Kornimate/medical-research-clean huggingface dataset:
syncope prediction study

Conditions: Vasovagal Syncope

Summary: the purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called tilt test analyzer, during head up tilt testing tests in one center in the united kingdom.

vasovagal syncope (vvs) is a form of neurally-mediated reflex syncope, which is marked by a sudden fall in blood pressure with an associated fall in heart rate often resulting in syncope, head-up tilt (hut) testing is commonly used to bring information about vvs using ecg and blood pressure monitoring with medical observation. we developed an algorithm, called tilt test analyzer, to predict vvs during hut based on the simultaneous analysis of heart rate (rr interval), systolic blood pressure (sbp) and an indicator of autonomic modulation represented by heart rate and blood pressure variability (hrv and bpv). the primary objective of this study is to evaluate the vvs prediction algorithm in a prospective cohort of patients in the tilt laboratory the primary endpoint is the vvs prediction algorithm performance by means of measuring the sensitivity and specificity values. the study is designed to test if the prospective analysis of tilt-test patients can reproduce the results previously obtained in the published retrospective analysis on 1155 patients with a similar clinically relevant sensitivity and specificity.

Eligibility criteria:
inclusion criteria: * patients referred to the center with vasovagal syncope for tilt testing. * the patient is willing and able to cooperate with the study procedures. * the subject or legal guardian is able to provide written informed consent exclusion criteria: * patients under 18 years or over 90 years old. * women who are currently pregnant or have a positive pregnancy test. * patients who had a prior tilt test. * patients enrolled in another device or drug study.
early detection of arteriosclerosis

Conditions: Arteriosclerosis; Atherosclerosis; Myocardial Infarction; Stroke; Diabetes Mellitus; Peripheral Arterial Occlusive Disease

Summary: arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. in addition to life-style factors there is also a genetic predisposition to develop complicated atherosclerosis. objective: improve individual risk prediction by clinical phenotyping and genotyping.

about 300 patients who are treated for various conditions at the department of general medicine at our hospital will be included prospectively in the study. this observational cohort will be followed for at least 10 years follow-up examinations. at baseline and during follow up visits detailed clinical phenotyping is planned (medical and family history,standardized clinical and physical examinations, lab, rx, ecg, stress-test or echocardiogram). the genotyping is performed by dna-isolation from leucocytes collected at baseline.

Eligibility criteria:
inclusion criteria: * 18 years and older * informed consent exclusion criteria: * life-threatening disease * life expectancy \< 1 month * uncapable to provide informed consent

Keywords: physical examination diagnostic techniques and procedures diagnosis immunologic tests diagnostic tests causality genetic test biomarker
mesenchymal stem cell for osteonecrosis of the femoral head

Conditions: Osteochondritis of the Femoral Head

Summary: mesenchymal stem cells (mscs) have been shown to have immunosuppressive and repairing properties. bone marrow mononuclear cells (bmmncs) have revascularization properties and complimentary effects to mscs. the investigators will infuse expanded autologous mscs and bmmncs into patients with osteonecrosis of the femoral head. the study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.

mesenchymal stem cells (mscs) have been shown to have immunosuppressive and repairing properties. bone marrow mononuclear cells (bmmncs) have revascularization properties and complimentary effects to mscs. patients in this study will receive infusion of expanded autologous msc and bmmncs. the puncture of femoral artery will be conducted with digital subtraction angiography(dsa), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. the study will evaluate the safety and effectiveness of msc infusion in patients with osteonecrosis of the femoral head. this study will last for 5 years. patients will undergo infusions at day 0. afterward, patients will be evaluated for response, and undergo x-ray examination, ct and mr scanning at a 6-month interval.

Eligibility criteria:
inclusion criteria: * ages: 12 to 60 years old. * association research circulation osseous(arco) classification criteria for osteonecrosis of the femoral head: arco phase i and phase ii. * able to give informed consent. exclusion criteria: * pregnant women. * previous history of malignancy * active infection including hepatitis b, hepatitis c, hiv, or tb as determined by a positive skin test or clinical presentation, or under treatment for suspected tb. * evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months. * psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible. * any illness that in the opinion of the investigator would jeopardize the ability of the patient to tolerate this treatment.

Keywords: mesenchymal stem cells osteonecrosis of the femoral head
efficacy study exploring the effect of lu ae58054 as augmentation therapy in patients with schizophrenia

Conditions: Schizophrenia; Cognition

Summary: the objective of this study is to explore the efficacy, safety and cognitive properties of lu ae58054 as augmentation therapy to risperidone in patients with schizophrenia.

lu ae58054 is a selective 5-ht6 antagonist that is currently being investigated for treatment of conditions of cognitive impairment associated with schizophrenia. substantial experimental evidence suggests that selective 5-ht6 receptor antagonists may be effective in treating cognitive deficits since they have been shown to improve performance in various animal models of cognitive function and are known to enhance cholinergic and glutaminergic neuronal function. lu ae58054 has been investigated in healthy volunteers and patients with schizophrenia, is generally well tolerated and has a benign side-effect profile. moreover, no safety concerns or issues have been identified to date. the study is designed to provide data on the efficacy, safety and cognitive properties of lu ae58054 as augmentation therapy to risperidone in patients with schizophrenia. efficacy will be assessed in patients who are in a stable phase of their illness, but with a predefined minimum and maximum level of symptoms that will allow them to be included in the study. patients will be randomly assigned to receive either the investigational medicinal product (imp) or placebo as add-on therapy to their existing risperidone treatment.

Eligibility criteria:
inclusion criteria: * primary diagnosis of schizophrenia * man or woman, aged between 18-65 * patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening * the patient has a panss total score between 70 and 100 (extremes included) at screening exclusion criteria: * primary psychiatric diagnosis other than schizophrenia * acute exacerbation requiring hospitalisation within the last 3 months * clinically significant extrapyramidal symptoms * clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia * significant ecg abnormalities * in concurrent treatment with drugs inhibiting the p450 enzymes system cyp2d6 and other cyp isozymes * failed to respond to adequate courses of treatment with risperidone * treated with an antipsychotic other than risperidone within 4 weeks prior to screening

Keywords: schizophrenia cognition bacs risperidone augmentation therapy add-on therapy lu ae58054
retrospective study to evaluate the safety of duvie in korean patients with type 2 diabetes mellitus

Conditions: Type2 Diabetes

Summary: previous thiazolidinediones (tzds) have issued various safety concerns including weight gain, bladder cancer, and congestive heart failure (chf). this study aimed to evaluate the efficacy and safety of lobeglitazone, a novel tzd in patients with type 2 diabetes in real world.

lobeglitazone have clinical trials conducted in korean type 2 diabetics patients for 6 months to up to 12 months, and the results of study on the efficacy and safety of lobeglitazone are relatively limited. in pre-marketing clinical trials, a controlled group of patients is enrolled to minimize other possible effects in determining the efficacy and safety of the drug. consequently, in real clinical practice, unexpectable safety information that has not been discovered at the pre-marketing stage may accur because it is more extensively and longer administered to a variety of patients who may have various underlying conditions and diseases. therefore, there should be an ongoing assessment of safety information in real world. there have been the safety concerns of tzd, such as congestive heart failure (chf), fractures, bladder cancer (long-term use), edema, and weight gain. previous study has reported that lobeglitazone has better safety on bladder cancers and bone fractures than other tzds, but currently, there is a lack of large-scaled, long-term safety and efficacy data of lobeglitazone in korean real practice. this is a non-interventional, multi-centered, retrospective and observational study and aimed to evaluate the efficacy and safety of lobeglitazone in patients with type 2 diabetes in real world.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between february 1, 2014 and december 20, 2018 exclusion criteria: * patients who are not appropriate to participate in this research based on principal investigators' decision
the stepp study: sensors to evaluate physical performance

Conditions: Oncology

Summary: this study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like karnofsky performance score (kps).

this study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. the study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. the participants will also be asked to fill out survey data regarding their health. at-home data will be collected for 14 days. during this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data. primary objective: 1. assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. kps)

Eligibility criteria:
inclusion criteria: 1. all genders aged ≥ 18 years of age 2. patients being seen at uncch for treatment of cancer. 3. english-speakers 4. able to understand and cooperate with study procedures. 5. patients with solid tumors or hematological malignancies, and self-reported kps ≤70 to ≥ 100. signed and dated informed consent and hippa. exclusion criteria: 1. subjects using investigational/experimental products. 2. has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent. 3. unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days. 4. unable to speak english. 5. subjects who report any other medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent. 6. subjects who are allergic to silicone or adhesives. subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.
adjuvant treatment of postoperative pain following endoscopic carpal tunnel surgery by auriculotherapy

Conditions: Chirurgical Intervention; Auriculotherapy

Summary: retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery

the project consists of a retrospective analysis of data from the medical records of patients followed by doctor, between 2016 and 2017, at the bizet clinic. this study includes measurements of pain levels and analgesic consumption in patients who received during their care in the clinic a preoperative auriculotherapy session offered by the clinic, during the three days following carpal tunnel surgery. for comparison, this studie also includes a group who underwent the same surgery treated only with analgesics. the objective of study is to analyze the results obtained in the two groups in order to evaluate the effectiveness of auriculotherapy for the management of postoperative pain.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 84 years. * patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated exclusion criteria: * have already benefited from an auriculotherapy session. * presence of cryoglobulinemia. * presence of raynaud's syndrome. * presence of hemoglobinopathy (hemoglobin and capillary abnormalities). * allergy to cold. * presence of dermatological lesions on the auricle of one of the two ears
the effect of group exercise in children with special needs

Conditions: Developmental Disability; Child Autism

Summary: thirty children with special needs were included in the study. participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. the participants' balance was assessed using the bruininks-oseretsky motor proficiency test short form (balance parameters), pediatric balance scale; functional mobility was evaluated using the timed up and go test, and attention level was assessed using the stroop test before and after the intervention.


Eligibility criteria:
inclusion criteria: * children aged 6-15 years with special needs * able to walk independently exclusion criteria: * children with visual problems, * any orthopaedic, rheumatic or neurological problems affecting balance, * any contraindication to exercise

Keywords: developmental disability balance attention group exercise
experiences of pain in healthy adults

Conditions: Pain in Healthy Adults

Summary: the experiment aims to investigate the experience of pain in healthy adults and includes a total of 60 participants. pain is a subjective experience that has a complicated neurological and psychological basis. around 20% of the danish population suffers from persistent pain, which has both personal and societal consequences. personal consequences include, among others, reduced quality of life, loss of social life and risk of anxiety and depression. however, more knowledge is needed about which mechanisms are involved in the experience of pain, so that the treatment of patients with pain can be improved. in the experiment, healthy participants will be inflicted with a tolerable pain on their forearm using a thermode. the application of heat causes pain for a short, limited period, but it is tolerable and without risks. during the experiment, the participants will be exposed to heat several times, with and without a cream on their forearm. it is a cream that has previously proved to have pain-relieving effects on participants in similar experiments. participants will be asked about how they experience the intensity of the pain on a scale of 1-10 (0 = no pain and 10 = worst imaginable pain), and what they expect the pain intensity will be, also on a 1-10 scale. the participants are allowed to pause or stop the experiment anytime. the experiment contributes to insights into pain and the mechanisms involved. this knowledge can in the future contribute with knowledge to improve the treatment of patients with pain. for the individual participant, the trial will contribute with knowledge about how they experience and assess pain themselves.


Eligibility criteria:
inclusion criteria: * normal health, i.e. no known acute or chronic illness * fluid in danish exclusion criteria: * chronic pain condition * other medical or psychiatric disorder * use of antidepressants * daily use of painkillers * use of pain medication 24 hours prior to testing * drug abuse * pregnancy * studying or with completed education in psychology or journalism

Keywords: healthy adults pain experience of pain
a healthy volunteer study evaluating the the safety, tolerability, and pharmacokinetics of rt234

Conditions: Healthy Volunteer

Summary: the objective of this two part study was to demonstrate safety, tolerability, and pharmacokinetics of rt234 in healthy volunteers. this study is also known as vardenafil inhaled for pulmonary arterial hypertension prn phase 1 (vipah-prn 1) study

this study was designed to evaluate safety and tolerability and to characterize the pk profiles of single and repeated doses of inhaled vardenafil as rt234. in addition, vardenafil pk after single 0.6 mg doses of rt234 was compared to that following administration of a single 20 mg dose of oral vardenafil tablets.

Eligibility criteria:
inclusion criteria: 1. healthy male or female, 18 to 45 years of age (inclusive at time of informed consent) 2. normal heart, lung, kidney, and liver function based on physical examination 3. systolic blood pressure of 100-145 mmhg, diastolic blood pressure of 50-90 mmhg, and a resting heart rate of 40-100 bpm at screening 4. a body mass index (bmi) of ≤18 to ≥30 kg/m2 at screening 5. must be a non-smoker or ex-smoker with less than a 5-pack year history of smoking (including the use of electronic cigarettes) and have ceased smoking ≥1 year prior to screening; or a social smoker (defined as less than 10 cigarettes in the previous 12 months) exclusion criteria: 1. has serum transaminase (i.e., alanine aminotransferase \[alt\], aspartate aminotransferase \[ast\], or gamma-glutamyl transferase \[ggt\]) levels greater than three times the upper level of normal 2. abnormal orthostatic vital signs (at screening) defined as a decrease of ≥20 mmhg in systolic blood pressure and/or a decrease of ≥10 mmhg in diastolic blood pressure and/or \>25 bpm increase in heart rate within 3 minutes of standing, or with symptoms of light-headedness, dizziness, or fainting upon standing. 3. history of hypotension including fainting, syncope, orthostatic hypotension, and/or vasovagal reactions 4. history of retinitis pigmentosa 5. vision loss due to non-arteritic anterior ischemic optic neuropathy (naion) or other optic perfusion impairment 6. history of priapism or anatomical deformation of the penis 7. history of sudden sensorineural hearing loss (sshl), need for hearing aids, and/or other documented hearing loss 8. a corrected qt interval using fridericia's formula (qtcf) \>450 msec 9. has evidence of significant obstructive lung disease on spirometry. subjects with any of the following criteria will be excluded: 1. fev1 \<60% (predicted) (pre-bronchodilators); or 2. fev1/fvc \<65% (pre-bronchodilators)

Keywords: pulmonary arterial hypertension familial primary pulmonary hypertension vascular diseases cardiovascular diseases hypertension, pulmonary lung diseases respiratory tract diseases vardenafil dihydrochloride inhaled vardenafil vasodilator agents phosphodiesterase 5 inhibitors phosphodiesterase inhibitors enzyme inhibitors molecular mechanisms of pharmacological action
pharmacokinetics and safety study of pt010 and pt003 in healthy chinese adult subjects

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a study to assess the pharmacokinetics and safety of two doses of pt010 and a single dose of pt003 in healthy chinese adult subjects

a phase i, randomized, double-blind, parallel group, study to assess the pharmacokinetics and safety of two doses of pt010 and a single dose of pt003 in healthy chinese adult subjects following a single administration and after chronic administration for 7 days

Eligibility criteria:
inclusion criteria: * male and female chinese subjects 18-45 years of age * females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception a female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. a male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception -be in good general health as assessed at screening and have no clinically significant abnormal labs at screening. exclusion criteria: * pregnant or nursing female subjects or subjects who are trying to conceive * subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study * subjects with a history of ecg abnormalities * subjects who have cancer that has not been in complete remission for at least 5 years * male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the investigator * male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening * males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the investigator * subjects with a diagnosis of glaucoma that in the opinion of the investigator has not been adequately treated * history of substance-related disorders within 1 year of screening * history of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of screening by self-reporting * a positive alcohol breathalyzer or urine drug screen for drugs of abuse at the screening visit or at the beginning of each inpatient period * treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days * positivity for human immunodeficiency virus (hiv) or hepatitis b surface antigen (hbsag) or positive hepatitis c antibody at screening * positive for syphilis antibody * subjects with any flu-like syndrome or other respiratory infections * recently vaccinated with an attenuated live virus