Kornimate/medical-research-clean huggingface dataset:
effects of ranolazine and exercise on daily physical activity trial

Conditions: Chronic Stable Angina

Summary: the primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. the study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (tdee) and angina-related quality of life.


Eligibility criteria:
inclusion criteria: * documented cad diagnosis * stable angina ≥ 3 months exclusion criteria: * class iii or iv heart failure * myocardial infarction or coronary revascularization procedure within 2 months * qt interval \> 500ms or prescribed medication known to prolong the qtc interval * contraindicated medications * metformin dose \> 1700mg/day * class ia, ic and iii anti-arrhythmics * cyp3a inhibitors * simvastatin \>20mg/day * severe renal disease (\< 30ml/min creatinine clearance) * currently on dialysis * lack of transportation to the exercise and testing facilities * implanted pacemaker that is not rate responsive
clinical evaluation of an approved contact lens

Conditions: Tear Film Characteristics

Summary: this is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid ph and tear film osmolarity in an fda-cleared contact lens in new contact lens users over a 14-day period.


Eligibility criteria:
inclusion criteria: 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. the subject must be between 18 and 45 years of age. 4. the subject must have a valid spectacle prescription with expiration date not over 1 year. 5. the subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 diopters (d) to -6.00 d in each eye. 6. the subject's refractive cylinder must be ≤1.00 cylindrical diopter (dc) in each eye. 7. the subject must have best corrected visual acuity of logmar 0.20 or better in each eye. 8. subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days. 9. the subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses. 10. the subject must have normal eyes (i.e. no ocular medications or infections of any type). exclusion criteria: 1. currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. use of any medication with known tear film effects within 2 weeks prior to and during the study. 5. entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.. 6. any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (prk), laser-assisted in situ keratomileusis (lasik), etc.) 7. any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the fda classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 8. any ocular infection. 9. any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. hiv) by self-report. 10. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 11. participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. 12. employee of investigational clinic (e.g. investigator, coordinator, technician).
evaluation of the diagnostic value of the tpd system in determining adhf causing acute dyspnea

Conditions: ADHF

Summary: the objective of this study is to evaluate lung doppler signals (lds) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate adhf causing dyspnea from any other cause i.e., non-adhf causes of dyspnea.

dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. it can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. a number of disorders cause dyspnea, including acute decompensated heart failure (adhf), chronic obstructive pulmonary disease (copd), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. the overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge. acute heart failure (ahf) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. patients presenting to the ed with adhf must be evaluated and treated rapidly to ensure the best possible outcomes. the diagnosis should be made as soon as possible and therapy initiated. delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. the key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests. previous studies showed that the tpd has the potential to differentiate between the cardiac cause of dyspnea and any other cause.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with acute onset dyspnea (defined as shortness of breath (sob) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration. * patients designated to undergo chest x-ray as part of standard of care assessment. exclusion criteria: * obvious trauma contributing to dyspnea * inability to provide written informed consent * not speaking english or spanish * right-sided lobectomy * patients with implanted ventricular assist device * patient is unable to undergo the tpd test * patient is already enrolled in a clinical study with experimental medications

Keywords: adhf dyspnea ed
closed-loop control of glucose levels (artificial pancreas) during exercise in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. a dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. the objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise. the investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.

closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. a dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. we aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. a moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (vo2max). a high intensity exercise will be 40 minutes of interval training. the interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of old. * clinical diagnosis of type 1 diabetes for at least one year. * the subject will have been on insulin pump therapy for at least 3 months. * last (less than 3 months) hba1c ≤ 12%. exclusion criteria: * clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. * recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * ongoing pregnancy. * severe hypoglycemic episode within two weeks of screening. * other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation). * failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc). * problems with venous access

Keywords: type 1 diabetes hypoglycemia insulin glucagon closed-loop system artificial pancreas
pilot study of bupropion for smoking cessation in postpartum non-breastfeeding women

Conditions: Tobacco Use Disorder

Summary: the purpose of this small preliminary study is to determine whether it is feasible to recruit women smokers who have just delivered a baby and are not breastfeeding into a study that would test whether starting bupropion, a smoking cessation medication, after a baby's birth helps a postpartum woman to stop smoking.

purpose: a pilot randomized double-blind placebo-controlled trial is testing the feasibility of conducting a full-scale trial of the efficacy of bupropion sr vs. placebo in non-breastfeeding postpartum women who smoked \>1 cigarette in the last month of pregnancy and want to stop smoking. the study will estimate achievable enrollment and retention rates; estimate the effect size of the drug on tobacco abstinence; assess the tolerability of bupropion in postpartum women; and allow refinement of recruitment, retention, intervention, and assessment protocols. research design: pilot double-blind placebo-controlled randomized clinical trial. study population: 40 postpartum women aged 18 years or older who smoked \> 1 cigarette in the last month of pregnancy, want to stop smoking, and are not breastfeeding. subjects will be recruited postpartum while hospitalized after delivery. intervention: bupropion sr (or matching placebo) for 8 weeks, starting immediately post-delivery. the dose is 150 mg qd for one week then 150 mg bid for 7 weeks. all subjects will receive behavioral counseling delivered face-to-face during the post-delivery hospitalization and by telephone 4 times over 8 weeks. outcome measures: (assessed at 2, 4, 8, and 12 weeks postpartum): 1. study eligibility, recruitment, and retention rates (primary outcome). 2. tobacco abstinence (7-day point prevalence nonsmoking by self-report and confirmed by saliva cotinine at 2 weeks, 8 weeks (end of drug treatment), and 12 weeks postpartum. 3. postpartum weight loss and symptoms of depression and anxiety. 4. tolerability of postpartum bupropion, assessed by medication adherence and adverse effects.

Eligibility criteria:
inclusion criteria: postpartum women who: * smoked \>1 cigarette in last month of pregnancy * deliver a baby at brigham and women's hospital in boston, ma * do not breastfeed or plan to breastfeed. * want to attempt to stop smoking exclusion criteria: * age \<18 years; * current use of bupropion or antidepressant; * current major depression or other severe psychiatric illness (e.g., schizophrenia, mania); * contraindication to use of bupropion; * illegal substance use in past 6 months; * \>1 drink/day of alcohol during pregnancy; * newborn with major congenital anomaly or \<25 weeks' gestation; * inability to speak or read english; * no telephone.

Keywords: tobacco use cessation bupropion zyban puerperium
energy expenditure & activity during & after exercise-induced weight loss

Conditions: Obesity

Summary: this project is aimed at determining whether an exercise-based weight loss intervention causes a compensation in some component of energy expenditure such that the increase in measured energy expenditure is less than the added exercise. the study will compare two separate exercise interventions to determine if this is influenced by exercise intensity.

the primary aim of this proposed study is to determine how total daily activity thermogenesis (tdat) and total daily energy expenditure (tdee) are regulated in obese humans attempting to lose weight and maintain weight loss through exercise. two exercise interventions will be compared; a structured aerobic exercise program and a walking program. exercise activity thermogenesis (eat) will be verified, and non-exercise physical activity (neat), total daily activity thermogenesis (tdat), and tdee will be measured using state-of-the-art technologies. subjects will be studied during a 6 month intervention period and then during a 6 month follow-up period. it is hypothesized that the walking program will have more favorable effects on tdat and tdee during both the intervention and follow-up periods. if the investigators hypotheses are correct, then data from the proposed study could be used to improve the effectiveness of exercise-based weight loss and weight loss maintenance programs.

Eligibility criteria:
inclusion criteria * body mass index (bmi) 30-35.0 kg/m2 * age 18-45 years * weight stable (\<2 kg weight fluctuation during previous 6 months) * no regular exercise (\> 1 bout of exercise/wk or participation in any sporting activities \> 1 hr/wk) * no self-report of acute or chronic disease (diabetes, heart diseases, and joint problems in particular) * no current use of prescribed medications * no plans to relocate within the next year * no plans for extended travel (\> 1 week) within the next 6 months * no tobacco use for females: * no evidence of amenorrhea (regular menstrual cycles of 21-35 days) * pre-menopausal status (self-report, to be confirmed during screening) * pregnancy or lactating within the past year * no pregnancy or planned pregnancies; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control. exclusion criteria: * claustrphobia; * any contraindication(s) to \> mri, e.g. aneurysm, cochlear implant, cardiac pacemaker, or implantable cardiac defibrillator, artificial heart valve, metallic stents, any implantable devices or shunt, weight less than 300 lbs; * left handed.
novel crown-cut biopsy needle (fnb) vs standard aspiration needle (fna) for eus-guided diagnosis of spls

Conditions: Pancreas Neoplasm; Pancreas Cancer

Summary: the aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (fnb) and a standard aspiration needle (fna) for eus-guided diagnosis of solid pancreatic lesions.


Eligibility criteria:
inclusion criteria: * adult patients with a newly discovered spl scheduled for eus-guided tissue acquisition who can understand and provide a written consent. exclusion criteria: * patients with uncorrected coagulopathies (inr \>1.5 or platelet count \<50,000) or patients treated with anticoagulants that cannot be discontinued. * pregnant or lactating females. * interposed, large vessels between the transducer and the target lesion.

Keywords: fine needle aspiration fine needle biopsy solid pancreatic lesion pancreatic neoplasm pancreatic cancer endoscopic ultrasound eus-fna eus-fnb
study to evaluate the effects of zemplar injection and calcijex on intestinal absorption of calcium

Conditions: Secondary Hyperparathyroidism; Chronic Kidney Disease

Summary: a study to investigate the effects of zemplar and calcijex on intestinal calcium absorption in hemodialysis subjects.


Eligibility criteria:
inclusion criteria * subject is ≥ 20 years of age. * subject is diagnosed with esrd, and must be on maintenance hemodialysis (hd) three times a week for at least 2 months prior to the screening phase and expected to remain on hd for the duration of the study. * if female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: * condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud) * contraceptives (oral or parenteral) for three months prior to study drug administration * in a monogamous relationship with a vasectomized partner * if female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase. * subject had an intact pth value \> 200 pg/ml. * serum calcium level \< 10.2 mg/dl at screening visit. * serum phosphorus level \< 6.5 mg/dl at screening visit. * ca´p product ≤ 65 at screening visit. * must voluntarily sign and date an informed consent, approved by an institutional review board (irb)/independent ethics committee (iec), prior to the conduct of any study-specific procedure exclusion criteria * subject has a history of an allergic reaction or significant sensitivity to vitamin d or vitamin d related compounds. * subject has chronic gastrointestinal disease, which in the investigator's opinion, may result in clinically significant gi malabsorption. * liver function defects defined as \> 2 times the upper limit of normal for liver enzyme or \> 1.5 times the upper limit of normal coagulation levels. * subject is taking maintenance calcitonin, glucocorticoids in an equivalent dose \> 5 mg prednisone, or other drugs that may affect calcium or bone metabolism, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy. * for any reason, subject is considered by the investigator to be an unsuitable candidate to receive pharmacological doses of vitamin d. * subject has received any investigational drug within 4 weeks prior to the treatment phase.

Keywords: secondary hyperparathyroidism
a study of lumigan® 0.01% in patients with primary open angle glaucoma (poag) or ocular hypertension (oht)

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: a study of lumigan® 0.01% as administered in standard practice for patients with poag or oht. all treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.


Eligibility criteria:
inclusion criteria: * diagnosis of poag or oht * prescribed lumigan® 0.01% exclusion criteria: * none
role of psychiatric profile in prehabituated patients after vestibular schwannoma surgery

Conditions: Vestibular Schwannoma; Vestibular Function Disorder

Summary: the aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.


Eligibility criteria:
inclusion criteria: * t3, t4 vestibular schwannoma * recorded growth of a tumour * hearing loss greater than 50% in pta exclusion criteria: * t1 vestibular schwannomas * no growth progression * normal hearing
neuropathic pain syndrome patient study (mk-0000-072)

Conditions: Neuralgia, Postherpetic; Diabetic Neuropathy; Painful Small-Fiber Neuropathy; Idiopathic Distal Sensory Polyneuropathy

Summary: the purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). this study will see if generic pregabalin has any effect on neuropathic pain.


Eligibility criteria:
inclusion criteria: * patient has moderate to severe nerve pain due to one of the following conditions: postherpetic neuralgia, painful diabetic neuropathy, small fiber neuropathy or idiopathic distal sensory polyneuropathy * patient is able to complete questionnaires in either english or spanish * patient is at least 18 years of age exclusion criteria: * patient is either pregnant or breastfeeding * patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling) * patient has a history of congestive heart failure * patient has a seizure disorder * patient has a history of drug and/or alcohol abuse within the past 1 year * patient failed treatment due to lack of pain relief with more than three drugs for nerve pain * patient has had cancer (except basal cell carcinoma) within the past two years * patient anticipates the need for surgery while participating in the study * patient has a reported history of hepatitis b, c, or hiv infection * patient has another type of pain that is more painful than the nerve pain * patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder * patient is involved in litigation or receives worker's compensation related to nerve pain