Kornimate/medical-research-clean huggingface dataset:
oral anticoagulant therapy for venous thrombosis - scor in thrombosis

Conditions: Venous Thrombosis; Cardiovascular Diseases; Venous Thromboembolism

Summary: to perform a randomized clinical trial comparing continuing one month of treatment with heparin in patients with deep venous thrombosis to standard care using heparin for five days and oral warfarin for three months.

background: the study, a subproject within a scor in thrombosis, should help to improve the long-term clinical outcome of patients with proximal deep-vein thrombosis (popliteal, femoral or iliac vein thrombosis) by improving their survival and reducing morbidity from recurrent thromboembolic events, and should help to determine if one or more specific biochemical measures, including antiphospholipid antibodies and activated factor vii, will define a subset of patients at increased risk of recurrent venous thromboembolism. the study is part of a scor in hemostatic and thrombotic diseases, the rfa for which was released by the nhlbi in april 1994. design narrative: warfarin trial a multicenter, randomized clinical trial was conducted from march 1996 through january 2001 comparing warfarin therapy for three years to warfarin therapy for three months. the study was performed at thirteen participating hospitals in oklahoma. the 600 hundred patients were recruited, randomized to either warfarin therapy for three years or warfarin therapy for three months and followed for at least three years. the primary outcome measure was total mortality. secondary outcome measures included vascular death, objectively documented recurrent venous thromboembolism, and bleeding complications (major and minor). additional specific aims included: determining the prevalence of antiphospholipid antibodies, antithrombomodulin antibodies, and activated protein c resistance in consecutive patients with proximal-vein thrombosis; determining if these measures, and/or the level of activated factor vii were associated with an increased risk of recurrent venous thromboembolic events, and if so, whether these events were reduced by continuing long term warfarin treatment. these latter specific aims were achieved by performing the laboratory parameters concurrently in patients entered into the clinical trial, and relating these measures to the clinical outcomes on long-term follow-up. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cardiac t1 mapping enables risk prediction of lv dysfunction after surgery for aortic regurgitation

Conditions: Aortic Regurgitation

Summary: to assess whether cardiac t1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.

we hypothesized that a diffuse interstitial myocardial fibrosis may be present in ar patients who experience early systolic lv dysfunction after aortic valve surgery. we aimed to evaluate the association between preoperative cardiac t1 mapping for detection of myocardial fibrosis and early systolic lv dysfunction after surgery for aortic regurgitation.

Eligibility criteria:
inclusion criteria: * consecutive patients with severe aortic regurgitation referred for aortic valve surgery were prospectively enrolled in the study. exclusion criteria: * history of coronary artery disease * acute aortic valve disease (i.e., type a aortic dissection or infectious endocarditis) * common contraindications for mri such as severe obesity and metallic foreign bodies.
graded exercise hypoxia testing

Conditions: Hypoxia

Summary: the purpose of this study is to develop a single, standardized test to determine how individuals tolerate acute hypoxia in a stepwise fashion. we aim to evaluate the association between multiple factors, such as ventilatory compensation, heart rate response, acid-base changes, sex, pulmonary function, etc, which may explain why some individuals tolerate exercise in hypoxia better than others. identifying these factors of association will inform future pharmacological and non-pharmacological attempts to combat acute hypoxic exercise.


Eligibility criteria:
inclusion criteria: • physically active (≥150 minutes of moderate physical activity per week) exclusion criteria: * contraindications to exercise testing * currently pregnant * musculoskeletal or metabolic disease * allergies to lidocaine * body-mass index ≤18 or ≥35 kg·m-2 * pacemaker * no confounding cardiorespiratory disease * persistent tobacco use (\>15 pack years)
regaining confidence after stroke a feasibility randomised controlled trial

Conditions: Stroke

Summary: the regaining confidence after stroke course (rcas) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. the study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.

the regaining confidence after stroke course (rcas) is an is an eleven week group intervention that is designed to help stroke survivors when they have finished rehabilitation to improve confidence in daily life. this feasibility study aimed to evaluate the acceptability of the course in improving confidence, mood, adjustment and increasing activity levels in stroke survivors as well as improving mood and coping in their carers.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of stroke within two years * discharged from all other rehabilitation therapies * not involved in trials of other psychological interventions * not previously attended an rcas course exclusion criteria: * score of \<10 on the barthel index (sufficiently independent to cope in a group setting) * score \<8 on the sheffield screening test for acquired language disorders so that participants would be able to understand the materials being presented * unable to speak english * unable to give informed consent

Keywords: feasibility confidence group intervention psycho-social intervention stroke recovery
covid-19 community research partnership

Conditions: Coronavirus; COVID

Summary: the purpose of this research is to collect information about the north carolina community's coronavirus exposures, symptoms, and health care visits due to the virus. participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

investigators will conduct a prospective, cohort study for sars-cov-2 infections among clients and health care workers of wake forest baptist health (wfbh). investigators will conduct real-time syndromic respiratory disease surveillance and, for sars-cov-2 infections, calculate baseline seroprevalence and seroconversion rates, hazard risks from close contacts, estimate efficacy of personal protective equipment, and assess sequelae incidence. investigators will utilize the covid-19 therapeutic learning system, an oracle developed self-reporting data collection system that can be easily modified to address these specific questions. over the course of the study, volunteers will report daily exposures, risk reduction behaviors, and symptoms through a secure app on their smartphone, tablet, or computer. in addition to daily syndromic surveillance, at baseline and once every month after that we will use a serologic igm/g test kit to identify infections and reinfections in volunteers and send results to the oracle developed database. the areas covered by this study are experiencing community spread of covid-19 but are early enough in the epidemic to capture potentially a significant number of seroconversions over the 12 months of the study. this surveillance model will be expanded to include the clients and health workers of other medical agencies in north carolina and in other states.

Eligibility criteria:
inclusion criteria: * all clients and health care worker of wfbh are eligible for enrollment. exclusion criteria: * health care workers who do not receive medical services through wfbh will not be enrolled.

Keywords: covid-19
steroids in the postoperative transient hypoparathyroidism total thyroidectomy

Conditions: Transient Hypoparathyroidism

Summary: the incidence of thyroid cancer (tc) has increased exponentially worldwide. the increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (tt), given that at present is still the gold standard of treatment. transient postoperative hypoparathyroidism (hpt) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. hpt involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin d (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system. while the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the hpt making clear the need for randomized clinical trials specific to analyze these variables more accurately. as inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of hpt component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in tt. our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (pth, serum calcium and symptoms) in patients after tt.

triple-blind randomized clinical trial

Eligibility criteria:
inclusion criteria: * adult * thyroidectomy postoperative * prepaid affiliate patients exclusion criteria: * allergy * ckd * idiophatic thrombocytopenic purpura * hyperthyroidism * chronic use of corticoids * no follicular cancer, nonpapillary * refusal to participate

Keywords: transient hypoparathyroidism steroids total thyroidectomy
study of 124i-nm404 in advanced solid malignancies

Conditions: Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer

Summary: the purpose of this study is to assess the use of investigational compound 124i-nm404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.

124i-nm404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (pet) scans. an investigational drug is a drug that has not been approved by the food and drug administration (fda) and is available for research use only. 124i-nm404 is only taken up by the cancer cells, not the normal cells. compared to traditional methods such as ct (computed tomography) or mri (magnetic resonance imaging), 124i-nm404 may help physicians more accurately see and evaluate cancerous tumors. this agent has been safely studied in animals and a limited number of human patients with lung cancer. this study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced solid malignancy. * allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head \& neck cancer * disease must be at least 1cm in diameter * brain metastasis must be stable for at least one month. * ecog performance status 0-2 * anticipated survival less than 5 years, as per the treating physician exclusion criteria: * skin lesions only * chemotherapy or radiotherapy within 1 week * residual toxicities of grade 2 or greater from prior therapy * adequate organ function as per specified laboratory parameter * platelet count \> or = to 75,000/ul
allo-hsct as first-line consolidation in high-risk ptcl

Conditions: T Cell Lymphoma

Summary: results of conventional therapy in patients with peripheral t-cell lymphoma(ptcl) are poor. allogeneic hematopoietic stem cell transplantation(allo-hsct) gave excellent results in ptcl after failure of conventional therapy and in many cases also of hdt/asct. a disadvantage of allo-hsct is high trm rate, especially in refractory or relapsed patients. another limitation to the use of allo-hsct is the availability of a hla matched donors. haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. thus, allo-hsct could be used as first-line consolidation following conventional chemotherapy in high-risk ptcl patients. the study hypothesis: using allo-hsct as consolidation following chemotherapy in high-risk ptcl exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.

after primary diagnosis eligible patients receive 2 to 3 courses of choep-21 with formal restaging after course 2. patients with cr, pr or no change proceed to allo-hsct. donor selection: matched sibling donor(msd) is the first choice. an unrelated donor or haploidentical family donor search is performed in patients without sibling donor. the primary end point was 1 year progression-free survival. the secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (gvhd) . following time is 2 years

Eligibility criteria:
inclusion criteria: * primary diagnosis of mature t-cell lymphoma, stage 2-4, or stage 1 with aa ipi\>=0 * age \<= 60 years * kps\>=70 exclusion criteria: * stage i with aaipi 0, alcl alk positive, t-lymphoblastic lymphoma, cutaneous t-cell lymphoma * hiv positivity * major organ dysfunction * pregnancy * patient unable to give informed consent
reduction of occurence of acute kidney injury (aki) through administration of glutamine

Conditions: Cardiac Surgery; Acute Kidney Injury

Summary: the aim of this study is to evaluate whether the application of glutamine versus control in patients with high risk for aki identified by biomarkers can reduce kidney damage after cardiac surgery.

cardiac surgery is characterized by an increased production of free radicals as a consequence of surgical trauma, ischemia-reperfusion injury, inflammatory response syndrome in response to the use of the extracorporeal circulation. this results in an increased production and release of free radicals which may lead to an exhaustion of antioxidants and organ failure since the lungs, kidneys, liver and gastrointestinal tract are particularly susceptible to reactive oxidant species. glutamine is considered as a conditionally indispensable amino acid in catabolic states of critically ill patients. it belongs, together with other mediators, to the host defense as major intracellular direct free radical scavengers. its depletion has been demonstrated to be an independent predictor of mortality in a group of icu (intensive care unit) patients. clinical studies showed a positive outcome effect. in animal models, glutamine reduces the occurrence of aki after ischemia-reperfusion injury. this could be demonstrated through reduced functional markers as well as reduced renal biomarker levels. preliminary data suggest that glutamine has pleiotropic effects since it has effects on the immune system (reduced expression of cytokines) as well as on tubular epithelial cells (unpublished animal data from our laboratory). thus, a randomized-controlled trial to analyze the effects of glutamine supplementation in high risk patients identified by renal biomarkers undergoing cardiac surgery with cardiopulmonary bypass (cpb) on the effects of kidney damage is urgently needed.

Eligibility criteria:
inclusion criteria: * adult patients undergoing cardiac surgery with cpb * urinary \[timp-2\]\*\[igfbp7\] \>= 0.3 4h after cpb * written informed consent exclusion criteria: * preexisting aki (stage 1 and higher) * patients with cardiac assist devices * pregnant women, nursing women and women of childbearing potential * known (glomerulo-) nephritis, interstitial nephritis or vasculitis * chronic kidney disease (ckd) with estimated glomerular filtration rate (egfr) \< 30 ml/min * dialysis dependent ckd * prior kidney transplant within the last to 12 months * hypersensitivity to the active substance, or to any of the excipients of the study medication * hepatic insufficiency * severe metabolic acidosis (ph \< 7.2) * participation in another intervention trial in the past 3 months * persons with any kind of dependency on the investigator or employed by the institution responsible or investigator * persons held in an institution by legal or official order

Keywords: cardiac surgery glutamine
greenlight laser photoselective vaporization of the prostate vs bipolar transurethral vaporization of the prostate; rct

Conditions: Benign Prostatic Hyperplasia

Summary: with a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the greenlight pvp/xps, it seems to be a real contender in the world of mis. contenders of greenlight laser technology includes bipolar as well as holmium laser technology. in this study the investigators planned to test the greenlight (532-nm) laser pvp using (xps) 180w system compared to bipolar electro-vaporization, in reduction of luts secondary to small to moderate sized bph in a prospective randomized trial.

patients with luts due to bph seen through the outpatient prostate clinic in the mansoura unc were assessed to evaluate if the patient is eligible to the study inclusion criteria. patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. study participants were enrolled and randomized, and the appropriate scheduled procedures were performed. preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (dre), prostate specific antigen (psa), urinalysis and urine culture, international index of prostate symptom score (ipss), quality of life (qol), transrectal ultrasound (trus) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (pvr), and maximum urinary flow rate (qmax). preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.

Eligibility criteria:
inclusion criteria: 1. patients' age ≥50 years 2. luts secondary to boo due to bph who failed medical treatment 3. international prostate symptom scores (ipss) \>15 and bother score (qol) ≥ 3 (according to ipss question 8) 4. peak urinary flow rate (qmax) \<15 ml/sec with at least 125 ml voided volume or patients with acute urine retention secondary to bph who failed trial of voiding on medical treatment. 5. asa (american society of anaesthesiologists) score ≤3. 6. trus prostate size (from 30 to 80ml) exclusion criteria: 1. patient with neurological disorder which might affect bladder function as cerebrovascular stroke, parkinson disease 2. active urinary tract infection, 3. presence of active bladder cancer (within the last 2 years) 4. known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and trus imaging followed by prostate biopsies if necessary.

Keywords: laser prostate bipolar hyperplasia vaporization
valproate response in aggressive autistic adolescents

Conditions: Autism

Summary: this study will examine the effect of valproate, a medication used to treat seizures and bipolar disorder, on aggressive behavior in children and adolescents with autism.

autism is a complex biological disorder that generally lasts throughout a person's life. it starts before age three and causes delays or problems with many different ways in which a person develops or grows. some people with autism become very aggressive and can hurt others or themselves. this study will test the hypothesis that aggressive autistic adolescents will show a significantly greater response to valproate maintained at blood levels of 75-100 mcg/ml than to placebo. the study will also assess the safety of valproate in autistic adolescents. this represents the first double-blind study of valproate in mentally retarded/developmentally delayed populations. participants in this study will undergo dsm-iv evaluation, the autism diagnostic interview-revised and autism diagnostic observation schedule, and baseline blood tests. after baseline screening, all participants will be given a placebo for 1 week. participants will then be randomized to receive either valproate or placebo for 8 weeks. dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind. the aberrant behavior check-list-community (abc-c) irritability subscale will be the primary measure; the overt aggression scale (oas), abc-c hyperactivity subscale, clinical global impressions (cgi) problem severity, self-injurious behavior questionnaire (sib-q), and a valproate side effects checklist will be secondary measures.

Eligibility criteria:
inclusion criteria * autism * lives in the kansas city area exclusion criteria * psychoactive maintenance medication * degenerative central nervous system disorder * unstable medical illness * seizures in the 6 months prior to study entry * history of valproate sensitivity or previous liver disease * history of ovarian cysts * low platelet count or raised liver transaminases

Keywords: adolescents
comparison of calcium silicate-based sealer and epoxy resin-based sealer

Conditions: Pulpitis - Irreversible; Pain, Postoperative

Summary: background: sealers have been concerned with obturation. however, studies for assessing the effectiveness of endodontic treatment of sealer based on calcium silicate have been not much. objective: this study aimed to assess the effectiveness of endodontic treatment of sealer based on calcium silicate methods: a prospective, single-blind, clinical trial was conducted from june 2020 to december 2020 with 42 irreversible pulpitis teeth by one clinician. the postoperative pain was assessed after root canal treatment using sealer based on calcium silicate and sealer based on epoxy resin after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days and inconvenient symptoms were assessed after 7 days, 3 months and 6 months. t-test, mann-whitney and wilcoxon analysis were applied. key words: obturation, sealer based on calcium silicate and sealer based on epoxy resin


Eligibility criteria:
inclusion criteria: * aged 18 years or older * teeth diagnosed with irreversible pulpitis by electrical and thermal tests (+) * had clinical symptoms like continuous or spontaneous pain, teeth exposed to sudden temperature changes, especially cold stimuli, causing sharp pain and persisting after stimulus removal * these teeth must have healthy periodontal tissue and sufficient clinical teeth crown for isolation with a rubber dam exclusion criteria: patients with: * pregnant * have a systemic disease requiring antibiotics or have an allergic reaction * have maxillofacial pathology, cellulitis, occlusal trauma, and temporomandibular disorders, have endodontic periodontal lesions, periodontal abscesses * have taken a previous pain reliever within 24 hours tooth: * roots internally or externally resorbed, cracked or broken * have had failed endodontic treatment, or the root canal cannot be controlled for leakage * no opposing teeth

Keywords: calcium silicate-based sealer epoxy resin-based sealer