Kornimate/medical-research-clean huggingface dataset:
giving a low carbohydrate diet to overcome hypertension

Conditions: Hypertension; African Americans; Diet, Carbohydrate-Restricted; Risk Reduction Behavior

Summary: this study will test the preliminary efficacy of adding a very low carbohydrate dietary intervention to the evidence-based dpp-glb on blood pressure reductions for lower-income aa men and women in a community-based clinic.

this study will evaluate the effects of consuming a very low carbohydrate (vlc) diet in a sustainable community care setting, in addition to routine medical care, to african american (aa) with pre-hypertension, hypertension (stage 1-3), or cardiovascular disease risk factors. this study will also secondarily assess the feasibility of following a vlc diet in a low-income, aa population.

Eligibility criteria:
inclusion criteria: * 1) men and women aged ≥ 18 years * 2) willingness to participate in a 10-month study * 3) systolic blood pressure \> 120 mm/hg +/- diastolic blood pressure \> 80 mm/hg * 4) african american race exclusion criteria: * 1) diagnosed congestive heart failure * 2) hypertension stage 4 or higher (e.g., sbp \>180 mm/hg; dbp \> 110 mm/hg) * 3) received or needing more than 3 anti-hypertensive medications * 4) pregnant or planning to become pregnant * 5) receiving or needing a heart transplant * 6) using injected long or short-acting insulin for diabetes treatment * 7) not african american race * 8) unable to speak and read english with fluency

Keywords: hypertension low carbohydrate diet african american race cardiovascular disease risk weight loss
liothyronine in children with single ventricle congenital cardiac malformations undergoing the fontan procedure

Conditions: Tricuspid Atresia; Heart Defects, Congenital

Summary: objectives: i. determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified fontan procedure. ii. determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified fontan procedure. iii. evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified fontan procedure.

protocol outline: this is a randomized, placebo controlled, dose escalation study. initially, patients are randomized to receive either 1 of 3 different dosages of liothyronine or placebo after undergoing the fontan procedure. if no unacceptable toxicity is observed in this group, a third dose level of liothyronine is added to the randomization. a total of 7 patients are enrolled at each dose level. all randomized study drugs are administered by continuous infusion over 1 hour after surgery. cardiac function is assessed 5 days after surgery.

Eligibility criteria:
* single ventricle congenital cardiac malformation * must undergo modified fontan procedure * no concurrent medications known to interfere with thyroid metabolism including propranolol and amiodarone * no hepatic dysfunction * no renal dysfunction * no pre-existing thyroid dysfunction

Keywords: cardiovascular and respiratory diseases heart defects rare disease
effects of guided written disclosure protocol on psychological distress and positive functioning in persons with skin diseases: a randomized-controlled trial

Conditions: Psychological Distress; Emotional Stress; Skin Diseases; Disclosure

Summary: we conducted a randomized-controlled trial of guided written disclosure protocol for dermatological patients with the aim of reducing psychological distress, expressive suppression, and skin-related symptoms, and improving spiritual well-being, cognitive reappraisal, and sense of coherence.

sample size assessment: a recent meta-analysis reported a study which showed that guided written disclosure protocol reach on effect size of 0.89 on psychosocial outcomes (gidron et al., 2002; mogk et al., 2006). power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 34 participants to detect effect sizes of 0.89 and higher. plan for missing data: occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced. statistical analysis plan: we conducted a 2 (group) x 2 (time \[pre-treatment vs. post-treatment\]) repeated measures multivariate analysis of variance (manova) for a set of variables.

Eligibility criteria:
inclusion criteria: * age over 18 years; * diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist. exclusion criteria: * patients with certified mental disorders (e.g., psychotic illness, major depressive disorder) * patients undergoing psychotherapy for at least 6 months in the last 3 years; * patients who currently receive psychopharmacological treatment.

Keywords: dermatology guided writing disclosure protocol psychological distress positive psychology randomized-controlled trial
laser treatment of basal cell carcinoma under imaging guidance

Conditions: Carcinoma, Basal Cell

Summary: this pilot study will examine the treatment of basal cell carcinoma (bcc) with laser technology under the guidance of imaging modalities to assist with surgical excision, including optical coherence tomography imaging (oct) and reflectance confocal microscopy (rcm). the laser modality that we plan to use is the long-pulse nd:yag 1064nm laser, which is a nonablative laser already shown to effectively treat bcc. the addition of oct and rcm has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. oct is being used to enhance the effectiveness of mohs micrographic surgery of these cancers by elucidating more definitive tumor margins. rcm has been shown to detect changes in the composition of cells consistent with bcc. we propose to use these imaging devices to guide the laser treatment to achieve optimal efficacy with minimized side-effects. primary outcome measured include complete clearance of the bcc lesion, which will be determined through clinical examination, dermoscopy, imaging (oct and/or rcm), and saucerization biopsy. secondary outcome variables include the significance of lesion depth (by oct and/or rcm), lateral extent (by oct and/or rcm), bcc type, and anatomical region on rate of clearance and recurrence.


Eligibility criteria:
inclusion criteria: * age 18 or older * at least one (1) biopsy-proven superficial or nodular bcc, less than or equal to 2.0 cm in largest dimension * willing to have photographs taken of the treatment area * ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative exclusion criteria: * pregnancy * patients with a bcc lesion that requires excision. this would include relatively large lesions (greater than or equal to \>2.0 cm diameter), lesions that penetrate deep into the skin beyond the depth of the oct image capture, high risk lesions as defined by the american academy of dermatology as recurrent and sclerosing subtype bcc, or metastases. * subjects unable to follow-up for the full 12 months * subjects not willing to have biopsy taken from the treatment area * subjects with herpes simplex virus infection in treatment areas.

Keywords: optical coherence tomography, reflectance confocal microscopy
study to investigate the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination for 12 weeks in subjects with chronic genotype 1 and 4 hcv infection with autoimmune disease

Conditions: Chronic Hepatitis C

Summary: this study is evaluating the safety and efficacy of a 12 week treatment ldv/sof fdc in patients with chronic gt1 or gt4 hcv infection and autoimmune disease


Eligibility criteria:
inclusion criteria: * chronic gt1 or gt4 hcv infection * diagnosed with autoimmune disease (rheumatoid arthritis, psoriatic arthritis, lupus, etc.) and is currently receiving treatment for the condition. exclusion criteria: * infection with hiv or hbv
effects on plantar support after deep dry needling in posterior tibial muscle

Conditions: Movement Disorders

Summary: this study aims to analyze the changes in plantar support after the technique of deep dry puncture in the posterior tibial. the data will be analyzed by a baropodometer which will record the possible changes in the footprint. the investigator will perform a pre-intervention measurement and 3 post-intervention measurements (immediately after the intervention, at 24 hours and at 72 hours)


Eligibility criteria:
inclusion criteria: * presence of myofascial trigger point in the posterior tibialis * accept participation in the study (signature of informed consent) * do not present any exclusion criteria exclusion criteria: * do not present myofascial trigger point in the tibialis posterior. * suffering and / or having suffered from lower limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics. * not clearly identify the myofascial trigger point in the tibialis posterior. * have been diagnosed with fibromyalgia, myelopathy or radiculopathy. * having contraindicated the technique of dry needling for suffering, for example, coagulation problems. * be pregnant. * have used analgesics 24 hours before participating in the study.
role of absolute cerebral oximetry to prevent neurocognitive injury in elderly patients undergoing cardiac surgery

Conditions: Post-Operative Delirium; Postoperative Cognitive Dysfunction

Summary: the purpose of this study is to determine whether brain oxygenation measured by cerebral oximeter has an impact on neurocognitive dysfunction.

both postoperative delirium (pd) and postoperative cognitive dysfunction (pocd) are well known complications seen in elderly patients after cardiac surgery. the etiologies of pd and pocd are unknown, but cerebral ischemia remains a prime candidate. attempts to correlate reduced levels of systemic oxygenation (i.e. spo2) with the development of pd/pocd have been to date disappointing. we believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (scto2), will enable us to answer the question of whether or not a correlation exists. the availability of an absolute cerebral oximeter (fore-sight), with its ability to establish and manipulate threshold values for scto2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications. we propose a randomized, masked trial of 120 patients, adequately powered to assess the following: * is there an association between deficits in cerebral oxygenation and the occurrence of pd at some time in the 1st 5 days after the operation? * is there an association between deficits in cerebral oxygenation and changes in pocd scores shortly (5 days) after the operation and/or 4-6 weeks later? we hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain scto2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: * 65 and older * elective cardiac or thoracic aortic surgery * capable and willing to consent * participants literate in english exclusion criteria: * emergency surgery * major neurological disease * gross cognitive dysfunction * patients not expected to be able to complete the 1 week and 3 months post-operative visit.

Keywords: pd pocd post-op delirium (pd) post-op cognitive dysfunction (pocd)
entospletinib (ento) as monotherapy and in combination with chemotherapy in japanese adults

Conditions: Hematologic Malignancy; Acute Myeloid Leukemia

Summary: the primary objective of this study is to evaluate the safety and tolerability of entospletinib (ento) monotherapy and in combination with chemotherapy in japanese participants.


Eligibility criteria:
key inclusion criteria: * ento monotherapy (group a): relapsed or refractory hematologic malignancies by world health organisation (who) criteria and who are not eligible to receive standard of care * ento + cytarabine + daunorubicin (group b): previously untreated aml by who criteria, who are deemed fit for cytarabine and daunorubicin (7+3) induction chemotherapy and are able to undergo up to 2 cycles of induction chemotherapy, as determined by the treating physician * must have been born in japan and must not have lived outside of japan for a period \> 1 year in the 5 years prior to day 1 of study treatment * must be able to confirm the japanese origin of their maternal and paternal ancestry key exclusion criteria: * known active central nervous system or leptomeningeal leukemic involvement * ongoing liver injury, or known infection with chronic active hepatitis c virus (hcv) or chronic active hepatitis b virus (hbv) note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: relapsed or refractory hematologic malignancy previously untreated aml
the effect of rebamipide for non-steroidal anti-inflammatory drugs (nsaid) - induced small-intestinal injuries

Conditions: NSAIDs-induced Small-intestinal Injuries

Summary: the purpose of this study is to evaluate the efficacy of rebamipide for nsaid-induced small-intestinal injuries.


Eligibility criteria:
inclusion criteria: * written informed consent * 20 to 85 years of age * ra, oa, or low back pain * no change of drugs before 3 months * under 5 mg of corticosteroid use * crp \< 1mg/dl * small-intestinal mucosal injuries more than one * hemoglobin level is below normal range exclusion criteria: * known or suspected small-bowel disease, including crohn's disease and seronegative arthritis * prostaglandins, metronidazole or salazosulfapyridine * can not swallow * eith pacemaker * after gastrointestinal operation * serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease. * taking rebamipide before one week * any other conditions that the investigator feels would interfere with data interpretation or create under risk.
the efficacy of cilostazol on ischemic complications after des implantation

Conditions: Coronary Artery Disease

Summary: objectives : * to evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation study design : prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. patients will be randomized according to the use of cilostazol patient enrollment: 960 patients enrolled at 5 centers in korea patient follow-up : clinical follow-up will occur at 1, 3 and 6 months. angiographic follow-up will be recommended to all patient at 6 months after index procedure. primary endpoint * composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months secondary endpoint * all cause of death, stent thrombosis, and each component of primary endpoint at six months * pru level measured at discharge after the index procedure and after six months safety endpoint * bleeding complications according to timi criteria * the incidence of drug discontinuation * heart rate

stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed

Eligibility criteria:
inclusion criteria: * subject must be at leat 18 years of age * subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * subject must have significant coronary artery stenosis (\>50% by visual estimate) * subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ecg) consistent with ischemia. in subjects with coronary artery stenosis\>75%, evidence of myocardial ischemia does not have to be documented. * coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents. exclusion criteria: * subject who undergoes primary percutaneous coronary intervention due to acute st elevation myocardial infarction * subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol) * subject who has thrombocytopenia (\<120,000/ul) * subject who has liver cirrhosis (child class b or c) * subject who is on the anticoagulation therapy * subject who has severe congestive heart failure (left ventricular ejection fraction \<30%)

Keywords: cilostazol clopidogrel statin drug-eluting stent
sub-tenon's injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery

Conditions: Inflammation; Bacterial Infections

Summary: the purpose of this study is to compare one intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery.

topical steroids effectively control ocular inflammation, but are associated with the well-recognized problems of patient compliance. injection of depot corticosteroids into sub-tenon's capsule is an established method of treating various ocular inflammatory diseases. its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation. the use of topical antibiotic agents poses unique and challenging hurdles for drug delivery, especially because recent reports have suggested that the incidence of endophthalmitis may be increasing. exploiting the permeability of the sclera, subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes. in theory, the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives, i.e., eliminate topical medications, enhance patient compliance, improve drug bioavailability, and protect the patient from infection.

Eligibility criteria:
inclusion criteria: * patients with uncomplicated, senile cataract * best-corrected visual acuity (va) of 20/100 or better in the fellow eye exclusion criteria: * patients in use of oral or topical anti-inflammatory agents * history of steroid-induced ocular hypertension * hypermature cataracts * previous ocular surgery * preexisting uveitis * diabetic retinopathy * glaucoma * corneal disease

Keywords: cataract endophthalmitis antibiotics anti-inflammatory agents drug delivery systems
effect of magnesium sulphate infusion on lung mechanics and oxygenation in copd patients undergoing total laryngeal

Conditions: Chronic Obstructive Pulmonary Diseases

Summary: chronic obstructive pulmonary disease \[copd\] is a major cause of chronic morbidity and mortality worldwide. copd is characterized by persistent progressive airflow limitation that adversely affects the ventilation/perfusion (v/q) matching and mechanics of the respiratory muscles and leads to hypoventilation and reduced gas transfer. copd was identified as a significant comorbidity associated with increased incidences of postoperative pulmonary complications and prolonged hospital stay. mgso4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. mgso4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. administration of mgso4 in patients with stable copd was associated with reduced lung hyperinflation and improvement of respiratory muscle strength. this randomized control trial is designed to assess the effect of intravenous mgso4 infusion on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications and length of hospital stay in patients with copd undergoing cancer larynx surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing cancer larynx surgery (partial laryngectomy, total laryngectomy with or without neck dissection). * age more than 40 years old * asa physical status ii and iii. * diagnosed as having copd by preoperative spirometry. the classification is bases on the post-bronchodilators forced expiratory volume in the first second (fev1). mild copd is diagnosed when fev1 is \> 80% of predicted while moderate copd is diagnosed when fev1 is \ 50% of predicted and sever copd is diagnosed when fev1 is \ 30% of predicted exclusion criteria: * o patients with heart failure. * history with arrhythmias or treatment with antiarrhythmic drugs. * patient with heart block or on beta blockers or calcium channel blockers. * patients with impaired renal function (creatinine \> 2) * patients with impaired liver function (alt more than 2 folds). * patient with combined restrictive and obstructive pulmonary disease. * patients with preoperative tracheostomy. * patients with huge mass obstructing \> 50% of the view. (due to its influence on the spirometry measurements).

Keywords: magnesium sulphate, chronic obstructive pulmonary diseases
post-marketing study for the evaluation of profilm cold sores

Conditions: Cold Sores

Summary: experimental clinical study with a post-marketing, prospective, intra-subject controlled design to evaluate the efficacy and safety of the use of a medical device for the treatment of cold sores, over a maximum period of two weeks (or until the outbreak has resolved).


Eligibility criteria:
nclusion criteria: * male / female / aged 18 years or older. * presence of a herpes labial outbreak, regardless of the number of days since its appearance. * at least 30 days have passed since the last episode. * willingness to return for all study-related visits. * sufficient willingness and ability, as judged by the investigator, to respond to the questionnaires included in the study. exclusion criteria: * pregnant women or women in the breastfeeding period. * patients undergoing treatment with antiviral medications, hydrocortisone, or other medications. * patients with immunodeficiency diseases, such as acquired immunodeficiency syndrome or altered immune activity in the last 7 days. * patients undergoing other pharmacological therapy forrecurrent herpes labial. * patients with other oral mucosa diseases simultaneously. * known allergy or hypersensitivity to any of the components.

Keywords: herpes oral herpes simplex oral ulcer