Kornimate/medical-research-clean huggingface dataset:
safety and preliminary efficacy of activated recombinant human factor vii for preventing early hematoma growth in acute intracerebral haemorrhage

Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor vii (novoseven®) for preventing early hematoma growth in acute intracerebral hemorrhage (ich).


Eligibility criteria:
inclusion criteria: * spontaneous ich diagnosed by ct (computerized tomography) scanning within 3 hours of onset * signed informed consent form, or an exception from standard informed consent requirements exclusion criteria: * time of onset of symptoms of ich unknown or more than 3 hours prior to ct * patients with secondary ich related to infarction, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, avm (arteriovenous malformation) or severe trauma * surgical haematoma evacuation planned or performed within 24 hours of onset
altavalve pivotal trial

Conditions: Mitral Regurgitation; Mitral Insufficiency; Mitral Valve Incompetence; Mitral Valve Regurgitation; Mitral Incompetence

Summary: this is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the altavalve system for the treatment of mitral regurgitation in a targeted patient population.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * symptomatic new york heart association (nyha) class ii-iv. * moderate-to-severe or severe mr (3+) despite optimal guideline-directed medical therapy (gdmt) as determined by an independent echo core lab. * unsuitable for surgery and transcatheter edge-toedge repair (teer) as determined by the local site heart team. exclusion criteria (abbreviated list): * inability to understand the trial or a history of non-compliance with medical advice. * inability to provide signed informed consent form (icf). * history of any cognitive or mental health status that would interfere with participation in the trial. * currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)). * female subjects who are pregnant or planning to become pregnant within the trial period. * known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications. * known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated. * known hypersensitivity to contrast media that cannot be adequately medicated. * evidence of current left ventricular ejection fraction (lvef) ≤ 25%. * concurrent medical condition with a life expectancy of less than 12 months. * transcatheter aortic repair or replacement within 90 days prior to the index procedure. * percutaneous coronary intervention (pci) within 90 days prior to the index procedure.

Keywords: mitral regurgitation tmvr functional regurgitation degenerative regurgitation transcatheter mitral valve replacement primary regurgitation secondary regurgitation
candin for the treatment of common warts

Conditions: Common Warts (Verruca Vulgaris)

Summary: the goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (verruca vulgaris) following treatment with candin or placebo. the main questions it aims to answer are: * does treatment with candin result in better clearance of warts than placebo * how many injections are required to result in wart clearance participants will * have one wart selected for injection every two weeks until clearance * return 12 weeks after wart clearance for assessment of durability of response

this study involves a comparison of an equal volume injection of candin with an injection of placebo (unpreserved normal saline solution) in common warts. subjects will be randomized 2:1 to receive candin or placebo. during the treatment period, 1 dose (0.5 ml) of investigational product (ip) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered. subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the observational period for 12 weeks. complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.

Eligibility criteria:
inclusion criteria: * at least 3, but not more than 20 common warts (verruca vulgaris) * willing to agree to use adequate contraception methods during the study exclusion criteria: * systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function * candin delayed type hypersensitivity reaction test wheal sized \ 25 mm at the baseline visit * history of keloid formation * prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the investigator's opinion, does not exhibit complete healing from the treatment * treatment with immunotherapy (e.g., diphenylcyclopropenone \[dpcp\], dinitrochlorobenzene \[dncb\], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the baseline visit or during the study * prior treatment with candida albicans within 12 weeks of the baseline visit or during the study * systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half lives prior to the baseline visit or during the study (e.g., azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids \[topical or inhaled steroids are acceptable\]). * use of cantharidin or an investigational agent or device within the 30 days prior to the baseline visit or during the study

Keywords: common wart intralesional injection candida albicans immunotherapy
use of naltrexone in a clinical setting

Conditions: Alcoholism

Summary: this 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. a followup period of 12 months is included. the effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. the study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence (within the past 3 months). * meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse. * must be able to provide an informed consent. * consent to random assignment and be willing to commit to possible medication treatment and research follow-up. * must be eligible for treatment at the dorchester alcohol and drug commission. exclusion criteria: * meets criteria for opiate dependence. * clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion. * hepatocellular disease. * women who are pregnant, nursing, or not practicing an effective means of birth control. * currently being prescribed naltrexone. * known sensitivity or allergy to naltrexone.
artificial intelligence to implement cost-saving strategies for colonoscopy screening based on in vivo prediction of polyp histology

Conditions: Colonic Neoplasms

Summary: this three parallel-arms, randomized, multicenter trial is aimed at investigating the value of ai-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. a cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. to improve personalized treatment with a novel colonoscopy cadx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of ai-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.


Eligibility criteria:
inclusion criteria: * all \>40 years-old patients undergoing colonoscopy for selected indications exclusion criteria: * patients with personal history of crc, or ibd * patients affected with lynch syndrome or familiar adenomatous polyposis. * patients with inadequate bowel preparation (defined as boston bowel preparation scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.
i-scan for the detection of helicobacter pylori

Conditions: Gastritis

Summary: this study aims to assess whether iscan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising helicobacter pylori (h pylori) and comparing this to standard endoscopic imaging with white light endoscopy (wle), narrow band imaging (nbi) and histology.

the ultimate goal of endoscopy will be the 'optical biopsy' i.e. forgoing the need to take histological samples to make a diagnosis in order to reduce complication rates, cost and time. there are a number of imaging techniques which promise to improve our diagnostic rates for pathology, but there have been few comparative studies. this is randomized controlled parallel trial in a 1:1 ratio with examination of the upper gastrointestinal tract with wle followed by either nbi or iscan. (note: prior to commencement of the study, technical issues and operational changes in our organisation forced the removal of the pentax 'i-scan' endoscopes. recruitment to this arm was anticipated, but was ultimately not possible.) patients attending the department for routine examinations for dyspepsia and abdominal pain will be randomised into 2 study arms (1wle and nbi, and the other - wle and iscan). the investigator carrying out the procedure will be blinded to the indication for the procedure until a full examination with both white light endoscopy and either nbi or iscan has been used as this could lead to bias. they will determine if h pylori is present, and if so the severity of infection with wle and again with either nbi or iscan depending on their study arm. histopathological confirmation of h pylori and an assessment to the degree of infection will be assessed with samples taken using the updated sydney system (5 gastric samples from different parts of the stomach). the endoscopists reviewing the images will be blinded to all patient information and indications throughout the study period. questionnaires will then be given to the endoscopists to determine what endoscopic features led them to their diagnosis.

Eligibility criteria:
inclusion criteria: • all patients attending for a routine diagnostic endoscopic procedure at st mary's hospital nhs trust for dyspepsia and abdominal pain exclusion criteria: * patients attending for a therapeutic endoscopic procedure e.g. variceal banding, stent insertion, balloon dilatation. * patients with a known diagnosis e.g. upper gastrointestinal cancer * patients previously treated with hp eradication therapy * patients who had taken ppi, h2 receptor antagonists and antibiotics within 4 weeks * patients with acute gastrointestinal bleeding * patients who'd had previous gastric surgery * patients with chronic liver disease * patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures * patients who are unable or unwilling to give informed consent * patients under the age of 18 years
supplementation with cholecalciferol in dialysis patients

Conditions: Chronic Kidney Disease

Summary: hypovitaminosis d is highly prevalent among patients with chronic kidney disease, especially in those undergoing dialysis. the loss of protein to the dialysis solution seems to contribute significantly to the reduced serum levels of vitamin d in these patients. as a result of the disease and the dialysis procedure, there is high prevalence of chronic inflammation and high risk of infections. there is evidence in other populations, that vitamin d has immunomodulatory effects by stimulating the production of cathelicidin, an antimicrobial peptide and suppressing the production of proinflammatory cytokines. thus, this study aims to investigate the effects of cholecalciferol supplementation on immunological markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis d . this is a randomized, double-blind, placebo-controlled trial in which patients who have vitamin d deficiency \[25 (oh) d \<20 ng / ml\] will be allocated to the intervention group (cholecalciferol) or control (placebo). patients will receive supplemented 100,000 iu / week cholecalciferol a period of 12 weeks. before and after the intervention will be determined 25(oh)d, cathelicidin, interleukin-6 (il-6), tumor necrosis factor-α (tnf-α) and c-reactive protein serum. in monocytes, we will evaluate cathelicidin, il-6 and tnf-α, 25(oh)d receptor and α 1-hydroxylase enzyme expression.


Eligibility criteria:
inclusion criteria: * 25 (oh) \< 20 ng/ml * peritoneal dialysis or hemodialysis \> 3 months exclusion criteria: * use of vitamin d or its analogues, corticosteroids and immunosuppressive * peritonitis in the previous month at baseline * liver, neoplastic, infectious or autoimmune diseases and positive hiv * hypercalcemia

Keywords: cholecalciferol kidney diseases
nexalin therapy as a viable adjunctive treatment for substance use disorders

Conditions: Depression; Anxiety; Insomnia; Substance Abuse

Summary: the purpose of this research study is to determine whether nexalin trans-cranial electrical stimulation (tes) is a viable adjunctive treatment of substance use treatments.

a randomized controlled trial with block randomization. inpatient subjects actively seeking substance abuse treatment at the carrier clinic who are diagnosed with a substance use disorder, including alcohol use disorder, tobacco use disorder, polysubstance use disorder, or other substance use disorder.

Eligibility criteria:
inclusion criteria: 1. be able to provide informed consent, assessed by the study clinician 2. be able to speak, read and write fluently in english, assessed by the study clinician 3. be committed to completion of the study. the subject will need to attest to availability for 10 to 15 treatments over a 5 to 8 day period for the treatment protocol. 4. be adults over age 18 and under age 65 5. be actively receiving substance use treatment for a substance use disorder exclusion criteria: 1. pregnant or at risk of becoming pregnant 2. individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk
onabotulinumtoxina for the treatment of new daily persistent headache: an open label study

Conditions: New Daily Persistent Headache

Summary: the purpose of this study is to evaluate the effect of botox® (onabotulinumtoxina) on the number of headache days in patients with new daily persistent headache (ndph). ndph is a benign form of chronic daily headache that comes in two forms: one that resolves on its own after months to years, or one that is difficult to treat and does not respond to preventive or abortive medications. some patients experience migrainous features such as nausea, vomiting, photophobia, or phonophobia. botox®, a treatment approved for chronic migraine, will be injected into specific muscles of the head and neck area by your study doctor, to evaluate its effectiveness in reducing or relieving ndph days or severity. botox has not been approved for ndph and this is the first time it will be used for treatment of ndph. all participants in this study will only receive botox® and no other study drug.


Eligibility criteria:
inclusion criteria: subjects aged 18 or older, male or female of any race with the diagnosis of ndph meeting international classification of headache disorders (ichd-2) criteria will be included in the study. the criteria is as follows: a. persistent headache fulfilling criteria b and c b. distinct and clearly remembered onset, with pain becoming continuous and unremitting within 24 hours c. present for \>3 months d. not better accounted for by another ichd-3 diagnosis exclusion criteria: 1. those with relevant physical or psychological illness, particularly conditions that might put them at risk if exposed to onabotulinumtoxina (myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other neuromuscular disease). 2. diagnosis of other primary/secondary headache disorder. 3. psychiatric disorders that could interfere with study participation. 4. subjects who abuse drugs, including headache treatments and alcohol (dsm iv criteria). 5. those allergic to compounds similar to the study medication. 6. those who are pregnant or breastfeeding, or who do not use adequate contraceptive methods. 7. those who have had any prior exposure to any botulinum toxin serotype.
food frequency questionnaire to assess sodium intake

Conditions: Hypertension; Renal Insufficiency

Summary: evalsel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. it can determine salt consumption to the nearest gram. the objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients. evalsel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. it can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.


Eligibility criteria:
inclusion criteria: * patients with high blood pressure, ckd stages 4-5 and patients free from any diseases * patients over 18 years old * patients in nephrology and cardiology consultation or recruited by cic * patients with health insurance * patients willing to follow the full study exclusion criteria: * loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis * modification of the therapeutic management of patients during the study period * taking certain drugs like effervescent drugs, gaviscon and tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis * pregnant or breastfeeding women * patients protected by law

Keywords: natriuresis hypertension renal insufficiency sodium table salt
rapid hiv testing and counseling in drug abuse treatment

Conditions: Substance-Related Disorders

Summary: this is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center hiv testing and counseling study. the purpose of this study is to assess the relative effectiveness of three hiv testing strategies on increasing receipt of test results: (1) on-site hiv rapid testing with brief, participant-tailored prevention counseling, (2) on-site hiv rapid testing with information only, and (3) referral for off-site hiv testing. the study will also assess the effectiveness of the three testing strategies in reducing hiv risk behaviors.

this is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center hiv testing and counseling study. the purpose of this study is to assess the relative effectiveness of three hiv testing strategies on increasing receipt of hiv test results: (1) on-site hiv rapid testing with brief, participant-tailored prevention counseling, (2) on-site hiv rapid testing with information only, and (3) referral for off-site hiv testing. the study will also assess the effectiveness of the three testing strategies in reducing hiv sexual risk behaviors. injection drug risk behavior will be a secondary outcome. participants will complete a baseline assessment to report their demographics, hiv testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. at one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their hiv test results. at six months post-randomization, participants will complete a follow-up assessment to assess any changes in their hiv sexual risk behaviors.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * hiv-negative or hiv status unknown * no receipt of results from hiv test initiated within last 12 months * be able to communicate in english
effects of video game on patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: to investigate the effects of video game play therapy in patients with knee osteoarthritis

a total of 80 patients with knee osteoarthritis were randomized into two groups, including video game group and exercise group. physical activity, quality of life, emotion, and balance were assessed at before treatment and follow-up assessments, including at after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated, respectively.

Eligibility criteria:
inclusion criteria: * knee osteoarthritis with kellgren/lawrence grade ii of greater ambulatory for more than 15 meters without support or orthosis usage exclusion criteria: * knee operation history participants with pregnancy stroke history infection or fracture over lower limbs previously

Keywords: knee osteoarthritis video game therapeutic effects