Kornimate/medical-research-clean huggingface dataset:
transient ecg changes in patients with acute biliary disease

Conditions: Acute Cholecystitis; Biliary Colic; Acute Cholangitis

Summary: background: the importance of ischemic ecg changes including st segment elevation, st segment depression or t wave inversion that indicate myocardial ischemia are well established and require appropriate investigation and treatment. however, there is an abundance of clinical situation, with apparently ischemic ecg change not indicate traditionally coronary artery related ischemia and therefore require prompt recognition and treatment of underlying condition, that may be serious and life-threatened. for example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte abnormalities, intracranial hemorrhage and hypothermia. together with them, an ecg st segment changes may appeared in abdominal serious illness such as pancreatitis and cholecystitis(17,18,19,20,23). whereas in pancreatitis various vasoactive and toxic for myocardium substances released, the cause of st segment changes in cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma rennin activity resulted by distension of the gallbladder. the certain proportion of the patients with ecg changes actually didn't have coronary artery disease(9,15) or other acute cardiac condition and therefore require treatment of the underlie illness only without spend the time for cardiac investigation or special treatment(1,3,4,7,8). some kind of treatment may be even harmful for the patients with abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or unnecessary cardiac catheterization. in the medical literature the investigators found some case reports and works about the ecg changes in acute biliary disease in patient with knowing cardiac disease and without it, but actually incidence of ecg changes that suggest but not represent an acute coronary illness isn't knowing. therefore this is necessary to investigate actually incidence of ecg changes that mimic acute coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical and laboratory characteristics that helps to differentiate this patients.


Eligibility criteria:
inclusion criteria: 1. patients from age 18 and up to 75years old. 2. causes of admission to the ed are acute cholecystitis, biliary colic, acute cholangitis 3. the patient is willing to participate in the study and is able to sign an informed consent form. exclusion criteria: 1. elective hospitalization with known and not acute condition. 2. inability to give inform consent . 3. sepsis as complication of illness. 4. chronic ecg changes known by medical history. 5. knowing history of ihd. 6. previous cardiac catheterization with documented stenosis of at least 1 major coronary artery equal or more 50%.

Keywords: acute ecg changes acute illness of gallbladder acute illness of biliary tract
lake washington vascular venaseal™ post-market evaluation

Conditions: Varicose Veins; Venous Reflux

Summary: new-waves study seeks to expand understanding/results from prior study (nct02585726). assessing both clinical outcomes and patient satisfaction after treatment with venaseal/cyanoacrylate adhesive closure system

new waves is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with venaseal(tm)/ cyanoacrylate adhesive closure system 3 years post-treatment. all patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the venaseal closure system; 3. treatment occurred at least 30 months prior to study; 4. ability to understand the requirements of the study and to provide informed consent. - exclusion criteria: 1. subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after venaseal closure; 2. patients in whom index procedure information is unavailable; 3. patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. limbs that were treated in the veclose trial (patients who participated in veclose and later had contralateral limb treatment will be included). -

Keywords: venaseal cyanoacrylate closure
evaluating tolerability of epuhrt with brachytherapy boost

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: elective pelvic ultra hypofractionated irradiation treatment (epuhrt), which is an external beam radiotherapy with high dose rate brachytherapy boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old at the time of informed consent 2. capable of providing informed consent and hipaa authorization 3. karnofsky performance score ≥ 70 4. pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician 5. candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure 6. up to date colon cancer screen per per american cancer society guidelines exclusion criteria: 1. prior pelvic irradiation treatment 2. prior rectal surgery which precludes instrumentation with rectal ultrasound probe. 3. evidence of nodal or distant disease on screening diagnostic work up. 4. prior prostatectomy, holmium laser enucleation of the prostate or transurethral resection of the prostate procedure 5. international prostate symptom score (ipss) score \> 16 despite medical therapy

Keywords: brachytherapy boost
effectiveness of public health model of latent tuberculosis infection control for high-risk adolescents

Conditions: Lung Diseases; Tuberculosis

Summary: this study will determine the differential cumulative mean number of isoniazid (inh) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. the study will also estimate the costs and cost effectiveness of peer adherence coaching versus control procedures; this will be done from a provider and societal perspective.

background: tuberculosis (tb) was responsible for almost one billion deaths in the 20th century. it is epidemic in the developing world and immigrants introduce tb to developed nations. tb control requires treatment for latent tb infection (ltbi) and active disease, as well as adherence to medical regimens. this study will determine the effectiveness of a public health model of ltbi control among high-risk adolescents. the integration of behavioral science, medical services, parent instruction, and assistance from schools and clinics (coordinated by the county health department) is based on recommendations from the centers for disease control and prevention (cdc). the effectiveness of this system is dependent, in part, on patient adherence. design narrative: the primary outcome of this study is adherence to an inh treatment regimen. for a given participant, adherence is assessed every 30 days, with the final outcome determined 12 months after treatment start date. adherence is assessed using participant recall, urine testing for inh metabolites, pill counts, and medication event monitoring system (mems) caps. the key secondary outcomes are parent knowledge and practice of intervention support procedures, parent knowledge of tb, self-esteem effects and life skills acquisition, cost and cost effectiveness of the intervention, and knowledge and practice of ltbi care by providers at participating community clinics.

Eligibility criteria:
inclusion criteria: * ppd positive * san diego county residents (without plans to relocate out of the county in the 12 months after study entry) * able to respond to the interview questions in english or spanish * eligible for inh treatment exclusion criteria: * receiving treatment in mexico (due to differing medications and length of treatment)
a randomised, double-blind, placebo-controlled study to investigate the efficacy and safety of sevelamer carbonate tablets dosed three times a day in hyperphosphataemic chronic kidney disease patients not on dialysis

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Summary: approximately 207 hyperphosphatemic ckd patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 european countries. the purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (tid) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic ckd patients not on dialysis. total length of participation is approximately 24 weeks.


Eligibility criteria:
inclusion criteria: * serum phosphorus measurement ≥4.6 mg/dl (≥1.49 mmol/l) and ≤5.5 mg/dl (≤1.76 mmol/l after discontinuation of current phosphate binder therapy if applicable. exclusion criteria: * active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
real-life assessment of abilify maintena + rexult in schizophrenia

Conditions: Schizophrenia and Related Disorders; Anxiety Depression

Summary: mainrexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorder prescribed with the combination therapy with abilify maintena and rexulti on its efficacy and tolerability in a real-life clinical setting.

currently, there is no recommendation on next-step treatment strategy if the patients remain suffering from residual symptoms, have incomplete remission, or have acute exacerbation of schizophrenia whilst receiving aripiprazole long acting injection at its recommended (maximum) dose, except to switch to other second generation antipsychotics (sga) or to clozapine if they are in their treatment-resistant course. such practice may incur risks of full relapse and/or unnecessary side effects to the patients, in particularly to those already showed insufficient treatment response, intolerability to side effects, or non-adherence to other antipsychotics before. on the contrary, adding another sgas to this special cohort appears to be rational. especially, brexpiprazole might be an ideal choice for its serotonin-dopamine activity modulator property to achieve better symptom control, and at the same time retaining the benefits from the lower incidence of side effects than other sgas. cases reports on combination therapy with aripiprazole (oral or lai) with brexpiprazole had demonstrated initial favorable outcomes, albeit lacking empirical evidence from randomized controlled trial or longer term follow-up study. therefore, the current mainrexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorders prescribed with the combination therapy with abilify maintena and rexulti on its efficacy and tolerability in an non-interventional, naturalistic real-life clinical setting.

Eligibility criteria:
inclusion criteria: * age: 18- 65 years old at the time of enrollment * able to read and communicate in english and/or chinese * able to give informed consent * has been diagnosed to have schizophrenia (dsm-5 or icd-10 f20 \[except f20.81\], schizotypal (personality) disorder (dsm-5 or icd-10 f21), or schizoaffective disorder (dsm-5 or icd-10 f25), (persistent) delusional disorder (dsm-5 or icd-10 f22), schizophreniform disorder (dsm-5 or icd-10 f20.81), brief psychotic disorder (dsm-5) or acute and transient psychotic disorder (icd-10 f23) * is receiving the combination with abilify maintena and brexpiprazole as treatment ≤8 weeks at the time of recruitment exclusion criteria: * age \<18 years old * unable to read english or chinese * unable to give informed consent * had been diagnosed to have intellectual disabilities (dsm-5) or mental retardation (icd-10 f70-73)

Keywords: schizophrenia antipsychotics aripiprazole brexpiprazole
advanced cardiovascular imaging consortium

Conditions: Chest Pain; Coronary Occlusion; Coronary Artery Disease

Summary: the acic is a collaborative quality improvement (cqi) program involving the collection of data related to: indications for coronary computed tomography (ccta), patient health characteristics, acquisition techniques of ccta scans, physician interpretation of results and short-term outcomes over a 90 day period.

this study is a collaborative quality assurance initiative organized by blue cross blue shield of michigan and blue cross network (bcbsm/bcn) for initiation of insurance coverage of coronary artery ct scanning (ccta), a relatively new procedure that can provide non-invasive coronary angiograms. while this procedure has promise in that it can rapidly diagnose patients with unknown chest pain and reduce the cost of medical care, there is substantial potential for abuse and excess cost and inappropriate care if not appropriately used. the consortium's objectives are to educate participating sites of the clinical uses of ccta as well as other best-practice recommendations; to create a database (registry) to develop evidence of the best-practice utilization of ccta; to provide a feedback mechanism to the sites about the positive or negative evidence of best-practice utilization of ccta; to develop strategies to improve the utilization of ccta; to monitor the cqi process of the individual participating sites; to reduce cost and improve safety and efficiency in in the care of patients with acute chest pain, indeterminate stress tests results, and to assess coronary bypass graft patency.

Eligibility criteria:
inclusion criteria: (patient must meet one criteria) * patient has had a ccta examination ordered by a referring physician at a participating site. * patient is a self referral. exclusion criteria: clinical contraindications to ccta are present as determined by attending physician or staff, including but not limited to: * pregnancy or potential pregnancy. * renal failure or dysfunction. * inability to receive beta blockers. * allergy to iodinated contrast without prior premedication. * unwillingness to participate. * inability to read or understand patient information sheet. * age less than 18 years without parent or guardian's evaluation of patient information sheet. underage and other vulnerable populations are included as the cqi process is intended to detect and correct adverse consequences of ccta, e.g., excessive radiation, and protect such patients.

Keywords: coronary artery disease chest pain coronary artery bypass graft stress test coronary angiography
acute cardiovascular responses and chronic adaptations of strength exercise in intermittent claudication patients

Conditions: Peripheral Artery Disease; Intermittent Claudication

Summary: the aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.

several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. however, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. in addition, it also do not know the chronic effects on cardiovascular function in these patients.

Eligibility criteria:
inclusion criteria: * had a graded treadmill test that was limited by claudication (2 minutes) * had an ankle brachial index \<0.90 * had systolic blood pressure ,160 mmhg and/or diastolic blood pressure,105 mmhg * were not performing any regular exercise program * were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers) * were nonobese * individuals who have not undergone bypass surgery or angioplasty least one year ago exclusion criteria: * had no symptoms related to myocardial ischemia during the treadmill test * amputation
robot assisted mastectomy via axillary way with areola conservation and immediate reconstruction

Conditions: Breast Cancer

Summary: the objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the da vinci robot xi and immediate breast reconstruction using prosthesis. the interest is to avoid scars on the breast. the scars are limited to the armpit and under the arm. the aim is also to study the rate of complications, cosmetic results and quality of life.


Eligibility criteria:
inclusion criteria: 1 .patients with an indication of mastectomy with areola conservation 2. in case of carcinologic surgery: * disease located more than 2cm of the areola on the clinical and paraclinical evaluation * patients with indication of total mastectomy * patients looking for immediate reconstruction 3. in case of prophylactic surgery * patients wishing a prophylactic surgery because of highly risked mutation (brca1, brca2....) 4. cup a, b or c maximum 5. aged between 18 and 70 years old 6. oms 0, 1 7. signed informed consent 8. patients affiliated to a social security system exclusion criteria: 1. patients with a high risk of skin necrosis 2. planned post operative radiotherapy 3. patients with an historic of breast surgery on the side that needs to be operated 4. pregnant or breastfeeding women 5. persons deprived of liberty 6. persons not able to undergo medical follow up due to geographical, social or psychic reasons
a safety study of dapivirine (tmc120) vaginal microbicide gel in south africa

Conditions: HIV Infections

Summary: approximately 42 hiv-negative women, aged \>18 and \< 50, will be enrolled in this study. each volunteer will have a 2:1 chance of receiving dapivirine gel-002 versus placebo. the volunteers will receive investigational product for a total of 42 days.


Eligibility criteria:
inclusion criteria: * hiv-negative * willing to participate and sign an informed consent form * willing to be tested for hiv, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group. * willing to use two forms of contraception during the study * willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study. * have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses exclusion criteria: * currently pregnant or breast-feeding * clinically detectable genital abnormality on the vulva, vaginal walls or cervix * laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed gud or active hsv-2 lesion * breakthrough bleeding or gynecologic surgery within 60 days prior to randomization * symptomatic bacterial vaginosis at screening and unwilling to undergo treatment. * women who require treatment for tuberculosis (tb) within 21 days prior to randomization.

Keywords: hiv-1 hiv seronegativity
modulation of vasoreactivity in septic shock: impact of recombinant protein c

Conditions: Septic Shock

Summary: the purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein c (apc). this amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ros) markers and increase of circulating catecholamines.


Eligibility criteria:
inclusion criteria: - patients with septic shock as determined by standard criteria (including infection and severe infection) exclusion criteria: * pregnant women * absence of signed informed consent. due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. as soon as possible, an informed consent will be obtained by patient * contraindication to xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy \>= 15 iu/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count \< 30000 x 10\^6/l, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin

Keywords: vasoreactivity recombinant activated protein c
a phase 2a study of tpn-101 in patients with progressive supranuclear palsy (psp)

Conditions: Progressive Supranuclear Palsy

Summary: this is a phase 2a study to assess the safety and tolerability of tpn-101 patients with psp.

this is a phase 2a multi-center, randomized, double-blind, placebo-controlled parallel-group, 4-arm study with an open-label treatment phase in patients with psp. this study includes a 6-week screening period, a 24-week double-blind treatment period, a 24-week open label treatment period, and a follow-up visit 4 weeks post treatment.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of probable progressive supranuclear palsy (psp) 2. presence of psp symptoms for less than 5 years 3. has a reliable caregiver/informant to accompany the patient to all study visits. 4. score ≥ 18 on the mini mental state exam (mmse) at screening 5. patient must reside outside a skilled nursing facility or dementia care facility at the time of screening, and admission to such a facility must not be planned. residence in an assisted living facility is allowed exclusion criteria: patients must not meet any of the following criteria: 1. presence of other significant neurological or psychiatric disorders 2. history of clinically significant brain abnormality 3. presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic dysfunction, or moderate to severe resting tremor, responsive to levodopa 4. known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean 5. known presence of disease-associated mutation in tardbp, grn, chmpb2, or vcp genes; or any other frontotemporal lobar degeneration causative genes not associated with underlying tau pathology 6. history of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, or gastrointestinal disease