical iterative reconstruction (asir) in the diagnosis acute renal colic

Eligibility criteria:
inclusion criteria: * informed and a written consent * acute flank pain needed abdominal ct exploration. exclusion criteria: * juvenile patients * pregnant women

Keywords: model-based iterative reconstruction mb-ir veotm ultra low-dose abdominal ct dose reduction adaptative statistical iterative reconstruction asir acute renal colic
letrozole and metronomic capecitabine in er-positive her2 negative advanced breast cancer (b-001 study)

Conditions: Breast Cancer; Estrogen Receptor-positive Breast Cancer; Metastatic Breast Cancer

Summary: a phase ii clinical trial designed to test the effect of combining endocrinal therapy (letrozole) with chemotherapy (capecitabine) in first line treatment of advanced cases of female breast cancer with er positive disease.

this is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. arm a contains letrozole with metronomic capecitabine versus arm b that contains letrozole alone. this is to be applied on er positive her2 negative tumours.

Eligibility criteria:
inclusion criteria: * female sex * age 18-70 * ecog-ps 0-ii. * histopathological proof of breast cancer * er positive (allred score of ≥3 out of 8), and her2 negative by ihc (or ish if her2 +2). * metastatic/recurrent disease as proven by ct scan, bone scan or clinical examination (for skin lesions). biopsy of the recurrent lesions is encouraged but not mandatory. * either hormone sensitive setting (denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or dp of metastatic disease after more than 6 months of first line tamoxifen). * adequate organ function. * signed informed consent exclusion criteria: * inadequate organ functions. * disease progression while on prior aromatase inhibitor therapy. * primary endocrine resistance. * double primary cancer (history of other malignancy apart from a non melanoma skin cancer). * refusal to sign consent.

Keywords: advanced breast cancer chemo-hormonal hormone positive metronomic capecitabine
incidence of perioperative hypothermia in pediatric patients

Conditions: Hypothermia; Anesthesia; Hypothermia Following Anesthesia

Summary: perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. in this study the investigators aimed to detect the incidence of perioperative hypothermia in pediatric patients in the operating room, and to detect the possible associated risk factors.


Eligibility criteria:
inclusion criteria: * any elective operation * american society of anaesthesiologists (asa) i-iii physical status * age 0-18 years exclusion criteria: * emergency operations * asa iv-v physical status * open heart surgeries * age \>=18 years

Keywords: hypothermia intraoperative perioperative postoperative
long term safety of aliskiren alone or with the optional addition of hydrochlorothiazide in patients with essential hypertension

Conditions: Hypertension

Summary: assess the long-term safety and tolerability of aliskiren, with the optional addition of hctz, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.


Eligibility criteria:
inclusion criteria 1. patients with essential hypertension. 2. patients who are eligible and able to participate in the study. exclusion criteria 1. severe hypertension. 2. history or evidence of a secondary form of hypertension. 3. history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined exclusion criteria may apply.

Keywords: hypertension, blood pressure, aliskiren
patient empowerment and risk-assessed treatment to improve outcome in the elderly after onco-surgery

Conditions: Cancer

Summary: the aims of this study are to investigate whether patient empowerment, including information and decision-aids adapted to the risk and the need of the elderly patient, can improve outcome in an evidence-based modular pathway in terms of * shortened hospital stay by a reduced postoperative complication rate and * quality of life in elderly patients compared to control patients receiving standard of care.


Eligibility criteria:
inclusion criteria: * patients aged 65 years and older with abdominal, thoracical or urogenital cancer scheduled for surgery * offered patient information and written informed consent * confirmed cancer diagnosis via histology * mini mental state \> 23 * life-expectance \> 2 months exclusion criteria: * participation in another trial according to the german drug law 7 days to and 7 days after the operation during the study * no informed consent * emergency patients * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * concurrent malignancies * insufficient knowledge of the german language * in case of the inclusion of a peratecs - study patient in an adjuvant therapy study during the study period, the patient will be excluded from the peratecs-study

Keywords: elderly cancer surgery quality of life empowerment shared-decision
the correlation between sleep quality and atrial fibrillation undergoing high-flow nasal cannula oxygen (hfnc)

Conditions: Hypoxemia

Summary: the investigators hypothesized that heated humidified high-flow nasal cannula oxygen(hfnc) along with high quality of sleep, in comparison with noninvasive positive pressure ventilation (niv), could reduce the release of inflammatory marker c-reactive protein(crp), which as independent predictor of atrial fibrillation（af）, further lower the incidence of new-onset af following coronary artery bypass grafting(cabg).

atrial fibrillation (af) has been reported to occur in up to 20-40% of patients undergoing coronary artery bypass grafting (cabg). postoperative af plays a major role in the determination of hemodynamic deterioration and can be associated with thromboembolic stroke. aside from the risk factors of age, pain, cardiac dysfunction and hypokalemia, hypoxemia is also considered to be the major contributor to af initiation and persistence. aiming to the common postoperative complications, noninvasive positive pressure ventilation (niv) provides an available modality to improve the oxygen and even obviate the reintubation. however, some patients are contraindications for niv, with loss of consciousness, hemodynamic instability, and some are intolerance due to dryness, gastric distension, skin breakdown and noise, with complaints of insomnia and sleep disturbance. the aforementioned factors largely limits its use. recently, the heated humidified high-flow nasal cannula (hfnc), free of psychic stress and physical discomfort, shows a favorable compliance and tolerance in treating the hypoxemic patients. as a result, in this comfortable setting we predict a high sleep quality in hfnc oxygen therapy. evidence has suggested that sleep abnormalities trigger the cascaded release of c-reactive protein (crp). as is well known that crp is involved in atrial structural remodeling and asynchronous conduction, which attribute to the initiation and maintenance of af. therefore, in this present study, the investigators first evaluate the sleep quality (architecture and duration) by the polysomnographic (psg) monitoring after coronary surgery. based on the sleep parameters, the investigators hypothesize that hfnc, along with high quality of sleep, in comparison with niv, could reduce the release of c-reactive protein, which as independent predictor of atrial fibrillation (af), further lower the incidence of new-onset af following cabg.

Eligibility criteria:
inclusion criteria: hypoxemic respiratory failure exclusion criteria: cardiac or respiratory arrest

Keywords: hypoxemia high-flow atrial fibrillation sleep
oral hygiene procedures on reduction of oral malodor

Conditions: Halitosis

Summary: the purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

thirty volunteers who matched with including criteria were divided randomly into two groups. both groups were instructed to brush their teeth with a scrubbing method for the first one week. then, each group received the different additional oral malodor reduction regimen- in addition to tooth brushing tongue cleaning in one group and chlorine dioxide (clo2) mouthwash in another group for three consecutive weeks. after that, all the participants were instructed to practice all the three oral hygiene procedures (tooth brushing, mouth washing, tongue cleaning) the last one week. total volatile sulfur compounds (vscs) measured by breathtron, tongue coating, plaque score and bleeding on probing (bop) were outcomes of this study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of oral malodor * at least 20 functional teeth * no systemic diseases * no severe dental diseases exclusion criteria: * habit of smoking and betel quid chewing * oral malodor by food and other craniofacial abnormalities * current use of any kind of mouthwash

Keywords: halitosis chlorine dioxide tongue cleaning
inhaled corticosteroid treatment of covid19 patients with pneumonia

Conditions: Coronavirus Infection

Summary: randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-o2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti il-6 or anti il-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.


Eligibility criteria:
inclusion criteria: * covid19 positive * hospitalized because of pneumonia (status #3 - #4 world health organization (who) scale) * without contraindications to receive study treatment * informed consent exclusion criteria: * receiving corticoids (inhaled or systemic) * receiving anti interleukin-1 (il-1) or anti-il-6 drugs * receiving high flow oxygen therapy * receiving mechanical ventilation * pregnancy * participating in another intervention trial for covid19
effects of drinking at pacu discharge after general anaesthesia with airway control on aspiration, vomiting and patients comfort

Conditions: Scheduled General Anaesthesia With Airway Control

Summary: national guidelines about post-operative fasting after general anesthesia are missing. current clinical practices are highly variable and no study has ever evaluated on a large scale the real risk of an early drinks recovery in postoperative period. the aim of this study is to state the impact of early drinks recovery after general anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.


Eligibility criteria:
inclusion criteria: * scheduled surgery * general anaesthesia with laryngeal mask or endotracheal intubation. * length of surgery \< 4 hours exclusion criteria: * emergency surgery * intra-cranial, cervical or ear, nose and throat surgery * guts surgery with guts anastomosis. * glottic topical anesthesia * patient with nasogastric tube * aspiration during surgery or during pacu stay
development and validation of a regional multi-scale system for the prediction of the patient flow in the emergencies and the need for hospitalization

Conditions: Emergency Department; Hospitalization

Summary: the main objective of this retrospective study is to validate a prediction system of emergencies department (ed) attendance on a wide range of time and the need for hospitalization, at various levels of perimeter (with all emergency departments or one ed in particular), with all patients or with one sub-group of patients (age, gravity, care).

as secondary objectives, the study aims: * to measure the influence of different factors as environmental or structural and to identify the modifiable factors, then to allow us to test by simulation, impact of various interventions (for example: opening of hospitals and reinforcement of ed teams) on arrival flows or regenerated tension inside ed teams. * to study the relation between the flows (arrival patients, hospitalized patients) and the time of ed visit or the indicators of tension of ed team. * typology of ed in the region of paris permitting afterward comparison the benchmarking type between similar structures. this retrospective study will be performed on database: individual data in the region of paris of summation of ed visits and data on the structures of health cares, as well as environmental data (principal given cares, weather, moves, circulations, pollution, strikes, vacations, etc.)

Eligibility criteria:
inclusion criteria: * all subjects have been recorded as patients in emergency departments between 2010 and 2015. exclusion criteria: * none

Keywords: multi-scale prediction patient flow emergency department hospitalization ile-de-france
screening of genetic susceptibility genes for breast cancer patients in chinese communities

Conditions: Breast Cancer; Genetic Susceptibility

Summary: this is a community-based prospective study and the research object is breast cancer patients. it is planned to take the community as the unit to inform and collect the breast cancer patients who voluntarily participate to carry out the detection of brca1, brca2, pten, chek2 and palb2 genes through the community health service center.

this is a population-based, prospective, cohort study which has been ongoing in 3 provinces of eastern china since 2019. up to 5000 breast cancer survivors will conduct brca1, brca2, pten, chek2, and palb2 genetic susceptibility genes testing, fill in clinical and genetic information forms, and collect family history. mutation rate of brca1/2 and other genetic susceptibility genes in chinese community breast cancer population will be measured. logistic regression will be performed to establish a prediction model for the probability of brca1/2 and other gene mutations. kin-cohort method will be used to calculate the penetrance of breast cancer and other common malignancies in brca1/2 and other genetic mutation carriers.

Eligibility criteria:
inclusion criteria: * breast cancer patients of any age; * both male and female; * the subjects signed the informed consent to participate in the study and abide by the study procedure before being selected. exclusion criteria: * healthy people or other malignant tumor patients without breast cancer; * unable to interview the investigator and sign the informed consent due to any reason; * it is impossible to collect peripheral blood or oral mucosa samples for any reason.