Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate the safety and pharmacokinetics of aju-c52h in healthy volunteers

Conditions: Hypertension

Summary: to evaluate the safety and pharmacokinetic characteristics of aju-c52h in healthy adults

this study is to assess the safety and pharmacokinetic characteristics between co-administration of c52r1m with c52r2 and administration of aju-c52h. this is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.

Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19-year-old 2. weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(bmi) of 18 to 30 kg/m2 3. those who are eligible for adequate blood pressure criteria during screening tests systolic blood pressure: 90 to 139 mmhg diastolic blood pressure: 60 to 89 mmhg 4. those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 5. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ecg results during screening tests 6. those who agree to contraception during the participation of clinical trial 7. those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial exclusion criteria: 1. those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug 2. those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug 3. those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks 4. those who has a history of gastrointestinal surgery 5. those who exceeding an alcohol and smoke consumption criteria alcohol: men - 21 glass/week, women - 14 glass/week (1 glass: soju 50 ml, beer 250ml, wine 30 ml) smoke: 20 cigarettes/day 6. those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema 7. genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption 8. those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests 9. women who are pregnant or who may be pregnant and breastfeed
effect of mulligan's mobilization on shoulder joint range of motion and subacromial space in paraplegic patients

Conditions: Paraplegia, Incomplete

Summary: the aim of the study is to determine the effect of mulligan's mobilization on shoulder range of motion and subacromial joint space in paraplegic patients with subacromial impingement so, thirty patients will be randomly assigned to two groups group (a) and group (b)

30 patients will be randomly assigned to two groups group (a): will receive mulligan's mobilization plus steroid injection for rotator cuff tendinopathy group (b): will receive steroid injection for rotator cuff tendinopathy only outcome measures will be: * shoulder joint range of motion will be measured by laser goniometer * subacromial joint space will be measured by 3d ultrasonography

Eligibility criteria:
inclusion criteria: * more than one year after traumatic spinal cord injury * the injury is at the second thoracic level or below. * no cognitive impairment * relying on manual wheelchair for main movement. exclusion criteria: * no frozen shoulder * no subluxation

Keywords: range of motion subacromial impingement
efficacy and safety of chidamide in cbf leukemia

Conditions: AML

Summary: in this open-label, randomized, prospective clinical trial, cbf acute myeloid leukemia (aml) patients who have reached cr are randomised into two groups and receive high-dose cytarabine (hdac) or high-dose cytarabine plus chidamide.the safety and efficacy of chidamide is evaluated.

in this open-label, randomized, prospective clinical trial, cbf aml(including aml1-eto or cbf-myh11 mutated patients) patients who have reached cr are randomised into two groups and receive hdac or high dose of cytarabine plus chidamide. in experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.patients in control group only receive cytarabine at the same dose. the safety and efficacy of chidamide is evaluated. the primary outcome is relapse-free survival rate after treatment.

Eligibility criteria:
inclusion criteria: 1. age of 14 to 55 years old; 2. patients that meet the diagnostic criteria(who 2008 criteria) of aml (except apl subtypes) and with aml1-eto or cbf-myh11 mutation. 3. reached cr after induction regimen. 4. ecog score of ≤ 2; 5. patients with eligible laboratory examination including liver,renal and heart function. 6. adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. patients under 18 years old willing to participate should have their legal guardians sign the informed consent. exclusion criteria: 1. secondary leukemia. 2. patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor. 3. patients with other blood diseases(for example, haemophiliacs) are excluded.however, patients with abnormal blood count, but with undiagnosed mds or mpd patients are included. 4. acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 5. with bcr-abl fusion gene; 6. pregnant or lactating women; 7. with ineligible renal or liver function; 8. with active cardiovascular disease; 9. severe infection disease including uncured tuberculosis pulmonary aspergillosis; 10. aids; 11. patients had central nervous system involvement when they were diagnosed as aml. 12. patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research. 13. drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results. 14. patients with other factors which were considered unsuitable to participate in the study by the investigators.
dose estimation for studies of acute respiratory effects

Conditions: Lung Diseases

Summary: to modify and expand an existing pharmacokinetic model for nasal dose as well as to develop a new model to estimate tracheobronchial dose of an active agent for each subject in a study of acute respiratory health effects.

background: epidemiologic analysis of acute, reversible respiratory health effects is uncommonly performed, yet these are important health outcomes because acute responses by the respiratory defense system appear to represent one end of the continuum toward progressive, chronic and potentially disabling physiologic changes. repeatable epidemiologic studies of dose-response relationships necessitate accurate measures of 'dose'. however, in occupational and environmental settings, exposure to a toxin is seldom found at identical concentrations and/or particle sizes among persons with the same activity patterns. in addition, air concentration does not account for factors such as clearance or metabolism which may alter the biologically effective tissue dose. these factors cause the target tissue dose of the toxin to vary greatly despite exposure to similar air concentrations. design narrative: the results of these toxicokinetic models were individual measures of tissue dose used in a 2-stage epidemiologic analysis which placed special emphasis on the definition of individual dose-response curves for exposure to an irritant dust, sodium borate, and the reversible effects of peak expiratory flow and irritant symptoms. a primary advantage of the two stage epidemiologic approach was that it permitted particular attention to be focused on the factors which determined the sensitivity (threshold) and reactivity (slope) for an individual. the use of tissue dose estimates were also compared to simple exposure measurements in the epidemiologic analysis to evaluate the efficacy of using dosimetric methods in epidemiologic studies. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the efficacy and safety of oral oxcarbazepine 300-1200 mg/day as adjuvant therapy in the treatment of adolescents with impulsivity and aggressive behavior in conduct disorder this study is not being conducted in the united states.

Conditions: Conduct Disorder

Summary: conduct disorder is a group of psychiatric symptoms that can include clinical characteristics of impulsivity and aggressive behavior. this study will investigate the efficacy a safety of oxcarbazepine in the treatment of adolescents with conduct disorder.


Eligibility criteria:
inclusion criteria: * history of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified * score \>8 on the impulsivity rating scale exclusion criteria: * other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified * treatment with antiepileptic medications other protocol-defined inclusion/exclusion criteria may apply.

Keywords: oxcarbazepine, conduct disorder, adolescents
prospective trial of autologous platelet rich plasma in aortic surgery

Conditions: C.Surgical Procedure; Cardiac

Summary: the purpose of this study is to determine whether autologous platelet rich plasma (aprp)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.


Eligibility criteria:
inclusion criteria: * patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、 * preoperative platelet counts\>150000000000/l、 * preoperative hematocrit\>33%、 * without recent anticoagulants less than 5 days exclusion criteria: * preoperative coagulation disorder * severe renal and liver dysfunction * preoperative hemodynamic instability

Keywords: autologous platelet rich plasma deep hypothermic circulatory arrest transfusion
quality of life and quality of sleep studies in children with home care ventilation in the west of france

Conditions: Quality of Life; Non Invasive Ventilation

Summary: home ventilation in children, invasive or non invasiv,e is an interesting treatment for different disease which cause chronic respiratory impairement. the aim of this treatment is to support alveolar hypoventilation. concerned diseases are : neuro-muscular disease, upper airways pathologies, whest wall or lung pathologies, central control ventilation disease. prevalence of home children ventilation is in augmentation in france. the last national study in 2021 about infants show a prevalence of 9.3/100 000. advantages with home children ventilation in addition of improvement of survey, it can observe improvement of quality of life and improvement of the quality of their sleep. quality of life is a thematic less studying. last studies show an impairment of quality of life in all thematics compare to children with no disease but also with infants whith chronic diseases. this study were about few numbers of patients. the aim of this study is to evaluate the quality of life and the quality of sleep in children with home ventilation to complete the actual littérature to improve the respiratory care of this population.


Eligibility criteria:
inclusion criteria: * child aged 6 months to 17 years treated with non-invasive ventilation at home for at least 1 month * follow-up in one of the five centers participating in the study (angers, nantes, le mans, rennes and brest) * informed consent form signed by both parents, or holder of parental authority, for the participation of their child * to be affiliated or beneficiary of social security exclusion criteria: * parents with poor command of the french language, implying not being able to complete the various questionnaires * refusal of the child to participate in the study
post critical illness dysphagia in the intensive care unit

Conditions: Dysphagia

Summary: the aims of the study are to determine: 1) the prevalence of icu acquired dysphagia, 2) identify risk factors for icu acquired dysphagia, and 3) consequences of icu acquired dysphagia including: icu mortality, hospital mortality, days of mechanical ventilation, icu length of stay, hospital length of stay, post extubation aspiration pneumonia, and rate of percutaneous endoscopic gastrostomy placed feeding tube (peg-tube) insertion, and/or total parenteral nutrition (tpn) and/or dobhoff feeds.

the rc will collect daily data on the use of advance life support, need for mechanical ventilation and outcomes (mortality, duration of mechanical ventilation, icu length of stay, hospital length of stay). enrolled patients will undergo a water sip test in the icu and a videofluroscopic swallowing study (vfss) performed by a registered speech-language pathologist (slp). a vfss is a videotaped or digitized dynamic fluoroscopic image that focuses on the oral, pharyngeal, laryngeal and upper esophageal swallow physiology. patients will then be followed as two cohorts 1) patients that have dysphagia (or abnormal test) based on the vfss, and 2) patients who have normal vfss. we will then prospectively follow these two groups of patients during hospital stay censored at 30 days.

Eligibility criteria:
inclusion criteria: 1. adults (18 years of age and older) 2. received mechanically ventilated for \> 24 hours 3. have been extubated for \>24 hours 4. hemodynamically stable (i.e. not requiring active resuscitation or vasoactive agents) 5. able to participate in vfss - with n the first 7 days after successful extubation. (+/- 2 days) exclusion criteria: 1. gastrostomy tube or a gastro-jejunostomy tubes 2. current contraindication to oral feeding (eg. recent gastrointestinal surgeries as indicated by their surgeons) 3. being actively palliated 4. tracheostomy 5. neuromuscular condition associated with dysphagia: (e.g., amyotrophic lateral sclerosis, myasthenia gravis) 6. pre-existing history of dysphagia 7. ongoing respiratory support (defined as requiring ≥ 50% oxygen, bi-level positive airway pressure, or high flow nasal cannula) for 7 days or more after extubation. 8. caring physician declined

Keywords: mehanical ventilation, dysphagia, videofluroscopy
atriclip® left atrial appendage exclusion concomitant to structural heart procedures (atlas)

Conditions: Post-Operative Atrial Fibrillation

Summary: patients without a documented history of atrial fibrillation (af) and will undergo a valve or coronary artery bypass graft (cabg) procedure with direct visual access to the left atrial appendage (laa) will be eligible to participate. patients enrolled will be randomized 2:1 (2 with atriclip to 1 without atriclip. subjects who develop post-operative atrial fibrillation (poaf) and receive the atriclip will be followed for 365 days post index procedure.

patients without a documented history of af but who present with a cha2ds2- vasc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (tia), vascular disease, age 65 to 74 years, sex category) of =\> 2 and hasbled (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile inr, elderly, drugs/alcohol concomitantly) of =\> 2 and will undergo a valve or cabg (structural heart) procedure with direct visual access to the laa will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol. up to 2000 patients will enroll at up to 40 sites and will be randomized 2:1 (2 with atriclip to 1 without atriclip. subjects who not develop post-operative atrial fibrillation (poaf) will be followed for 30 days for safety. subjects who develop poaf and receive the atriclip will be followed for 365 days post index procedure.

Eligibility criteria:
inclusion criteria: patients satisfying the following criteria will be considered the screening population and will be eligible for participation: * age \> 18 years male or female. * scheduled for any non-mechanical valve and/or cabg (structural heart) procedure where direct access to the laa is expected. * no documented preoperative af. * cha2ds2-vasc score of =\> 2. * hasbled score of =\> 2. * acceptable surgical candidate, including use of general anesthesia. * willing and able to provide written informed consent. exclusion criteria: patients satisfying the following criteria will not be eligible for participation: * redo cardiac surgery. * mechanical heart valve or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period. * hypercoagulability conditions that may confound the study. * ejection fraction \< 30. * left atrium \> 6 cm. * severe diastolic dysfunction. * requires anticoagulation therapy. * patient had a stroke/cerebrovascular accident (cva) within previous 30 days prior to signing informed consent. intra-operative exclusion criteria * presence of thrombus in the left atrium or laa. * laa tissue is deemed friable or has significant adhesions (as evaluated by the surgeon) near or on the laa making atriclip placement overly risky. * left atrial appendage is outside the range of manufacturer's recommendations - width \ 50mm. * direct visualization access is not available for atriclip placement.

Keywords: left atrial appendage anticoagulation cha2ds2- vasc hasbled
model-informed individualized treatment of anti-infective drugs

Conditions: Osteoarticular Infections

Summary: the study aims to optimize individualized treatment of anti-infective drugs in osteoarticular infections by analyzing drug exposure in patients blood and/or tissues using population pharmacokinetics.


Eligibility criteria:
inclusion criteria: * patients with suspected/confirmed osteoarticular infections who are undergoing anti-infective drug therapy. exclusion criteria: * pregnant/lactating women. * there are other factors that the researchers think are not suitable for inclusion.
the role of vitamin d3 and calcium supplementation in attenuating t2dm severity

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate the effect of vitamin d3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.

subjects of this study received a total of 1800 iu vitamin d3 and 720 mg of calcium per day for 3 years. the study was conducted in toronto, ontario, canada.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * non-white, post menopausal female * have access to community health center exclusion criteria: * neurodegenerative disease * kideny disease * gluten allergy

Keywords: serum calcidiol t2dm vitamin d3 supplementation post-menopausal women ethnic diverse calcium supplementation
empower opioid misuse & chronic pain

Conditions: Chronic Pain; Opioid Use

Summary: this study evaluates the effects of peripheral nerve stimulation on opioid craving and use and pain in participants with chronic non-cancer pain (ncp) and opioid misuse. participants will be randomized to receive the active or sham control treatment for the duration of the study.

this pilot study aims to examine the feasibility, acceptability, and preliminarily examine efficacy of peripheral nerve stimulation with the empower neuromodulation system on reducing opioid craving and use and decreasing pain. opioid prescribing for chronic pain has increased dramatically over the past several decades, with devastating public health consequences, including high rates of opioid misuse and overdose deaths. safe nonpharmacological treatments are urgently needed. in this randomized, controlled study, thirty veterans with chronic non-cancer pain (ncp) and opioid misuse will be recruited and randomly assigned (1:1) to either the active or control treatment. on days 1-7, participants will undergo baseline monitoring, and on days 8-21, participants will undergo daily nerve stimulation treatment. pain scores, craving, and opioid use will be measured daily days 0-21. our goal is to provide an intervention that, alone or in conjunction with current treatments, reduces craving and reduces reliance on opioids in high-risk chronic pain patients.

Eligibility criteria:
inclusion criteria: * va-eligible veterans * ages 18-75 * currently prescribed and taking chronic opioids (≥90 days dispensed in past 12 months) for non-malignant, non-palliative pain * current (past 12 months) opioid misuse, defined as opioid use not as prescribed. participants with comm ≥ 9, soapp-r ≥ 18, and/or medical and pharmacy records reflective of opioid misuse in the past 12 months. exclusion criteria: * injury or damage to the ulnar nerve, and/or neuropathy in the upper extremities * pregnant or planning to become pregnant * currently implanted with an electrical and/or neurostimulator device, including cardiac pacemaker or defibrillator, vagal neuro-stimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant * use of an investigational drug/device therapy within the past 4 weeks * current medical or psychiatric instability as determined by the participant's primary care provider and/or study pi * severe opioid use disorder (oud) requiring medication-assisted therapy (buprenorphine, methadone, or naltrexone im) for oud * injury or nerve damage at the arm or palm that prevents safe use of empower device at either site * unable to provide informed written consent * prone to epilepsy or seizures
a study to evaluate the combination of valsartan + amlodipine in hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.


Eligibility criteria:
inclusion criteria: 1. male or female patients (18 years) 2. patients with moderate essential hypertension (untreated must have mssbp ≥160 and \<180 mmhg at visit 1, treated must have mssbp \<180 mmhg at visit 1) (who grade ii) exclusion criteria: 1. severe hypertension(msdbp ≥110 mmhg or mssbp ≥ 180 mmhg) 2. pregnant or nursing women 3. treated hypertensive patients with controlled hypertension under current therapy (diastolic bp \< 90 mmhg and systolic bp \< 140 mmhg) 4. a history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure nyha ii - iv other protocol-defined inclusion/exclusion criteria may apply.

Keywords: moderate essential hypertension (who grade ii)