Kornimate/medical-research-clean huggingface dataset:
sort out xi - combo stent versus biomatrix alpha stent

Conditions: Coronary Artery Disease

Summary: sort out xi comparison of combo™ stent and biomatrix alpha™ stent in the treatment of unselected patients with ischemic heart disease.

randomized clinical comparison of the sirolimus eluting and endothelial progenitor cell combo™ stent and the biolimus eluting absorbable polymer coated biomatrix alpha™ stent in patients treated with percutaneous coronary intervention

Eligibility criteria:
inclusion criteria: all patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in aarhus, odense and aalborg can be included in the study. exclusion criteria: * age \< 18 years * the patient does not wish to participate * the patient is not able to consent to randomization (eg. intubated patients) * the patient do not speak danish * the patient is already included in the sort out xi study * life expectancy \<1 year * allergic to study related treatment

Keywords: drug eluting stent stent
sleep apnea and periodic breathing

Conditions: Sleep Apnea Syndrome

Summary: the purpose of this study is to determine the double loop index (dli) threshold with optimal sensitivity and specificity. the investigators hypothesize that the dli gives a better reflection of the pathophysiology of the disease than the apnea-hypopnea-index (ahi).

sleep apnea syndrome (sas) is characterized by repetitive events of apnea and hypopnea. these events are often part of a periodic breathing pattern, in which relative hyperventilation is followed by apnea or hypopnea. recently the investigators described the 'double-loop gain' of the respiratory control system as a measure of periodic breathing. this is a frequency-dependent variable which describes 1) the tendency of the respiratory system to oscillate at a given frequency and 2) the degree to which the relation between oscillations in ventilation and oscillations in arterial blood gas values is linear. the underlying hypothesis is that periodic breathing results from negative feedback regulation of arterial o2 and co2 pressure through the chemoreflexes. the double-loop gain describes the gain in the negative feedback loop under the assumption that accidental changes occur in both ventilation and arterial blood gas pressures. a simple version of the double-loop gain is derived from nasal pressure changes and arterial o2 saturation. from all-night recordings, the 'double-loop index' (dli) can be derived, which is determined by the time during which the double-loop gain exceeds a given threshold. currently, the presence of sleep-apnea is determined by the apnea-hypopnea index (ahi), using in-hospital sleep recording. with a growing number of referrals, waiting lists for sleep registration are emerging. screening for sas using home-measurement of nasal pressure and sao2 seems to be a good alternative. the investigators hypothesize that the dli derived from these signals gives a better reflection of the pathophysiology of the disease than the ahi. as a result, the investigators expect that the dli improves the distinction between healthy and diseased subjects in comparison to the simple counting of apneas and hypopneas. this is reflected in a higher area under the roc curve, which describes the sensitivity and specificity of the test.

Eligibility criteria:
inclusion criteria: * suspected sleep apnea syndrome * \> 18 yr * outpatient * able and willing to use the necessary equipment for registration of nasal pressure and o2 saturation at home exclusion criteria: * hospitalized patients * \< 18 yr * not able to use the necessary equipment

Keywords: sleep apnea syndrome sas double loop gain dli double loop index periodic breathing polysomnography
investigation on safety, tolerability, pharmacokinetics and pharmacodynamics of nn9924 in healthy male subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of nn9924 in healthy male subjects


Eligibility criteria:
inclusion criteria: * healthy male subjects, based on an assessment of medical history, physical examination and * bmi between 21 and 30 kg/m2 (21 inclusive) exclusion criteria: * male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner * any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological * the receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial
intradermal acupuncture and self-rehabilitation program in patients with severe bell's palsy

Conditions: Bell Palsy

Summary: this study aims to assess the effect of intradermal acupuncture(ia) and guided self-rehabilitation management program(grmp) (either single or combined) for patients with severe bell's palsy.

after confirming the details of the trial process and signing an informed consent, all participants will be randomly divided into the following four groups: active ia+grmp, active ia+ he, sham ia+ grmp, sham ia + he. they will receive active or sham ia and grmp or he until complete recovery or completion of follow up (a duration of 24 weeks).follow-ups will be done in 4-week, 8-week, 12-week,16-week, 20-week, and 24-week.

Eligibility criteria:
inclusion criteria: * patients diagnosed with bell's palsy according to "clinical practice guideline: bell's palsy" published by aao-hns in 2013; * first onset of bell's palsy with only one side affected; * on the 10th day after the onset of palsy, hbgs score ranging from grade iv to vi; * according to the latest chinese guidelines for bell's palsy, within 72 hours of symptom onset for bell's palsy, oraling prednisolone 30mg qd for 5 days, followed by tapering to zero in decrements of 5 mg per day; * adults aged 18 years of age or older (no limitation on gender). exclusion criteria: * facial paralysis caused by acoustic neuroma, otitis media, mastoiditis, mumps, hunter's syndrome, cranial base meningitis, intracranial metastasis of cancer or multiple sclerosis; * fear of intradermal acupuncture; * allergy to adhesive tape; * severe allergic diseases, significant skin lesions, tumors, and severe or unstable internal diseases involving the cardiovascular, respiratory, endocrine, digestive, or hematological system; * cognitive impairment, mental illness, contagious disease, pregnant and lactating; * previously treated withintradermal acupuncture or participating in other clinical trial within 3 months.

Keywords: bell palsy intradermal acupuncture self-rehabilitation
prosthetic complications in fixed all-on-four prosthesis reinforced with poly ether ether ketone (peek) versus cobalt chromium (co-cr) framework

Conditions: Complete Edentulism

Summary: prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients.

four implants will be placed in the edentulous mandible following all on four surgical protocol. after 3 months as a healing phase, a definitive prosthesis will be fabricated after ensuring the complete osseointegration of all implants. provisional restorations will be removed, and final impressions will be taken for each patient using addition silicon impression materials. framework will be constructed using either cobalt chromium (co-cr) or poly ether ether ketone (peek) according to the randomization process. jaw relation and try-in will be done to ensure the correct centric relation. final prosthesis is then screwed to the abutments and the screw hole channels are closed with composite resin restorations. occlusal adjustments will be done after the delivery and in the subsequent follow up visit. prosthetic complications (primary outcome) and biological considerations (secondary outcome) will be measured every 3 months along the follow up period which is one year.

Eligibility criteria:
inclusion criteria: * any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration. * patients aged from 50 to 70, able to sign an informed consent will be considered eligible for this trial. * implant sites must allow the placement of four implants. * non- heavy smokers will be included (smoking up to 10 cigarettes/day) * in case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study. * patients with no systemic condition that may interfere with implant placement (e.g., immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates) exclusion criteria: * patients with poor oral hygiene and motivation. * pregnancy or nursing. * drug abusers. * psychiatric problems or unrealistic expectations. * patients with infection and or inflammation in the area intended for implant placement. * patients participating in other studies, if the present protocol cannot be properly adhered to. * patients with signs of hyperactive muscles.

Keywords: all on four , peek, co-cr, cobalt chromium, hybrid prosthesis
confirmatory study nepafenac 0.3%

Conditions: Cataract

Summary: the purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.


Eligibility criteria:
inclusion criteria: * planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens; * patients who, in the opinion of the investigator, would have improvement in best-corrected visual acuity after surgery; * able to understand and sign an informed consent; * other protocol-defined inclusion criteria may apply. exclusion criteria: * use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit; * use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit; * history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye; * diabetic retinopathy in the operative eye; * known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (nsaids), or to any component of the test article; * other protocol-defined exclusion criteria may apply.
whole- body vibration among egyptian elderly with sarcopenia

Conditions: Sarcopenia

Summary: to investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly.

participants will be assigned randomly into two groups of equal number (study group a and study group b ) the randomization will be performed by computerized randomization. assessors will be blinded to the groups of the subjects. c- subject selection 84 patients with sarcopenia will participate in this study and will be divided randomly into three equal groups with 28 participants in each group. d- groups: group a (study group): will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style group b (study group): will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style. group c (control group): will receive conventional progressive resistance exercises and diet modification life style. during the study, the participants will receive study information form, instructions and signed the consent form.

Eligibility criteria:
inclusion criteria: 1. patients age older than 60 years 2. patients with skeletal muscle index (smi) below 8.87 kg/m2 and 6.42 kg/m2 in males and females, respectively. 3. patients with hand grip strength below \< 27 kg in men and \< 16 kg in women. 4. patients with no regular exercise habit for more than 3 months . 5. patients with gait speed \> 0.8 m/s. 6. patients with proper conscious and cognition that will be detected by using mini mental state examination(scores \> 21). - exclusion criteria: acute injury. 2- severe heart diseases. 3- pacemaker. 4-history of orthopedic surgery of the lower limbs and/or fracture less than 1 year earlier. .5 - inability to walk without assistance. 6-neurological diseases or acute conditions that would interfere with testing and training. 7-patients with improper conscious and cognition that will be detected by using mini mental state examination(scores \< 21). 8- patients who cannot exercise at all due to conditions like deep vein thrombosis or blood clotting issues. 9- patients with severe illnesses that influence assessments and interventions, such as those with disabilities or musculoskeletal conditions (such as fracture, dislocation, osteoporosis, and rheumatoid arthritis). 10- people with major spinal conditions or surgical histories, such as cauda equina syndrome, tumor, vertebral fracture, inflammatory joint disease, spondylolisthesis, and ankylosing spondylitis. every participant will get a primary checkup to get a full picture of their health, find out if there are any restrictions, and decide whether they can take part in the study. -

Keywords: sarcopenia elderly performance whole body vibration aerobic exercises
effect of motor cortex versus sacral magnetic stimulation in multiple sclerosis patients with urinary tract dysfunction

Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms

Summary: this work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction.

twenty multiple sclerosis patients with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on sacral roots. another twenty multiple sclerosis patient with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor cortex. treatment outcome will be assessed and compared between the two groups. twenty trains of 50 stimuli at 5 hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for four consecutive days for two weeks.

Eligibility criteria:
inclusion criteria: * multiple sclerosis patients (diagnosed by mcdonald criteria 2010) with lower urinary tract dysfunction * adults more than 18 years * unresponsiveness to medical treatment * urodynamic diagnosis of detrusor overactivity and/or detrusor underactivity and/or detrusor-sphincter dyssynergia exclusion criteria: * urinary tract infections * pregnancy

Keywords: magnetic stimulation, multiple sclerosis
computational fluid dynamics predicting intraprosthetic thrombus formation and progression following evar

Conditions: Intraprosthetic Thrombus; Limb Graft Occlusion

Summary: intraprosthetic thrombus (ipt) formation and its progression to limb graft occlusion (lgo) are significant complications following endovascular aneurysm repair (evar). morphological metrics based on preoperative cta have limited predictive value for these complications. this study aims to assess the potential of computational fluid dynamics (cfd) in predicting ipt formation and its progression to lgo after evar.


Eligibility criteria:
inclusion criteria: 1. aged 18 and above; 2. patients undergone endovascular aneurysm repair; 3. signed informed consent forms, willing to receive treatments. exclusion criteria: 1. inflammatory aortic aneurysm; 2. patients diagnosed with connective tissue diseases; 3. patients diagnosed with atrial fibrillation; 4. patients lacking post-operative cta; 5. patients who are participating in other clinical projects; 6. patients are not suitable to participate in this study.
effect of apelin on insulin sensitivity: proof of concept in healthy volunteers

Conditions: Healthy

Summary: the (pyr1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). the apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue. recent work by the team of prof. p.valet (inserm u1048, toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. the investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.


Eligibility criteria:
inclusion criteria: * men aged 18 to 40 years. * bmi between 25 and 30 kg / cm ² (excluding terminals). * free of known chronic disease and any medication (any medication within 30 days prior to the inclusion visit). * non-pathological ecg. * heart rate between 50 and 80 beats per minute rest. * complete blood count (cbc) with no significant anomaly in terms of the investigator. * liver function tests without clinically significant abnormalities in terms of the investigator. * renal function tests without clinically significant abnormalities in terms of the investigator. * serum electrolytes without clinically significant abnormalities in terms of the investigator. * fasting plasma glucose less than 1.1 g / l. * hba1c within the normal range (4-6%). * good peripheral vein (forearm and back of the hand). * agreement to participate in the establishment of a serum bank. * sedentary or practicing occasional physical activity. * ability to sign informed consent. * affiliation to a social security scheme. exclusion criteria: * risk factor, treatment or ecg as recommended by international conference on harmonization e14 (ich e14) "clinical evaluation of qt / corrected qt interval (qtc interval= prolongation and proarrhythmic potential for non-antiarrhythmic drugs" * repeated a qtc interval\> 450 ms measurement * risk factor: myocardial infarction, hypokalemia, family history of long qt syndrome * personal history of cancer. * positive hiv serology. * hepatitis b serology positive. * positive hepatitis c serology. * cognitive impairment or mental illness (at the discretion of the investigator). * chronic excessive alcohol consumption (consumption\> 30g/jour or 210g/week). * person under judicial protection, guardianship. * subject with a resting systolic blood pressure greater than 140 mm hg and diastolic blood pressure greater than 90 mmhg * smoking\> 10 cig / day and can not be interrupted for 24 hours. * subject exclusion period of another protocol.

Keywords: apelin insulin volunteers
the relationship between allergic rhinitis, forward head posture, and anxiety levels in iranian children

Conditions: Forward Head Posture; Allergic Rhinitis (Disorder)

Summary: forward head posture is a common postural issue across all age groups, often linked to the overuse of electronic devices such as computers, smartphones, and tablets, leading to poor posture in children. allergic rhinitis is also prevalent in children, but its effects on musculoskeletal and psychological health are not well understood. objective: this study aimed to explore the relationship between allergic rhinitis, forward head posture, and anxiety levels in iranian children aged 7-12 years. materials and methods: fifty children aged 7-12 were recruited from the allergy-infection clinic at bandar abbas children's hospital. the participants were divided into two groups: 25 healthy children and 25 children diagnosed with allergic rhinitis. anxiety levels were assessed using the spence anxiety scale, while forward head posture was measured by analyzing photographs of the children's body profiles using autocad software.


Eligibility criteria:
the inclusion criteria : 1. children to be between 7 to 12 years old, 2. with and without allergic rhinitis, 3. body mass index below 95% 4. without asthma, cardiac diseases, neuromuscular diseases, tonsillectomy, congenital anomalies, 5. using smart devices less than 3 hours. the exclusion criteria : 1-no consent

Keywords: allergic rhinitis forward head posture anxiety children
mindfulness intervention for sleep disturbance and symptom management in hematologic cancer patients during and after inpatient treatment

Conditions: Hematologic Malignancy

Summary: people with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. this study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (nite2day+). participants will complete a baseline survey online, using a mobile application, or paper/pencil. once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive nite2day+ or standard care. nite2day+ will include activities during and after inpatient treatment. during inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. after inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. participants randomized to nite2day+ will be given the option to complete an exit interview to provide feedback on the nite2day+ program. participants randomized to standard care will only complete the four surveys. all participants will continue to receive their usual medical care. the total study duration is about 16 weeks.


Eligibility criteria:
inclusion criteria: 1. male and female patients, \>18 years old 2. initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, non-hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome 3. at least 7 days of hospitalization for treatment (e.g., chemotherapy, car-t immunotherapy) 4. 8 or greater on the insomnia severity index with timeframe adjusted to be "past 7 days" 5. ability to speak and read english, and intact hearing and vision exclusion criteria: 1. reported or suspected cognitive impairment, confirmed via folstein mini-mental status exam \<25 2. serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider 3. expected survival of \<6 months