Kornimate/medical-research-clean huggingface dataset:
predictive value of systolic rise time of the plantar arch on the risk of major adverse limb events (male) and major adverse cardiovascular events (mace) in peripheral artery disease (pad) at critical ischaemia stage

Conditions: Major Adverse Limb Events; Major Adverse Cardiovascular Events; Peripheral Artery Disease; Critical Limb Ischemia; Hemodynamic Measure

Summary: peripheral artery disease (pad), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. it has various symptoms ranging from mild arterial claudication to critical limb ischemia. the critical ischaemia stage in pad is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%). it is a medico-surgical pathology. a haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. the systolic rise time (srt) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of pad. the aim of this study is to show the prognostic value of the systolic rise time on major adverse limb events (male).


Eligibility criteria:
inclusion criteria: * patients at least 18 years old, * willing and able to provide written informed consent, * with documented atherosclerosis critical limb ischemia (pain rest and/or ulcer and gangrene manifestations) * with hemodynamic measures (ankle pressure less than 50mmhg and/or tbi less than 30mmhg and/or tcpo2 less than 30 mmhg), * followed or send to chu amiens picardie, and eligible to chirurgical revascularization. exclusion criteria: * with non atherosclerosis arteriopathy, * ineligible to the gold standard treatment such as the chirurgical revascularization, * with life expectancy less than 3 months.

Keywords: major adverse limb events major adverse cardiovascular events peripheral artery disease critical limb ischemia hemodynamic measure
fast-acting insulin aspart and insulin pump settings

Conditions: Type 1 Diabetes

Summary: to clarify the role of fast-acting insulin aspart (fiasp) in insulin pump-treated type 1 diabetes more research is needed. the aim of this study is twofold: 1. to compare the effects of fiasp and iasp in adults with type 1 diabetes who are using insulin pump and cgm and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and cgm therapy. 2. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for ≥ 5 years * hba1c 53-75 mmol/mol (7.0-9.0%) * insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion) * cgm use for ≥ 6 months (all cgm makes are eligible for inclusion) * carbohydrate counting for all snacks and meals * use of the insulin pump bolus calculator for all meals and snacks exclusion criteria: * breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods * gastroparesis (clinical assessment) * shift work * changing insulin needs throughout the menstrual cycle that requires different basal rate patterns * use of a hybrid closed-loop system * use of flash glucose monitoring * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start * chronic paracetamol use * alcohol or drug abuse * severe cardiac disease or retinopathy contraindicating hba1c below 53 mmol/mol * impaired renal function (egfr\< 60 ml/min/1.73 m2) * history of local skin reactions to fiasp and/or iasp * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation * lack of compliance with key study procedures at the discretion of the investigator * unacceptable adverse events at the discretion of the investigator * less than 40 weeks guarantee remaining on insulin pump

Keywords: insulin pump
effects of citrus reticulate unripe fruit extraction on body weight and body fat.

Conditions: Overweight and Obesity

Summary: the aim of this study is to investigate the effects of immature ponkan (citrus reticulate) extract on body weight and body fat in overweight and obese adults.

this randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. during the 8 weeks intervention, the subjects should take 25ml liquid of placebo or immature ponkan extract a day (drink 25ml for once, and once a day). the two drinks are supplied in aluminum foil packages, and both the products taste the same. subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.

Eligibility criteria:
inclusion criteria: * male or female * aged 20-60 years old * body mass index is greater than or equal to 24 kg/m2, or body fat more than 30% exclusion criteria: * subjects diagnosed with cancer and on curative care. * subjects diagnosed with heart disease and on curative care. * subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug. * subjects with systemic infection requiring antibiotics.
sildenafil for chronic obstructive pulmonary disease (copd) associated pulmonary hypertension

Conditions: COPD; Pulmonary Hypertension

Summary: chronic obstructive pulmonary disease (copd)can be complicated by an increased pressure in the pulmonary circulation. this worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms. in this study 32 patients with increased pulmonary blood pressure due to copd will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension. our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.


Eligibility criteria:
inclusion criteria: * a mean pulmonary arterial pressure of 25 mmhg measured by right heart catheterization. * a diagnosis of copd-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present. * stable copd, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study. * age \> 18 * informed written consent. * reliable anticonception for fertile women. exclusion criteria: * rheumatic disease limiting walking capacity. * exacerbation in copd during the study. * age\>80 years * fev1 \< 25 % of predicted. * allergy towards contents of sildenafil or placebo tablets. * fall in blood pressure of \> 30 mmhg systolic or \>20 mmhg diastolic after intake of the first dose of trial medication. * fall in peripheral saturation of \> 5% after intake of the first dose of trial medication. * treatment with nitrous vasodilators or aminophyllamines.

Keywords: copd pulmonary hypertension sildenafil nt-pro bnp apelin
effect of electrical muscle stimulation in critically ill patients

Conditions: Critical Illness

Summary: electrical muscle stimulation (ems) is the therapy used to passively activate muscles using electrodes on the surface of the skin. ems may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. the purpose of this study is to determine the safety and feasibility of implementing ems in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of ems on leg muscle size, muscle strength and functional outcomes in these patients. the investigators hypothesize that ems will be safe and feasible and that critically ill patients receiving ems will show a smaller loss of muscle size and strength than those in the control group, who do not receive ems.


Eligibility criteria:
inclusion criteria: * admitted to the medical-surgical icu or cardiovascular icu * walking independently prior to admission * mechanically ventilated for more than 7 days (i.e. prolonged ventilation) * receiving enteral or parenteral nutrition. exclusion criteria: * history of neurological or psychiatric disease * primary muscle disease (e.g. muscular dystrophy, polymyositis) * catastrophic neurological event * receiving palliative care * contraindications to ems (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites) * inadequate access to electrode sites due to medical devices * lower extremity edema affecting the thighs or buttocks * bmi \> 35 kg/m2 * allergies to adhesives or latex

Keywords: critical illness myopathy electrical muscle stimulation
effect of frankincense extract gel on non-surgical treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: this study will evaluate the effect of the subgingival application of frankincense extract gel as an adjunct to scaling and root planning (srp) in chronic periodontitis.

: twenty patients will be randomly selected and equally divided into group i: will receive srp only, group ii: will receive srp and frankincense extract the gel. subgingival application of frankincense extract gel will be performed following initial srp )day 1) and at 7, and 14 days. clinical measurements included pocket depth (pd), bleeding on probing (bop), and clinical attachment level (cal). real-time pcr was carried out to determine the effect of the treatment on porphyromonas gingivalis (pg). clinical measurements and plaque samples for pcr were recorded at baseline (before treatment), one, and three months after treatment.

Eligibility criteria:
inclusion criteria: * systemically healthy patients were selected * patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing. * patients should demonstrate their ability to maintain good oral hygiene exclusion criteria: * smokers and pregnant patients. * medically compromised patients and systemic conditions precluding periodontal surgery.

Keywords: chronic periodontitis. frankincense non surgical treatment
virtual reality intervention alleviates dyspnea in patients recovering from covid pneumonia

Conditions: Covid19; Dyspnea

Summary: the present covid-19 virtual reality (covvr) clinical study is performed to test the hypothesis that an immersive virtual reality (ivr)-based digital therapeutics (dtx), would alleviate dyspnea by improving breathing comfort in patients recovering from covid-19 pneumonia presenting with persistent dyspnea. we will further evaluate participants' perceived awareness of and agency over their breathing movements. finally, we will track patients' perceived benefits related to the ivr intervention and the feasibility of using covvr in the clinic or at home.

persistent dyspnea is the experience of breathlessness that persists despite optimal treatment of the underlying pathophysiology, and results in physical, psychosocial disability for the patient. as observed for sars-cov and mers-cov patients, a significant portion of covid-19 patients present with persistent respiratory physiological impairment and persistent breathlessness that may not be addressed with conventional respiratory treatment such as oxygen, bronchodilators, diuretics or non-invasive ventilation. previous research on respiration-related feedback in virtual reality (vr) has demonstrated strong and replicable effects of vr feedback over one's perceived sense of agency and control over one's virtually embodied respiration. based on these studies, the vr intervention evaluated here aims to alleviate symptoms of perceived breathlessness. this within-subject study will compare breathing comfort as well as breathing discomfort, prior, during, and after a vr intervention that provides embodied visual feedback of participants' on-going respiration. primary outcomes include subjective reports from participants (breathing comfort and breathing discomfort) and the intervention's clinical feasibility. secondary outcomes include subjective ratings on perceived embodiment and sense of agency, as well as changes in respiration rate and variability.

Eligibility criteria:
inclusion criteria: * recovering from covid-19 pneumonia confirmed by rt-pcr for sars-cov-2 * presented with persistent dyspnea with a self-rated intensity of five or higher (out of ten) on a visual analog dyspnea scale. ( "do you have difficulty breathing?" "on a scale of 0 to 10, with 0 being no difficulty to breathe and 10 being the worst difficulty to breathe that you can imagine, where do you rank?".) this dyspnea rating will only used as an inclusion criterion and not as an outcome. * being able to give consent * being able to understand and speak french or english exclusion criteria: * any unstable respiratory, neurological, and cardiac conditions * any psychiatric illness * montreal cognitive assessment (moca) score below 25.
study of lurbinectedin (pm01183) in combination with cisplatin in patients with solid tumors

Conditions: Advanced Solid Tumors

Summary: clinical and pharmacokinetic study of lurbinectedin (pm01183) in combination with cisplatin in patients with advanced solid tumors to determine the recommended dose (rd) of pm01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (pk) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (pgx) analysis.


Eligibility criteria:
inclusion criteria: * voluntarily signed written informed consent * age ≥ 18 years old * eastern cooperative oncology group (ecog) performance status (ps) of ≤ 1. * life expectancy ≥ 3 months. * patients with confirmed diagnosis of advanced solid tumors. * patients may have received ≤ 2 chemotherapy-containing lines in the advanced setting. * adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ seven days before inclusion in the study) * recovery or stabilization to grade ≤ 1 from any adverse event derived from previous treatment (up to grade 2 alopecia or asthenia/fatigue are allowed). * no clinically significant changes in ecg. * at least four weeks since the last monoclonal antibody containing therapy or definitive radiotherapy (rt) * at least two weeks since the last biological/investigational single-agent therapy (excluding mabs) and/or palliative rt (≤10 fractions or ≤30 gy total dose) * fertil women must have pregnancy excluded by appropriate testing before study entry exclusion criteria: * prior treatment with pm01183 or trabectedin. * concomitant diseases/conditions: * history within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment. * ongoing, non-neoplastic, chronically active liver disease of any origin. * active infection. * patients who are requiring any ongoing oxygen support. * known human immunodeficiency virus (hiv) infection. * any other major illness. * symptomatic or corticosteroid-requiring brain metastases or leptomeningeal disease involvement. patients with asymptomatic documented stable brain metastases not requiring corticosteroids during the last three months are allowed. * peripheral sensory/motor neuropathy grade \>1. hearing impairment grade \>1. * fertile men or women not using an effective method of contraception. * history of bone marrow or stem cell transplantation * radiotherapye to \>35% of the bone marrow.

Keywords: lurbinectedin pm01183 tumors cancer pharma mar
comparison of smart-shear wave elastography and transient elastography

Conditions: Fibrosis, Liver

Summary: the aim of this prospective study was to evaluate the applicability and diagnostic performances of smart-shear wave(ssw) imaging, in comparison with transient elastography(te) for the staging of liver fibrosis using pathologic results as the reference standard.


Eligibility criteria:
inclusion criteria: 1. patients with liver disease: plan to undergo liver surgery 2. potential liver donors 3. smart-shear wave \& transient elastography were performed within one month from liver surgery 4. aged between 20 to 80 years 5. compliance with scheduled visits, evaluation plans and other study procedures exclusion criteria: 1. previous history of hepatic surgery 2. previous history of transarterial chemoembolization 3. huge or infiltrative tumor in the right lobe of the liver 4. bile duct dilatation in the right lobe of the liver 5. older than 80 years 6. the opinion of the investigator would make the patient unsuitable for enrollment

Keywords: smart-shear wave(ssw) transient elastography(te) liver cirrhosis
safety and effectiveness of daily dosing with sunitinib or imatinib in patients with gastrointestinal stromal tumors

Conditions: Gastrointestinal Stromal Tumor

Summary: a phase iiib study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. this study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

the study prematurely discontinued on july 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. there were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily. exclusion criteria: * current treatment with any chemotherapy other than imatinib. * current treatment with any dose of imatinib other than 400 mg
insulin signaling in skeletal muscle

Conditions: Insulin Sensitivity

Summary: the insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.


Eligibility criteria:
inclusion criteria: * pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dl general inclusion criteria: * able to communicate meaningfully with the investigator and legally competent to provide informed written consent. * female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control. exclusion criteria: * oral glucose tolerance test \ 200mg/dl * treated with any of the following medications: * systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening * start or change of hormonal replacement therapy within 3 months prior to screening * short-acting insulin (more than15 units per day) in dmt2 subjects, indicating severe insulin deficiency within 6 months prior to screening * history or presence of any of the following conditions: * clinically significant heart disease (new york heart classification greater than grade ii; more than non-specific st-t wave changes on the ekg) * peripheral vascular disease (history of claudication) * clinically significant pulmonary disease. * current uncontrolled hypertension (systolic bp\>160 mmhg, diastolic bp\>100 mmhg) * history or presence of malignancy other than basal cell or squamous cell skin cancer * autonomic neuropathy * clinically significant hematologic disease * any of the following abnormal laboratory values: * hematocrit \< 35 vol% * serum creatinine \> 1.6 mg/dl * ast, alt or alkaline phosphatase \> 2.5 times the upper limit of normal * pt, ptt outside the normal reference range * tsh outside the normal reference range * triglycerides \> 400 mg/dl * platelet count \< 50,000 * current or history of drug abuse or alcohol abuse * blood donation within 2 months prior to screening * engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week. * diagnosed with type 1 diabetes
effect of itraconazole on the pharmacokinetics of biib074

Conditions: Neuropathic Pain

Summary: the primary objective of the study is to assess the effect of cytochrome p450 (cyp) 3a4 inhibition on the pharmacokinetics (pk) of biib074. the secondary objectives of this study are to assess the safety and tolerability of biib074 when co-administered with a strong cyp3a4 inhibitor and to assess the effect of cyp3a4 inhibition on the pk of 3 metabolites of biib074 (cnv3000497 \[m13\], cnv2283325 \[m14\], and cnv2288584 \[m16\]).


Eligibility criteria:
key inclusion criteria: * body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and ≥45 kg for females. * male or postmenopausal or surgically sterile females. * must be in good health as determined by the investigator (or designee), based on medical history and screening evaluations. key exclusion criteria: * females of childbearing potential. * other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment. note: other protocol-defined inclusion/exclusion criteria may apply.
validation of the french version of the health assessment questionnaire ii (haq-ii) for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to develop a validated french version of the haq-ii questionnaire for rheumatoid arthritis.

the haq is the original health assessment questionnaire used in rheumatology. it is available in more than 60 languages and includes 42 items. however the questionnaire is not easy to use in the clinic : complicated questions, long to answer for the patient and not easy to score for the doctor. the haq-ii is a reliable and valid 10-item questionnaire that performs at least as well as the haq and is simpler to administer and score. it includes 5 items already translated in english and 5 new items not yet translated. the aim of the study is the validation of the french version of the haq-ii for rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: * patient older than 18 years old * patient with rheumatoid arthritis exclusion criteria: * none

Keywords: haq-ii rheumatoid arthritis