Kornimate/medical-research-clean huggingface dataset:
feasibility of reducing respiratory drive using the through-flow system

Conditions: Respiratory Insufficiency; Diaphragm Injury; Lung Injury

Summary: mechanical ventilation can lead to diaphragm and lung injury. during mechanical ventilation, the diaphragm could be completely rested or it could be overworked, either of which may cause diaphragm injury. mechanical stress and strain applied by mechanical ventilation or by the patient's own respiratory muscles can also cause injury to the lungs. diaphragm and lung injury are associated with increased morbidity and mortality. throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory drive.

patients with acute respiratory failure often develop significant diaphragm weakness during mechanical ventilation. diaphragm weakness is associated with prolonged duration of mechanical ventilation and higher risk of death. clinical data and experimental evidence indicate that the ventilator injures the diaphragm via two opposing mechanisms, disuse and excessive loading. cessation of diaphragm activity leads to rapid disuse atrophy within hours. on the other hand, high inspiratory loads result in myofibril edema, inflammation and contractile dysfunction. in light of this, studies found that patients with an intermediate level of inspiratory effort, similar to that of healthy subjects breathing at rest, exhibited the shortest duration of ventilation. arterial co2 (paco2) tension and physiological dead space play an important role in determining the ventilatory requirements and respiratory drive in patients with ahrf. throughflow (neurovent) is a novel system that reduces anatomical dead space by providing a constant flow of fresh gas (i.e., gas that is free of co2) during inspiration in patients receiving invasive mechanical ventilation. by clearing the co2 that normally remains in the upper airway after exhalation (anatomical dead space), tf can dramatically reduce anatomical dead space without the need to increase the delivered vt. reducing dead space offers a theoretical benefit in mitigating the mechanisms of lung and diaphragm injury during spontaneous breathing by reducing the ventilation demands to the lungs. animal studies using the tf have shown extremely promising results, however, the impact of reducing anatomical dead space using the tf on gas exchange, ventilation, and respiratory drive in critically ill patients with ahrf is unknown.

Eligibility criteria:
inclusion criteria: * pao2/fio2 less than or equal to 300 at time of screening * oral endotracheal intubation with ett 7.5 or 8.0 and on invasive mechanical ventilation * bilateral airspace opacities on chest radiograph or chest ct scan exclusion criteria: * contraindication to esophageal catheterization (upper gastrointestinal tract surgery within preceding 6 weeks, bleeding esophageal/gastric varices) * intubation for traumatic brain injury or stroke * intracranial hypertension (suspected or diagnosed by medical team) * anticipated liberation from mechanical ventilation within 24 hours
in vivo clinical trial of porous starch - hydroxyapatite composite biomaterials for bone regeneration

Conditions: Open Fracture of Foot

Summary: biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. in this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.

the products were prepared from medical grade thai rice starch mixed with high purity (\>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. there were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.

Eligibility criteria:
inclusion criteria: * a patient who requires treatment by surgery and product implant in bone. * not indicate sex type * 18-65 years * patients accepted participate in the study. * type of surgery will be treat for only bone. exclusion criteria: * refused to join the study. * patients have an allergic history of carbohydrates and bovine bone.

Keywords: rice starch porous composite biomaterial bone regeneration clinical trial hydroxyapatite
fosaprepitant for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (npc).

scheme: eligible fosaprepitant sensitive (complete response \[defined as no emesis and no use of rescue antiemetics\] during the overall phase \[0 to 120 hours\] of all cycles of cisplatin-based induction chemotherapy) npc patients will be randomized to 2 arms at 1:1 ratio. * weekly arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy. * triweekly arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy.

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including who ii or iii * stage ii - iva npc patients (according to the 8th ajcc edition) * male and no pregnant female * scheduled for cisplatin-based induction chemotherapy (cisplatin≥ 70 mg/m2)and concomitant triweekly cisplatin * fosaprepitant sensitive (complete response \[defined as no emesis and no use of rescue antiemetics\] during the overall phase \[0 to 120 hours\] of all cycles of cisplatin-based induction chemotherapy) * age between 18-70 * adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl * normal liver function test: alanine aminotransferase (alt)、aspartate aminotransferase (ast) \<2.0×upper limit of normal (uln) * adequate renal function: creatinine clearance ≥60 ml/min * satisfactory performance status: karnofsky scale (kps) ≥ 70 * without radiotherapy or chemotherapy * patients must give signed informed consent exclusion criteria: * evidence of relapse or distant metastasis * pregnancy or lactation * history of prior malignancy or previous treatment for npc * had other current malignant diagnoses apart from non-melanoma skin cancers * emesis or clinically significant nausea (moderate or severe) in the 24 h before the first dose of study medication * drugs with antiemetic activity were not allowed for the 24 h before receiving the first dose of study medication * known history of central nervous system disease (e.g., a seizure disorder or brain metastases ) * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance.
smoking cessation for young adults who binge drink - 1

Conditions: Adherence; Tobacco Use Cessation; Alcohol & Drug Use; Nicotine Transdermal System

Summary: the purpose of this study is develop and test the success of a new smoking cessation intervention that includes a component to eliminate binge drinking.

the primary aim of this pilot investigation is to develop and evaluate the acceptability and feasibility of a novel tobacco dependence intervention that includes a component to eliminate binge drinking. this study will also estimate the magnitude of the effect of the novel intervention on the cigarette smoking behavior of young adult college student smokers.

Eligibility criteria:
inclusion criteria: (1) aged 18-25 years. (2) enrolled as a student at a two or four year technical or non-technical college or university. (3) smoked \> 10 or more cigarettes per day during the past 6 months. (4) binge drank on \> 2 occasions per month during the past 3 months. binge drinking is defined as consumption of \> 5 standardized alcoholic drinks in a row for males or \> 4 drinks in a row for females. (5) able to participate fully in all aspects of the intervention and keep all scheduled appointments. (6) willing to participate in 6 months of follow-up. (7) willing to stop smoking and use nicotine patch therapy. (8) willing to refrain from participating in additional smoking interventions for the duration of the study. (9) provide written informed consent. (10) general good health as determined by screening physician or registered nurse. exclusion criteria: (1) current (past 90 days) alcohol dependence as assessed by the structured clinical interview for dsm-iv axis i disorders, alcohol dependence module. (2) current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a drug abuse screening test-20 score of \> 6. (3) current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a beck depression inventory-ii score of \> 20. (4) current use (past 30 days) of nicotine containing medication or tobacco products other than cigarettes. (5) current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions. (6) any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (past 30 days) of myocardial infarction or stroke, history of severe skin allergies, or evidence of severe chronic dermatosis. (7) currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase.

Keywords: tobacco use cessation
first-in-human paincart study for str-324

Conditions: Pain

Summary: this is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of str-324 infusions in healthy volunteers.

part i : ascending doses of short lasting infusion part ii : ascending doses of long lasting infusion

Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure * healthy male subjects, 18 to 45 years of age, inclusive at screening. * body mass index (bmi) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. * all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment. * has the ability to communicate well with the investigator in the dutch language and willing to comply with the study restrictions. exclusion criteria: * evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator * subject with clinically significant abnormalities in blood pressure, heart rate, ecg recording and laboratory parameters * abnormal renal function (egfr (mdrd) \< 60 ml/min/1.73m2). * previous history of seizures or epilepsy. * acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day. * positive hepatitis b surface antigen (hbsag), hepatitis b antibodies, hepatitis c antibody (hcv ab), or human immunodeficiency virus antibody (hiv ab) * use of any medications (prescription or over-the-counter \[otc\]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). * use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). * participation in an investigational drug or device study within 3 months prior to first dosing. * history of abuse of addictive substances or current use of substances (alcohol, illegal substances) * positive test for drugs of abuse or alcohol breath test at screening or pre-dose. * any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). * loss or donation of blood over 500 ml within three months prior to screening * any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain
collagen cross-linking in keratoconus

Conditions: Keratoconus

Summary: optical coherence tomography (oct) devices are non-contact instruments that can measure the depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in patients with keratoconus. laser custom corneal collagen cross-linking (cxl) significantly decreases corneal aberrations and improves vision. this study will use oct-guided setting for the lasers used in the corneal smoothing portion of the laser custom cxl procedure to assess the affect on visual outcomes.

in the u.s., cxl and topography-guided laser ablation were approved independently, but not together. another variation in technique involves the use of mitomycin-c (mmc), which is effective in reducing corneal haze after the laser surface ablation. use of mmc during the laser custom cxl was associated with better outcomes, but in separate trials that could not be directly compared. this study will use oct measurements to evaluate the magnitudes of direct and indirect laser actions after the procedure.

Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus * minimum corneal thickness of 410 microns exclusion criteria: * inability to maintain fixation for oct imaging * inability to commit to required study visits * inability to give informed consent * eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery * mature cataracts if found to limit visual potential to worse than 20/40

Keywords: keratoconus (kcn) optical coherence tomography (oct) collagen cross-linking (cxl)
role of dbxell in the treatment of subjects with mildly uncontrolled type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of therapy to evaluate the efficacy and safety of dbxell in improving metabolic control in patients with type 2 diabetes that is mildly uncontrolled, defined as hba1c above target but less than 8.0% on their current conventional therapy.


Eligibility criteria:
inclusion criteria: * male or female subjects with age of 18-70 years established type 2 diabetes mellitus as defined by the american diabetes association, but of duration less than 10 years. * suboptimal glycemic control as judged by hba1c over target but not more than 8.0%.current medication of not more than 2 oral hypoglycemic agents. no current or past insulin or glp1 therapy. * fpg ≤ 180 mg/dl * hemoglobin level of ≥ 10.0 g/dl * serum alt ≤ 2.5 times upper limit of normal * serum creatinine \< 1.5 times upper limit of normal exclusion criteria: * female of childbearing potential * subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment * uncontrolled hypertension (sbp \> 160 mmhg and/or dbp \> 100 mmhg) * history of renal and/or liver disease * history of or the presence of any clinical evidence of malignancies * presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections * current treatment with systemic corticosteroids or herbal (alternative) medicines * participation in any other intervention trial within 30 days prior to screening

Keywords: diabetes diabetes mellitus herbal food supplement
metabolic phenotyping of individuals born following assisted reproduction techniques

Conditions: Metabolic Syndrome; Diabetes

Summary: this study is to compare the effects of high fat overfeeding on metabolic risk factors in children born though assisted reproduction technologies (art) versus children conceived naturally (controls). the investigators will utilize state of the art measures to characterize the physiological, endocrine and molecular responses to high fat overfeeding. the investigators hypothesize that children conceived following art will have greater responses to high fat dietary challenge and that this will be associated with dna hypermethylation of genes that are involved in lipid metabolism.

this study represents a novel initiative by the investigators to determine whether children conceived through art have different metabolic responses at baseline or in response to high fat overfeeding as compared to age and body mass index-matched spontaneously conceived controls. furthermore, the investigators will identify any differences in dna methylation of candidate genes involved in lipid metabolism in adipose tissue and blood, to determine whether this is related to adverse outcomes during high fat overfeeding. the results from this study will help answer growing questions of the future health of in vitro fertilisation (ivf) babies, and may stimulate further research into optimising protocols for ovarian stimulation or in-vitro conditions during early blastocyst development.

Eligibility criteria:
inclusion criteria: * post-pubertal healthy individuals aged 18-25years exclusion criteria: * participants are ineligible if they have any significant medical conditions (e.g. personal history or clinical manifestation of cardiovascular disease, type 2 diabetes), * strong family histories of diabetes or cardiovascular disease (e.g. first-degree relatives), * take concomitant medications (eg: metformin), * if they smoke or drink \>140g of alcohol/week, , or * were born prematurely (\<37 weeks), or * from mothers who had gestational diabetes.

Keywords: assisted reproduction technology metabolic risk factors in vitro fertilisation
persona cohort nordic multicenter study

Conditions: Knee Arthropathy

Summary: in this project the investigators wish to: evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (proms) following primary total knee replacement using persona total knee system. this project is carried out as prospective cohort study. recruitment of participants to this project is expected to begin in october 2016 or as soon as permission from the regional ethics committee and the local data protection agency is obtained as required. a total of 700 participants (including 155 participants from a randomized controlled trial (rct) investigating the persona and the nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. recruitment is expected complete after a period of 1,5 years per site. the patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. survivorship will be collected until 10 years after the recruitment of the last participant. participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. after the 2 year follow-up visit the patients recruited in the scandinavian sites will be followed for survivorship through the national knee arthroplasty registries at 5, 7 and 10 years postoperatively. since france does not have a national registry, the french site will also perform 5 year follow-up visits.

the investigators will retain the subject data sources, case report forms (crfs) and electronic-crfs in accordance with local laws and regulations. the enrollment is competitive between the participating centers. project information and consent according to local requirements before surgery is completed. surgery is performed as described in the manufacturer's surgical technique. a senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant. participants will receive standard pain treatment and rehabilitation until discharge.

Eligibility criteria:
inclusion criteria: * clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement exclusion criteria: * patients who are unwilling or unable to give consent, or to comply with the follow-up program. * patients that meet any contraindications listed in the instruction for use

Keywords: total knee arthroplasty persona knee system osteoarthrosis knee
mechanisms for covid-19 disease complications

Conditions: COVID; Coronavirus Infection

Summary: covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with covid-19 remains unclear. this study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with sars-cov2.


Eligibility criteria:
inclusion criteria: * all patients \>18 years of age with a positive test for sars-cov2 are eligble for inclusion. * healty age-matched volunteers will be included as a control group exclusion criteria: * none

Keywords: covid-19 biomarkers cardiovascular disease prognosis
a prospective pilot study for the evaluation of 18f- fluciclovine pet/mri in radio-recurrent prostate cancer (rrpc-pet/mri study)

Conditions: Prostate Cancer; Prostate Nodule

Summary: to perform both pet scans and mris in the same setting using a simultaneous pet/mri scanner.

primary objective: --to compare the diagnostic performance of 18f- fluciclovine pelvic pet/mri to that of pelvic mpmri and to determine whether 18f- fluciclovine pelvic pet/mri is more accurate than a pelvic mpmri in detecting pelvic rrpc in men with biochemical recurrence with histopathology as reference standard. secondary objective: --to study inter-reader reliability of 18f- fluciclovine pelvic pet/mri and pelvic mpmri among the readers. exploratory objective: --to study correlation between suvmax and adcmean in the pelvic rrpc.

Eligibility criteria:
inclusion criteria: 1. male patients who are 18 years and older 2. histologically or cytologically proven prostate carcinoma s/p definitive radiation 3. patients suspected to have bcr based on phoenix criteria (prostate specific antigen value (psa) of 2 ng/ml above the psa nadir) 4. ability to understand and willingness to sign informed consent exclusion criteria: 1. patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements. 2. patients with contraindication to undergo mri 3. patients with prior allergy to mri contrast agent. 4. extreme claustrophobia