Kornimate/medical-research-clean huggingface dataset:
reliability of the swiss emergency triage scale (sets®) used by emergency medical service (ems) providers

Conditions: Emergency Medical Services; Triage

Summary: the swiss emergency triage scale (sets) in used for triage in emergency departments in switzerland, france and belgium. no validated triage scale is actually used by emergency medical service (ems) providers. the objective of this project is to evaluate the reliability and performance of triage by ems providers with the sets.

the swiss emergency triage scale (sets) in used for triage in emergency departments in switzerland, france and belgium. no validated triage scale is actually used by ems providers. the objective of this project is to evaluate the reliability and performance of triage by ems providers with the sets. in order to perform this evaluation a cohort of 22 ems providers will evaluate 28 standardized clinical scenarios using a computer simulator.

Eligibility criteria:
inclusion criteria: * all ems providers employed by a private ambulance company in the state of geneva, switzerland exclusion criteria: * not giving informed consent
safety and efficacy of different oral doses of bay94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: to assess a new drug, bay94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. these treatment doses were compared to placebo.


Eligibility criteria:
inclusion criteria: * men and women aged 18 years and older.the lower age limit may be higher if legally required in the participating country * women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active. * subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria * are on oral antidiabetics and / or insulin, * have a documented fasting glucose \>/= 7.0 mmol/l in the medical history, * have a 2 hour plasma glucose \>/=11.1 mmol/l during an oral glucose tolerance test in the medical history, or * have a glycated hemoglobin (hba1c) \>/=6.5% \[national glycohemoglobin standardization program (ngsp) / diabetes control and complications trial (dcct)\] in the medical history or at the run-in visit * subjects with a clinical diagnosis of diabetic nephropathy (dn) based on at least 1 of the following criteria: * persistent very high albuminuria defined as urinary albumin-to-creatine ratio (uacr) of \>/=300 mg/g ( \>/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (egfr) \>/=30 ml/min/1.73 m² but \< 90 ml/min/1.73m² (chronic kidney disease epidemiology collaboration, ckd epi) (ml = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or * persistent high albuminuria defined as uacr of \>/=30 mg/g but \ /=3.4mg/mmol but \ /=30 ml/min/1.73 m² but \< 90 ml/min/1.73m² * subjects treated with an angiotensin-converting enzyme inhibitor (acei) and/or angiotensin receptor blocker (arb) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit * serum potassium \</= 4.8 mmol/l at both the run-in visit and the screening visit exclusion criteria: * non-diabetic renal disease * glycated hemoglobin (hba1c) \>12% at the run-in visit or the screening visit * uacr \>3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit * hypertension with mean sitting systolic blood pressure (sbp) \>/=180 mmhg or mean sitting diastolic blood pressure (dbp) \>/=110 mmhg at the run-in visit or mean supine sbp \>/=160 mmhg or mean sitting dbp \>/=100 mmhg at the screening visit * subjects with a clinical diagnosis of heart failure with reduced ejection fraction (hfref) and persistent symptoms (new york heart association class ii-iv) at the run-in visit * concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic * dialysis for acute renal failure within the previous 6 months prior to the run-in visit
evaluation of psma in her2- ar+ metastatic breast cancer

Conditions: Breast Cancer; HER2-negative Breast Cancer; Metastatic Breast Cancer

Summary: the purpose of this research is to determine the expression of prostate specific membrane antigen (psma) in human epidermal growth factor receptor 2 (her2)-negative, androgen receptor (ar)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. the investigators hypothesize that psma expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with her2-negative, ar-positive metastatic breast cancer will be enrolled and be on study for about 3 days.

primary objective: * to evaluate the expression of psma via 18f-dcfpyl psma-based pet/ct in patients with metastatic her2-negative, ar-positive breast cancer. expression of psma will be quantified using psma-based pet imaging using a novel agent, 18f-dcfpyl, as a non-invasive imaging biomarker of tumor neovasculature in her2-negative, ar-positive metastatic breast cancer. secondary objectives: * psma pet will be compared with the expression of psma in ctcs and diagnostic metastatic tissue from patients with her2-negative, ar-positive metastatic breast cancer. * psma expression will be correlated with clinical benefit (objective response and progression-free survival) to bicalutamide and ribociclib for patients enrolled in nct03090165.

Eligibility criteria:
inclusion criteria: * patients diagnosed with metastatic her2-negative breast cancer ar expression of ≥ 10% exclusion criteria: * other (non-breast) known active malignancy. participants with previously treated cancers which are in remission or have no evidence of disease are eligible. * unable to lie flat during or tolerate pet/ct * participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study * women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to pet/ct
adaptive intervention model for hypertension self-management in rural areas: a doctor-patient interaction approach

Conditions: Hypertension Self-management; Hypertension

Summary: the aim of this project is to develop and validate an adaptive intervention model to improve self-management behavior in rural hypertensive patients. the primary question it seeks to answer is: can a tailored, interaction-based intervention model, guided by key doctor-patient interaction elements, effectively enhance self-management behavior among rural hypertensive patients and improve long-term blood pressure control? researchers will evaluate the impact of different intervention strategies on self-management behavior and identify the most effective combination to establish a sustainable intervention model for rural hypertension management.


Eligibility criteria:
inclusion criteria: * diagnosed hypertension patients who are permanent residents in rural areas. * no plans for long-term relocation within the next year. * willing to participate in this study. * no cognitive impairment. * no other diseases that significantly affect self-management behavior, such as malignant tumors. exclusion criteria: * age over 80 years. * having conditions such as stroke, paralysis, or mental disorders that prevent the completion of self-management behaviors. * severe hearing impairment or speech disorders that prevent participation in interviews. * likely to relocate or be away from the local area for an extended period within one year.
evaluation of meningococcal acwy immune response in children aged 40 and 60 months

Conditions: Meningococcal Disease

Summary: the purpose of this study is to evaluate how well the immuno response against meningococcal serogroups a, c, w and y lasts in children who were vaccinated with menacwy as infants.


Eligibility criteria:
inclusion criteria: * follow-on, healthy 40, 60 months old participants who have completed the v59p5 study and are in good health * control subjects: healthy 60 months old who had received a complete menc immunization course exclusion criteria: * subjects with any serious, acute or chronic progressive disease

Keywords: prevention of meningococcal disease
a study to evaluate lti-01 in patients with infected, non-draining pleural effusions

Conditions: Pleural Effusion

Summary: the lti-01-2001 study is a double-blind, placebo-controlled, phase 2 study to evaluate lti-01 (single-chain urokinase plasminogen activator, scupa) in patients with infected, non-draining pleural effusions.


Eligibility criteria:
key inclusion criteria: * male or female ≥ 18 years of age who provide written informed consent * clinical presentation compatible with complicated parapneumonic pleural effusion (cpe), empyema or other type of pleural infection * has pleural fluid requiring drainage as determined by chest ultrasonography or by chest ct, and which is either: * a) purulent; b) gram stain positive; c) culture positive; d) ph \< 7.2; or e) glucose \< 60 mg/dl (3.3 mmol/l) * failure to adequately drain pleural fluid ≥ 3 hours post insertion of patent chest tube within the pleural space, as evidenced by one or more of the following criteria: * \> 2 cm depth of fluid by ultrasound or ct * \< 80% drainage from chest radiograph obtained prior to chest tube insertion. key exclusion criteria: * current pleural infection already treated with intrapleural fibrinolytic therapy * evidence of ipsilateral fibrothorax (e.g. ct scan with \> 0.5 cm visceral pleural thickening) * history of multiple thoracenteses or thoracic surgical procedures within 3 months of screening * previous pneumonectomy on the side of the pleural effusion * current bilateral pleural infections * known non-expandable lung prior to this pleural infection * known or high clinical suspicion of a malignant pleural effusion * existing indwelling or tunneled pleural catheter * current infected hepatic hydrothorax or evidence of another abdominal process (e.g. pancreatic cyst or renal cyst) communicating with the pleural space * active bleeding, or any condition in which bleeding is either a significant risk or would be difficult to manage * fully anticoagulated patients on heparin, warfarin or novel oral anti-coagulants who are not able to temporarily discontinue anti-coagulants while receiving study medication and for 2 days after last dose of study medication note: patients receiving low-molecular weight heparin for immobilization or anti-platelet agents are not excluded. * presence of severe metabolic derangements that would interfere with study assessments * systolic blood pressure \>185 mmhg or diastolic blood pressure \> 110 mmhg at screening * hemodynamically unstable and/or requires use of intravenous vasopressor therapy * expected survival \< 3 months from a pathology other than the qualifying infected, non-draining pleural effusion (e.g. metastatic lung carcinoma)
effect of adding magnesium sulphate in pericapsular nerve group block

Conditions: Hip Fractures

Summary: our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in hip joint surgeries. * our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative. * our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by ramsay sedation scale) and pain score (by visual analog scale)


Eligibility criteria:
inclusion criteria: * • patients aged 18 years or more. * patients with american society of anesthesiologists (asa) classification class i or ii * patients weight range from 50 to 90 kgs exclusion criteria: * • patient refusal of peripheral nerve block * patient with infection at the site of injection * patient with coagulopathy * patients with known allergy to used medications.
safety and pharmacokinetic study of imm0306 in patients with refractory or relapsed cd20-positive b-cell non-hodgkin's lymphoma (b-nhl)

Conditions: B-cell Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to assess the safety and efficacy of imm0306-02 in patients with refractory or relapsed cd20-positive b-cell non-hodgkin's lymphoma (b-nhl).


Eligibility criteria:
inclusion criteria: * 18-75 years old * diagnosed with b-nhl * relapsed after or be refractory to at least 2 line of standard therapy exclusion criteria: * active central nervous system (cns) metastases * positive direct antiglobulin test (dat) * active autoimmune disorder * skin disorders that do not requires hormone replacement therapy

Keywords: imm0306
wuling powder for the treatment and underlying mechanism of depressive symptoms in patients with parkinson's disease

Conditions: Antidepressive Agents

Summary: depression is one of the most important nonmotor features of idiopathic pd（parkinson's disease ）which may not just interfere with the motor symptoms of pd but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. however,there is little hard evidence to guide clinical treatment. although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.however, the side-effects of these agents may also worsen some preexisting nonmotor problems in pd. wuling powder is a chinese medicine which is made by cultivating xylariasp mycelium using submerged fermentation technology. xylariasp is the fungus sclerotia which grow in termite nests. wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. the antidepressant effect of wuling powder has been confirmed in clinical, but not in the patients of parkinson's disease. therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of wuling powder in pd patients and its underlying mechanism.


Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic parkinson's disease according to the 2015 mds（movement disorder society）-pd criterion 2. hoehn-yahr stage: 1-3 3. under steady therapy of antiparkinsonian drugs for at least 28 days 4. hamd≥13 5. mmse（mini-mental state examination）≥24 6. neither use antidepressant drugs nor antipsychotic drugs within 4 weeks 7. signed informed consent exclusion criteria: 1. have other psychotic symptoms 2. suicide ideation or behavior 3. severe cognitive impairment，chronic organs failure，malignant tumors 4. glutamic-pyruvic transaminase or glutamic oxalacetic transaminase≥1.5 times of the high normal range or white blood cell\ 84umol/l 5. pregnancy or lactation period 6. participant in other trials or have taken other experimental drugs within 90 days 7. allergic to fungal food or fungal drugs

Keywords: parkinson's disease depression wuling powder
investigation of the freespira breathing system in the treatment of post traumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic

Summary: this study will test the efficacy of the freespira breathing system in adults with post traumatic stress disorder (ptsd).

the freespira breathing system (fbs) developed by palo alto health sciences, inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (pd). the fbs has received fda clearance for the treatment of pd adults and is currently commercially available. this study is a prospective, single arm, un-blinded investigation of the freespira breathing system in the ptsd population.

Eligibility criteria:
inclusion criteria: note: office visits required. patients must live locally in san francisco/silicon valley bay area to participate. patients with a primary diagnosis of ptsd * additional dsm-v disorders are acceptable and will be documented. * subjects over 18 years of age * subjects with a clinician's global impression (cgi-s) score of ≥ 4 * subjects with a caps-5 score of ≥ 30 * if on psychotropic medication(s), on a stable dose during the course of treatment * this can include benzodiazepine use that is prescribed on an as needed basis. • if on psychotropic medication(s), patient agreement to maintain their current stable dose from point of study entry until the 2-month post-treatment assessment. exclusion criteria: * subject is pregnant. * current enrollment in another device or drug study. * enrollment in another drug or device study that is not at least 30 days past the final follow-up visit. * currently undergoing cognitive behavioral therapy, or equivalent that is focused addressing ptsd including any evidenced based therapy that focuses on ptsd, including cognitive processing therapy, emdr, prolonged exposure therapy, virtual reality therapy, during trial and 2 month follow up. cognitive therapy must be discontinued 1 month prior to enrolling in this study. * severe suicidality, in the judgment of the interviewer and taking the chart assessment into account * psychotic disorder diagnosis, including schizophrenia and schizoaffective disorder * presence of uncontrolled bipolar disorder as described below - * the subject has experienced a manic episode in the past 6 months and is not considered under control by reviewer * bipolar disorder is considered the primary diagnosis for the subject, in the interviewer's opinion. * no alcohol, drug use disorder that requires medical treatment . if stable under medical supervision treatment for drug/alcohol use, then ok * cardiovascular or pulmonary disease, such as copd. * score of ≥ 10 on the copd assessment * etco2 of ≥ 48 mmhg at first treatment visit * epilepsy or seizures * inability to understand or comply with study procedures. * the investigator feels that for any reason the subject is not eligible to participate in the study.

Keywords: ptsd
a study comparing menopur in a pen formulation with a powder and solvent formulation in healthy women

Conditions: Infertility, Female

Summary: menopur is a human menotrophin product, with a combination of human follicle-stimulating hormone (fsh) and luteinizing hormone (lh) activity. human chorionic gonadotrophin (hcg) is the major contributor to the lh activity in the product. menopur is approved in more than 130 countries for a variety of strengths and indications. in china, menopur, 75 iu is approved for controlled ovarian hyperstimulation in relation to assisted reproductive technology (art). the current trial is intended for supporting marketing authorization approval of a new formulation of menopur in china. menopur is currently available in china as a powder and solvent for solution for injection, containing 75 iu of fsh and 75 iu of lh activity. a new liquid formulation is developed by ferring pharmaceuticals for administration with a disposable pre-filled injection pen, containing 600 iu of fsh and 600 iu of lh activity. menopur solution for injection in pre-filled pen, 600 iu/0.96 ml is the test product and menopur powder and solvent for solution for injection, 75 iu is the reference product in this trial.


Eligibility criteria:
key inclusion criteria: * chinese women between the ages of 21 to 40 years at the time of signing the informed consent form * non-users or users of the combined oral contraceptive (coc) pill who describe experiencing menstrual cycles of 24 to 35 days in duration (both inclusive) * healthy according to medical history, physical and gynecological examinations, vital signs, 12-lead electrocardiogram, and laboratory tests in blood and urine * serum fsh levels ≤5 iu/l and estradiol levels ≤50 pg/ml on day -3 and day -1 in tp1 key exclusion criteria: * any finding at the gynecological examination, transvaginal ultrasound or by cervical smear that is considered medically important * a history of medical problems that could affect the functioning of the reproductive organs (ovaries and womb) * a history of any medical problems that may prevent use of the combined hormonal contraceptive pill
single-dose escalation study of idx184 in healthy volunteers (mk-2355-002)

Conditions: Hepatitis C

Summary: the purpose of this study is to obtain single dose safety and pharmacokinetic (pk) data of idx184 in humans. no formal hypotheses are to be tested in this study.


Eligibility criteria:
inclusion criteria: * participants are in general good health. * all participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control exclusion criteria: * participant is pregnant or breastfeeding.

Keywords: hepatitis c, healthy volunteers
motor control during rapid eye movement (rem) sleep behaviour disorder

Conditions: Parkinson Disease

Summary: to compare the electrical activity of subthalamic nuclei (stn), by mean of local field potentials recordings, during the phasic behaviours of rbd with the electrical activity recorded at this level during the execution of voluntary movements during the "off" and the "on" phases in patients with rbd secondary to pd.

patient with severe parkinson's disease (pd) with motor fluctuations are akinetic and bradykinetic during the "off" phases. their motor status dramatically improves during "on" phases, due to the effect of dopaminergic agents. in the off phases, the plasmatic levels of dopaminergic drugs are the lowest. the plasmatic levels of dopaminergic drugs are also very low during nocturnal sleep. nevertheless, pd patients may show vigorous and rapid movements during rem behaviour disorder (rbd). thirty-three to 46% of the patients with pd have rbd. akinesia and bradykinesia are the consequence of a hyperactivity of the subthalamic nuclei (stn). the electrophysiological correlate of this hyperactivity causing akinesia and bradykinesia is represented by stn beta activity, recorded by local field potentials. stn beta activity is not present during the execution of a voluntary movement at an "on" phase. levodopa therapy, which can revert akinesia and bradykinesia, also suppress stn beta activity in pd patients the stn is the surgical target for deep brain stimulation (dbs) of the basal ganglia to improve the motor symptoms of pd. the stn has bilateral connections with the laterodorsal nucleus/pedunculopontine tegmentum (ldt/ppn), a key structure for rem sleep regulation. the investigators hypothesize that during the execution of the phasic motor behaviours of rbd the pattern of discharge of stn differs from the one observed during voluntary movements in the "off" phase, in pd patients. in other terms, we expect the stn beta activity to disappear during the execution of phasic motor behaviors of rbd.

Eligibility criteria:
inclusion criteria: * men and women, 35 to 70 years old, with idiopathic pd (ukpdsbb criteria) with motor fluctuations * having rbd according to the international classification of sleep disorders, 2nd edition (icsd-2) criteria * eligible to neurosurgical treatment of pd by implantation of intracranial electrodes for the dbs of stn * giving a written informed consent * affiliated to the french social security program exclusion criteria: * atypical or secondary parkinsonian syndrome * cognitive impairment which may compromise the understanding and patient's participation to the protocol (mattis dementia rating scale score ≥ 136) * patient under guardianship, trusteeship or judicial protection * pregnancy or breastfeeding * patient participating to another clinical research study in the same period

Keywords: rem behaviour disorder subthalamic nucleus local field potential motor control