Kornimate/medical-research-clean huggingface dataset:
bdp/ff versus formoterol fumarate (ff) in patients with severe copd (lung function and exacerbation rate)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

Eligibility criteria:
inclusion criteria: * severe copd * at least one copd exacerbation in previous year exclusion criteria: * asthma, allergic rhinitis or other atopic disease * unstable concurrent disease: * evidence of heart failure
"smart-fm": smart-phone based digital therapeutic for management of fibromyalgia

Conditions: Fibromyalgia

Summary: this is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. the primary endpoint is mean change from baseline to week 12 in the weekly revised fibromyalgia impact questionnaire (fiq-r) total score.


Eligibility criteria:
key inclusion criteria: 1. subject is 22 to 75 years of age, inclusive 2. subject has a diagnosis of primary fm as defined by the 2016 american college of rheumatology preliminary diagnostic criteria for fm, which requires satisfaction of the following criteria: 1. widespread pain index (wpi) ≥7 and symptom severity (ss) scale score ≥5, or wpi 4-6 and ss scale score ≥9; 2. symptoms have been present at a similar level for at least 3 months; 3. pain must be present in at least 4 out of 5 body regions 3. subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. 4. subject is capable of reading and understanding english and has provided written informed consent to participate. key exclusion criteria: 1. lifetime history of bipolar disorder as assessed by the mini. 2. current, untreated, major depressive episode and/or anxiety disorders as assessed by the mini. 3. subject has a bdi-ii total score \> 25 at either the screening appointment or baseline appointment. 4. the subject is at increased risk of suicide on the basis of the investigator's judgment, a response \> 1 to bdi item #9, or the results of the columbia-suicide severity rating scale ("c-ssrs") conducted at screening or baseline (i.e., any suicidal behavior during the preceding year or c-ssrs type 3, 4, or 5 suicidal ideation during the preceding year). 5. subject has any other disease or medical condition that, in the opinion of the investigator or sponsor, could endanger the subject, interfere with the evaluation of the study device's efficacy or safety, or compromise the subject's ability to comply with/complete the study.
impact of clomiphene citrate administration during the early luteal phase on endocrine profile in ivf cycles

Conditions: Female Infertility

Summary: the purpose of this study is to evaluate the effect on lh levels of the 5-day cc administration during luteal phase in oocyte donors, to investigate whether the cc corrects the suppressed lh levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.


Eligibility criteria:
inclusion criteria: * oocyte donors * 18-35 years old * bmi 18-29 kg/m2 * normal basal hormonal levels * no contraceptive pill exclusion criteria: * polycystic ovarian syndrome (pcos) * previous participation in the study
interventions in nutrition education and skills

Conditions: Obesity

Summary: healthy eating can be difficult for people who live in poor, geographically isolated regions of the united states. in particular, people who live in appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. this pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability

participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (mi) conducted by a trained registered nurse. three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). all participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. the investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.

Eligibility criteria:
inclusion criteria: • people who live in one of six rural kentucky food desert counties exclusion criteria: * \<16 years old * unable to read/write english * any gi malabsorption disorder that prevents high fiber consumption
vascular response to isoproterenol and β2 adrenergic receptor polymorphisms

Conditions: Coronary Disease

Summary: single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic receptor (ß2ar) modify its pharmacological properties and may alter the response to ß2ar agonists. the goal of the present study was to evaluate the role played by the arg16gly and gln27glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries segments ex-vivo. internal mammary leftover segments were collected from 96 patients undergoing coronary artery bypass graft operation. four rings that were prepared from each specimen were allowed to reach equilibrium with physiological krebs solution prior to precontraction with u46619. using the organ bath technique, cumulative dose response curve of isoproterenol was constructed and mean ec50 calculated for each patient.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo coronary artery bypass graft operation exclusion criteria: * chronic treatment with corticosteroids
bioglue as an adjunct for structural repair and hemostasis in chinese acute type a aortic dissections patients

Conditions: Type A Aortic Dissection

Summary: a multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of bioglue as an adjunct for structural repair and hemostasis to traditional surgical repair in chinese subject with acute type a aortic dissections.

a multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of bioglue as an adjunct for structural repair and hemostasis in chinese subjects with acute type a aortic dissection. the trial consists of three phases: phase one - a non-randomized, lead-in phase. during the lead-in phase, the first 2-3 eligible subjects at each center will receive bioglue in open surgery. these subjects will be evaluated for safety separately from the randomized phase of the trial. phase two - a randomized, controlled phase. type a aortic dissection subjects will be randomized into tsr group (control group) and surgical repair with bioglue group (test group) with a ratio of 1:1, so that equal number of subjects in test and control groups can be ensured. phase three - a follow-up of late safety outcomes of using bioglue in "the china trial" . subjects enrolled in "the china trial," from both the bioglue and the control (tsr) group, will be invited to participate. clinical data evaluating mortality, adverse events, and re-operation rates will be collected from subject's medical charts.

Eligibility criteria:
inclusion criteria: * male or female subjects 18-70 years of age. * subject has a confirmed diagnosis of acute type a aortic dissection with subtype a2. * subject is willing and able to give written consent for the trial. if the subject is unconscious or under the influence of medications which render him or her unable to give fully informed consent, a guardian may provide informed consent for the subject regarding trial participation. exclusion criteria: * subjects with known allergy to albumin, bovine products, or glutaraldehyde. * subjects who have been treated with an investigational product who have not completed the entire follow-up period. * subjects who do not meet the eligibility criteria, including those who do not wish to participate or give informed consent for trial participation, will not be enrolled into the trial, and will be offered equivalent, non-trial surgical or other treatment, as judged appropriate by the investigator. * subjects with previous cardiac and aortic surgery. * end stage malperfusion syndromes (i.e. end-organ failure such as coma, paraplegia, hemiplegia, intestinal necrosis, or hepatic failure). * subjects with marfan syndrome or other connective tissue disorders. * previous chronic dissections resulting from non-cardiac surgery and/or trauma. * concomitant surgery of valve replacement (both in screening and intraoperative).

Keywords: bioglue surgical adhesive type a aortic dissection
empiric versus selective prevention strategies for kidney stone disease

Conditions: Kidney Stones; Nephrolithiasis

Summary: the aims of this study are to 1) conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) determine adverse effects from, and adherence to selective and empiric strategies.

diet and pharmacologic interventions for preventing future kidney stone episodes are effective, however clinical guideline panels disagree on whether clinicians should perform selective therapy: performing 24-hour urine testing to guide choosing interventions to correct abnormal urinary parameters. the alternative strategy is empiric therapy: applying interventions without 24-hour urine testing. while 24-hour urine testing is considered the standard of care by nephrology and urology specialties for higher risk patients, the american college of physicians does not recommend 24-hour urine testing. this is a randomized clinical trial of selective versus empiric therapy for patients with presumed idiopathic calcium stone disease, representing \>80% of the kidney stone population. the primary outcome is change in urinary supersaturation, which associates with symptomatic stone recurrence. we will recruit patients with presumed idiopathic calcium stone disease with at least 2 stone events within the previous 5 years. participants will be randomly assigned to empiric diet plus thiazide with potassium citrate daily, or to selective diet plus pharmacologic therapy based on the 24-hour urine abnormalities identified at baseline and adjusted during follow-up. the primary outcomes will be the calculated calcium oxalate and calcium phosphate supersaturations. in addition, we will determine adverse effects from, and adherence to, selective and empiric strategies.

Eligibility criteria:
inclusion criteria: * two or more symptomatic kidney stone events in the last 5 years * adult exclusion criteria: * medullary sponge kidney or renal tubular acidosis * untreated urinary obstruction * primary hyperparathyroidism * primary hyperoxaluria * pregnancy * inflammatory bowel disease or bowel resection * sarcoidosis * cystinuria * prior stone composition with uric acid, struvite, cystine, carbonate apatite * use of specific medications (thiazides, topiramate, xanthine oxidase inhibitors, citrate, bicarbonate) * chronic kidney disease stage 3 or higher (egfr\<60) * gouty arthritis or 3 gout episodes in 1 year * known allergy to study medications * hypokalemia or hyponatremia at screening. * age \< 18 years

Keywords: prevention
personalized, predictive, precise & preventive medicine for major depression

Conditions: Major Depressive Disorder; Persistent Depressive Disorder

Summary: depressive disorders are among the most common psychiatric disorders. however, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. within the framework of the p4d study, 1000 patients with depression will be comprehensively examined. in addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural mri, eeg) are used to assess brain structure and function. in addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). drug level measurements are also performed. the goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. these findings could be used to individualize and improve therapy for depressive disorders.


Eligibility criteria:
inclusion criteria: * mdd: icd-10: f32.1-3, f33.1-3 first or recurrent depressive episode (confirmed by mini-dips) and/or pdd: f34.1 * symptom severity: moderate to severe (madrs ≥ 20). * first depressive episode before 50 years of age * signed informed consent form * capacity to consent exclusion criteria: * acute suicidality * placement according to state law (e.g. §16/17 nds. psychkg) * the following diagnoses in the life course: dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification * concurrent participation in other clinical trials that are not being conducted within the framework of the p4d project
a pilot study of a contact force catheter for pulmonary vein antrum isolation

Conditions: Atrial Fibrillation; Burden of Atrial Fibrillation

Summary: the knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.

a randomized controlled study comparing pulmonary vein antrum isolation with and without the knowledge of the real-time contact force. in both groups, a catheter, which is able to measure contact force (smarttouch, thermocool catheter, biosense webster) will be used. in the control group, the operator will be blinded to the measured contact-force. in all patients, the ablation will be guided by a circumferential mapping catheter (lasso, biosense webster), carto 3 mapping system and ablation of adenosine-induced reconnection will be performed in all patients. follow-up will be performed by continuous monitoring using an implantable loop recorder (reveal xt, medtronic inc, minneapolis, minn)

Eligibility criteria:
inclusion criteria: * patients \<75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included. * patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included exclusion criteria: * contraindication to anticoagulation treatment with vitamin k antagonists amiodarone therapy expected surgery for structural heart disease within the follow-up period significant mitral valve disease nyha iii-iv left ventricular ejection fraction \ 5 cm secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) age \< 18 years

Keywords: contact force catheter loop recorder
gabapentin for alcohol relapse prevention

Conditions: Alcohol Use Disorder; Alcohol Withdrawal

Summary: this treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. it is a "sugar pill").

this treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. it is a "sugar pill"). this study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. upon enrollment into this study there will be 11 outpatient visits. each visit will last about 1-1.5 hours.

Eligibility criteria:
inclusion criteria: 1. meets criteria for alcohol use disorder based on dsm-5 criteria 2. meets criteria for history of alcohol withdrawal based on dsm-5 criteria 3. able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine etg, and breathalyzer. exclusion criteria: 1. significant psychiatric or medical illness 2. no other substance abuse 3. taking other medications known to treat alcohol use disorder 4. unstable living arrangements 5. significant legal problems pending
study on the effect mechanism of acupuncture combined with swallowing training in oral dysphagia of stroke

Conditions: Dysphagia; Stroke; Oral Phase

Summary: up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral dysphagia. the oral phase is the initial phase of swallowing activity and the only stage of swallowing that is completely discretionary. swallowing activity in the oral stage is not only related to the formation and push of food pellets, but also affects the continuity between the transition from spontaneous swallowing to the swallowing reflex.

after stroke, patients are prone to oral dysphagia, poor control of food masses and liquids in the mouth, resulting in food spillover, residual and premature overflow, resulting in dehydration, malnutrition, aspiration, pneumonia and other serious consequences, which greatly reduce the eating safety and quality of life of patients after stroke. therefore, the rehabilitation of oral swallowing function is a way for patients with swallowing disorder after stroke to return to society and improve their quality of life. previous studies have found that acupuncture is an effective intervention to improve swallowing disorder in oral stage after stroke. whether acupuncture promotes the improvement of swallowing function in oral stage by regulating the synergic activity of cortical swallowing network and muscle group has not been fully clarified.

Eligibility criteria:
inclusion criteria: 1. patients meeting the diagnostic criteria for acute ischemic stroke established by the neurology society of the chinese medical association and confirmed by craniocerebral ct or mri; 2. oral dysphagia caused by stroke; 3. currently diet is restricted, fois score is 5 or less; wst score 3 or above; 4. moca score of 21 or above, able to understand and follow simple instructions from the treatment staff, able to cooperate and willing to undergo examination and treatment; 5. 40 to 75 years old; 6. conscious and stable vital signs; 7. convalescent patients with stroke course and dysphagia duration between 1-6 months; 8. voluntary participation and informed consent. exclusion criteria: 1. patients with dysphagia not caused by stroke or non-stroke oral dysphagia; 2. previous history of stroke or dysphagia; 3. patients with serious primary diseases or mental disorders of other systems; 4. suffering from various bleeding prone diseases; 5. severe needle fainting; 6. people with metal implants. 7. patients with poor compliance are not treated as prescribed

Keywords: dysphagia stroke cortical swallowing network oral phase
a study to evaluate ckd-701 and lucentis® in patients with neovascular(wet) age related macular degeneration

Conditions: Neovascular(Wet) Age Related Macular Degeneration

Summary: this is a multicenter, randomized, double-blind, active-controlled, parallel group, phase iii clinical trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of ckd-701 and lucentis® in patients with neovascular(wet) age related macular degeneration

subjects will be randomised in a 1:1 ratio to receive either ckd-701 or lucentis®. investigational products (ip) (ckd-701 or lucentis®) will be administered once a month during the loading phase(the first three months), and for the next nine months(prn phase), administion will be determined based on the prn administration criteria.

Eligibility criteria:
inclusion criteria: 1. age ≥50 years 2. presence in the study eye of active subfoveal cnv lesion due to amd 3. the total lesion size ≤ 12 da in the study eye 4. the presence of cnv foci of more than 50% of the total lesion area in the study eye 5. the best-corrected visual acuity within a range from 78 to 34 letters (20/32\~20/200) measured using the etdrs chart in the study eye 6. written informed consent exclusion criteria: 1. any previous anti-vascular endothelial growth factor(anti-vegf) treatment to treat neovascular amd 2. presence of eye-related inflammation or infection, such as infectious ophthalmitis, corneal inflammation, conjunctivitis (including scleromalacia), endocular inflammation 3. any history or clinical basis of disease affecting the retina except age-related macular degeneration(amd), such as diabetic retinopathy, diabetic macular edema 4. presence of cnv in either eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks retinopathy or pathologic myopia 5. patients with macular abnormalities other than age-related macular degeneration (amd)

Keywords: neovascular(wet) age related macular degeneration ckd-701
individualized neurodevelopmental treatment

Conditions: Cerebral Palsy

Summary: the purpose of the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data.

the intervention lasted 6 weeks. there were 3 sessions per week. at each session there was a part of standard physical therapy program and there was also a part with emphasis on dynamic balance exercises.

Eligibility criteria:
inclusion criteria: * spastic tetraplegia exclusion criteria: * vision problems
effect of vascuactive device on foot perfusion, hemodynamics and exercise capacity in patients with pvd & limb ischemia

Conditions: Peripheral Vascular Diseases

Summary: the purpose of this study is to assess the safety and the immediate effect of the vascuactive device on patients with peripheral vascular disease and limb ischemia.


Eligibility criteria:
inclusion criteria: * leg ischemia, fontaine grade iia and iib, i.e.: pain free walking distance in the range of 50 - 100 meters. * absent pulses in the two foot arteries (anterior tibial a., posterior tibial a.) * abi \< 0.7 by doppler, in at least one of the two foot arteries exclusion criteria: * absent femoral pulses * venous insufficiency by duplex * pregnancy * infectious disease * malignant disease * severe cardiac disease, e.g., chf grade 3 or higher * acute mi within last 3 months * cabg within last 3 months * other severe systemic disease