Kornimate/medical-research-clean huggingface dataset:
value of potassium magnesium citrate in preventing and treating hypertension in african americans

Conditions: Hypertension

Summary: in the dash (dietary approaches to stop hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension, particularly in african americans (aa). key components of such a diet are potassium, magnesium, and alkali, each of which has been implicated in lowering blood pressure. in the original ind 116,208, the investigators explored whether potassium-magnesium citrate (kmgcit) as a powder pharmaceutical formulation (dissolved in water before ingestion) could serve as a surrogate for the dash diet and would lower blood pressure among patients with pre- or stage i hypertension. unfortunately, previous studies did not include adequate number of african american patients.

this is a double blind, randomized crossover trial comprising two phases: placebo phase (microcrystalline cellulose in water) and kmgcit phase (kmgcit powder in water) to investigate the use of kmgcit in lowering blood pressure and reducing arterial stiffness. one half of the subjects will undergo the placebo phase first followed by the kmgcit phase. the other half will undergo the kmgcit phase first followed by the placebo phase. each phase is 4 weeks in duration with at least 1 week washout between phases. forty-five african american patients of either sex with pre- or stage i hypertension, with systolic blood pressure of 120-139 mm or diastolic of \ 21 years of age). they may be on ace inhibitor or arb, but not on spironolactone or diuretic. excluded will be patients with diabetes mellitus, renal impairment, heart disease, chronic nsaid use, gastrointestinal reflux disease requiring treatment with acid reducing agent of antacid more than once a week, esophageal-gastric ulcer, chronic diarrhea, hyperkalemia, abnormal liver function test, subjects who require potassium supplementation on a regular basis for any reason, pregnancy, history of major depression, bipolar disorder or schizophrenia, and history of substance abuse

Eligibility criteria:
inclusion criteria: -african american patients with pre- or stage i hypertension, with systolic blood pressure of 120-139 mm or diastolic bp of \< 90 mmhg. exclusion criteria: * diabetes mellitus, * renal impairment (serum creatinine \> 1.4 mg/dl), * any heart diseases such as congestive heart failure or sustained arrhythmia, * chronic nsaid use, * treatment with diuretics, including spironolactone * gastroesophageal reflux disease (gerd) requiring treatment with acid reducing agent or antacid more than once a week, * esophageal-gastric ulcer, * chronic diarrhea, * hyperkalemia (serum k \> 5.0 mmol/l), * abnormal liver function test (ast or alt above upper limit of normal range), * subjects who require any potassium supplement on a regular basis for any reason, * pregnancy, * history of major depression, bipolar disorder, or schizophrenia, and * history of substance abuse.
perclose multi-access duplex ultrasound (dus) study

Conditions: Arrhythmia

Summary: the aim of this prospective, single-arm, united states (us) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the smc system by scheduled dus at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.


Eligibility criteria:
inclusion criteria: * age ≥18 years * subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein * all the access sites are planned to be treated with perclose smc * written informed consent is obtained prior to the procedure exclusion criteria: * visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure * prior ipsilateral deep vein thrombosis within 6 months * international normalization ratio \>3.5 for patients on warfarin * subject who is not able to ambulate pre-procedure * women who are pregnant (based on site standard pre-procedure pregnancy test) * has active symptoms and/or a positive test result of covid-19 or other rapidly spreading novel infectious agent within the prior 2 months

Keywords: abt-cip-10410 ablation dus femoral dus
dexmedetomidine combined with hydromorphone in tonsillectomy and adenoidectomy

Conditions: Agitated; State, Acute Reaction to Stress

Summary: tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. the combination of the two is more conducive to the management of postanesthetic agitation and pain. this study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.

the computer generates random numbers to allocate patients into different group. trained research staff who are not involved in the study collect the data. the observer who only stayed in pacu was blinded to the allocation and responsible to record the data. the primary measurement are pain scores, paed scores, coughing was evaluated on a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm), and extubation time. the secondary measurements are the time to discharge from the post-anaesthesia care unit, and the number of postoperative desaturation. a sample size of 57 was determined by analysis based on the assumption of the decline of extubation time from other similar study and α=0.05,β=0.2. the continuous variables were presented as means ± sd and the categorical variables were expressed as frequency. the outcome of interest is extubation time decline.

Eligibility criteria:
inclusion criteria: * experienced tonsillectomy and adenoidectomy * asa physical status i-ii * weight 12-30 kg exclusion criteria: * respiratory disease * circulatory or nervous system disease * hepatic dysfunction * known adverse reactions to hydromophine and dexmedetomidine

Keywords: dexmedetomidine hydromophine tonsillectomy and adenoidectomy
long-term safety and efficacy of sirukumab in participants with ra completing studies cnto136ara3002 or cnto136ara3003

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of cnto 136 (sirukumab) in participants with rheumatoid arthritis (ra) who are unresponsive to treatment with modifying antirheumatic drugs (dmards) or anti-tnf alpha agents.

this is a multicenter, long-term study of sirukumab (cnto 136) that will be conducted in two groups of participants at the same time (parallel-group study). the maximum duration of participation in this study is 208 weeks, followed by approximately 16 weeks of safety and efficacy follow-up after the administration of the final study agent injection of sirukumab. participant safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * completed participation in studies cnto136ara3002 or cnto136ara3003 * signed an informed consent form (icf) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * signed an informed consent form (icf) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. refusal to give consent for this component does not exclude a participant from participation in this clinical study exclusion criteria: * withdraws consent and/or discontinues participation in study cnto136ara3002 or cnto136ara3003 * is pregnant * has active diverticulitis * has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments

Keywords: rheumatoid arthritis sirukumab cnto 136 cnto136ara3002 sirround-d cnto136ara3003 sirround-t sirround-lte
hypoglycemic effects of fermented red ginseng in subject with impaired fasting glucose or type 2 diabetes

Conditions: Impaired Glucose or Type 2 Diabetes

Summary: this study was conducted to investigate the effects of daily supplementation of fermented red ginseng (frg) on glycemic status in subjects with impaired fasting glucose (ifg) or type 2 diabetes.

this study was a 4 weeks, randomized, double-blind, placebo-controlled trial. forty-two subjects with ifg or type 2 diabetes were randomly allocated to 2 groups to consume placebo or frg three times per day for 4 weeks. fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 20-75 years with fasting glucose 100\~140 mg/dl at least two of the following exclusion criteria: * lipid metabolic disorder * acute or chronic inflammatory disease * taking medication of corticosteroid within 4 weeks of the study * cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker) * allergic or hypersensitive to any of the ingredients in the test products * participation in other clinical trials within 2 months * abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome) * taking medication of lipid phosphates within 3 months of the study etc,
neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer (nsclc) especially in lung squamous cell carcinoma has a better tumor response rate and safety than solvent-based paclitaxel.however, the safety and efficacy is uncertain in neoadjuvant therapy.

the main purpose of this study is to observe the safety and efficacy of platinum-based albumin-bound paclitaxel regimen in the treatment of non-small cell lung cancer (nsclc) of stage ⅱ b and iiia .

Eligibility criteria:
inclusion criteria: 1.histological or cytological diagnosis of nsclc of stage ⅱ b and iiia . 2.18 years or older 3.performance status 0 to 2; 4.appraisable disease; 5.patients can tolerant chemotherapy; 6.total bilirubin 1.5 x upper limit of normal (uln); 7.creatinine clearance 60ml/min (calculated according to cockcroft-gault formula). exclusion criteria: 1.any systemic anticancer treatment for nsclc；2.local radiotherapy for nsclc；3.in this study within five years prior to the start of treatment with other than nsclc patients with other cancers.4.any instability in systemic disease; 5.allergic to paclitaxel or platinum;6.pregnant or lactating women;7.other researchers believe that does not fit into the group
nac trial for anosmia

Conditions: Anosmia

Summary: the purpose of this research study is to evaluate the use of nac in the treatment of anosmia (a loss of the sense of smell). this drug is already approved by the food and drug administration (fda) for oral or pulmonary (lung) inhaled use for other medical conditions. however, there is research evidence that the medication may promote nerve recovery (help nerves work better after they are damaged). since anosmia involves nerve problems, we believe the nasal spray may help treat anosmia. the medication has been in use for many years for other conditions, without safety problems.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age with documented microsmia or anosmia by university of pennsylvania smell identification test. * patients must have no evidence of active sinonasal disease by nasal endoscopy or ct or mri * negative ct or mri exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women, prisoners, employees or subordinates, * patients with known sensitivity to nac or severe asthma * patients with sinus or central disease on ct or mri imaging.

Keywords: loss of smell olfaction hyposmia
d-serine treatment of negative symptoms and cognitive deficits in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study is based on the hypothesis that by increasing n-methyl-d-aspartic acid (nmda) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either d-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder exclusion * pregnant or lactating
validation of the fluid responsiveness index in critically ill patients

Conditions: Shock; Critically Ill

Summary: fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. by increasing cardiac preload, it aims at elevating cardiac output (co) and thus restoring hemodynamic conditions in patients who are preload responsive. by contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (ppv) and stroke volume variation (svv) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation. however, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration. a new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (fri), has been elaborated. the advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation. the fri is based upon the analysis of continuous arterial and continuous central venous pressure. the fri is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded. the aim of this study is to test the value of the fri to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hospitalization in an intensive care unit * presence of an acute circulatory failure as defined by the presence of at least one clinical sign of inadequate global perfusion * decision by the attending physician to give fluids will not be taken upon criteria predefined by the study protocol but considers: * systolic arterial pressure \< 90 mmhg (or fall of systolic arterial pressure of more than 50 mmhg in known hypertensive patients) * urinary flow \< 0.5 ml/kg/hr than two hours * tachycardia ≥ 100 beats/min * delayed capillary refill * mottled skin * high lactate * co (cardiac output) that is not considered adequate and * low gedv (global enddiastolic volume) * monitoring by a picco2™ device (pulsion medical systems, munich, germany) already in place as part of the routine hemodynamic monitoring exclusion criteria: * clinical evidence of pulmonary edema, hypervolemia or elwi \> 10 ml/kg
multiple ascending dose study to assess the safety profile of sar113244 versus placebo in lupus male and female patients

Conditions: Systemic Lupus Erythematosus

Summary: primary objective: to assess the tolerability and safety of sar113244 in male and female lupus patients after every 4 (q4) weeks repeated ascending subcutaneous doses of sar113244. secondary objectives: to assess in male and female lupus patients: * the pharmacokinetics of sar113244. * the pharmacodynamics of sar113244 for the following disease-related parameters: * safety of estrogens in lupus erythematosus national assessment - systemic lupus erythematosus disease activity index (selena-sledai) score, british isles lupus assessment group (bilag) score (if applicable), bilag-based composite lupus assessment (bicla) (if applicable), systemic lupus erythematosus responder index (sri) (if applicable), lupus-quality of life (qol) and functional assessment of chronic illness therapy (facit)-fatigue, anti-double stranded deoxyribonucleic acid antibody (anti-dsdna ab) and anti-nuclear antibody levels (ana) and plasma complement levels (c3, c4), erythrocyte sedimentation (sed) rate and c-reactive protein. * peripheral blood b and t cells subsets.

the total duration of screening to end of study per subject is 20 weeks with post-study observation on day 226 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).

Eligibility criteria:
inclusion criteria: * male or female patients, between 18 and 75 years of age, inclusive. * clinical diagnosis of systemic lupus erythematosus (sle) by american college rheumatology criteria. * autoantibody-posititve. * on active and stable sle disease. exclusion criteria: * pregnant and nursing. * have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, whichever is longer. * have received intravenous or oral cyclophosphamide within 180 days of day 0. severe active lupus nephritis or chronic renal insufficiency. * active or chronic, severe neuropsychiatric lupus. * acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection. * have current drug or alcohol abuse or dependence. * have a historically positive test or test postitive at screening for hiv, hepatitis b, or hepatitis c. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effectiveness of transcutaneous auricular vagus nerve stimulation in bruxism

Conditions: Bruxism

Summary: our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (tavns) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions.

our study was designed as a randomized, single-blind experimental clinical trial. it was planned to include 40 individuals diagnosed with bruxism in our research. outcome measurements and assessments will be performed immediately after the participants are recruited and at the end of the 8-week program. pain intensity, oral health quality of life, stress level and sleep quality will be assessed by self-report through questionnaires. pressure pain threshold and muscle activation for the masseter muscle and heart rate variables measurements will be performed by physiotherapists. after completing the initial evaluations, the participants will be randomly divided into two groups. an eight-week exercise program will be applied to the control group. in the tavns group, in addition to the eight-week exercise program, tavns will be used twice weekly for 16 sessions with the vagustim device.

Eligibility criteria:
inclusion criteria: * diagnosed with bruxism between the ages of 18-65, * a history of bruxism for at least 6 months, * individuals with masseter muscle pain gas≥4 at rest and during mastication exclusion criteria: * masseter botox application in the last 6 months, * regular use of analgesics and anti-inflammatories that affect the oss, * presence of infection or tumoral structures within intraoral structures, * wearing multiple ear piercings, * with tmj disc displacement and joint degeneration, * musculoskeletal problem with evidence of cervical or tmj fracture, systemic disease, specific pathologic condition, * any surgical operation related to a cervical or tmj problem, * less than 6 months of cervical or tmj-related physiotherapy and rehabilitation services, * the one with facial paralysis, * diagnosed psychiatric illness

Keywords: bruxism vagus stimulation parasympathetic
evaluation of the ease of use, preference, and safety of eutropinpen inj.

Conditions: Short Stature, Idiopathic; Infant, Small for Gestational Age; Growth Hormone Deficiency; Chronic Renal Failure; Turner Syndrome

Summary: the purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of eutropinpen inj. in patients pretreated with recombinant human growth hormone by reusable device.


Eligibility criteria:
inclusion criteria: * subjects who has been using reusable device growth hormone injection in recent 3 months at least for 6 weeks * subjects who meets the indication of eutropinpen inj. exclusion criteria: * subjects who has diseases below on screening visit * diabetes * malignant tumor * epiphyseal closure * chronic kidney disease (recieved kidney transplantation) * acute respitory failure
the impact of intermittent nutritional tube supplementation in elderly patients with dysphagia

Conditions: Dysphagia

Summary: this is a prospective, randomized controlled clinical trail involved elderly patients with dysphagia.the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding in elderly patients with dysphagia. the main questions it aims to answer: can intermittent nutritional tube supplementation help improve the nutritional status in elderly patients with dysphagia. participants will be divided into two groups randomly. all patients are given routine rehabilitation and the intervention group is given intermittent oro-esophageal tube feeding once a day.

the current situation of dysphagia in elderly individuals is characterized by difficulty or discomfort in swallowing. this condition can occur due to various factors such as muscle weakness, neurological disorders, or structural abnormalities in the throat or esophagus. dysphagia can lead to complications such as malnutrition, dehydration, aspiration pneumonia, and reduced quality of life. it is important for healthcare professionals to assess and manage dysphagia in elderly patients to ensure proper nutrition and prevent potential health risks. this is a prospective, randomized controlled clinical trail involved elderly patients with dysphagia.the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding in elderly patients with dysphagia. the main questions it aims to answer: can intermittent nutritional tube supplementation help improve the nutritional status in elderly patients with dysphagia. participants will be divided into two groups randomly. all patients are given routine rehabilitation and the intervention group is given intermittent oro-esophageal tube feeding once a day.

Eligibility criteria:
inclusion criteria: * age\>60 years. * dysphagia confirmed by videofluoroscopic swallowing study. * clear consciousness. * stable vital signs. exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study.